RhoGAM

RhoGAM 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.

RhoGAM 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) by a healthcare professional.

Common side effects of RhoGAM include pain and redness at the site of injection, rash, body aches, and fevers.

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

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

• Kedrion Biopharma, Inc.

• Kedrion Melville, Inc.

• Ortho-Clinical Diagnos., Inc.

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

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

This is not a complete list of RhoGAM 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. RhoGAM 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 RhoGAM. If RhoGAM 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 RhoGAM.

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

Serious side effects have been reported with RhoGAM 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 take RhoGAM if you:

• are allergic to RhoGAM 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 RhoGAM, there are no specific foods that you must exclude from your diet when receiving this medication.

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

• are allergic to RhoGAM 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.

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

Receive RhoGAM exactly as prescribed.

This medication is available in an injectable form to be given directly into a muscle (IM) 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

The recommended dose of RhoGAM for prevention of pregnancy-related complications is 300 micrograms.

The recommended dose range of RhoGAM 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 RhoGAM, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If RhoGAM 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 a RhoGAM patient identification card and present it to other healthcare providers while you are receiving this medication.