Note: This document contains side effect information about efalizumab. Some dosage forms listed on this page may not apply to the brand name Raptiva.

Applies to efalizumab: subcutaneous powder for injection.

Hematologic

Hematologic side effects including lymphocytosis (40%), leukocytosis (26%), and thrombocytopenia (0.3%) have been reported.^[Ref]

Nervous system

Nervous system side effects including headache (32%) have been reported. Cases of Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy, facial palsy, and transverse myelitis have been observed in patients receiving efalizumab (the active ingredient contained in Raptiva) in the postmarketing setting. A case of efalizumab-induced aseptic meningitis and a case of efalizumab-induced isolated cerebral Lupus-like syndrome have also been reported.^[Ref]

Immunologic

The most common nonspecific infection was upper respiratory infection.

Serious infections requiring hospitalization have included cellulitis, pneumonia, abscess, sepsis, bronchitis, gastroenteritis, aseptic meningitis, Legionnaire's disease, and vertebral osteomyelitis. (Some of the patients had more than one infection.)^[Ref]

Immunologic side effects including infection (29%) have been reported. The proportion of patients with serious infection was 0.4%. Inflammatory, potentially immune-mediated adverse reactions resulting in hospitalization included inflammatory arthritis (0.4%) and rare cases of interstitial pneumonitis. Transverse myelitis, bronchiolitis obliterans, aseptic meningitis, idiopathic hepatitis, sialadenitis, and sensorineural hearing loss have been reported rarely. Postmarketing reports of serious infections have included necrotizing fasciitis and tuberculosis pneumonia. Bacterial sepsis with seeding of distant sites, severe pneumonia with neutropenia, and worsening of infection (e.g. cellulitis, pneumonia) despite antimicrobial treatment have also been reported. Three confirmed, and one possible case of progressive multifocal leukoencephalopathy (PML) have been reported. Three of those patients have died. A case of immune-mediated pancytopenia and a case of serum sickness-like reaction have been reported.^[Ref]

General

General side effects including chills (13%), pain (10%), flu syndrome (7%), fever (7%), and asthenia have been reported.^[Ref]

Gastrointestinal

Gastrointestinal side effects including nausea (11%) have been reported. A case of candida colitis has also been reported.^[Ref]

Musculoskeletal

Musculoskeletal side effects including myalgia (8%), back pain (4%) and arthralgia have been reported.^[Ref]

Dermatologic

Dermatologic side effects including acne (4%) and serious psoriasis (0.7%) have been reported. Four cases of papular psoriasis, one case of hypertrichosis, and one case of repigmentation of vitiligo have also been reported.^[Ref]

Serious adverse events of psoriasis included pustular, erythrodermic, and guttate subtypes.^[Ref]

Oncologic

Oncologic side effects have included an overall incidence of malignancies of any kind at 1.8 per 100 patient-years for efalizumab (the active ingredient contained in Raptiva) treated patients compared to 1.6 per 100 patient-years for placebo-treated patients.^[Ref]

Malignancies reported in the efalizumab-treated patients included non-melanoma skin cancer, non-cutaneous solid tumors, Hodgkin's lymphoma, non-Hodgkin's lymphoma, and malignant melanoma. The majority of the malignancies were non-melanoma skin cancers (50% basal cell and 50% squamous cell).^[Ref]

Hypersensitivity

Hypersensitivity side effects were reported at a rate of 8% (versus 7% in the placebo group).^[Ref]

Hepatic

Hepatic side effects including a mean elevation in alkaline phosphatase (5 Units/L) has been reported. A shift to above normal values of alkaline phosphatase was reported in 4% of efalizumab-treated patients. Higher numbers of efalizumab-treated patients experienced elevations to above normal in two or more liver function tests than in placebo-treated patients (3.1% versus 1.5%).^[Ref]