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Efalizumab Side Effects

Applies to efalizumab: subcutaneous powder for solution.

Important warnings This medicine can cause some serious health issues

Subcutaneous routePowder for Solution

  • Risk of Progressive Multifocal Leukoencephalopathy (PML):
    • Efalizumab increases the risk for PML, a rapidly progressive viral infection of the central nervous system that has no known treatment and that leads to death or severe disability.

      The risk of PML may markedly increase with longer duration of efalizumab exposure.

      The time dependent threshold when the risk for PML increases is unknown.

    • Patients on efalizumab should be monitored frequently to ensure they are receiving significant clinical benefit, to ensure they understand the significance of the risk of PML, and for any sign or symptom that may be suggestive of PML.
    • Efalizumab dosing should be withheld immediately at the first sign or symptom suggestive of PML.

      For diagnosis, brain magnetic resonance imaging (MRI) and, when indicated, cerebrospinal fluid analysis for JC viral DNA are recommended.

  • Risk of Serious Infections:
    • Infections, including serious infections leading to hospitalizations or death, have been observed in patients treated with efalizumab.

      These infections have included bacterial sepsis, viral meningitis, invasive fungal disease and other opportunistic infections.

      Patients should be educated about the symptoms of infection and be closely monitored for signs and symptoms of infection during and after treatment with efalizumab.

      If a patient develops a serious infection, efalizumab should be discontinued and appropriate therapy instituted.

Efalizumab increases the risk for progressive multifocal leukoencephalopathy (PML).

The risk of PML may markedly increase with longer duration of efalizumab exposure.

Monitor patients for signs and symptoms of PML and discontinue therapy if any sign or symptom of PML develops.

Serious infections, some leading to hospitalizations or death, have been observed in patients treated with efalizumab and include bacterial sepsis, viral meningitis, invasive fungal disease and other opportunistic infections.

Educate patients about the symptoms of infection and monitor for signs and symptoms of infection during and after treatment.

Discontinue efalizumab if a serious infection develops.

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:

More common side effects

  • difficulty in moving
  • general feeling of discomfort or illness
  • joint pain
  • loss of appetite
  • muscle cramping
  • shivering
  • sweating
  • swollen joints
  • trouble sleeping

Less common side effects

  • blemishes on the skin
  • lack or loss of strength
  • pimples
  • swelling of the hands, ankles, feet, or lower legs

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:

Less common side effects

  • 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 side effects

  • 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
Managing side effects (general information)

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]

References

1. (2003) "Product Information. Raptiva (efalizumab)." Genentech

2. Kluger N, Girard C, Gonzalez V, Guillot B, Bessis D (2007) "Efalizumab-induced aseptic meningitis." Br J Dermatol, 156, p. 189-91

3. Victor F, Menon K, Latkowski JA, Fernandez-Obregon A, Strober BE (2008) "Efalizumab-associated Guillain-Barre syndrome." Arch Dermatol, 144, p. 1396-7

4. Wendt M, Wohlrab J, Zierz S, Deschauer M (2009) "Efalizumab-induced isolated cerebral lupus-like syndrome." Neurology, 72, p. 96-7

5. Tom WL, Miller MD, Hurley MY, et al. (2006) "Efalizumab-induced autoimmune pancytopenia." Br J Dermatol, 155, p. 1045-7

6. Ashraf-Benson S, Wall GC, Veach LA (2009) "Serum sickness-like reaction associated with efalizumab." Ann Pharmacother, 43, p. 383-6

7. Kitagawa KH, Kalb RE (2008) "Efalizumab treatment associated with Candida colitis." J Am Acad Dermatol, 59(5 Suppl), S120-1

8. Hassan AS, Simon D, Simon HU, Braathen LR, Yawalkar N (2007) "Efalizumab-associated papular psoriasis." Arch Dermatol, 143, p. 900-6

9. Rallis E, Tapinis P, Verros CD (2008) "Efalizumab-induced hypertrichosis." Br J Dermatol

10. Wakkee M, Assen YJ, Thio HB, Neumann HA (2008) "Repigmentation of vitiligo during efalizumab." J Am Acad Dermatol, 59(2 Suppl 1), S57-8

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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