Frequently Asked Questions

What does “Rh” stand for?

Rh is the abbreviation for “rhesus,” which is the name of one of many different blood group systems in the body. Within the rhesus blood group system, there are many “antigens” or “Rh factors.” One of these is the “D” antigen, “Rho(D).”

 

What does it mean to be Rh-negative?

People have a blood type that is either Rh-negative or Rh-positive. Rh-positive people have the Rh antigen (also called Rhesus factor or D antigen) on the surface of their red blood cells. Rh-negative people do not have this antigen. The Rh antigen is inherited, like eye color. Be sure to talk to your doctor if your have any questions about your blood type.

 

What is RhoGAM and why do I need it?

RhoGAM is a solution of antibodies, collected from plasma donors. Your doctor is prescribing RhoGAM because you are Rh-negative. During pregnancy, it is normal for a small amount of the baby’s blood to enter your bloodstream. When the blood from your Rh-positive baby enters your Rh-negative bloodstream, there will be a blood type mismatch. This is called Rh-incompatibility. Your immune system sees the baby’s red blood cells as “foreign” and will produce antibodies that try to eliminate them. RhoGAM, if given to you at the right time, will prevent your immune system from reacting to your baby’s blood. RhoGAM is made from human blood and may carry a risk of transmitting disease-causing agents.

 

Can the antibodies my immune system produces hurt my baby?

Rh-incompatibility usually does not affect your first baby (but can occur during your first pregnancy). However, once you have produced an immune response (called “Rh-sensitization”), all future Rh-positive fetuses are at risk for developing hemolytic disease of the fetus and newborn (HDFN). HDFN is caused when your antibodies try to destroy your baby’s red blood cells. HDFN is a serious condition that affects the fetus and/or newborn and may cause anemia, jaundice, and in severe cases, heart failure and possible brain damage.

 

How does RhoGAM work?

RhoGAM prevents the Rh-negative mother from making antibodies during her pregnancy.  As long as the Rh-negative mother receives RhoGAM appropriately during every pregnancy, her babies are at very low risk of developing hemolytic disease of the fetus and newborn (HDFN).

 

Will my unborn baby be harmed by the antibodies in RhoGAM?

RhoGAM is only administered to Rh-negative moms, and is never injected into babies. While there can be mixing of blood between mom and baby, the dose of antibodies in RhoGAM given to Rh-negative moms has never been shown to harm the fetus. Millions of doses of RhoGAM have been administered safely to Rh-negative mothers without affecting their babies. RhoGAM is made from human blood and may carry a risk of transmitting disease causing agents.

 

When will I receive RhoGAM?

Your doctor will administer at least one dose of RhoGAM Ultra-Filtered PLUS between 26 and 28 weeks of pregnancy. If your baby is found to be Rh-positive at birth, you will receive an additional dose within 72 hours after delivery.

You should also receive RhoGAM after abdominal trauma, obstetrical manipulation or an invasive procedure (such as amniocentesis, chorionic villus sampling or percutaneous umbilical blood sampling), maternal or fetal bleeding during pregnancy or an ectopic pregnancy (pregnancy in which the fertilized egg implants outside the uterus). RhoGAM should also be considered after a threated pregnancy loss or pregnancy termination. The dose and dosing schedule will be determined by your doctor.

Please see Full Prescribing Information for a full list of indications and dosing schedules.

 

Will I need RhoGAM during each pregnancy?

If you are Rh-negative, you should receive RhoGAM during every pregnancy unless your doctor has determined that you have already been sensitized.

 

What if my baby inherited my Rh-negative blood?

During pregnancy, the baby’s Rh blood type can only be determined through invasive procedures. Since the Rh-positive blood type is much more common than Rh-negative, most physicians will administer RhoGAM without determining the blood type of the baby during pregnancy. If your baby is determined to be Rh-negative at birth, you will not need an additional dose of RhoGAM.

 

Will I need RhoGAM after a pregnancy termination?

Your doctor will determine when you need RhoGAM. Since the Rh factor is present on red blood cells from the time the fetus is eight weeks old, your doctor may prescribe RhoGAM (300 µg) for a spontaneous or induced pregnancy termination that occurs at or beyond 13 weeks of pregnancy. For a spontaneous or induced pregnancy termination occurring up to and including 12 weeks of gestation, MICRhoGAM (50 µg) may be prescribed. MICRhoGAM contains exactly the same ingredients as RhoGAM, but is provided in a smaller dose.

 

Are there any side effects from RhoGAM?

The most common side effects of RhoGAM are swelling, hardening, redness, and mild pain at the site of the injection. A small number of patients have noted a slight fever. If you experience other symptoms, please call your doctor. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/Safety/MedWatch, or call 1-800-FDA-1088.

