Revlimid

Generic Name: lenalidomide (Oral route)

len-a-LID-oh-mide

Oral route(Capsule)

Lenalidomide may cause human birth defects, hematological toxicity (neutropenia and thrombocytopenia), deep vein thrombosis (DVT), and pulmonary embolism (PE). Lenalidomide is an analogue of thalidomide, a known human teratogen that causes severe life-threatening human birth defects. If taken during pregnancy, lenalidomide may cause birth defects or death to an unborn baby. Avoid pregnancy due to potential toxicity and to avoid fetal exposure. Lenalidomide is only available under a special restricted distribution program called RevAssist(R). Lenalidomide is associated with significant neutropenia and thrombocytopenia in patients with del 5q myelodysplastic syndromes. CBC should be monitored weekly for the first 8 weeks of therapy and at least monthly thereafter. Patients may require dose interruption and/or reduction and the use of blood product support and/or growth factors. There is an increased risk of DVT and PE in patients with multiple myeloma who receive lenalidomide. Observe patients for signs and symptoms of thromboembolism .

Commonly used brand name(s)

In the U.S.

• Revlimid

Available Dosage Forms:

• Capsule

Therapeutic Class: Immune Modulator

Uses For Revlimid

Lenalidomide is used to treat anemia (low red blood cells) in patients with a certain type of myelodysplastic syndrome (MDS) called 5q MDS. Patients with this type of MDS may have very low red blood cell counts and require blood transfusions.

Lenalidomide is also used in combination with dexamathasone to treat multiple myeloma (plasma cell cancer) in patients who have received at least one prior therapy.

This medicine is available only under a special restricted distribution program called RevAssist® program.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, lenalidomide is used in certain patients with the following medical condition:

• Multiple myeloma, first-line treatment, in combination with dexamethasone (treatment of bone marrow cancer; used together with dexamethasone).

Before Using Revlimid

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of lenalidomide in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of lenalidomide in the elderly.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	X	Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Digoxin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Neutropenia (low white blood cells) or


• Thrombocytopenia (low platelets)—Use with caution. May make these conditions worse.

• Infection—May decrease your ability to fight infections.

• Kidney disease, severe—May increase the amount of lenalidomide in your body and increase the risk of side effects.

• Liver disease—Use caution as studies have not been done.

• Multiple myeloma—May increase your risk for serious side effects.

Proper Use of Revlimid

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Also, do not stop taking this medicine without checking with your doctor first.

It is very important that you understand the requirements of the RevAssist® program, and become familiar with the RevAssist® educational materials and Patient Medication Guide. Direct any questions to your doctor or pharmacist before starting lenalidomide therapy. .

You should take the necessary precautions to avoid pregnancy while taking lenalidomide. Use one highly effective form of birth control plus an additional effective form of birth control at the same time, if abstinence is not the chosen method. Begin this 4 weeks before starting lenalidomide and continue it for 4 weeks after stopping the medication.

There is a telephone survey and patient registry that you must participate in while taking lenalidomide. Ask your doctor or pharmacist if you have any questions about what you need to do.

Swallow the capsule whole, do not break, chew, or open it.

It is important that you have blood tests at regular intervals. Keep all appointments with your doctor for the tests.

It is important that you have pregnancy tests at regular intervals.

Male patients, even those who have had a vasectomy, must use a latex condom during sexual contact with a female patient.

Male patients: Do not donate semen or sperm while taking lenalidomide.

Do not donate blood while taking lenalidomide.

You should not share this medication with anyone, even if someone else has similar symptoms.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  
  • For anemia in patients with myelodysplastic syndrome:
    
    • Adults—10 milligrams (mg) once a day, taken with water. Your doctor may adjust your dose if needed.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For multiple myeloma:
    
    • Adults—25 milligrams (mg) once a day, taken with water. This medicine may be taken together with dexamethasone. Your doctor may adjust your dose as needed.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Revlimid

It is very important that your doctor check your progress closely while you are using this medicine to see if it is working properly and to allow for a change in the dose. Blood tests may be needed to check for any unwanted effects.

Your doctor will want to see you every 4 weeks for pregnancy tests if you have a regular menstrual cycle, and every 2 weeks if you have an irregular cycle.

Call your doctor or 1-888-688-2528 for emergency contraception information if you think you are pregnant or, for males, if you think that your sexual partner may be pregnant.

Seek medical attention if you develop any shortness of breath, chest pain, or arm or leg swelling.

Do not breastfeed while you are using this medicine.

This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin; red skin lesions; severe acne or skin rash; sores or ulcers on the skin; or fever or chills while you are using this medicine.

Lenalidomide may cause a serious type of reaction called tumor lysis syndrome. Your doctor may give you a medicine to help prevent this. Call your doctor right away if you have a decrease or change in urine amount; joint pain, stiffness, or swelling; lower back, side, or stomach pain; a rapid weight gain; swelling of the feet or lower legs; or unusual tiredness or weakness.

Revlimid Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Black, tarry stools


• bleeding gums


• blood in the urine or stools


• chest pain


• chills


• convulsions


• cough


• decreased urine


• difficult or labored breathing


• dry mouth


• fever


• increased thirst


• irregular heartbeat


• loss of appetite


• lower back or side pain


• mood changes


• muscle pain or cramps


• nausea or vomiting


• numbness or tingling in the hands, feet, or lips


• painful or difficult urination


• pale skin


• pinpoint red spots on the skin


• shortness of breath


• sore throat


• sores, ulcers, or white spots on the lips or in the mouth


• swollen glands


• tightness in the chest


• unusual bleeding or bruising


• unusual tiredness or weakness


• wheezing

Incidence not known

• Anxiety


• dizziness or lightheadedness


• fainting


• fast heartbeat


• pain, redness, or swelling in the arm or leg


• sudden shortness of breath or troubled breathing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Abnormal or decreased touch sensation


• back pain


• bloody nose


• blurred vision


• body aches or pain


• bruising


• burning while urinating


• burning, numbness, tingling, or painful sensations


• change in taste


• constipation


• contusion


• cough-producing mucus


• depressed mood


• diarrhea


• difficulty having a bowel movement (stool)


• difficulty with moving


• discouragement


• drowsiness


• dry skin and hair


• dryness or soreness of the throat


• ear congestion


• fast, slow, irregular, pounding, or racing heartbeat or pulse


• feeling sad or empty


• feeling unusually cold


• flushing, redness of the skin


• hair loss


• headache


• hoarseness or husky voice


• irritability


• itching skin


• itching, pain, redness, swelling, tenderness, or warmth on the skin


• lack or loss of strength


• large, flat, blue or purplish patches in the skin


• loose stools


• loss of appetite


• loss of interest or pleasure


• loss of taste


• loss of voice


• muscle aching


• muscle spasms, stiffness, or twitching


• nasal congestion


• nervousness


• night sweats


• pain


• pain in the arms or legs


• pain in joints


• pain or tenderness around the eyes and cheekbones


• pounding in the ears


• rash


• runny nose


• seizures


• shivering


• sleeplessness


• sneezing


• stomach pain


• stuffy or runny nose


• sweating increased


• swelling of the hands, ankles, feet, or lower legs


• swollen joints


• tender, swollen glands in the neck


• tiredness


• trembling


• trouble with concentrating


• trouble with sleeping


• trouble with swallowing


• troubled breathing with exertion


• unable to sleep


• unsteadiness or awkwardness


• unusually warm skin


• upper abdomen or stomach pain


• voice changes


• vomiting


• weakness in the arms, hands, legs, or feet


• weight gain


• weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Revlimid side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Revlimid resources

