(a LE fa sept)
Treatment of moderate-to-severe chronic plaque psoriasis in adults who are candidates for systemic therapy or phototherapy
Hypersensitivity to alefacept or any component of the formulation; patients with HIV infection
Psoriasis (moderate-to-severe chronic plaque psoriasis):
IM: 15 mg once weekly; duration of treatment: 12 weeks
Second course: A second 12-week course of treatment may be initiated at least 12 weeks after completion of the initial course of treatment, provided CD4+ T-lymphocyte counts are within the normal range.
Refer to adult dosing. Use with caution since elderly patients may be at an increased risk for infections and malignancies.
Use has not been evaluated in patients with renal impairment; there are no dosage adjustments provided in manufacturer 's labeling.
Use has not been evaluated in patients with hepatic impairment; there are no dosage adjustments provided in manufacturer 's labeling.
Hazardous agent; use appropriate precautions for handling and disposal (NIOSH, 2012). Reconstitute 15 mg vial for IM solution with 0.6 mL of SWFI (supplied); reconstituted solution contains 15 mg/0.5 mL of alefacept. Gently swirl to avoid excessive foaming. Do not filter reconstituted solutions.
IM injections should be administered at least 1 inch from previous administration sites.
Hazardous agent; use appropriate precautions for handling and disposal (NIOSH, 2012).
Some products may contain sucrose.
Store under refrigeration at 2 ‚ °C to 8 ‚ °C (36 ‚ °F to 46 ‚ °F). Protect from light. Following reconstitution, may be stored for up to 4 hours at 2 ‚ °C to 8 ‚ °C (36 ‚ °F to 46 ‚ °F). Discard any unused solution within 4 hours of reconstitution.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Injection, powder for reconstitution:
Amevive ‚ ®: 15 mg [DSC] [contains sucrose 12.5 mg; for I.M. administration]
Do not mix with other medications or solutions.
BCG: Immunosuppressants may diminish the therapeutic effect of BCG. Avoid combination
Belimumab: Alefacept may enhance the adverse/toxic effect of Belimumab. Avoid combination
Coccidioidin Skin Test: Immunosuppressants may diminish the diagnostic effect of Coccidioidin Skin Test. Monitor therapy
Denosumab: May enhance the adverse/toxic effect of Immunosuppressants. Specifically, the risk for serious infections may be increased. Monitor therapy
Echinacea: May diminish the therapeutic effect of Immunosuppressants. Consider therapy modification
Leflunomide: Immunosuppressants may enhance the adverse/toxic effect of Leflunomide. Specifically, the risk for hematologic toxicity such as pancytopenia, agranulocytosis, and/or thrombocytopenia may be increased. Management: Consider not using a leflunomide loading dose in patients receiving other immunosuppressants. Patients receiving both leflunomide and another immunosuppressant should be monitored for bone marrow suppression at least monthly. Consider therapy modification
Natalizumab: Immunosuppressants may enhance the adverse/toxic effect of Natalizumab. Specifically, the risk of concurrent infection may be increased. Avoid combination
Pimecrolimus: May enhance the adverse/toxic effect of Immunosuppressants. Avoid combination
Roflumilast: May enhance the immunosuppressive effect of Immunosuppressants. Consider therapy modification
Sipuleucel-T: Immunosuppressants may diminish the therapeutic effect of Sipuleucel-T. Monitor therapy
Tacrolimus (Topical): May enhance the adverse/toxic effect of Immunosuppressants. Avoid combination
Trastuzumab: May enhance the neutropenic effect of Immunosuppressants. Monitor therapy
Vaccines (Inactivated): Immunosuppressants may diminish the therapeutic effect of Vaccines (Inactivated). Monitor therapy
Vaccines (Live): Immunosuppressants may enhance the adverse/toxic effect of Vaccines (Live). Vaccinial infections may develop. Immunosuppressants may diminish the therapeutic effect of Vaccines (Live). Management: Avoid use of live organism vaccines with immunosuppressants; live-attenuated vaccines should not be given for at least 3 months after immunosuppressants. Avoid combination
Baseline CD4+ T-lymphocyte counts prior to initiation and every 2 weeks during treatment course; weekly CD4+ T-lymphocyte counts if CD4+ counts are <250 cells/ Ž ¼L during therapy; severity of psoriatic lesions; signs and symptoms of infection
≥10%:
