RhoGAM

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.

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.

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

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.

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.

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:

• fever, chills, shaking, back pain, unusual weakness, red or pink urine;

• pale or yellowed skin, dark colored urine;

• rapid breathing, rapid heart rate, confusion, feeling short of breath;

• signs of kidney failure--little or no urinating, swelling, rapid weight gain; or

• signs of a blood clot--sudden numbness or weakness, slurred speech, problems with vision or balance, chest pain, coughing up blood, swelling with redness and warmth in one or both legs.

Common side effects may include:

• nausea, diarrhea, vomiting, stomach pain;

• headache, dizziness;

• drowsiness, weakness, general ill feeling;

• joint or muscle pain;

• flushing (warmth, redness, or tingly feeling);

• mild itching or skin rash;

• increased sweating; 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.

Other drugs may interact with RHo (D) immune globulin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Rho(D) immune globulin is used to treat immune thrombocytopenic purpura (ITP) in patients with Rh-positive blood. ITP is a type of blood disorder where the person has a very low number of platelets. Platelets help to clot the blood. Rho(D) immune globulin is also used to prevent antibodies from forming after a person with Rh-negative blood receives a transfusion with Rh-positive blood, or during pregnancy when a mother has Rh-negative blood and the baby is Rh-positive. It belongs to a group of medicines called immunizing agents. Rho(D) immune globulin works to boost the immune system and prevent excessive bleeding.

The Rh factor is one part of the red blood cell. A person has either Rh-positive or Rh-negative blood. If you receive the opposite type of blood, your body will create antibodies that can destroy the red blood cells. When a pregnant woman is Rh-negative and her baby is Rh-positive, the baby's blood can get into her system and cause her to make antibodies. When the same woman has a second baby with Rh-positive blood, the antibodies will destroy the red blood cells in the baby. Rho(D) immune globulin is given to these women during pregnancy or after delivery to prevent them from making antibodies.

This medicine is to be administered only by or under the supervision of your doctor.

This section provides information on the proper use of a number of products that contain rho(d) immune globulin. It may not be specific to Rhogam. Please read with care.

A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed in one of your veins or as a shot into one of your muscles.

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 or nurse immediately if any of the following side effects occur:

• Bloody urine
• decreased frequency of urination or amount of urine
• fever
• increased blood pressure
• increased thirst
• loss of appetite
• lower back pain
• nausea or vomiting
• pale skin
• swelling of the face, fingers, or lower legs
• troubled breathing
• unusual bleeding or bruising
• unusual tiredness or weakness
• weight gain

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:

• Soreness at the place of injection

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.