 

Who should NOT take RhoGAM?

RhoGAM or MICRhoGAM should NOT be used if you are Rh-positive. RhoGAM or MICRhoGAM should never be injected into a newborn baby.

 

What should I tell my doctor before taking RhoGAM or MICRhoGAM?

If you have known severe allergic reactions or a severe response to human immune globulin. Tell your doctor if you have had a serious reaction to other medicines that contain immune globulin.

If you have an immunoglobulin A (IgA) deficiency. RhoGAM and MICRhoGAM contain a small quantity of IgA and there is a potential risk of an allergic reaction in IgA-deficient individuals. Ask your healthcare provider if you are not sure.

Your recent history of vaccinations. Certain types of vaccines (ones containing a live virus) may not work as well for you if you are also receiving immunoglobulin products like RhoGAM or MICRhoGAM. The antibodies in RhoGAM and MICRhoGAM may prevent the vaccine from working. Before you get a vaccine, tell the doctor or nurse that you have received RhoGAM or MICRhoGAM.

 

What other potential risks should I be aware of?

RhoGAM and MICRhoGAM are made from human blood and therefore, carry a risk of transmitting infectious agents, such as viruses, the agent of the variant Creutzfeldt-Jakob disease (vCJD), or unknown infectious agents. You should consult with your healthcare provider if you have any questions or concerns.

 



Contact your doctor if you have any additional questions about RhoGAM.

APPROVED USES
RhoGAM® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg), is a prescription medicine given by intramuscular injection that is used to prevent Rh immunization, a condition in which an individual with Rh-negative blood develops antibodies after exposure to Rh-positive blood. MICRhoGAM® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (50 μg) is a lower dose of Rho(D) immune globulin that is used in certain clinical situations. 

If the father or baby is not conclusively shown to be Rh-negative, RhoGAM should be given to a Rh-negative mother in the following clinical situations to prevent Rh immunization:

  • After delivery of a Rh-positive baby.
  • Routine prevention of Rh immunization at 26 to 28 weeks of pregnancy.
  • Maternal or fetal bleeding during pregnancy from certain conditions.
  • Actual or threatened pregnancy loss at any stage. MICRhoGAM should be used in Rh-negative women who experience pregnancy loss at or up to 12 weeks of pregnancy.
  • Ectopic pregnancy (pregnancy in which the fertilized egg implants outside the uterus).

RhoGAM or MICRhoGAM may also be used to prevent Rh immunization in Rh-negative patients after the incompatible transfusion of Rh-positive blood or blood products. 

IMPORTANT SAFETY INFORMATION
RhoGAM or MICRhoGAM should NOT be used if you are Rh-positive.
Be sure to tell your healthcare provider about all your medical conditions, including:

  • If you have known severe allergic reactions or a severe response to human immune globulin.
  • If you have experienced a serious reaction to other medicines that contain immune globulin.
  • If you have an immunoglobulin A (IgA) deficiency. RhoGAM and MICRhoGAM contain a small quantity of IgA and there is a potential risk of an allergic reaction in IgA-deficient individuals. Ask your healthcare provider if you are not sure.
  • Your recent history of vaccinations. Certain types of vaccines (ones containing a live virus) may not work as well for you if you are also receiving immune globulin products, like RhoGAM or MICRhoGAM. The antibodies in RhoGAM and MICRhoGAM may prevent the vaccine from working. Before you get a vaccine, tell your healthcare provider that you have received RhoGAM or MICRhoGAM.

RhoGAM and MICRhoGAM are made from human blood and therefore, carry a risk of transmitting infectious agents, such as viruses, the agent of the variant Creutzfeldt-Jakob disease (vCJD), or unknown infectious agents. You should consult with your healthcare provider if you have any questions or concerns.

Reactions to RhoGAM or MICRhoGAM that affect the entire body are extremely rare. However allergic responses to RhoGAM or MICRhoGAM may occur. You should be observed for at least 20 minutes after administration for early signs of an allergic reaction.  Signs and symptoms of an allergic reaction include itchy rash (hives), tightness of the chest, wheezing, low blood pressure and anaphylaxis (which may also include throat or tongue swelling, shortness of breath, vomiting, hives and/or lightheadedness).

The most common side effects of RhoGAM and MICRhoGAM are swelling, hardening, redness, and mild pain at the site of the injection.  A small number of patients have noted a slight fever.

Your healthcare provider should provide you with a completed Patient Identification Card for you to retain and present to other healthcare providers.

You are encouraged to report adverse events of prescription drugs to the FDA.
Visit www.fda.gov/Safety/MedWatch/ or call 1-800-FDA-1088.

Click here for the RhoGAM Full Prescribing Information

This site is intended for residents of the US only.

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