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- Injection, lyophilized powder for solution 150 mg (designed to deliver 125 mg per 1.25 mL)
Inhibits binding of leukocyte function antigen-1 to intercellular adhesion molecule-1, thereby interfering with the adhesion of leukocytes to other cell types.
Bioavailability following subcutaneous administration is 50%. Steady-state trough concentrations are about 9 mcg/mL.
Mean steady-state Cl is 24 mL/kg/day; mean time to elimination following the last steady-state dose is 25 days.
Indications and Usage
Treatment of chronic moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.
Dosage and AdministrationAdults
Subcutaneous Single 0.7 mg/kg conditioning dose followed by weekly doses of 1 mg/kg (max single dose, 200 mg).
- For subcutaneous administration only. Not for intradermal, IM, or IV administration.
- Reconstitute powder for injection following manufacturer's guidelines using the prefilled diluent syringe provided with medication.
- Do not shake the vial during reconstitution. Do not reconstitute with diluents other than those supplied or add other medications to vial.
- Do not administer if particulate matter, cloudiness, or discoloration is noted.
- Rotate injection sites (thigh, buttocks, abdomen, upper arm). Give new injections at least 1 inch from previous site and never into areas where the skin is tender, bruised, red, or hard.
Reconstituted solution should be administered immediately after reconstitution but can be stored, if necessary, for up to 8 h at room temperature. Discard any unused solution or reconstituted solution that is not used within 8 h of dilution. Do not save for future administration. Store vials in refrigerator (36° to 46°F). Store in original carton until time of use. Protect from light.
Drug InteractionsImmunosuppressive agents
Do not use efalizumab with other immunosuppressive agents.Live vaccines (eg, acellular, live, live-attenuated)
Do not use during efalizumab therapy.
Laboratory Test Interactions
Increased lymphocyte counts related to pharmacologic action are frequently observed.
Headache (32%); chronic inflammatory demyelinating polyneuropathy, facial palsy, Guillain-Barré syndrome, transverse myelitis, (postmarketing).
Acne (4%); psoriasis (1% or 2% more than placebo); urticaria (1%); photosensitivity, toxic epidermal necrolysis (postmarketing).
lymphocytosis (40%); leukocytosis (26%); elevated alkaline phosphatase (4%); elevated LFTs.
Myalgia (8%); arthralgia (1% or 2% more than placebo); myositis (postmarketing).
Eosinophilic pneumonitis (postmarketing).
Infection (29%); chills (13%); pain (10%); fever, flu-like syndrome (7%); antibodies to efalizumab (6%); back pain (4%); malignancies (2%); asthenia, peripheral edema (1% or 2% more than placebo); serious bacterial, viral, fungal, and opportunistic infections; worsening of infections (postmarketing).
Infections, including serious infections leading to hospitalization or death, may occur. Use with caution in patients with a chronic infection or history of recurrent infections.Leukoencephalopathy
Progressive multifocal leukoencephalopathy (PML) resulting from virus infection may occur. Consider PML in any patient with new-onset neurologic manifestations.
Monitor platelet counts prior to and periodically during treatment.Allergic reaction
Monitor patient for signs and symptoms of anaphylactic or serious allergic reactions. Be prepared to treat appropriately if noted.
Category C .
Safety and efficacy not established.
Use with caution because of increased incidence of infections in elderly patients.
Infrequent new-onset or recurrent severe arthritis events, including psoriatic arthritis, have been reported in clinical trials and postmarketing experience. These events may occur during or following treatment.
The conditioning dose is recommended to reduce the incidence and severity of reactions associated with initiation of therapy (eg, headache, fever, nausea, vomiting).
Hemolytic anemia, some serious, has been reported 4 to 6 mo after starting treatment.
Psoriatic patients should receive all age-appropriate immunizations prior to the start of treatment.
The risk of infection and reactivation of latent, chronic infections may be increased. Ensure that patient does not have an active infection prior to starting therapy. Monitor patient for signs and symptoms of infection. Be prepared to discontinue efalizumab if infection is determined to be serious.
Because many immunosuppressants have the potential to increase the risk of malignancies, use with caution in patients at high risk for malignancy or history of malignancy.
Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy, facial palsy, and transverse myelitis have been reported during postmarketing experience.
Thrombocytopenia may occur. Ensure that platelet counts are determined before starting therapy and periodically during treatment. Be prepared to discontinue efalizumab if thrombocytopenia develops or signs or symptoms of thrombocytopenia (eg, petechiae, easy bruising or bleeding) are noted.
Worsening of psoriasis
May occur during or after discontinuation of efalizumab.
- Advise patient to read the patient package insert before starting therapy and with each refill.
- Ensure that the patient or caregiver understands how to store, prepare, and administer the dose, and dispose of used equipment and supplies if administering at home. The first injection should be performed under the supervision of a qualified health care provider.
- Advise patient that if a dose is missed, to contact health care provider to find out when the next dose should be taken and the schedule to follow after that.
- Advise patient to notify health care provider if psoriasis is not improving or appears to be worsening.
- Instruct patient to continue taking other psoriasis medications as prescribed by health care provider.
- Advise patient to report any of the following to health care provider: easy bleeding from gums, fever or other signs of infection, hives, intolerable injection-site reactions, itching, new neurological signs or symptoms, rash, small purple spots under the skin, sore throat, unexplained bruising, unexplained shortness of breath or difficulty breathing.
- Advise women to notify health care provider if they become pregnant while on treatment or within 6 wk after stopping therapy.
Copyright © 2009 Wolters Kluwer Health.