Rhophylac

Generic Name: RHo (D) immune globulin (ROE D im MYOON GLOB yoo lin)
Brand Names: HyperRHO S/D Full Dose, HyperRHO S/D Mini Dose, MicRhoGAM, MicRhoGAM Ultra-Filtered Plus, RhoGAM, RhoGAM Ultra-Filtered Plus, Rhophylac, WinRho SDF

What is Rhophylac?

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 (loss of 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 other purposes not listed in this medication guide.

Important information about Rhophylac

You should not receive Rhophylac 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. You should not receive Rhophylac if you have hemolytic anemia (a lack of red blood cells).

Before you receive Rhophylac, tell your doctor if you have heart disease or a history of coronary artery disease, high triglycerides, a bleeding disorder, or immune globulin A (IgA) deficiency.

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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.

Call your doctor at once if you suffer a serious side effect from using Rhophylac, such as fever, chills, shaking, back pain, dark colored urine, rapid breathing, feeling short of breath, urinating less than usual, swelling, rapid weight gain, pale skin, easy bruising or bleeding, rapid heart rate, trouble concentrating, feeling light-headed. 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), oral polio, typhoid, chickenpox (varicella), BCG (Bacillus Calmette and Guérin), and nasal flu vaccine.

Before receiving Rhophylac?

You should not receive Rhophylac 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. You should not receive Rhophylac if you have hemolytic anemia (a lack of red blood cells).

If you have any of these other conditions, you may need a dose adjustment or special tests:

• heart disease or a history of coronary artery disease (hardened arteries);

• high triglycerides (a type of fat in the blood);

• a bleeding disorder (such as hemophilia); or

• immune globulin A (IgA) deficiency.

Rhophylac is used during and after pregnancy. Rhophylac 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.

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 this medication.

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.

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 for at least 8 hours after you receive immune globulin. Your urine will also need to be tested every 2 to 4 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, the medication is given when symptoms of an immune response appear (when the body starts making Rh antibodies).

To be sure Rhophylac is helping your condition, your blood will need to be tested often. Your liver and kidney function may also need to be tested. Visit your doctor regularly.

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 Rhophylac.

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), oral polio, typhoid, chickenpox (varicella), BCG (Bacillus Calmette and Guérin), and nasal flu 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 a serious side effect such as:

• fever, chills, shaking, back pain, dark colored urine;

• rapid breathing, feeling short of breath.

• urinating less than usual or not at all, swelling, rapid weight gain; or

• pale skin, easy bruising or bleeding, rapid heart rate, trouble concentrating, feeling light-headed.

Less serious Rhophylac side effects may include:

• joint or muscle pain;

• headache, dizziness;

• feeling weak or tired;

• mild itching or skin rash;

• nausea, diarrhea, vomiting, stomach pain; or

• pain or tenderness where the medicine was injected.

This is not a complete list of Rhophylac 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: Rhophylac side effects (in more detail)

What other drugs will affect Rhophylac?

There may be other drugs that can interact with Rhophylac. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your doctor or pharmacist can provide more information about Rhophylac.