Efalizumab Side Effects

Applies to efalizumab: subcutaneous powder for solution.

Precautions

It is very important that your doctor check you at regular visits for any blood problems or any other side effects that may be caused by this medicine.

It is important to tell your doctor if you become pregnant. Your doctor may want you to join a pregnancy registry for patients taking this medicine.

While you are being treated with efalizumab, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. Efalizumab may lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent. In addition, the other persons living in your household should not take oral polio vaccine since there is a chance they could pass the polio virus on to you. Also avoid persons who have recently taken oral polio vaccine. Do not get close to them or stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective mask that covers the nose and mouth.

This medicine may increase your risk of developing infections, including a serious brain infection called progressive multifocal leukoencephalopathy. Check with your doctor right away if you are having more than one of these symptoms: back pain; blurred vision; confusion; convulsions; dizziness; drowsiness; fever; headache; or unusual tiredness or weakness.

It is important to check with your doctor if you have any symptoms of an infection such as fever or chills, cough or hoarseness, lower back or side pain, painful or difficult urination. If your symptoms do not improve within a few days or if they become worse, check with your doctor.

Check with your doctor right away if you start having numbness, tingling, or weakness in your arms, legs, or face; or problems with thinking, balance, talking, walking, or vision. These could be symptoms of a nervous system disorder.

Check with you doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.

When you first start using this medicine, you may have a headache, fever, muscle aches, nausea, and vomiting, especially after your first dose. These symptoms usually clear up once you are using the medicine regularly.

Tell your doctor if you want to stop using this medicine. Your psoriasis may become worse if you miss a dose or stop using the medicine altogether.

Common side effects of efalizumab

Some side effects of efalizumab may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Serious side effects of efalizumab

Along with its needed effects, efalizumab may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking efalizumab:

For healthcare professionals

Applies to efalizumab: subcutaneous powder for injection.

General adverse events

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

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]

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]

Hematologic

Hematologic side effects including lymphocytosis (40%), leukocytosis (26%), and thrombocytopenia (0.3%) 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 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]

See also:

Further information

Efalizumab side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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