• Revlimid Side Effects (in more detail)
• Revlimid Use in Pregnancy & Breastfeeding
• Revlimid Drug Interactions
• Revlimid Support Group
• 1 Review for Revlimid - Add your own review/rating

• Revlimid Prescribing Information (FDA)


• Revlimid Consumer Overview


• Revlimid Monograph (AHFS DI)


• Revlimid MedFacts Consumer Leaflet (Wolters Kluwer)


• Lenalidomide Professional Patient Advice (Wolters Kluwer)

Compare Revlimid with other medications

• Anemia
• Multiple Myeloma

Rezamid

Generic Name: sulfur topical (SULL fur)

Brand Names: Acnotex, Fostril, Liquimat Light, Liquimat Medium, Rezamid, Sulfo-Lo, Sulfoam, Sulforcin, Sulmasque, Sulpho-Lac, Sulpho-Lac Soap

What is Rezamid (sulfur topical)?

Topical sulfur causes drying and peeling of the skin. This allows excess oil and dirt to be easily washed away.

Sulfur topical is used to treat acne.

Sulfur topical may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Rezamid (sulfur topical)?

Do not use sulfur on sunburned, windburned, dry, chapped, or irritated skin or on open wounds.

Avoid abrasive, harsh, or drying soaps and cleansers while using sulfur topical.

Who should not use Rezamid (sulfur topical)?

Do not use sulfur topical on sunburned, windburned, dry, chapped, or irritated skin. It could make these conditions much worse. Also avoid using sulfur topical on wounds or on areas of eczema. Wait until these conditions have healed before using this medication.

Do not use sulfur topical during treatment with other topical acne products unless otherwise directed with your doctor. The combination could lead to severe skin irritation.

It is not known whether sulfur topical will harm an unborn baby. Do not use sulfur topical without first talking to your doctor if you are pregnant. It is also not known whether sulfur passes into breast milk. Do not use sulfur topical without first talking to your doctor if you are breast-feeding a baby.

How should I use Rezamid (sulfur topical)?

Use sulfur topical exactly as directed by your doctor, or follow the instructions that accompany the package. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Wash your hands before and after applying this medication.

Shake lotions well before using them. Clean and dry the area to which you will apply sulfur topical. Apply the medication to the affected area. When applying sulfur topical, avoid your eyes, the inside of your nose and mouth, your lips, and areas where the skin is broken to prevent excessive irritation. If you get medication in any of these areas, rinse it off with water.

Do not cover the affected area after applying sulfur topical, unless otherwise directed by your doctor. Doing so could cause too much medicine to be absorbed by your body and could be harmful.

Sulfur topical is usually applied one to three times daily.

It may take several weeks or more to see the effects of this drug. Do not stop using sulfur topical if you do not see results immediately.

Apply sulfur topical less often if you experience excessive burning, dryness, or irritation.

Store sulfur topical at room temperature away from moisture and heat.

What happens if I miss a dose?

Apply the missed dose as soon as you remember. However, if it is almost time for your next dose, skip the dose you missed and apply only your next regularly scheduled dose.

What happens if I overdose?

An overdose of sulfur topical is unlikely to occur. If you do suspect an overdose, or if sulfur topical has been ingested, call a poison control center or emergency room for advice.

What should I avoid while using Rezamid (sulfur topical)?

Do not use sulfur topical on sunburned, windburned, dry, chapped, or irritated skin or on open wounds.

Avoid using other topical products on the same area unless otherwise directed to do so by your doctor. They may interfere with the effects or absorption of sulfur topical.

Do not cover the area after applying sulfur topical, unless otherwise directed by your doctor. Doing so could cause too much medicine to be absorbed by your body and could be harmful.

Avoid using harsh, abrasive or irritating cleansers, perfumes or cosmetics on the area you are treating.

Rezamid (sulfur topical) side effects

Serious side effects are not likely to occur. Stop using sulfur topical and seek emergency medical attention if you experience an allergic reaction (shortness of breath; closing of your throat; swelling of your lips, face, or tongue; or hives).

You may experience some burning, stinging, tingling, itching, redness, dryness, peeling, or irritation while you are using sulfur topical. If these side effects are excessive, apply sulfur topical less often.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Rezamid (sulfur topical)?

Do not use other topical preparations unless directed to do so by your doctor. They may interfere with your treatment or increase irritation to your skin.

Avoid using harsh, abrasive or irritating cleansers, perfumes, or cosmetics on the area you are treating.

Drugs other than those listed here may also interact with sulfur topical. Talk to your doctor and pharmacist before taking any prescription or over the counter medicines.

More Rezamid resources

• Rezamid Side Effects (in more detail)
• Rezamid Use in Pregnancy & Breastfeeding
• Rezamid Drug Interactions
• Rezamid Support Group
• 0 Reviews for Rezamid - Add your own review/rating

• Sulfo-Lo Topical Advanced Consumer (Micromedex) - Includes Dosage Information

Compare Rezamid with other medications

• Acne

Where can I get more information?

• Your pharmacist has additional information about sulfur topical written for health professionals that you may read.

See also: Rezamid side effects (in more detail)

Rho(D) Immune Globulin

Class: Serums
ATC Class: J06BB01
VA Class: IM500
Brands: HyperRHO S/D, MICRhoGAM, RhoGAM, Rhophylac, WinRho SDF

Special Alerts:

[Posted 03/10/2010] Cangene, Baxter and FDA notified healthcare professionals that cases of intravascular hemolysis (IVH) and its complications, including fatalities, have been reported in patients treated for immune thrombocytopenic purpura (ITP) with Rh_o(D) Immune Globulin IV -[Human] (WinRho SDF). IVH can lead to clinically compromising anemia and multi-system organ failure including acute respiratory distress syndrome. Serious complications including severe anemia, acute renal insufficiency, renal failure and disseminated intravascular coagulation have also been reported. Fatal outcomes associated with IVH and its complications have occurred most frequently in patients of advanced age (age over 65) with co-morbid conditions.

The Boxed Warning informs healthcare professionals that:

• 
  

  Patients should be closely monitored in a health care setting for at least eight hours after administration.

  
  


• 
  

  A dipstick urinalysis should be performed at baseline, 2 hours, 4 hours after administration and prior to the end of the monitoring period.

  
  


• 
  

  Patients should be alerted to and monitor for signs and symptoms of IVH, including back pain, shaking chills, fever, and discolored urine or hematuria. Absence of these signs and/or symptoms of IVH within eight hours do not indicate IVH cannot occur subsequently.

