Patient Counseling Information

Both Indications

Allergic Reactions

Inform patients of the early signs of allergic or hypersensitivity reactions to Rhophylac® including hives, chest tightness, wheezing, hypotension, and anaphylaxis (see Warnings and Precautions) and advise them to notify their physician if they experience any of these symptoms.

Transmissible Infectious Agents

Inform patients that Rhophylac® is made from human plasma (part of the blood) and may contain infectious agents that can cause disease (e.g., viruses and, theoretically, the CJD agent). Explain that the risk that Rhophylac® may transmit an infectious agent has been reduced by screening the plasma donors, by testing the donated plasma for certain virus infections, and by inactivating and/or removing certain viruses during manufacturing (see Warnings and Precautions ).

Live Virus Vaccines

Inform patients that administration of immunoglobulin may temporarily impair the effectiveness of live virus vaccines (e.g., measles, mumps, rubella, and varicella) and to notify their immunizing physician of recent therapy with Rhophylac® (see Drug Interactions).

Suppression of Rh Isoimmunization

Standard Dosing for Rh Isoimmunization

Inform patients receiving the antepartum dose of Rhophylac® for suppression of Rh isoimmunization that they will need a second dose within 72 hours of birth if the baby's blood type is Rh-positive (see Dosage and Administration for Suppression of Rh Isoimmunization).

ITP

Intravascular Hemolysis

Instruct patients being treated with Rhophylac® for ITP to immediately report symptoms of intravascular hemolysis, including back pain, shaking chills, fever, discolored urine, decreased urine output, sudden weight gain, edema, and/or shortness of breath (see Warnings and Precautions).

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