....the incidence and severity of reactions associated with initial dosing (see DOSAGE AND ADMINISTRATION). Cases of aseptic meningitis resulting in hospitalization has been observed in association with initial dosing (see ADVERSE REACTIONS, Inflammatory/Immune-Mediated Reactions).

Information for Patients

Patients should be informed that their physician may monitor platelet counts during therapy. Patients should be advised to seek immediate medical attention if they experience any new or worsening medical problems such as a new or sudden change in thinking, balance, strength, talking, walking, or vision; if they develop any of the signs and symptoms associated with severe thrombocytopenia (such as easy bleeding from the gums, bruising, or petechiae) or with severe hemolytic anemia (such as weakness, orthostatic light-headedness, hemoglobinuria or jaundice), or with worsening of psoriasis or arthritis. Patients should also be informed that RAPTIVA is an immunosuppressant, and could increase their chances of developing an infection, including PML, or a malignancy. Patients should be advised to promptly call the prescribing doctor's office if they develop any new signs of, or receive a new diagnosis of infection, including PML, or malignancy while undergoing treatment with RAPTIVA.

Female patients should also be advised to notify their physicians if they become pregnant while taking RAPTIVA (or within 6 weeks of discontinuing RAPTIVA) and be advised of the existence of and encouraged to enroll in the RAPTIVA Pregnancy Registry by calling 1-877-RAPTIVA (1-877-727-8482).

If a patient or caregiver is to administer RAPTIVA, he/she should be instructed regarding injection techniques and how to measure the correct dose to ensure proper administration of RAPTIVA. Patients should be also referred to the RAPTIVA Patient Package Insert. In addition, patients should have available materials for and be instructed in the proper disposal of needles and syringes to comply with state and local laws. Patients should also be cautioned against reuse of syringes and needles.

Laboratory Tests

Assessment of platelet counts is recommended upon initiating and periodically while receiving RAPTIVA treatment. It is recommended that assessments be more frequent.....

See Raptiva Page 11