  
  


• 
  

  If signs and/or symptoms of IVH are present or if IVH is suspected after Rh_o(D) Immune Globulin IV -[Human] administration, post-treatment laboratory tests should be performed including plasma hemoglobin, urinalysis, haptoglobin, LDH and plasma bilirubin (direct and indirect).

  
  

For more information visit the FDA website at: and .

Introduction

Specific immune globulin.^{1 14 15 16 23 25} Rh_o(D) immune globulin (Rh_o(D) IG) contains anti-Rh_o(D) antibody to RBC antigen Rh_o(D) prepared from plasma of Rh_o(D)-negative donors immunized with Rh_o(D)-positive RBCs.^{1 14 15 16 23 f m}

Uses for Rho(D) Immune Globulin

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Suppression of Rh Isoimmunization

Used to suppress the active antibody response and formation of anti-Rh_o(D) antibodies (i.e., isoimmunization) in Rh_o(D)-negative women who have been exposed to Rh_o(D)-positive blood as the result of pregnancy, other obstetric conditions, or transfusion of Rh_o(D)-positive blood or blood components to decrease the likelihood of hemolytic disease of the newborn (erythroblastosis fetalis) in the present or a future pregnancy.^{14 15 16 25 b j}

Rh isoimmunization can occur if sufficient number of RBCs from an Rh_o(D)-positive fetus gain access to its Rh_o(D)-negative mother's circulation.^{j n} Fetomaternal hemorrhage of sufficient magnitude to cause Rh isoimmunization occurs most commonly at delivery.^{j n} Spontaneous antenatal fetomaternal hemorrhage also can result in Rh isoimmunization; most of these hemorrhages occur in the third trimester.^{j n} Certain clinical events (e.g., abortion, threatened abortion, ectopic pregnancy) and procedures (e.g., amniocentesis, chorionic villus sampling, external cephalic version) may lead to fetomaternal hemorrhage and maternal Rh isoimmunization.^{j n}

American College of Obstetricians and Gynecologists (ACOG) recommends that Rh_o(D)-negative women who have not been sensitized to Rh_o(D) antigen receive Rh_o(D) IG at approximately 28 weeks of gestation (unless father of the baby is Rh_o(D)-negative), after delivery of an Rh_o(D)-positive infant, after a first-trimester pregnancy loss, and after invasive procedures (e.g., amniocentesis, chorionic villus sampling).ⁿ Consider Rh_o(D) IG in women with threatened abortion, second- or third-trimester antenatal bleeding, abdominal trauma, and in those undergoing external cephalic version.ⁿ

Used to suppress the active antibody response and formation of anti-Rh_o(D) antibodies (i.e., isoimmunization) in Rh_o(D)-negative female children and women following transfusion of Rh_o(D)-positive blood or blood components containing Rh_o(D)-positive RBCs provided the transfused Rh_o(D)-positive blood represents <20% of the total circulating RBCs.^{b c e f} Consider exchange transfusion prior to administration of Rh_o(D) IG if the transfused Rh_o(D)-positive blood represents >20% of the total circulating RBCs.^f

Passively acquired anti-Rh_o(D) antibodies usually are undetectable 6 months after administration of Rh_o(D) IG; administration of the IG after one pregnancy or transfusion does not suppress formation of anti-Rh_o(D) following a subsequent exposure to Rh_o(D)-positive blood.^a

Idiopathic Thrombocytopenic Purpura (ITP)

Rh_o(D) IGIV is used to increase platelet counts and to prevent excessive hemorrhage in adults with chronic ITP, children with acute or chronic ITP, and adults and children with ITP secondary to HIV infection^{1 2 3 4 5 6 7 8 9 10 11 12 13} (designated an orphan drug by FDA for this use).¹²

In patients in whom a response to Rh_o(D) IGIV is obtained, the rise in platelet count is generally rapid (1–3 days) and transient (usually lasting about 1 month).^{b f}

Efficacy established only in nonsplenectomized, Rh_o(D)-positive adults and children;^{1 2 3 4 5 7 f} safety and efficacy for the treatment of ITP in other patient groups (i.e., Rh_o[D]-negative individuals, splenectomized individuals) or for the treatment of patients with thrombocytopenia not related to ITP not established.^{1 2 3 7 f}

Rho(D) Immune Globulin Dosage and Administration

Administration

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Administer Rh_o(D) IGIM (HyperRHO, MICRhoGAM, RhoGAM) by IM injection; do not administer IV.^{c d e}

Administer Rh_o(D) IGIV (Rhophylac, WinRho SDF) by IM or IV injection.^{b f}

Rh_o(D) IG may be administered IM or IV for suppression of Rh isoimmunization.^{b c d e f}

Rh_o(D) IG must be administered IV for the treatment of ITP.^{b f}

Monitor patient for at least 20 minutes after administration.^e

IM Administration

HyperRHO, MICRhoGAM, RhoGAM, Rhophylac, WinRho SDF: Administer by IM injection for suppression of Rh isoimmunization.^{b c d e f}

Administer preferably into the deltoid muscle of the upper arm or anterolateral aspects of the upper thigh.^{14 15 b} Avoid the central gluteal region because of the risk of injury to the sciatic nerve; if the gluteal region is used, use only the upper outer quadrant of the gluteal muscle.^{14 15 b}

When dose is >5 mL, divide and inject into several muscle sites to reduce local discomfort.^f

Allow drug to reach room temperature before administration.^f

Rh_o(D) IG is administered to the mother; do not administer to the infant.^{b c e f}

IV Administration

Rhophylac and WinRho SDF: Administer by IV injection for the treatment of ITP.^{b f} May be administered by IV injection for suppression of Rh isoimmunization.^{b f}

When used for suppression of Rh isoimmunization, Rh_o(D) IG is administered to the mother; do not administer to the infant.^{b f}

Allow drug to reach room temperature before administration.^f

Do not mix with other drugs.^b

Rate of Administration

Rhophylac: 2 mL per 15–60 seconds.^f

WinRho SDF: Administer over 3–5 minutes.¹

Dosage

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Potency of Rh_o(D) IG is expressed in terms of international units (IU, units); potency established relative to the US, WHO, and European Pharmacopoeia Anti-D Reference Standard.^{1 25 e f}

Dose previously expressed in mcg; 1 mcg equals 5 units.^b

A single 1500-unit (300-mcg) dose of Rh_o(D) IG contains enough anti-Rh _o(D) to suppress the immunization potential of 15 mL of Rh_o(D)-positive RBCs.^{14 16} A single 250-unit (50-mcg) dose of Rh_o(D) IG contains enough anti-Rh_o(D) to suppress the immunization potential of 2.5 mL of Rh_o(D)-positive RBCs.^{15 16}

Pediatric Patients

Idiopathic Thrombocytopenic Purpura (ITP)

Confirm that the patient is Rh_o(D)-positive prior to initiating therapy.^b

Individualize the dosage based on clinical status (i.e., platelet count, RBC count, hemoglobin, reticulocyte count).¹

IV

Rhophylac: 250 units/kg (50 mcg/kg).^f For information on use of this agent in patients with anemia, see Hematologic Effects under Cautions.