Hematologic: Lymphopenia (up to 10% of patients required temporary discontinuation, up to 17% during a second course of therapy)
Local: Injection site reactions (up to 16% of patients; includes pain, inflammation, bleeding, edema, or other reaction)
1% to 10%:
Central nervous system: Chills (6%; primarily during intravenous administration), dizziness ( ≥2%)
Dermatologic: Pruritus ( ≥2%)
Gastrointestinal: Nausea ( ≥2%)
Hepatic: Transaminases increased (2%; AST and ALT ≥3 times ULN)
Neuromuscular & skeletal: Myalgia ( ≥2%)
Respiratory: Pharyngitis ( ≥2%), cough ( ≥2%)
Miscellaneous: Antibodies to alefacept (3%; significance unknown), infection (1% requiring hospitalization), malignancies ( ≤1%; includes skin, solid organ, lymphomas, leukemias)
<1% (Limited to important or life-threatening): Abscesses, allergic reaction, anaphylaxis, angioedema, appendicitis, C. difficile " “associated diarrhea (CDAD), cellulitis, cholecystitis, fatty liver, gastroenteritis, hepatitis, hepatic failure, herpes infections, MI, opportunistic infections (viral, fungal, bacterial), pneumonia, sepsis, toxic shock, urinary tract infection, wound infections
Concerns related to adverse effects:
- Hepatic injury: In postmarketing reports, significant transaminase elevations, as well as rare cases of hepatitis, fatty liver, decompensation of cirrhosis, and acute hepatic failure have occurred (causal relationship not established). Discontinue if signs and symptoms of hepatic injury occur.
- Hypersensitivity reactions: Has been associated with hypersensitivity reactions. Discontinue if anaphylaxis or severe reaction occurs.
- Immune suppression: May increase the risk of infection and may reactivate latent infection; monitor for new infections. Avoid use in patients with clinically important infections or a history of recurrent infections; not recommended for use in patients receiving other immunosuppressant drugs or phototherapy. Discontinue if a serious infection occurs.
- Lymphopenia: Induces a decline in circulating T-lymphocytes (CD4+ and CD8+); CD4+ lymphocyte counts should be monitored every 2 weeks throughout therapy. Do not initiate in pre-existing depression of CD4+ lymphocytes; withhold treatment in any patient who develops a depressed CD4+ lymphocyte count (<250 cells/ Ž ¼L) during treatment and monitor CD4+ lymphocyte counts weekly; permanently discontinue if CD4+ lymphocyte counts remain <250 cells/ Ž ¼L for 1 month.
- Malignancy: May increase the risk of malignancies; avoid use in patients with a history of systemic malignancy; use caution in patients at high risk for malignancy. Discontinue if malignancy develops during therapy.
Special handling:
- Hazardous agent: Use appropriate precautions for handling and disposal (NIOSH, 2012).
Other warnings/precautions:
- Immunizations: Patients should be brought up to date with all immunizations before initiating therapy. Live vaccines should not be given concurrently; there is no data available concerning secondary transmission of live vaccines in patients receiving therapy.
B
Teratogenic effects have not been observed in animal reproduction studies. Patients who become pregnant during therapy or within 8 weeks of treatment are advised to enroll in pregnancy registry (866-834-7223).
Binds to CD2, a receptor on the surface of lymphocytes, inhibiting their interaction with leukocyte functional antigen 3 (LFA-3). Interaction between CD2 and LFA-3 is important for the activation of T lymphocytes in psoriasis. Activated T lymphocytes secrete a number of inflammatory mediators, including interferon gamma, which are involved in psoriasis. Since CD2 is primarily expressed on T lymphocytes, treatment results in a reduction in CD4+ and CD8+ T lymphocytes, with lesser effects on other cell populations (NK and B lymphocytes).
IV: Vd: 0.094 L/kg
Clearance: IV: 0.25 mL/hour/kg
IV: 270 hours
This medication can only be administered by injection. Report immediately any pain or irritation at injection site; chills; rash; difficulty swallowing or breathing; or feelings of tightness in chest. Avoid alcohol. You will need weekly blood tests while receiving this medication. May cause nausea or muscle pain. Report unusual feelings of fatigue or weakness, signs of infection (eg, cough, runny nose, sore throat, swollen glands, mouth sores, burning on urination, fever, chills), abdominal pain, jaundice, easy bruising, dark urine, or pale stools.