Rhophylac contains RHo (D) immune globulin. 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 (low red blood cells), kidney failure, or shock.
Rhophylac is used to prevent an immune response to Rh positive blood in people with an Rh negative blood type. Rhophylac may also be used in the treatment of immune thrombocytopenic purpura (ITP).
Rhophylac may also be used for purposes not listed in this medication guide.
Important information
You should not receive Rhophylac 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.
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.
Before taking this medicine
You should not receive Rhophylac if you have ever had an allergic reaction to an immune globulin, or if you have:
To make sure Rhophylac is safe for you, tell your doctor if you have:
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a history of anemia;
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heart disease or a history of coronary artery disease (hardened arteries);
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a bleeding disorder (such as hemophilia);
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high triglycerides (a type of fat in the blood);
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kidney disease; or
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diabetes.
Rhophylac 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 Rhophylac 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.
Rhophylac 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 Rhophylac.
How is Rhophylac given?
Rhophylac 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, Rhophylac 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, Rhophylac 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 Rhophylac.
Rhophylac 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.
What happens if I miss a dose?
Call your doctor for instructions if you miss an appointment for your Rhophylac injection.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while receiving Rhophylac?
Do not receive a "live" vaccine for at least 3 months after treatment with Rhophylac. 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.
Rhophylac side effects
Get emergency medical help if you have any of these signs of an allergic reaction to Rhophylac: 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:
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fever, chills, shaking, back pain, unusual weakness, red or pink urine;
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pale or yellowed skin, dark colored urine;
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rapid breathing, rapid heart rate, confusion, feeling short of breath;
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signs of kidney failure--little or no urinating, swelling, rapid weight gain; or
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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 Rhophylac side effects may include:
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nausea, diarrhea, vomiting, stomach pain;
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headache, dizziness;
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drowsiness, weakness, general ill feeling;
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joint or muscle pain;
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flushing (warmth, redness, or tingly feeling);
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mild itching or skin rash;
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increased sweating; or
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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.
See also: Side effects (in more detail)
What other drugs will affect Rhophylac?
Other drugs may interact with Rhophylac, 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.