WinRho SDF: Initially, 250 units/kg (50 mcg/kg) as a single injection or in 2 divided doses given on separate days.¹ For patients with hemoglobin <10 g/dL, reduce dose to 125–200 units/kg (25–40 mcg/kg) to minimize the risk of increasing the severity of anemia.¹ If subsequent therapy needed in patients with adequate response to the initial dose, maintenance dose is 125–300 units/kg (25–60 mcg/kg).¹ For patients with an inadequate response to the initial dose, subsequent dose is based on hemoglobin.¹ If hemoglobin is >10 g/dL, maintenance dose is 250–300 units/kg (50–60 mcg/kg); if hemoglobin is 8–10 g/dL, maintenance dose is 125–200 units/kg (25–40 mcg/kg).¹ (See Hematologic Effects under Cautions.)

Adults

Suppression of Rh Isoimmunization

Rh_o(D) IG is used in unsensitized Rh_o(D)-negative women.^{b c d e f} Prior to administration, determine whether recipient has been sensitized to Rh_o(D) antigens.^j

Routine Antepartum Prophylaxis

IM

HyperRHO S/D Full Dose, RhoGAM: 1500 units (300 mcg) at about 28 weeks gestation.^{14 16}

IM or IV

WinRho SDF, Rhophylac: 1500 units (300 mcg) at about 28 weeks gestation.^{1 25}

Full-term Delivery (Postpartum)

Dosage depends on the magnitude of fetomaternal hemorrhage.^{14 16 b f} Additional doses needed whenever a large fetal-maternal hemorrhage occurs during delivery.^{14 16 b e}

IM

HyperRHO S/D Full Dose, RhoGAM: 1500 units (300 mcg) as soon as possible after delivery of an Rh_o(D)-positive infant, usually no later than 72 hours after delivery.^{14 16} Withhold postpartum dose if women received a dose in the preceding 3 weeks provided the women was not exposed to >15 mL of RBCs.^e

If a large fetal-maternal hemorrhage (>15 mL RBCs) occurs, additional doses needed based on the extent of hemorrhage.^{14 e} For HyperRHO S/D Full Dose, use an appropriate laboratory procedure to estimate the number of fetal Rh-positive RBC in maternal circulation and to calculate the RBC volume of the hemorrhage.¹⁴ Determine the number of HyperRHO Full Dose prefilled syringes (each syringe contains 1500 units [300 mcg]) needed by dividing the RBC volume of the hemorrhage by 15; if the calculated dose results in a fraction of a prefilled syringe, administer the next whole number of syringes.^c

May be less effective if administered >72 hours after delivery.^{14 16 e}

IM or IV

Rhophylac: 1500 units (300 mcg) within 72 hours of delivery of an Rh_o(D)-positive infant.^{25 f} If a large fetal-maternal hemorrhage (>15 mL RBCs) occurs or is suspected, give an additional 100 units (20 mcg) per mL of fetal RBCs >15 mL if bleeding is quantified; if excess transplacental bleeding cannot be quantified, give an additional 1500 units (300 mcg) dose.^f

WinRho SDF: 600 units (120 mcg) as soon as possible after delivery of an Rh_o(D)-positive infant, usually no later than 72 hours after delivery.¹ Administer even if the Rh status of the infant is not known at 72 hours.¹ If >72 hours have elapsed, administer as soon as possible up to 28 days after delivery.¹ In the event of massive fetal hemorrhage, additional doses of WinRho SDF are administered using the dosage recommended for transfusion of Rh_o(D)-positive blood or blood products.^b (See Transfusion of Blood or Blood Products under Dosage and Administration.)

May be less effective if administered >72 hours after delivery.^{14 16 f}

Termination of Pregnancy

IM

HyperRHO S/D Mini-Dose, MICRhoGAM: 250 units (50 mcg) as soon as possible (preferably within 3 hours, usually no later than 72 hours) after a spontaneous or induced abortion occurring in a pregnancy up to and including 12 weeks of gestation.^{d e}

HyperRHO S/D Full Dose, RhoGAM: 1500 units (300 mcg) within 72 hours of a spontaneous or induced abortion or ruptured tubal pregnancy in a pregnancy beyond 12 weeks of gestation.^{14 16}

IM or IV

Rhophylac: 1500 units (300 mcg) within 72 hours of a miscarriage, abortion, ectopic pregnancy, or hydatidiform mole.^f

WinRho SDF: 600 units (120 mcg) within 72 hours of an abortion.¹

Other Obstetric Procedures or Complications During Pregnancy

IM

HyperRHO S/D Full Dose, RhoGAM: 1500 units (300 mcg) within 72 hours of amniocentesis, percutaneous umbilical blood sampling, chorionic villus sampling, abdominal trauma, obstetric manipulation, or threatened pregnancy loss in a pregnancy beyond 12 weeks gestation.^{14 e}

If Rh_o(D) IG is administered early in the pregnancy, essential to give additional doses every 12 weeks to maintain adequate titers of anti-Rh_o(D).^{14 16} If delivery occurs within 3 weeks after an antepartum dose, withhold the postpartum dose (unless mother was exposed to >15 mL of RBCs).^{14 16}

IM or IV

Rhophylac: 1500 units (300 mcg) within 72 hours of amniocentesis, chorionic villus sampling, abdominal trauma, obstetric manipulation, transplacental hemorrhage, or threatened pregnancy loss.^f

WinRho SDF: 1500 units (300 mcg) immediately after amniocentesis or chorionic villus sampling in a pregnancy up to 34 weeks gestation; 600 units (120 mcg) within 72 hours of amniocentesis or other obstetrical manipulation in a pregnancy beyond 34 weeks gestation.^b

If Rh_o(D) IG is administered early in the pregnancy, essential to give additional doses every 12 weeks to maintain adequate titers of anti-Rh_o(D).^{b e} If delivery occurs within 3 weeks after an antepartum dose, withhold the postpartum dose (unless mother was exposed to >15 mL of RBCs).^{14 16}

Transfusion of Blood or Blood Products

Dosage depends on volume of blood products transfused.^{b c e f}

IM

HyperRHO S/D Full Dose: Calculate the volume of RBCs transfused by multiplying the volume of Rh_o(D)-positive whole blood administered by the hematocrit of the donor.¹⁴ Determine the number of HyperRHO S/D Full Dose prefilled syringes (each syringe contains 1500 units [300 mcg]) needed by dividing the RBC volume transfused by 15; if the calculated dose results in a fraction of a prefilled syringe, administer the next whole number of syringes.^c Ensure that the total dose is administered within 72 hours.¹⁴

MICRhoGAM: 250 units (50 mcg) within 72 hours of exposure to <2.5 mL of Rh-positive RBCs.^e

RhoGAM: 1500 units (300 mcg) within 72 hours of exposure to 2.5–15 mL of Rh-positive RBCs.^e Additional dose(s) needed for exposure to >15 mL of Rh-positive RBCs; administer 20 mcg per mL of RBCs.^e Ensure that the total dose is administered within 72 hours.^e

WinRho SDF: 6000 units (1200 mcg) every 12 hours until total dose given.^b Recommended dose is 60 units (12 mcg) per mL of Rh-positive blood or 120 units (24 mcg) per mL of Rh-positive RBCs.^b

IM or IV

Rhophylac: 100 units (20 mcg) per 2 mL of Rh-positive blood or per 1 mL of Rh-positive erythrocyte concentrate.²⁵ Administer within 72 hours of exposure.^f

IV

WinRho SDF: 3000 units (600 mcg) every 8 hours until total dose given.^b Recommended dose is 45 units (9 mcg) per mL of Rh-positive blood or 90 units (18 mcg) per mL of Rh-positive RBCs.^b

Idiopathic Thrombocytopenic Purpura (ITP)

Confirm that the patient is Rh_o(D)-positive prior to initiating therapy.^b

Individualize the dosage based on clinical status (i.e., platelet count, RBC count, hemoglobin, reticulocyte count).¹

IV

Rhophylac: 250 units/kg (50 mcg/kg).^f For information on use of this agent in patients with anemia, see Hematologic Effects under Cautions.

