Efalizumab
Pronouncation: (eh-fah-lih-ZOO-mab)Class: Immunosuppressive
Trade Names:
Raptiva
- Powder for injection, lyophilized 150 mg (designed to deliver 125 mg/1.25 mL)
Pharmacology
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Inhibits binding of leukocyte function antigen-1 to intercellular adhesion molecule-1, thereby interfering with the adhesion of leukocytes to other cell types.
Pharmacokinetics
Absorption
Bioavailability following subcutaneous administration is 50%. Steady-state trough concentrations are about 9 mcg/mL.
Elimination
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.
Contraindications
Standard considerations.
Dosage and Administration
AdultsSubcutaneous Single 0.7 mg/kg conditioning dose followed by weekly doses of 1 mg/kg (max single dose, 200 mg).
General Advice
- 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 or reconstitute with diluents other than those supplied or add other medications to vial.
- Do not administer if particulate matter, cloudiness, or discoloration 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.
Storage/Stability
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 Interactions
Immunosuppressive agentsDo 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.
Adverse Reactions
CNS
Headache (32%).
Dermatologic
Acne (4%); psoriasis (1% or 2% greater than placebo).
GI
Nausea (11%).
Lab Tests
Thrombocytopenia, lymphocytosis (40%); leukocytosis (26%); elevated alkaline phosphatase (4%); elevated LFTs.
Musculoskeletal
Myalgia (8%); arthralgia (1% or 2% greater than placebo).
Miscellaneous
Infection (29%); chills (13%); pain (10%); flu-like syndrome, fever (7%); back pain (4%); asthenia, peripheral edema, hypersensitivity (1% or 2% greater than placebo).
Precautions
MonitorAllergic reactionMonitor patient for signs and symptoms of anaphylactic or serious allergic reactions. Be prepared to treat appropriately if noted. |
Pregnancy
Category C .
Lactation
Undetermined.
Children
Safety and efficacy not established.
Elderly
Use with caution because of increased incidence of infections in the elderly.
Infections
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 and immediately report to health care provider if noted. Be prepared to discontinue efalizumab if infection is determined to be serious.
Malignancies
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.
Thrombocytopenia
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.
First-dose reaction
The conditioning dose is recommended to reduce the incidence and severity of reactions associated with initiation of therapy (eg, headache, fever, nausea, vomiting).
Overdosage
Symptoms
Vomiting.
Patient Information
- 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 professional.
- Advise patient that if a dose is missed to contact health care provider to find out when the next dose should be taken and what schedule to follow after that.
- Advise patient to notify health care provider if psoriasis is not improving or appears to be worsening. Caution patient not to change the dose or stop taking unless advised by health care provider.
- 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: intolerable injection site reactions, fever or other signs of infection, sore throat, rash, itching, hives, unexplained shortness of breath or difficulty breathing, easy bleeding from gums, unexplained bruising, small purple spots under the skin.
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More Efalizumab resources:
Efalizumab - Includes detailed dosage instructions.
