Rhophylac

Rhophylac 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.

Rhophylac can also be used to treat immune thrombocytopenia purpura (ITP), a bleeding disorder, in adults.

Rhophylac 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.

Common side effects of Rhophylac for prevention of Rh immunization include nausea, headache, malaise, and pain at the injection site. Common side effects of Rhophylac for treatment of ITP include chills, fever, and headache.

Rhophylac can also cause dizziness. Do not drive or operate heavy machinery until you know how Rhophylac affects you.

Rhophylac is a prescription medication used to prevent Rh immunization, also known as Rh incompatibility. Rhophylac 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.

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

The recommended dose of Rhophylac for prevention of pregnancy-related complications is 300 micrograms IM or IV.

The recommended dose range of Rhophylac 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 for treatment of ITP is 50 micrograms per kg body weight IV.

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).

Serious side effects have been reported with Rhophylac 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

Do not take Rhophylac if you are allergic to Rhophylac or to any of its ingredients.

Serious side effects have been reported with Rhophylac. See the “Rhophylac Precautions” section.

Common side effects of Rhophylac for prevention of Rh immunization include:

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

Common side effects of Rhophylac for treatment of ITP include:

• chills
• fever
• headache
• bleeding disorders

This is not a complete list of Rhophylac 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. Rhophylac may impair the efficacy of live vaccines such as measles, mumps, and varicella.

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

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.

Rhophylac falls into category C. No studies have been done in animals, and no well-controlled studies have been done in pregnant women. Rhophylac 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 Rhophylac 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 using Rhophylac.