WinRho SDF: Initially, 250 units/kg (50 mcg/kg) as a single injection or in 2 divided doses given on separate days.¹ For patients with hemoglobin <10 g/dL, reduce dose to 125–200 units/kg (25–40 mcg/kg) to minimize the risk of increasing the severity of anemia.¹ If subsequent therapy needed in patients with adequate response to the initial dose, maintenance dose is 125–300 units/kg (25–60 mcg/kg).¹ For patients with an inadequate response to the initial dose, subsequent dose is based on hemoglobin.¹ If hemoglobin >10 g/dL, maintenance dose is 250–300 units/kg (50–60 mcg/kg); if hemoglobin is 8–10 g/dL, maintenance dose is 125–200 units/kg (25–40 mcg/kg).¹ (See Hematologic Effects under Cautions.)

Special Populations

Hepatic Impairment

No specific dosage recommendations.^{b c d e f}

Renal Impairment

No specific dosage recommendations.^{b c d e f}

Cautions for Rho(D) Immune Globulin

Contraindications

• 
  

  History of anaphylactic or severe systemic reactions to immune globulins.^{1 f 16 25}

  
  


• 
  

  When used for the suppression of Rh isoimmunization, do not administer to the infant.^b

  
  


• 
  

  MICRhoGAM, RhoGAM: Rh-positive individuals.^e

  
  


• 
  

  IgA deficiency.^b (See Selective IgA Deficiency under Cautions.)

  
  

Warnings/Precautions

Warnings

Hematologic Effects

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Intravascular hemolysis, including some fatalities, reported in patients receiving Rh_o(D) IGIV for ITP.^{1 26 f} Serious complications of intravascular hemolysis (e.g., acute onset or exacerbation of anemia, acute onset or exacerbation of renal insufficiency, disseminated intravascular coagulation) have occurred.^{1 26 f} Monitor for signs and symptoms of intravascular hemolysis (e.g., back pain, shaking chills, fever, discolored urine), clinically compromising anemia, acute renal insufficiency, disseminated intravascular coagulation and, if necessary, perform confirmatory laboratory tests.^{1 26 e f} If transfusion needed, use Rh_o(D)-negative packed red blood cells (PRBCs) to avoid exacerbation of the ongoing hemolysis.^{b f}

Administration of Rh_o(D) IGIV to Rh_o(D)-positive individuals for the treatment of ITP expected to result in Rh_o(D)-positive RBC destruction and a decrease in hemoglobin concentration.^{1 2 3 4 5 6 7 8 10 13 f}

WinRho SDF: When used for the treatment of ITP, reduce dose in individuals with hemoglobulin <10 g/dL.^b Extreme caution advised in individuals with hemoglobulin <8 g/dL.^b (See Idiopathic Thrombocytopenic Purpura (ITP) under Dosage and Administration.)

Rhophylac: Safety in the treatment of ITP not established in patients with preexisting anemia.^f Weigh potential benefits against the risk of increasing the severity of anemia.^f

Bleeding may occur following IM administration in individuals with thrombocytopenia or other bleeding disorders.^{c d}

Risk of Transmissible Agents in Plasma-derived Preparations

Because Rh_o(D) IG is prepared from pooled human plasma, it is a potential vehicle for transmission of human viruses, including the causative agents of viral hepatitis and HIV infection, and theoretically may carry a risk of transmitting the causative agent of Creutzfeldt-Jakob disease (CJD).^{b c d e f}

Improved donor screening, viral-inactivation procedures (e.g., solvent/detergent treatment), and/or filtration procedures have reduced, but not completely eliminated, risk of pathogen transmission with plasma-derived preparations.^{b c d e f}

The manufacturing process for Rh_o(D) IG includes a solvent/detergent inactivation process and a filtering procedure to remove both enveloped and non-enveloped viruses.^{b c d e f}

Because no purification method has been shown to be totally effective in removing the risk of viral infectivity from plasma-derived preparations and because new blood-borne viruses or other disease agents may emerge that may not be inactivated by the manufacturing process or the chemical (solvent/detergent) treatment procedures currently used, Rh_o(D) IG should be administered only when a benefit is expected.^{b c d e f}

Report any infection believed to have been transmitted by Rh_o(D) IG to the manufacturer.^{b c d e f}

Blood Glucose Testing

Rh_o(D) IGIV preparations that contain maltose (WinRho SDF) may cause falsely elevated results in blood glucose determinations that use nonspecific methods based on glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ) or glucose-dye oxidoreductase.^b (See Specific Drugs and Laboratory Tests under Interactions.)

Sensitivity Reactions

Hypersensitivity

Systemic allergic reactions reported rarely.^{c d f} If signs of hypersensitivity, including generalized urticaria, tightness of the chest, wheezing, hypotension, or anaphylaxis occur, discontinue immediately^f and institute appropriate therapy (e.g., epinephrine) as indicated.^{c d}

Selective IgA Deficiency

Rh_o(D) IG preparations contain trace or small quantities of IgA.^{1 16 25 f}

Use with caution in individuals with selective IgA deficiency; these individuals may have antibodies to IgA or may develop such antibodies following administration of Rh_o(D) IG.^f Potential for severe hypersensitivity reactions (e.g., anaphylaxis) to IgA in such patients.^f

General Precautions

Renal Effects

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Renal dysfunction and/or acute renal failure reported in patients receiving IGIV.^{b i} These effects occur most frequently with IGIV preparations stabilized with sucrose.^{b i}

Rh_o(D) IGIV does not contain sucrose as a stabilizer.^{b f}

Assess renal function prior to administration of Rh_o(D) IGIV and at appropriate intervals during therapy, especially in those at risk of acute renal failure.^{b i} If renal dysfunction occurs, consider reducing the infusion rate or discontinuing the drug.^b

Specific Populations

Pregnancy

Category C.^{b c d e f}

Rhophylac: Not evaluated in pregnant women with ITP.^f

Lactation

Not distributed into milk;^a no adverse effects are expected during breast feeding.²⁵

Pediatric Use

For suppression of Rh isoimmunization related to pregnancy, do not administer Rh_o(D) IG to the infant.^{1 14 15 16 25 d f}

