follow-up (1 patient was lost to follow-up). Reports of severe thrombocytopenia have also been received postmarketing. Physicians should follow patients closely for signs and symptoms of thrombocytopenia. Assessment of platelet counts is recommended during treatment with RAPTIVA (see PRECAUTIONS, Laboratory Tests) and RAPTIVA should be discontinued if thrombocytopenia develops.

Immune-Mediated Hemolytic Anemia

Reports of hemolytic anemia, some serious, diagnosed 4-6 months after the start of RAPTIVA treatment have been received. RAPTIVA should be discontinued if hemolytic anemia occurs.

Psoriasis Worsening and Variants

Worsening of psoriasis can occur during or after discontinuation of RAPTIVA. During clinical studies, 19 of 2589 (0.7%) of RAPTIVA-treated patients had serious worsening of psoriasis during treatment (n = 5) or worsening past baseline after discontinuation of RAPTIVA (n = 14) (see ADVERSE REACTIONS, Adverse Events of Psoriasis). In some patients these events took the form of psoriatic erythroderma, pustular psoriasis, or development of new plaque lesions. Some patients required hospitalization and alternative antipsoriatic therapy to manage the psoriasis worsening. Patients, including those not responding to RAPTIVA treatment, should be closely observed following discontinuation of RAPTIVA, and appropriate psoriasis treatment instituted as necessary.

Neurologic Events

One case of transverse myelitis was observed during the clinical development program (2762 RAPTIVA-treated patients); neurologic events, including cases of Guillain-Barré Syndrome, chronic inflammatory demyelinating polyneuropathy, facial palsy, and transverse myelitis have been observed in patients receiving RAPTIVA in the postmarketing setting (see ADVERSE REACTIONS, Postmarketing Experience). Patients being treated with RAPTIVA should be instructed to report any new neurological signs or symptoms to their physician. Prescribers should exercise caution in considering the use of RAPTIVA in patients with significant existing or new onset nervous system adverse events. RAPTIVA should be discontinued in patients who develop PML.