Monograph Details
|
|
Dermatological Disorders
> Psoriasis
|
|
AMEVIVE I.M. |
| Manufacturer |
|
Astellas Pharma US, Inc. |
| Legal Classification |
|
Rx
|
| Pharmacological Class |
|
Immunosuppressant. |
| Generic Name |
|
Alefacept 15mg/0.5mL; pwd for IM inj after reconstitution; preservative-free. |
| Also |
|
• AMEVIVE I.V.
|
| Indications |
|
Moderate to severe chronic plaque psoriasis in patients who are candidates for systemic or phototherapy. |
| Children |
|
Not recommended. |
| Adults |
|
7.5mg once weekly as IV bolus or 15mg once weekly as IM inj; both: treat for 12 weeks. May repeat course after 12 treatment-free weeks. |
| Contraindications |
|
Lymphopenia. Clinically important infection (eg, HIV). History of systemic malignancy. |
| Precautions |
|
Monitor CD4+ counts before and every 2 weeks during therapy; withhold and monitor weekly if CD4+ count <250cells/µL; discontinue if a count of <250cells/µL persists for 4 weeks. History or risk of malignancy; discontinue if malignancy develops. Chronic or history of recurrent infections. Monitor closely if new infection develops during or after treatment; discontinue if serious infection develops. Monitor for hepatic injury; discontinue if signficant clinical signs of liver injury occur. Elderly. Pregnancy (Cat.B). Nursing mothers: not recommended. |
| Interactions |
|
Do not give with other immunosuppressants or phototherapy. Caution with concurrent live vaccines. |
| Adverse Reactions |
|
Pharyngitis, dizziness, cough, nausea, pruritus, myalgia, chills, inj site reactions, cardiovascular events, headache, antibody formation, malignancies, infection (may be serious), anaphylaxis, elevated transaminases, hepatic injury/failure. |
| Extra Text |
|
Note: Register pregnant patients exposed to alefacept by calling (866) 263-8483. |
| How Supplied |
|
Single-use vials—1, 4 |
|
|
|
|