HyperRHO S/D Full Dose, HyperRHO S/D Mini-Dose: Safety and efficacy not established in pediatric patients.^{14 15}

Rhophylac: Safety and efficacy established for the treatment of ITP in pediatric patients.^f Safety and efficacy not established for suppression of Rh isoimmunization in pediatric patients given an incompatible transfusion.^f Weigh the potential risks against the benefits, particularly in girls whose later pregnancies may be affected if Rh isoimmunization occurs.^f

WinRho SDF: Used in children for the treatment of acute or chronic ITP or ITP secondary to HIV infection.¹

Geriatric Use

Rhophylac: When used for the treatment of ITP, no substantial differences in safety and efficacy relative to younger adults.^f Has not been evaluated for the suppression of Rh isoimmunization following incompatible transfusions in geriatric patients ≥65 years of age.^f

Common Adverse Effects

Chills, pyrexia, headache, nausea, dizziness, mild extravascular hemolysis (increased bilirubin, decreased hemoglobin).^{b c d e f}

Interactions for Rho(D) Immune Globulin

Live Vaccine

Antibodies present in immune globulin preparations may interfere with the immune response to measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live, and varicella virus vaccines live;^{b c d e f} no evidence of interference with the immune response to yellow fever virus vaccine live or typhoid vaccine live oral.^{24 k} (See Specific Drugs and Laboratory Tests under Interactions.)

Postpartum administration of Rh_o(D) IG has not been shown to reduce the response to rubella vaccine RA27/3 strain.^k Rubella and varicella immunity are important in women of childbearing potential.^k The Advisory Committee on Immunization Practices (ACIP) recommends administering the appropriate vaccine immediately after delivery in women susceptible to rubella and/or varicella; do not delay administration because the woman received antepartum or postpartum Rh_o(D) IG.^k Perform serologic tests ≥3 months after vaccination to determine if seroconversion occurred.^k

Inactivated Vaccine and Toxoids

ACIP states that administration of inactivated vaccines and toxoids simultaneously with (at different sites) or at any interval before or after administration of immune globulin preparations should not have a clinically important effect on the immune response to the vaccines or toxoids.^k

Specific Drugs and Laboratory Tests

Drug or Test	Interaction	Comments
Measles, mumps, rubella, varicella vaccine live	Antibodies in Rho(D) IG may interfere with the immune response to these live virus vaccines1 14 15 22 24 f Rubella: No evidence that Rho(D) IG interferes with immune response to the vaccinek	ACIP recommends administering the appropriate vaccine immediately after deliveryk (See Live Vaccine under Interactions.) Manufacturers recommend deferring administration of these live virus vaccines for ≥3 months following administration of Rho(D) IG1 14 15 25
Tests, antibody screening	Possible positive antibody screening test from the presence of passively acquired anti-D in the maternal blood streame f
Tests, blood glucose (based on GDH-PQQ or glucose-dye oxidoreductase)	Maltose-containing Rho(D) IG preparations (e.g., WinRho SDF): Potential for falsely elevated blood glucose test resultsb	Use test methods not affected by maltose in patients receiving maltose-containing Rho(D) IG preparations b
Tests, blood typing	May affect blood typing test results in the mother and the infante f
Tests, immunohematology (Coombs’ test)	Passively transferred blood group antibodies (e.g., anti-A, anti-B, anti-C, anti-E) may result in positive direct and indirect antiglobulin (Coombs’) test resultsb	Interpret test results in the context of the patient’s underlying clinical condition and other laboratory resultsb
Typhoid vaccine live	No evidence that Rho(D) IG interferes with immune response to the vaccinek	Vaccine may be given simultaneously with or at any interval before or after Rho(D) IGk
Yellow fever virus vaccine	No evidence that Rho(D) IG interferes with immune response to the vaccinek	Vaccine may be given simultaneously with or at any interval before or after Rho(D) IGk

Rho(D) Immune Globulin Pharmacokinetics

Absorption

Bioavailability

Following IM administration of Rh_o(D) IG, peak serum concentrations are achieved in 2–7 days.^{b f}

Following IV administration of Rh_o(D) IG, peak serum concentrations are achieved in 30 minutes.^b

Rhophylac: Bioavailability of Rh_o(D) IG administered IM is approximately 69% of Rh_o(D) IG administered IV.^f

Distribution

Extent

Not distributed into milk.^a

Elimination

Half-life

IM administration: 18–31 days.^{b e f}

IV administration: 24 days.^b

Stability

Storage

Parenteral

Injection

2–8°C.^{b c d e f} Do not freeze.^{b c d e f}

Store Rhophylac in the original carton to protect product from light.^f

ActionsActions

• 
  

  Contains anti-Rh_o(D) antibody to the RBC cell antigen Rh_o(D); used to provide temporary passive immunity in Rh_o(D)-negative individuals exposed to Rh_o-positive blood from a pregnancy (when fetus is Rh_o(D)-positive) or from an Rh_o(D)-positive blood transfusion.^{1 14 15 16}

  
  


• 
  

  Mechanism by which Rh_o(D) IG suppresses anti-Rh_o(D) not fully elucidated;^{1 14 15 16 25} anti-Rh_o(D) antibody may bind to Rh_o(D) antigen thus preventing the primary immune response to Rh_o(D) and production of anti-Rh_o(D).^a

  
  


• 
  

  Mechanism by which Rh_o(D) IG increases platelet counts in the treatment of ITP not fully elucidated;^{1 2 3 7 20 21 b} administration of Rh_o(D) IG to Rh_o(D)-positive individuals results in formation of anti-Rh_o(D)-coated RBC complexes that may saturate Fc receptors and decrease Fc-mediated phagocytosis of antibody-coated platelets.^{1 2 3 4 7 20 21}

  
  

Advice to Patients

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

• 
  

  Instruct patients being treated for ITP to read the patient information leaflet prior to each treatment.^g

  
  


• 
  

  Importance of retaining the patient identification card with the record of Rh_o(D) IG administration and of presenting this card to healthcare providers.^e

  
  


• 
  

  Instruct patients receiving Rh_o(D) IGIV for the treatment of ITP to immediately report symptoms of back pain, shaking chills, fever, discolored urine, decreased urine output, swelling, and/or shortness of breath to their clinician.^{b f g}

  
  


• 
  

  Importance of patients understanding potential risks (e.g., hypersensitivity reactions, possible transmission of infectious agents) and benefits of therapy.^{b c d e f}

  
  


• 
  

  Instruct pregnant women receiving Rh_o(D) IG at gestation week 28 of the need for a second dose at delivery if the baby’s blood type is Rh-positive.^{f h}

  
  


• 
  

  Importance of notifying clinician if signs and symptoms of a hypersensitivity reaction (i.e., generalized urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis) occur.^{16 f}

  
  


• 
  

  Advise patients with selective IgA deficiency that Rh_o(D) IG contains trace amounts of IgA and potentially could result in life-threatening allergic reactions if used in patients who have developed antibodies to IgA.^{1 16 25 f}

  
  


• 
  

  Advise patients receiving WinRho SDF that this preparation contains maltose and may cause falsely-elevated glucose readings when blood glucose monitoring systems based on GDH-PQQ or glucose-dye oxidoreductase are used; importance of using glucose-specific test methods not affected by maltose.^b

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.^{b c d e f}

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including recent vaccinations (e.g., mumps, measles, rubella, varicella) and prescription and OTC drugs, as well as any concomitant illnesses.^{b c d e f g}

  
  


• 
  

  Importance of informing patients of other important precautionary information.^{b c d e f} (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations

RhoGAM

Generic Name: RHo (D) immune globulin (ROE D im MYOON GLOB yoo lin)

Brand Names: HyperRHO S/D Full Dose, HyperRHO S/D Mini Dose, MicRhoGAM Ultra-Filtered Plus, RhoGAM Ultra-Filtered Plus, Rhophylac, WinRho SDF

What is RHo (D) immune globulin?

