WinRho SDF 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 (low red blood cells), kidney failure, or shock.

WinRho SDF is used to prevent an immune response to Rh positive blood in people with an Rh negative blood type. This medicine may also be used in the treatment of immune thrombocytopenic purpura (ITP).

WinRho SDF may also be used for purposes not listed in this medication guide.

You should not receive WinRho SDF 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.

WinRho SDF 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, WinRho SDF 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 WinRho SDF.

WinRho SDF 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.

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 WinRho SDF 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.

WinRho SDF 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.

WinRho SDF 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.

Call your doctor for instructions if you miss an appointment for your WinRho SDF.

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 WinRho SDF. 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), zoster (shingles), and nasal flu (influenza) vaccine.

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.

WinRho SDF 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 WinRho SDF 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.