Rhophylac^®

Rho(D) Immune Globulin Intravenous (Human)

Q. What is hemolytic disease of the newborn (HDN)?

A. HDN is a serious medical condition of pregnancy caused when the blood of an Rh-negative mother mixes with the blood of her Rh-positive fetus. While it has no direct adverse effect on the mother, HDN can have consequences for her current child and children of future pregnancies, ranging from jaundice and anemia to critical conditions including brain damage, heart failure, and death. However, thanks to medical advances, HDN is easily preventable.

Q. What causes HDN?

A. Approximately 90% of people have a protein on the surface of their red blood cells called the Rh factor. People with the Rh factor are said to have "Rh-positive" blood. People who do not have the Rh factor are said to have "Rh-negative" blood.

Problems can develop after an Rh-positive man and an Rh-negative woman conceive a child. If the baby does not inherit the Rh factor from its father and is born Rh-negative, there is no danger. If the baby inherits the father's Rh factor, problems can occur if the baby's blood comes into contact with the mother's blood (for example, during delivery, a miscarriage, an abortion, prenatal testing such as amniocentesis, or an accident such as a fall).

When the two blood types mix, the mother's immune system reacts to the baby’s Rh-positive blood as an invader and automatically produces antibodies against Rh-factor to fight the "invasion." The mother's immune system keeps the antibodies handy to fight these blood cells if they ever appear again, even in future pregnancies. The mother is now referred to as being "Rh-sensitized."

Generally, the first time a woman becomes "sensitized," the risk to the child is low. This is because the mother doesn’t develop harmful Rh antibodies until late in her pregnancy, and the antibodies she does produce are relatively few in number. The real threat occurs with future pregnancies. If the unborn child is Rh-positive, the mother's immune system can create additional, stronger antibodies, which can attack her child's red blood cells.

Q. What are the consequences of HDN?

A. The newborn can face many serious and sometimes fatal problems due to HDN, including anemia, heart failure, abnormal accumulation of fluid in fetal tissues, liver and spleen enlargement, jaundice, brain damage, neurologic conditions resulting in paralysis, severe back and neck muscle spasms, convulsions, cessation of breathing, learning disabilities, deafness, abnormal twitching, or even death in utero or soon after birth. What's more, with each additional Rh-positive child conceived, the mother’s antibody reaction is quicker and more likely to cause severe consequences.

Q. Is HDN preventable?

A. Thanks to advances in prenatal care, HDN is easily preventable. If you have Rh-negative blood, your doctor will treat you with Rh immunoglobulin (RhIg) therapy, which helps prevent your body from producing the antibodies that attack the cells of your unborn child, thereby causing HDN. If HDN is suspected, it can be diagnosed through blood tests, ultrasound, and/or amniocentesis.

Q. What is Rhophylac^®?

A. Rhophylac^® is a sterile Rho(D) Immunoglobulin Intravenous (Human)—or RhIg—solution. Rhophylac^® is given to pregnant women who have an Rh-negative blood type. Without treatment, an unborn child who has an Rh-positive blood type may develop serious health problems from exposure to antibodies in the mother's Rh-negative blood during pregnancy or delivery. Rhophylac^® helps prevent this from happening.

Q. What are immunoglobulins?

A. Immunoglobulins—antibodies found in the human bloodstream—are protective substances produced by the body’s immune system to fight bacteria, viruses, and other foreign substances (including the antibodies that develop with HDN).

Q. How is Rhophylac^® made?

A. Rhophylac^® is made from plasma collected from human donors in the US only. Donors are screened to eliminate those with specific infections, such as human immunodeficiency virus (HIV) or hepatitis. All donations are tested for the presence of certain well-known viruses. Also, the manufacturing process for Rhophylac^® includes several steps that inactivate and remove any viruses that might remain in the plasma.

The screening and testing procedures and manufacturing process for Rhophylac^® are designed to minimize the risk of virus transmission. In clinical trials, there was no evidence of virus transmission with Rhophylac^®. As with all plasma-derived products, the risk of transmitting infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.

Q. How is Rhophylac^® given?

A. Rhophylac^® is given via an intramuscular (IM) injection in a doctor’s office or in the hospital. Intravenous (IV) administration may be used when a doctor determines that this is an appropriate choice based on patient variables or the presence of an IV line. Your doctor will decide which method is right for you.

Q. Why is Rhophylac^® the right choice for me?

A. Rhophylac^® has been proven to be safe and effective and it provides the convenience of both IM and IV administration. Make sure to ask your doctor if Rhophylac^® is right for you.

Q. How often will I need to receive Rhophylac^®?

A. If you are Rh-negative and pregnant, your doctor will likely give you Rhophylac^® 28 to 30 weeks into your pregnancy and again within 72 hours after delivering your baby. You may also receive additional doses if you undergo certain medical procedures, such as amniocentesis or external manipulation, or if you have an accident (for example, a fall) during pregnancy, all of which can cause your baby’s blood to come in contact with your blood. Your doctor will determine the exact timing and number of doses you need.

Q. Will I need Rhophylac^® if I get pregnant again?

A. Since protection lasts for only one pregnancy, you will need Rhophylac^® each time you become pregnant. In some situations, you may need Rhophylac^® several times during pregnancy if conditions are such that your doctor feels additional injections are warranted.

Q. How long has Rhophylac^® been available?

A. Rhophylac^® has been used successfully in Europe since 1996 and in the US since early in 2004. Clinical studies have shown that it is effective in preventing HDN.

Q. Is Rhophylac^® safe for me and my baby?

Q. What are the side effects of Rhophylac^®?

A. Some women have experienced mild and temporary side effects such as fever, overall discomfort or uneasiness, headache, skin reactions (such as hives or welts), and/or chills. If you received Rhophylac^® as a shot (intramuscular), you may experience pain or tenderness at the administration site. These side effects usually do not last long, but you should tell your doctor if you experience any side effects or unusual symptoms. This list of side effects is not complete, so talk with your doctor about the other side effects that may occur from Rhophylac^®.

Q. Will Rhophylac^® interact with any other drugs I may be taking?

A. If you recently received a vaccination of any kind, tell your doctor. Depending on the type of vaccine you received, you may need to repeat the vaccination at a later date if you are given Rhophylac^®. Your doctor will help you decide if this is necessary.

Q. Are there any reasons I might not be given Rhophylac^®?

A. You should not be given Rhophylac^® if you have had a previous serious allergic reaction to Rhophylac^® or other human blood products. You should not be given Rhophylac^® if you lack a specific protein in your blood called IgA. You doctor can give you a blood test to determine if you are IgA-deficient.

Important Safety Information

Rhophylac^® is derived from human plasma. As with all plasma-derived products, the risk of transmitting infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.

Rhophylac^® should not be given to Rh-positive patients or patients with hypersensitivity to human globulin. For antenatal and postpartum use, Rhophylac^® is intended for maternal administration only; Rhophylac^® should not be given to a newborn infant. Patients who receive Rhophylac^® for incompatible transfusions should be monitored clinically and biologically for potential hemolytic reactions.

Rhophylac^® may cause anaphylactic reactions in IgA-deficient individuals. As with all pharmaceutical agents, allergic reactions may occur, so patients should be observed for at least 20 minutes following administration. Occasionally, infusion-related adverse reactions, such as headache, fever, inflammation, and chills, may occur. In rare cases, nausea, vomiting, hypotension, tachycardia, and anaphylactic type reactions, including dyspnea and shock, have been reported, even when the patient has shown no hypersensitivity to previous administration.