RHo (D) immune globulin is a sterilized solution made from human blood. Rh is a substance that most people have in their blood (Rh positive) but some people don't (Rh negative). A person who is Rh negative can be exposed to Rh positive blood through a mismatched blood transfusion or during pregnancy when the baby has the opposite blood type. When this exposure happens, the Rh negative blood will respond by making antibodies that will try to destroy the Rh positive blood cells. This can cause medical problems such as anemia (loss of red blood cells), kidney failure, or shock.

RHo (D) immune globulin is used to prevent an immune response to Rh positive blood in people with an Rh negative blood type. RHo (D) immune globulin may also be used in the treatment of immune thrombocytopenic purpura (ITP).

RHo (D) immune globulin may also be used for purposes not listed in this medication guide.

What is the most important information I should know about RHo (D) immune globulin?

You should not receive this medication if you have ever had an allergic reaction to an immune globulin or if you have immune globulin A (IgA) deficiency with antibody to IgA. You should not receive RHo (D) immune globulin if you have hemolytic anemia (a lack of red blood cells).

Before you receive this medication, tell your doctor if you have heart disease or a history of coronary artery disease, high triglycerides, a bleeding disorder, or immune globulin A (IgA) deficiency.

If you are an Rh-negative woman and you become pregnant, you must tell your doctor if you have ever been exposed to Rh-positive blood in your lifetime. This includes exposure from a mismatched blood transfusion, or exposure during your first pregnancy. Your history of exposure and treatment will be extremely important to each and every one of your pregnancies.

Call your doctor at once if you have a serious side effect such as fever, chills, shaking, back pain, dark colored urine, rapid breathing, feeling short of breath, urinating less than usual, swelling, rapid weight gain, pale skin, easy bruising or bleeding, rapid heart rate, trouble concentrating, feeling light-headed. Do not receive a "live" vaccine for at least 3 months after treatment with RHo (D) immune globulin. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), Bacillus Calmette-Guérin (BCG), oral polio, rotavirus, smallpox, typhoid, yellow fever, varicella (chickenpox), H1N1 influenza, and nasal flu vaccine.

What should I discuss with my healthcare provider before I receive RHo (D) immune globulin?

You should not receive this medication if you have ever had an allergic reaction to an immune globulin or if you have immune globulin A (IgA) deficiency with antibody to IgA. You should not receive RHo (D) immune globulin if you have hemolytic anemia (a lack of red blood cells).

To make sure you can safely receive RHo (D) immune globulin, tell your doctor if you have any of these other conditions:

• 
  

  heart disease or a history of coronary artery disease (hardened arteries);

  
  


• 
  

  high triglycerides (a type of fat in the blood);

  
  


• 
  

  a bleeding disorder (such as hemophilia); or

  
  


• 
  

  immune globulin A (IgA) deficiency.

  
  

RHo (D) immune globulin is used during and after pregnancy. This medication is not known to be harmful to a baby during pregnancy or while breast-feeding.

If you are receiving this medication to treat a mismatched blood transfusion, tell your doctor if you are pregnant or if you ever plan to become pregnant.

If you are an Rh-negative woman and you become pregnant, you must tell your doctor if you have ever been exposed to Rh-positive blood in your lifetime. This includes exposure from a mismatched blood transfusion, or exposure during your first pregnancy. Your history of exposure and treatment will be extremely important to each and every one of your pregnancies.

RHo (D) immune globulin is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

How is RHo (D) immune globulin given?

RHo (D) immune globulin is injected into a muscle or a vein. You will receive this injection in a clinic or hospital setting.

Your breathing, blood pressure, oxygen levels, and other vital signs will be watched closely for at least 8 hours after you receive immune globulin. Your urine will also need to be tested every 2 to 4 hours.

For treatment during pregnancy, this medication is usually given at regular intervals during the last half of the pregnancy, and again after the baby is born.

For treatment of a mismatched blood transfusion, the medication is given when symptoms of an immune response appear (when the body starts making Rh antibodies).

To be sure this medicine is helping your condition, your blood will need to be tested often. Your liver and kidney function may also need to be tested. Visit your doctor regularly.

This medication can cause false results with certain lab tests for glucose (sugar) in the blood. Tell any doctor who treats you that you are using RHo (D) immune globulin.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your RHo (D) immune globulin injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while receiving RHo (D) immune globulin?

Do not receive a "live" vaccine for at least 3 months after treatment with RHo (D) immune globulin. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), Bacillus Calmette-Guérin (BCG), oral polio, rotavirus, smallpox, typhoid, yellow fever, varicella (chickenpox), H1N1 influenza, and nasal flu vaccine.

RHo (D) immune globulin side effects

Get emergency medical help if you have any of these signs of an allergic reaction: rash or hives; feeling light-headed, chest tightness, difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

• 
  

  fever, chills, shaking, back pain, dark colored urine;

  
  


• 
  

  rapid breathing, feeling short of breath.

  
  


• 
  

  urinating less than usual or not at all, swelling, rapid weight gain; or

  
  


• 
  

  pale skin, easy bruising or bleeding, rapid heart rate, trouble concentrating, feeling light-headed.

  
  

Less serious side effects may include:

• 
  

  joint or muscle pain;

  
  


• 
  

  headache, dizziness;

  
  


• 
  

  feeling weak or tired;

  
  


• 
  

  mild itching or skin rash;

  
  


• 
  

  nausea, diarrhea, vomiting, stomach pain; or

  
  


• 
  

  pain or tenderness where the medicine was injected.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect RHo (D) immune globulin?

There may be other drugs that can interact with RHo (D) immune globulin. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More RhoGAM resources

• RhoGAM Side Effects (in more detail)
• RhoGAM Use in Pregnancy & Breastfeeding
• RhoGAM Drug Interactions
• RhoGAM Support Group
• 0 Reviews for RhoGAM - Add your own review/rating

• RhoGAM MedFacts Consumer Leaflet (Wolters Kluwer)


• Bayrho-D full dose


• HyperRHO S/D Full Dose Prescribing Information (FDA)


• RhoGAM Ultra-Filtered PLUS Prescribing Information (FDA)


• Rhogam Advanced Consumer (Micromedex) - Includes Dosage Information


• Rhophylac MedFacts Consumer Leaflet (Wolters Kluwer)


• Rhophylac Consumer Overview


• Rhophylac Prescribing Information (FDA)


• WinRho SDF MedFacts Consumer Leaflet (Wolters Kluwer)

Compare RhoGAM with other medications

• Idiopathic Thrombocytopenic Purpura
• Rh-Isoimmunization

Where can I get more information?

