anti-D (rh) immunoglobulin

Anti-D (rh) immunoglobulin is a prescription medication used to prevent Rh immunization, also known as Rh incompatibility. This occurs when a person who has an Rh-negative blood type receives blood or blood products that are Rh-positive or when a mother who is Rh-negative is pregnant with a fetus who is Rh-positive. The immune system of an Rh-negative individual will attack Rh-positive cells.

Anti-D (rh) immunoglobulin can also be used to treat immune thrombocytopenia purpura (ITP), a bleeding disorder, in adults.

Anti-D (rh) immunoglobulin belongs to a group of drugs called immunoglobulins. These work by making the immune system work better.

This medication is available in an injectable form to be given directly into a muscle (IM) or a vein (IV) by a healthcare professional.

Anti-D (rh) immunoglobulin  can also cause dizziness. Do not drive or operate heavy machinery until you know how this medication affects you.

Anti-D (rh) immunoglobulin is a prescription medication used to prevent Rh immunization, also known as Rh incompatibility.

Anti-D (rh) immunoglobulin can also be used to treat immune thrombocytopenia purpura (ITP), a bleeding disorder, in adults.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

anti-D (rh) immunoglobulin may be found in some form under the following brand names:

• BayRHo-D

• HyperRHO

• MICRhoGAM

• RhoGAM

• Rhophylac

• WinRho SDF

Serious side effects have been reported with anti-D (rh) immunoglobulin. See the “Drug Precautions” section.

The most common side effect is injection site reactions that may include swelling, induration, redness, and mild pain or warmth.

Common side effects of anti-D (rh) immunoglobulin for prevention of Rh immunization include:

• nausea
• dizziness
• headache
• injection-site pain
• malaise

Common side effects of anti-D (rh) immunoglobulin for treatment of ITP include:

• chills
• fever
• headache
• bleeding disorders

This is not a complete list of side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you require immunizations. Anti-D (rh) immunoglobulin may impair the efficacy of live vaccines such as measles, mumps, and varicella. Administration of live vaccines should generally be delayed until 12 weeks after the final dose of anti-D (rh) immunoglobulin. If aAnti-D (rh) immunoglobulin is administered within 14 days after administration of a live vaccine, the efficacy of the vaccination may be impaired. The postpartum vaccination of rubella-susceptible women with rubella or MMR vaccine should not be delayed because of the receipt of anti-D (rh) immunoglobulin.

This is not a complete list of drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with anti-D (rh) immunoglobulin  including the following:

• Intravascular hemolysis (IVH). IVH is a serious blood problem. Tell your healthcare provider right away if you have some or all of the following symptoms of IVH:
  • back pain
  • shaking chills
  • a fever
  • dark urine
  • a decreased amount of urine
  • a sudden weight gain
  • swelling of the hands or feet
  • shortness of breath
• Allergic reactions, including anaphylaxis. Tell your healthcare provider right away if you have some or all of the following symptoms of an allergic reaction:
  • itching
  • a rash
  • hives
  • chest pain
  • dizziness or lightheadedness
  • trouble breathing
  • any swelling of your hands, face, or mouth

• Blood clots. Tell your healthcare provider right away if you have some or all of the following symptoms of a blood clot:
  • chest pain
  • shortness of breath
  • a severe headache
  • leg pain
  • problems with vision, speech, or walking

Do not receive anti-D (rh) immunoglobulin if you:

• are allergic to anti-D (rh) immunoglobulin  or to any of its ingredients
• are Rh-positive

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of anti-D (rh) immunoglobulin , there are no specific foods that you must exclude from your diet when receiving this medication.

Before receiving this medication, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to anti-D (rh) immunoglobulin or to any of its ingredients
• have anemia
• have or have had blood clotting problems
• have or have had breathing problems
• have or have had kidney problems
• have or have had pulmonary edema (fluid in the lungs)
• have or have had atherosclerosis (hardening of the arteries)
• have or have had heart or blood vessel problems
• have or have had hyperviscosity (thick blood)
• have or have had a stroke
• have diabetes
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X – are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Anti-D (rh) immunoglobulin falls into category C. No studies have been done in animals, and no well-controlled studies have been done in pregnant women. Anti-D (rh) immunoglobulin  should be given to a pregnant woman only if clearly needed.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if anti-D (rh) immunoglobulin crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of receiving aAnti-D (rh) immunoglobulin.

Receive anti-D (rh) immunoglobulin exactly as prescribed.

This medication is available in an injectable form to be given directly into a muscle (IM) or a vein (IV) by a healthcare professional.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• how you respond to this medication
• your weight

Rhophylac

• The recommended dose of Rhophylac (anti-D (rh) immunoglobulin) for prevention of pregnancy-related complications is 300 micrograms IM or IV.
• The recommended dose range of Rhophylac (anti-D (rh) immunoglobulin) for prevention of Rh-incompatibility related to the receipt of blood or blood products is 20 micrograms IM or IV.
• The recommended dose range of Rhophylac (anti-D (rh) immunoglobulin) for treatment of ITP is 50 micrograms per kg body weight IV.

RhoGAM

• The recommended dose of RhoGAM (anti-D (rh) immunoglobulin) for prevention of pregnancy-related complications is 300 micrograms.
• The recommended dose range of RhoGAM (anti-D (rh) immunoglobulin) for prevention of Rh-incompatibility related to the receipt of blood or blood products is 50 to 300 micrograms, depending on the amount of exposure to Rh-positive cells.

If you inject too much anti-D (rh) immunoglobulin, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If anti-D (rh) immunoglobulin is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Carry an anti-D (rh) immunoglobulin patient identification card and present it to other healthcare providers while you are receiving this medication.

WARNING: INTRAVASCULAR HEMOLYSIS IN ITP

This warning does not apply to Rh0(D)-negative patients treated for the suppression of Rh isoimmunization.

Intravascular hemolysis leading to death has been reported in Rh0(D)-positive patients treated for immune thrombocytopenic purpura (ITP) with Rh0(D) Immune Globulin Intravenous (Human) products.

Intravascular hemolysis can lead to clinically compromising anemia and multi-system organ failure including acute respiratory distress syndrome (ARDS), acute renal insufficiency, renal failure, and disseminated intravascular coagulation (DIC) have been reported.

Monitor patients treated for signs and symptoms of hemolysis in a healthcare setting for at least 8 hours after administration. Perform a dipstick urinalysis at baseline, 2 hours and 4 hours after administration, and prior to the end of the monitoring period. Alert patients to, and monitor them for back pain, shaking chills, fever, and discolored urine or hematuria. Absence of these signs and/or symptoms within 8 hours does not indicate IVH cannot occur subsequently. If signs and/or symptoms of intravascular hemolysis are present or suspected after Rhophylac administration, perform post-treatment laboratory tests, including plasma hemoglobin, haptoglobin, LDH, and plasma bilirubin (direct and indirect).