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 solution

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:

Less common
  • Accumulation of pus
  • chest pain
  • cough
  • cough producing mucus
  • diarrhea
  • difficulty in breathing or swallowing
  • fast heartbeat
  • fever or chills
  • headache
  • increased bone pain in vertebrae
  • itching, pain, redness, swelling, tenderness, or warmth on the skin
  • loss of appetite
  • muscle or joint stiffness, tightness, or rigidity
  • nausea
  • pain or tenderness around the eyes and cheekbones
  • rash or redness
  • shortness of breath
  • skin itching
  • sneezing
  • sore throat
  • stiff neck or back
  • stomach pain
  • stuffy or runny nose
  • swelling of the face, throat, or tongue
  • swollen, red, or tender area of infection
  • tightness in the chest
  • vomiting
  • weakness
  • wheezing
Rare
  • Back pain
  • black, tarry stools
  • bleeding gums
  • blood in the urine or stools
  • dark urine
  • difficulty in moving
  • general tiredness and weakness
  • hearing loss
  • light-colored stools
  • muscle pain
  • pain, swelling, or redness in the joints
  • pinpoint, red spots on the skin
  • small usually colored spots on the skin
  • spots on your skin resembling a blister or pimple
  • sudden and severe muscle weakness, sudden and progressing
  • swollen salivary glands
  • unusual bleeding or bruising
  • unusual lumps or skin changes
  • upper right abdominal pain
  • yellow eyes and skin
Incidence not known
  • Back pain, sudden and severe
  • blistering, peeling, or loosening of the skin
  • blurred vision
  • cold or flu-like symptoms
  • confusion
  • convulsions
  • dizziness
  • drowsiness
  • general feeling of illness
  • headache
  • inability to move arms and legs
  • increased sensitivity of the skin to sunlight
  • lower back or side pain
  • muscle weakness, sudden and progressing
  • numbness, tingling, pain, or weakness in the hands or feet
  • painful or difficult urination
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • redness or other discoloration of the skin
  • severe sunburn
  • skin rash
  • sores, ulcers, or white spots in the mouth or on the lips
  • sudden numbness and weakness in the arms and legs
  • swollen glands
  • unusual tiredness or weakness
  • weakness of the muscles in your face
  • weight loss

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:

More common
  • Difficulty in moving
  • general feeling of discomfort or illness
  • joint pain
  • loss of appetite
  • muscle cramping
  • shivering
  • sweating
  • swollen joints
  • trouble sleeping
Less common
  • Blemishes on the skin
  • lack or loss of strength
  • pimples
  • swelling of the hands, ankles, feet, or lower legs

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%).

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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