Efalizumab Side Effects

Some side effects of efalizumab may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to efalizumab: subcutaneous powder for injection

Get emergency medical help if you have any of these signs of an allergic reaction while taking efalizumab: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums), loss of appetite, or mouth sores;

• signs of a skin infection, such as redness, tenderness, and swelling;

• pale or yellowed skin, dark colored urine, confusion or weakness;

• change in your mental state, problems with speech or walking, decreased vision (these symptoms may start gradually and get worse quickly);

• cough with yellow or green mucus, stabbing chest pain or tightness, wheezing, trouble breathing;

• neck stiffness, increased sensitivity to light, purple spots on the skin, and/or seizure (convulsions);

• numbness or tingly feeling in your feet and spreading upward, muscle weakness in your face; or

• problems with vision, speech, swallowing, or bladder and bowel functions.

Less serious side effects of efalizumab may include:

• headache, muscle pain, and nausea or vomiting (especially after the first dose);

• back pain;

• joint pain, stiffness, or swelling; or

• swelling in your hands or feet.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to efalizumab: subcutaneous powder for injection

Hematologic

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

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 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.

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.)

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.

General

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

Gastrointestinal

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

Musculoskeletal

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

Dermatologic

Serious adverse events of psoriasis included pustular, erythrodermic, and guttate subtypes.

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.

Oncologic

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).

Oncologic side effects have included an overall incidence of malignancies of any kind at 1.8 per 100 patient-years for efalizumab treated patients compared to 1.6 per 100 patient-years for placebo-treated patients.

Hypersensitivity

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

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%).

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