Important Safety Information

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

• Pregnancy and obstetric conditions in non-sensitized, Rho(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 Rho(D)-negative individuals transfused with blood components containing Rho(D)-positive red blood cells.

For suppression of Rh isommunization, Rhophylac^® can be administered IM or IV.

Rhophylac^® is contraindicated in individuals with known anaphylactic or severe systemic reaction to human immune globulin products.

Allergic or hypersensitivity reactions may occur with Rhophylac^®; early signs of hypersensitivity include generalized urticaria, chest tightness, wheezing, hypotension, and anaphylaxis. Individuals with selective IgA deficiency can develop antibodies to IgA and may develop severe hypersensitivity and anaphylactic reactions. For these individuals, weigh the expected benefits of treatment against the potential risks.

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

For postpartum use following an Rh-incompatible pregnancy, Rhophylac^® should not be given to the newborn infant.

The most common adverse reactions in the suppression of Rh isoimmunization with Rhophylac^® are nausea, dizziness, headache, injection-site pain, and malaise.

Please see full prescribing information.

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.