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RhoGAM® Ultra-Filtered Plus is for Women
Who Are Rh-negative

WHY DO I NEED RhoGam Ultra-Filtered Plus?
Your doctor is advising you to receive an injection of RhoGam Ultra-Filtered Plus if your blood is Rh-negative. This means that you do not have a factor called the “D antigen” on your red blood cells. The Rh (D antigen) factor is inherited, like eye color, and some people simply do not receive it from their parents. When an Rh-negative woman becomes pregnant, RhoGam Ultra-Filtered Plus can help prevent problems.

WHAT KIND OF PROBLEMS MIGHT I HAVE DURING PREGANCY
BECAUSE I’M RH-NEGATIVE?

When an Rh-negative woman carries an Rh-positive baby, small numbers of the baby’s red blood cells may get into the mother’s bloodstream. This can happen during your pregnancy as well as at delivery. The mother’s immune system sees the baby’s Rh-positive red blood cells as foreign and goes to work to produce antibodies against them.

CAN THE ANTIBODIES MY IMMUNE SYSTEM PRODUCES HURT MY BABY?
Yes. The antibodies formed to protect you against Rh-positive red blood cells can pass to the baby you are carrying. They attack and destroy the baby’s Rh-positive red blood cells, causing anemia (low red blood cell count), jaundice, and in sever cases, heart failure. This condition is known as hemolytic disease of the newborn, or HDN.

IS EVERY RH-POSITIVE BABY CARRIED BY AN RH-NEGATIVE MOTHER AT RISK FOR HDN?
HDN usually does not affect the mother’s first baby, but once she has produced Rh antibodies, all future Rh-positive babies are at risk. RhoGam Ultra-Filtered Plus prevents the production of these antibodies.

WHAT IF MY BABY HAS INHERITED MY RH-NEGATIVE BLOOD?
Before birth, the baby’s Rh blood type can only be determined through invasive procedures (like amniocentesis). It is safer to assume that the baby is Rh-positive and administer RhoGam Ultra-Filtered Plus during pregnancy. If your baby is determined to be Rh-negative at birth, you do not need a second dose of RhoGam Ultra-Filtered Plus.

HOW DOES RhoGam Ultra-Filtered Plus WORK?
RhoGAM® Ultra-Filtered Plus is a sterile solution that contains antibodies to the Rh factor. The antibodies are derived from human plasma. When RhoGam Ultra-Filtered Plus is injected into the muscle of an Rh-negative mother, these antibodies circulate in her immune system and protect against any Rh-positive red blood cells that may have entered her bloodstream. Her immune system then sees no need to take further action.

WILL MY UNBORN BABY BE HARMED BY THE RHOGAM
ULTRA-FILTERED PLUS ANTIBODIES?

No. In over 35 years, the small amount of antibody in RhoGam Ultra-Filtered Plus has never been shown to harm the fetus. Millions of doses have been administered safely to Rh-negative mothers who have delivered healthy babies. Additionally, RhoGam Ultra-Filtered Plus does not contain the preservative thimerosal.

WHEN WILL I RECEIVE RhoGam Ultra-Filtered Plus?
Doctors usually prescribe at least one dose of RhoGam Ultra-Filtered Plus at around 28 weeks of pregnancy. An Rh-negative mother is most likely to be exposed to her baby’s blood during the last three months of pregnancy and at delivery, therefore a second dose is given for added protection within 72 hours after delivery if the baby is found to be Rh-positive. You must receive one dose of RhoGam Ultra-Filtered Plus if an invasive procedure (such as amniocentesis) or an induced termination is performed.

WILL I NEED RhoGam Ultra-Filtered Plus DURING AND
AFTER EACH PREGNANCY?

Yes, because every pregnancy puts the Rh-negative mother at risk of being exposed to the Rh-positive red blood cells of her baby.

HOW SAFE IS RhoGam Ultra-Filtered Plus?
RhoGam Ultra-Filtered Plus, the brand of anti-D immune globulin manufactured by Ortho-Clinical Diagnostics, Inc. a Johnson & Johnson company, is prepared using a patented ultrafiltration technology that is proven effective in removing enveloped and non-enveloped viruses. RhoGam Ultra-Filtered Plus has an excellent safety record. Since it was introduced in 1968, millions of women around the world have received RhoGAM, and there have been no confirmed cases of virus transmission.

RhoGam Ultra-Filtered Plus combines the proven effectiveness of RhoGAM with the Viresolve® ultra-filtration process. The patented process removes potential viruses such as HIV, HCV, HAV and Parvovirus B19 to protect newborns and their mothers from potential viral infection.

DOES RhoGam Ultra-Filtered Plus HAVE SIDE EFFECTS?
Side effects of RhoGam Ultra-Filtered Plus are rare and usually mild. You may feel soreness, tenderness, warmth, or develop a rash at the site of the injection. Other mild side effects may include fever, chills, headache, or a feeling of fatigue. If you experience other symptoms, please call your doctor.

Contact your doctor if you have any other questions about RhoGam Ultra-Filtered Plus and your pregnancy.

Important Safety Information
RhoGAM® and MICRhoGAM® Ultra-Filtered Plus are made from human plasma. Because these products are made from human blood, they may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically the Creutzfeldt-Jakob disease (CJD) agent. RhoGAM and MICRhoGAM are intended for maternal administration. Do not inject the newborn infant. Local adverse reactions may include redness, swelling, and mild pain at the site of injection and a small number of patients have noted a slight elevation in temperature. Patients should be observed for at least 20 minutes after administration. Hypersensitivity reactions include hives, generalized urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis. RhoGAM and MICRhoGAM contain a small quantity of IgA and physicians must weigh the benefit against the potential risks of hypersensitivity reactions. Patients who receive RhoGAM or MICRhoGAM for Rh-incompatible transfusion should be monitored by clinical and laboratory means due to the risk of a hemolytic reaction.

For more information on RhoGAM®, please visit the official RhoGAM® website at www.rhogam.com.

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