About Rhophylac

Rhophylac is indicated for suppression of rhesus (Rh) isoimmunization in:

  • Pregnancy and obstetric conditions in non-sensitized, Rh(D)-negative women with an Rh-incompatible pregnancy, including routine antepartum and postpartum Rh prophylaxis and Rh prophylaxis in cases of obstetric complications, invasive procedures during pregnancy, or obstetric manipulative procedures.
  • Incompatible transfusions in Rh(D)-negative individuals transfused with blood components containing Rh(D)-positive red blood cells.

Rhophylac is a sterile solution of anti-D, also known as Rh(D) Immune Globulin or Rh factor, which protects against Rh-sensitization or alloimmunization. Rhophylac can be administered by intravenous (IV) or intramuscular (IM) injection. For treatment of ITP, Rhophylac must be administered intravenously.

Rhophylac is made from human plasma collected from US donors using a patented manufacturing process called ChromaPlus. This unique manufacturing process not only helps reduce the risk of viral transmission, but also uses ion-exchange chromatography, a crucial element in allowing both intramuscular and intravenous administration by eliminating virtually all foreign aggregates from the collected plasma.

Each syringe contains 1500 IU (300 mcg) of IgG antibodies to Rh(D) in a 2 mL solution, sufficient to suppress the immune response to at least 15 mL of Rh-positive RBCs. For Rh-incompatible pregnancies, treatment consists of 2 doses delivered to the mother: first at 28 to 30 weeks' gestation and again within 72 hours after delivery.

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Important Safety Information

Rhophylac®, Rho(D) Immune Globulin Intravenous (Human), is a blood-derived injection given to women with an Rh-negative who might have an incompatible pregnancy—that is, who may be carrying an unborn child with Rh-positive blood. If a woman in such a pregnancy is not treated, the result could be “isoimmunization,” a condition in which the mother’s Rh-negative blood produces antibodies that could attack the unborn child’s Rh-positive blood cells, potentially creating serious health problems for the unborn child and any future children of the mother.

Rhophylac is given by physicians as routine protection against immunization, typically as administration during pregnancy, often with readministration within 72 hours following childbirth. It is also given in cases of obstetric complications, invasive procedures during pregnancies, incomplete pregnancies, and obstetric manipulative procedures in certain non-pregnant women. Rhophylac is also used in Rh-negative individuals who have received blood components containg Rh(D)-positive red blood cells. For suppression of Rh isoimmunization, Rhophylac can be administered intravenously or intramuscularly, but must not be given to newborn infant.

You should not receive Rhophylac if you have had a previous serious allergic reaction to Rhophylac or other human blood products. It should not be given if your blood has an insufficient quantity of a protein called IgA, has produced antibodies to IgA, or you have known hypersensititivy to IgA. Your physician will do a blood test to assess your situation regarding IgA.

Some women have experienced mild and temporary actions after receiving Rhophylac, such as fever; overall discomfort or uneasiness; headache; skin reactions (like hives or welts); and chills. If you received Rhophylac as a shot (intramuscularly), you could experience pain or tenderness at the injection site. Adverse reactions to Rhophylac typically do not last long. Discuss with your doctor any reaction or symptom you experience after administration of Rhophylac that concerns you.

Rhophylac is made from donated human blood. The risk of transmission of infections agents, including viruses, cannot be completely eliminated.

Immunoglobulin administration can transiently interfere with your response to live vaccines, such as measles, mumps and rubella. (Note that most influenza vaccines are not “live” vaccines.) Tell your doctor if you plan to receive a vaccine after receiving Rhophylac.

Please see full prescribing information for Rhophylac, which includes a boxed warning that does not apply to use of Rhophylac in pregnancy or in cases of incompatible transfusions.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

You can also report side effects to CSL Behring’s Pharmacovigilance Department at 1-866-915-6958.

Rhophylac is manufactured by CSL Behring AG and distributed by CSL Behring LLC.
Rhophylac® is a registered trademark of CSL Behring AG.
Other trademarks mentioned are the property of their respective owners.
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