• Your doctor or pharmacist can provide more information about RHo (D) immune globulin.

See also: RhoGAM side effects (in more detail)

Revatio

Pronunciation: sil-DEN-a-fil
Generic Name: Sildenafil
Brand Name: Revatio

Revatio is used for:

Treating high blood pressure in the lungs (pulmonary arterial hypertension [PAH]). It may also be used for other conditions as determined by your doctor.

Revatio is a phosphodiesterase type 5 (PDE5) inhibitor. It works by relaxing and dilating the blood vessels in the lungs. This lowers the blood pressure in the lungs and helps to improve your ability to exercise.

Do NOT use Revatio if:

• you are allergic to any ingredient in Revatio


• you have pulmonary veno-occlusive disease (PVOD)


• you are taking nitrates (eg, isosorbide, nitroglycerin) in any form (eg, tablet, capsule, spray, patch, ointment), or nitroprusside


• you take another medicine that contains sildenafil, another PDE5 inhibitor (eg, tadalafil, vardenafil), or ritonavir


• you use certain recreational drugs called "poppers" (eg, amyl nitrate or nitrite, butyl nitrate or nitrite)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Revatio:

Some medical conditions may interact with Revatio. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a history of a prolonged (more than 4 hours) or painful erection (priapism)


• if you have a deformed penis (eg, cavernosal fibrosis, Peyronie disease), certain blood cell problems (eg, leukemia, multiple myeloma, sickle cell anemia), or any other condition that may increase the risk of a prolonged or painful erection (priapism)


• if you have a history of certain eye problems (eg, macular degeneration, optic neuropathy, retinitis pigmentosa, sudden vision loss in one or both eyes) or hearing problems (eg, ringing in the ears, decreased hearing, hearing loss)


• if you are dehydrated or have a history of liver or kidney problems, high or low blood pressure, ulcers, bleeding problems, heart problems (eg, aortic stenosis, angina, irregular heartbeat, heart failure), blood vessel problems, or nervous system problems


• if you have a history of a heart attack, a stroke, or life-threatening irregular heartbeat, especially within the past 6 months


• if you have pulmonary hypertension caused by sickle cell anemia


• if you are taking bosentan or medicine for erectile dysfunction (ED)

Some MEDICINES MAY INTERACT with Revatio. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Alpha-blockers (eg, doxazosin), medicines for high blood pressure, nitrates (eg, isosorbide, nitroglycerin), or nitroprusside because severe low blood pressure with dizziness, light-headedness, and fainting may occur


• Azole antifungals (eg, itraconazole, ketoconazole), H₂ antagonists (eg, cimetidine), HIV protease inhibitors (eg, ritonavir, saquinavir), macrolide antibiotics (eg, erythromycin), or telithromycin because they may increase the risk of Revatio's side effects


• Barbiturates (eg, phenobarbital), bosentan, carbamazepine, efavirenz, nevirapine, phenytoin, rifabutin, or rifampin because they may decrease Revatio's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Revatio may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Revatio:

Use Revatio as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Revatio. Talk to your pharmacist if you have questions about this information.


• Take Revatio by mouth with or without food. Take your doses 4 to 6 hours apart unless your doctor tells you otherwise.


• Take Revatio on a regular schedule to get the most benefit from it. Take it at the same times each day.


• Continue to take Revatio even if you feel well. Do not miss any doses.


• Do not suddenly stop taking Revatio or change your dose without talking to your doctor.


• If you miss a dose of Revatio, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Revatio.

Important safety information:

• Revatio may cause drowsiness, dizziness, fainting, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Take Revatio with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Revatio may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.


• Patients with heart problems who take Revatio may be at increased risk of heart-related side effects, including a heart attack or stroke. Symptoms of a heart attack may include chest, shoulder, neck, or jaw pain; numbness of an arm or leg; severe dizziness, headache, nausea, stomach pain, or vomiting; fainting; or vision changes. Symptoms of a stroke may include confusion, vision or speech changes, one-sided weakness, or fainting. Contact your doctor or seek medical attention right away if you experience these symptoms.


• Revatio may rarely cause a prolonged (more than 4 hours) or painful erection. This could happen even when you are not having sex. If this is not treated right away, it could lead to permanent sexual problems, such as impotence. Contact your doctor right away if you have an erection that lasts more than 4 hours.


• If vomiting or diarrhea occurs, you will need to take care not to become dehydrated. Contact your doctor for instructions.


• Revatio may uncommonly cause mild, temporary vision changes (eg, blurred vision, sensitivity to light, blue/green color tint to vision). Contact your doctor if vision changes persist or are severe.


• Rarely, an eye problem called nonarteritic anterior ischemic optic neuropathy (NAION) has been reported in patients who took Revatio. This may lead to decreased vision or a permanent loss of vision in some cases. If you notice a sudden decrease in vision or loss of vision in one or both eyes, contact your doctor right away.


• Sudden decreases in hearing and loss of hearing have been reported in some patients who have taken Revatio. Sometimes they also noticed ringing in the ears or dizziness. If you notice a sudden decrease or loss of hearing, contact your doctor right away.


• Do not use medicines or treatments for ED while you are taking Revatio without first checking with your doctor.


• Use Revatio with caution in the ELDERLY; they may be more sensitive to its effects.


• Revatio should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Revatio while you are pregnant. It is not known if Revatio is found in breast milk. If you are or will be breast-feeding while you take Revatio, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Revatio:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; dizziness; flushing; headache; muscle aches; nausea; nosebleed; numb or tingling skin; stuffy or runny nose; trouble sleeping; upset stomach.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; confusion; fainting; fast or irregular heartbeat; fever; memory loss; numbness of an arm or leg; one-sided weakness; painful or prolonged erection; ringing in the ears; seizure; severe or persistent dizziness or nosebleed; severe or persistent vision changes; shortness of breath; speech problems; sudden decrease or loss of hearing; sudden decrease or loss of vision in one or both eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Revatio side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include fainting; prolonged erection; severe dizziness.

Proper storage of Revatio:

Store Revatio at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Revatio out of the reach of children and away from pets.

General information:

• If you have any questions about Revatio, please talk with your doctor, pharmacist, or other health care provider.


• Revatio is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Revatio. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Revatio resources

• Revatio Side Effects (in more detail)
• Revatio Dosage
• Revatio Use in Pregnancy & Breastfeeding
• Drug Images
• Revatio Drug Interactions
• Revatio Support Group
• 4 Reviews for Revatio - Add your own review/rating

• Revatio Prescribing Information (FDA)


• Revatio Consumer Overview


• Revatio Advanced Consumer (Micromedex) - Includes Dosage Information


• Sildenafil Citrate Monograph (AHFS DI)


• Viagra Prescribing Information (FDA)


• Viagra Consumer Overview

Compare Revatio with other medications

• Pulmonary Arterial Hypertension