Generic Name: rho(d) immune globulin (human) (roe D i-MUNE GLOB-ue-lin)
Brand Name: WinRho SDF
A small number of people who have used WinRho SDF have experienced a serious and potentially life-threatening reaction (intravascular hemolysis [IVH]) in which a large number of red blood cells are destroyed in their blood stream. In the patients that experienced this reaction, symptoms usually occurred within 4 hours of receiving WinRho SDF, although they may occur at any time. Your doctor's office, hospital, or clinic will monitor you closely for at least 8 hours after you receive WinRho SDF. Lab tests, including urine testing, should be performed before, during, and after you receive WinRho SDF. Contact your doctor right away if you experience back pain; bloody, discolored, or dark urine; decreased urination; fever; shaking chills; shortness of breath; sudden weight gain; or swelling. If you have any questions about WinRho SDF, or intravascular hemolysis (IVH) or its symptoms, contact your health care provider.
WinRho SDF may increase the risk of blood clots. The risk may be increased in older patients, if you will be confined to a bed or chair for a period of time, if you take estrogen products, or if you have certain catheters. The risk may also be increased if you have a condition that may increase your risk of blood clots, thick blood, heart problems, or a history of blood clots. Blood clots can occur if you do not have any of these conditions. Tell your doctor right away if you develop one-sided numbness or weakness; pain, redness, tenderness, warmth or swelling in the arms or legs; change in color of an arm or leg; chest pain or discomfort; shortness of breath; fast heartbeat; or coughing up blood. Discuss any questions or concerns with your doctor.
WinRho SDF is used for:
Preventing certain blood problems that may occur during pregnancy or blood transfusion. It may also be used to treat immune thrombocytopenic purpura (ITP).
WinRho SDF is an immunoglobulin (Ig), which contains antibodies to the Rho(D) antigen. Exactly how it works is not known.
Do NOT use WinRho SDF if:
- you are allergic to any ingredient in WinRho SDF or to another human immune globulin product
- you have immunoglobulin A (IgA) deficiency and you have antibodies against IgA
- you have hemolytic anemia
- you have a history of or are at high risk of a certain red blood cell problem (eg, hemolysis)
- you are Rh-negative
- you are Rh-positive and have had your spleen removed
- the patient is an infant
Contact your doctor or health care provider right away if any of these apply to you.
Before using WinRho SDF:
Some medical conditions may interact with WinRho SDF. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have had an allergic reaction to blood or blood products
- if you have other blood problems (eg, anemia, hyperviscosity), bleeding or clotting problems, IgA deficiency, or high blood levels of a certain protein (paraproteinemia)
- if you have heart problems (eg, heart failure), blood vessel problems (eg, atherosclerosis), diabetes, dehydration or low blood volume, or liver problems
- if you have kidney problems (eg, kidney failure), are at risk of kidney problems, or are taking medicines that may affect kidney function
- if you have a history of intravascular hemolysis, or if your spleen has been removed
- if you have recently received a vaccine, you are Rh immunized, or you are scheduled to receive a vaccine (eg, measles, mumps, rubella, chickenpox)
- if you will be confined to a bed or chair for a period of time
Some MEDICINES MAY INTERACT with WinRho SDF. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- Medicines that may harm the kidney (eg, aminoglycoside antibiotics [eg, gentamicin], amphotericin B, cyclosporine, nonsteroidal anti-inflammatory drugs [NSAIDs] [eg, ibuprofen], tacrolimus, vancomycin) because the risk of kidney side effects may be increased. Ask your doctor if you are unsure if any of your medicines might harm the kidney
- Live vaccines (eg, measles, mumps, and rubella) because their effectiveness may be decreased by WinRho SDF
This may not be a complete list of all interactions that may occur. Ask your health care provider if WinRho SDF may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use WinRho SDF:
Use WinRho SDF as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with WinRho SDF. Talk to your pharmacist if you have questions about this information.
- WinRho SDF is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using WinRho SDF at home, a health care provider will teach you how to use it. Be sure you understand how to use WinRho SDF. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
- Your doctor's office, hospital, or clinic will monitor you closely for at least 8 hours after you receive WinRho SDF.
- Do not use WinRho SDF if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
- Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
- If you miss a dose of WinRho SDF, contact your doctor right away.
Ask your health care provider any questions you may have about how to use WinRho SDF.
Important safety information:
- WinRho SDF may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use WinRho SDF with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- WinRho SDF may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
- Do not receive a live vaccine (eg, measles, mumps) while you are taking WinRho SDF. Talk with your doctor before you receive any vaccine.
- WinRho SDF is made from human plasma. There is an extremely low risk of developing a viral infection or Creutzfeldt-Jakob disease (CJD) after using WinRho SDF. Discuss any questions or concerns with your doctor.
- Tell your doctor or dentist that you take WinRho SDF before you receive any medical or dental care, emergency care, or surgery.
- Diabetes patients - WinRho SDF may cause the results of some glucose tests to be wrong. Ask your doctor before you change your diet or the dose of your diabetes medicine.
- WinRho SDF may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using WinRho SDF.
- Lab tests, including complete blood cell counts, urine tests, antibody titers, liver function, and kidney function, may be performed while you use WinRho SDF. These tests may be used to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
- Use WinRho SDF with caution in the ELDERLY; they may be more sensitive to its effects, especially intravascular hemolysis (IVH).
- WinRho SDF should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using WinRho SDF while you are pregnant. If you are or will be breast-feeding while you use WinRho SDF, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of WinRho SDF:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Diarrhea; dizziness; drowsiness; flushing of the skin; headache; joint or muscle pain; mild pain, itching, swelling, tenderness, or redness at the injection site; mild stomach or back pain; nausea; sweating; vomiting; weakness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); back or stomach pain; blood in the urine; chest, jaw, or left arm pain; confusion; dark or discolored urine; decreased urination; fainting; fast breathing or heartbeat; fever or chills; lightheadedness; numbness of an arm or leg; one-sided weakness; pale skin; severe or persistent dizziness, headache, nausea, or vomiting; shortness of breath; slurred speech; sudden weight gain; swelling; unusual bruising or bleeding; unusual tiredness or weakness; vision problems; wheezing; yellowing of the eyes or skin.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include back pain; bloody, discolored, or dark urine; decreased urination; fever; severe headache; shaking chills; shortness of breath; sudden weight gain; swelling; unusual tiredness or weakness; yellowing of the eyes or skin.Proper storage of WinRho SDF:
WinRho SDF is usually handled and stored by a health care provider. If you are using WinRho SDF at home, store WinRho SDF as directed by your pharmacist or health care provider. Keep WinRho SDF out of the reach of children and away from pets.
- If you have any questions about WinRho SDF, please talk with your doctor, pharmacist, or other health care provider.
- WinRho SDF is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take WinRho SDF or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about WinRho SDF. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to WinRho SDF. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using WinRho SDF.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.
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