RhoGAM Ultra-Filtered Plus

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 Rho(D) IG?

Rho(D) immune globulin (Rho(D) IG) 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.

Rho(D) IG is used to prevent an immune response to Rh positive blood in people with an Rh negative blood type. Rho(D) IG may also be used in the treatment of immune thrombocytopenic purpura (ITP).

Rho(D) IG may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Rho(D) IG?

While you are being treated with this medication, call your doctor right away if you have fever, chills, shaking, back pain, a change in the color of your urine or how much you urinate, sudden weight gain, or swelling in your hands, ankles, or feet. Do not receive live-virus vaccines such as measles, mumps, rubella, or chicken pox (also called MMR or Varivax) for at least 3 months after treatment with Rho(D) IG. These vaccines may not work properly during Rho(D) IG treatment and shortly afterward.

Rho(D) IG is made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although Rho(D) IG is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, 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.

What should I discuss with my healthcare provider before I receive Rho(D) IG?

You should not use this medication if you are allergic to it.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:

• an allergy to human immune globulin;

• a bleeding disorder (such as hemophilia); or

• immune globulin A (IgA) deficiency.

Rho(D) IG is used during and after pregnancy. This medication 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.

Rho(D) IG is made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although Rho(D) IG is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

How is Rho(D) IG given?

Rho(D) IG is given as an injection into a muscle or a vein. You will receive this injection while you are in a hospital or clinic.

For treatment during pregnancy, this medication 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 this medication is helping your condition, your blood will need to be tested on a regular basis. Your kidney or liver function may also need to be tested. It is important that you not miss any scheduled visits to your doctor.

What happens if I miss a dose?

Contact your doctor if you have a missed a dose of Rho(D) IG. Try to keep all appointments so you do not miss a dose of this medication.

What happens if I overdose?

Seek emergency medical attention if you think you have received too much of this medicine.

Since Rho(D) IG is given by a healthcare professional, an overdose is not likely to occur.

What should I avoid while receiving Rho(D) IG?

Do not receive live-virus vaccines such as measles, mumps, rubella, or chicken pox (also called MMR or Varivax) for at least 3 months after treatment with Rho(D) IG. These vaccines may not work properly during Rho(D) IG treatment and shortly afterward.

Rho(D) IG side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

• fever, chills, or shaking;

• urinating less than normal;

• a change in color of your urine;

• sudden weight gain, swelling in your hands, feet, or ankles;

• back pain; or

• shortness of breath.

Less serious side effects may include:

• muscle aches or pains;

• headache;

• feeling tired or light-headed;

• nausea, vomiting; or

• pain or tenderness where the injection is given.

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.

What other drugs will affect Rho(D) IG?

There may be other drugs that can interact with Rho(D) IG. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

• Your doctor or pharmacist can provide more information about Rho(D) IG.

• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 2.01. Revision Date: 08/26/2009 9:58:36 AM.