Dosing and uses of Amevive (alefacept)
Dosing Strengths & Forms
powder for injection
- 7.5mg/vial
- 15mg/vial
Psoriasis
Indicated for moderate-to-severe chronic plaque psoriasis
15 mg IM qWeek x 12 weeks
Regimen of 12 weekly injections recommended
Retreatment with additional 12 week course may be initiated, based on normal CD4+ T lymphocyte counts and a minimum 12 week intervaL
Pediatric dosage forms and strengths
Not recommended
Amevive (alefacept) adverse (side) effects
>10%
Injection site reactions (16%)
Lymphopenia (10-50%)
1-10%
Malignancies (1.3%)
Chills (6%)
Pharyngitis (>2%)
Dizziness (>2%)
Nausea (>2%)
Pruritis (>2%)
Myalgia (>2%)
Cough (>2%)
ALT/AST elevation (1.7%)
<1%
Serious infections
Hypersensitivity reactions
CAd
MI
Warnings
Contraindications
Hypersensitivity
CD4+ T lymphocyte count below normaL
HIV pts
Pts at high risk for malignancy
Lactation
Cautions
Monitor CD4+ T lymph counts weekly; withhold dosing if CD4 <250/mcL; discontinue if CD4 <250/mcL for one month
Pts who become pregnant should enroll in the Biogen Pregnancy Registry (1-866-263-8483)
May increase risk of malignancies
Risk of serious infection, anaphylaxis
15 mg lyophilized powder for IM administration ; 7.5 mg lyophilized powder for IV administration
Pregnancy and lactation
Pregnancy category: B
Lactation: excretion in milk unknown/not recommended
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Amevive (alefacept)
Mechanism of action
Recombinant dimeric fusion protein: extracellular CD2-binding portion of human leukocyte function antigen-3 (LFA-3) linked to the Fc portion of human IgG1
Inhibits LFA-3/CD2 interaction, thus inhibits T lymphocyte activation (decreases CD45RO+ T lymphs)
Absorption
Bioavailability: 63% (IM)
Distribution
Vd: 94 mL/kg (IV)
Elimination
Half-Life: 270 hr (IV)
Clearance: 0.25 mL/kg/hr (IV)
Administration
IV/IM Preparation
IV: reconsitute 7.5 mg vial with 0.6 mL of the supplied diluent; 0.5 mL will contain 7.5 mg of drug
IM: reconstitute 15 mg vial with 0.6 mL of supplied diluent; 0.5 mL will contains 15 mg of drug
Withdraw 0.6 mL of supplied diluent using supplied syringe & needle
Keep needle pointed at sidewall of vial & slowly inject diluent
Gently swirl contents during dissolution; do not shake
Reconstituted solution should be clear & colorless to slightly yellow; inspect solution for particulate matter
Do not use if discolored, cloudy, or if undissolved material remains
Do not reconstitute drug with other diluents
Do not filter reconstituted solution during preparation or administration
Use immediately or within 4 hr if stored in the vial at 2-8°C (36-46°F)
IV/IM Administration
Do not add other medications to solutions containing drug
Im
- Withdraw & inject the full 0.5 mL of solution
- Rotate injection sites
- Give new injections at least 1 inch from an old site & never into areas where skin is tender, bruised, red, or hard
IV
- Prepare 2 syringes with 3 mL NS for pre- & post-administration flush
- Prime the winged infusion set with 3 mL NS & insert into vein
- Attach drug-filled syringe to infusion set & administer over no more than 5 sec
- Flush infusion set with 3 mL NS
Other Information
Storage Store between 2-8°C/36-46°F Protect from light
