MicRhoGAM Ultra-Filtered Plus

MicRhoGAM Ultra-Filtered Plus is a sterilized solution made from human blood. Rh is a substance that most people have in their blood (Rh positive), but some people do not (Rh negative). An Rh negative person can be exposed to Rh positive blood through a mismatched blood transfusion or during pregnancy if the baby has the opposite blood type. When this exposure occurs, the Rh negative blood will react by making antibodies that will try to destroy the Rh positive blood cells. This can lead to medical issues such as anemia (low red blood cells), kidney failure, or shock.

MicRhoGAM Ultra-Filtered Plus is used to prevent an immune response to Rh positive blood in individuals with an Rh negative blood type. This medicine may also be used to treat immune thrombocytopenic purpura (ITP).

MicRhoGAM Ultra-Filtered Plus may also be used for other reasons not listed in this medication guide.

You should not receive MicRhoGAM Ultra-Filtered Plus if you have immune globulin A (IgA) deficiency with antibody to IgA, or if you have hemolytic anemia (a lack of red blood cells).

RHo(D) immune globulin can cause an abnormal breakdown of red blood cells. This effect can lead to life-threatening blood clots or organ failure.

Call your doctor right away if you have any of the following symptoms: fever, chills, back pain, unusual weakness, red or pink urine, pale skin, feeling short of breath, little or no urinating, rapid weight gain, sudden numbness or weakness, slurred speech, problems with vision or balance, coughing up blood, or swelling or warmth in your leg.

You should not receive this medicine 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; or
• hemolytic anemia (a lack of red blood cells).

To make sure MicRhoGAM Ultra-Filtered Plus is safe for you, tell your doctor if you have:

• a history of anemia;
• heart disease or a history of coronary artery disease (hardened arteries);
• a bleeding disorder (such as hemophilia);
• high triglycerides (a type of fat in the blood);
• kidney disease; or
• diabetes.

MicRhoGAM Ultra-Filtered Plus is often used during and after pregnancy. This medicine 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.

MicRhoGAM Ultra-Filtered Plus 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.

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.

MicRhoGAM Ultra-Filtered Plus may cause serious side effects. 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 of MicRhoGAM Ultra-Filtered Plus 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.

MicRhoGAM Ultra-Filtered Plus 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 after you receive immune globulin. Your urine may also need to be tested every 2 to 4 hours for at least 8 hours.

For treatment during pregnancy, MicRhoGAM Ultra-Filtered Plus 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 medicine 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, you may need frequent blood tests. You may not notice any change in your symptoms, but your blood work will help your doctor determine how long to treat you with MicRhoGAM Ultra-Filtered Plus.

MicRhoGAM Ultra-Filtered Plus can cause false results with certain lab tests for glucose (sugar) in the blood. Tell any doctor who treats you that you are using this medicine.

Call your doctor for guidance if you miss an appointment for your MicRhoGAM Ultra-Filtered Plus.

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

Do not receive a "live" vaccine for at least 3 months after treatment with MicRhoGAM Ultra-Filtered Plus. 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), rotavirus, typhoid, yellow fever, varicella (chickenpox), and nasal flu (influenza) vaccine.

Other drugs may interact with RHo (D) immune globulin. This includes both prescription and over-the-counter medicines, vitamins, and herbal products. Inform all your health care providers about every medicine you are currently using and any medicine you begin or stop using.