Alefacept

What is Alefacept?

• Alefacept (Amevive) is a CD2-directed LFA-3/Fc fusion protein and immunoglobulin G dimer that acts to inactive T cells, and is an immunosuppressive agent that was previously used to treat moderate-to-severe plaque psoriasis.

What are the uses of this medicine?

• Alefacept (Amevive) is a prescription medicine used to treat adults with moderate to severe plaque psoriasis that keeps coming back (chronic), who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light alone or with pills).

How does this medicine work?

• Alefacept (a lef' a sept) is a recombinant fusion protein that combines the lymphocyte function associated antigen-3 (LFA3) with the heavy chain of immunoglobulin G.
• The fusion protein inhibits the binding of endogenous LFA3 to CD2 cells interfering with activation of memory T cells which play an important role in the pathogenesis of inflammatory autoimmune diseases.
• In controlled clinical trials, alefacept therapy improved symptoms and skin lesions in patients with refractory psoriasis.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• have HIV infection

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Be sure to mention the medications listed below:

• immunosuppressive agents
• phototherapy
• warfarin
• cyclosporine
• theophylline

Is this medicine FDA approved?

• Alefacept was approved for use in the United States in 2003 and was the first biological agent approved for treatment of psoriasis.
• However, because of the availability of better tolerated and more effective biologics for psoriasis, alefacept was withdrawn from use by its sponsor in 2011.

How should this medicine be used?

Recommended dosage:

• The recommended dose of Amevive® is 15 mg intramuscularly once weekly for 12 weeks.
• The CD4+ T lymphocyte counts should be measured before initiating dosing.
• Amevive® therapy should not be initiated in patients who have CD4+ T lymphocyte counts below normal.
• Monitor CD4+ T lymphocyte counts every two weeks during the dosing period.
• If CD4+ T lymphocyte counts are below 250 cells/µL, withhold dosing and institute weekly monitoring. Discontinue Amevive® if CD4+ T lymphocyte counts remain below 250 cells/µL for one month (2).
• An additional 12-week course may be initiated if at least 12-weeks have passed since the previous treatment course and the CD4+ T lymphocyte counts are normal

Administration:

• Amevive is given as an injection into your muscle.
• Amevive is usually given one time each week for 12 weeks.
• Talk with your doctor to find out when you will receive injections.
• Keep all of your injection and follow-up appointments.
• It is important for you to stay under your doctor’s care during treatment.
• After you finish 12 weeks of treatment, you will stop treatment for at least 12 weeks.
• Your doctor may then decide that you should receive another 12 week treatment course of Amevive.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As injection; 15 mg of lyophilized powder in a single-use vial for reconstitution with Sterile Water for Injection, USP

This medicine is available in fallowing brand namesː

• Amevive

What side effects can this medication cause?

The most common side effects of this medicine include:

• sore throat
• dizziness
• cough
• nausea
• itching
• muscle aches
• chills
• injection site reactions such as pain, redness

Amevive can cause serious side effects, including:

• Cancers
• Serious Infections
• Serious allergic reactions
• lymphopenia

What special precautions should I follow?

• Amevive induces dose-dependent reductions in circulating CD4+ and CD8+ T lymphocyte counts. CD4+ counts should be normal before initiating treatment with Amevive® and should be closely monitored during Amevive® treatment.
• Amevive may increase the risk of malignancies. Exercise caution when considering the use of Amevive® in patients at high risk for malignancy. Discontinue Amevive® if a patient develops a malignancy.
• Amevive® is an immunosuppressive agent and, therefore, has the potential to increase the risk of infection and reactivate latent, chronic infections. Patients should be monitored for signs and symptoms of infection during or after a course of Amevive®. New infections should be closely monitored. If a patient develops a serious infection, Amevive® should be discontinued.
• Patients receiving other immunosuppressive agents or phototherapy should not receive concurrent therapy with Amevive® because of the possibility of excessive immunosuppression.
• The safety and efficacy of live or live-attenuated vaccines in patients being treated with Amevive® have not been studied.
• Urticaria and angioedema have been associated with the administration of Amevive®. If an anaphylactic reaction or other serious allergic reaction occurs, discontinue Amevive® immediately and initiate appropriate therapy.
• Alefacept is associated with a low rate of serum enzyme elevations during therapy and to rare instances of clinically apparent acute liver injury.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• chills, headache, arthralgia, and sinusitis

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• Patients who have been inadvertently administered an excess of the recommended dose should be closely monitored for effects on total lymphocyte count and CD4+ T lymphocyte count.

Can this medicine be used in pregnancy?

• Pregnancy Category B.
• There are no adequate and well-controlled studies of Amevive® in pregnant women.
• Amevive® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Can this medicine be used in children?

• The safety and efficacy of Amevive® in pediatric patients have not been studied.
• Amevive® is not indicated for pediatric patients.

What are the active and inactive ingredients in this medicine?

• Active ingredient: alefacept
• Inactive Ingredients: citric acid monohydrate, glycine, sodium citrate dehydrate, sucrose. Sterile water for injection is provided as a diluent.

Who manufactures and distributes this medicine?

Manufactured by:

• Astellas Pharma US, Inc.
• Northbrook, IL

What should I know about storage and disposal of this medication?

• Store Amevive® refrigerated between 2-8°C (36-46°F).
• Do not freeze.
• Store in carton until use to protect from light.

Antipsoriasis agents

• Acitretin, Alefacept, Apremilast, Cyclosporine, Methotrexate, Psoralen (Methoxsalen)

Monoclonal Antibodies IL-17A Antagonists

• Brodalumab, Ixekizumab, Secukinumab

Tumor Necrosis Factor Antagonists

• Adalimumab, Certolizumab, Etanercept, Golimumab, Infliximab

Other

• Efalizumab, Guselkumab, Tildrakizumab, Ustekinumab

• Dailymed label info on Alefacept
• FDA Alefacept