This site is intended for residents of the United States.
Already signed up?
Commonly asked questions about Amevive
What is Amevive?

Amevive® (alefacept) was the first biologic agent approved for treating moderate-to-severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.[1] Amevive is a prescription medication that is injected into the muscle.[1] It is given at your doctor’s office once a week for 12 weeks. You will also need blood tests before and periodically during treatment to check your T-cell levels.[1]

Before taking Amevive, be sure to tell your doctor if you have had a serious infection or cancer. Amevive should not be taken if you are HIV positive. Amevive should not be taken if you are known to be allergic to Amevive or any of its components.[1]

Back to top   Click here to see Important Safety Information

How does Amevive work?

Amevive fights a main source of moderate-to-severe chronic plaque psoriasis— in the cells beneath the skin’s surface.[1, 2] Your immune system is made of billions of cells. One type, T cells, are white blood cells that normally help your body fight infection. In the case of chronic plaque psoriasis, it is thought that some T cells become overactive and send signals to your skin cells to reproduce faster than normal. This results in plaques on your skin. Amevive helps prevent T cells from becoming overactive and sending signals to your skin cells.[1] Plus, Amevive reduces the number of overactive T cells. This generally does not affect your other T cells, so your body can still continue to fight infection.[3]

Back to top   Click here to see Important Safety Information

How is Amevive given?

Amevive is an injection into the muscle given at your doctor’s office once a week for 12 weeks. You will need blood tests before treatment and periodically during treatment to help your doctor guide your treatment.[1] Please see the next question for additional information about the blood tests you will need before and periodically during treatment.

Psoriasis is a chronic disease, so you may need additional treatment. After at least a 12-week treatment break, you and your doctor can decide if and when an additional course of treatment is right for you.[1]

Back to top   Click here to see Important Safety Information

Why do I need to get blood tests while taking Amevive?

Because Amevive can reduce the number of your T cells, you’ll need blood tests before, and every two weeks during treatment to monitor your T-cell levels.[1] Your doctor uses the results of these tests to schedule your doses of Amevive. If T-cell levels are too low, your doctor will check your blood weekly and either delay or stop treatment with Amevive.[1]

Back to top   Click here to see Important Safety Information

What kind of results can I expect with Amevive?

Amevive is a treatment that may provide significant improvement in your moderate-to-severe chronic plaque psoriasis. However, Amevive may not work for everyone. In a clinical study at 2 weeks after dosing ended:[1]

  • 21% of patients saw a 75% improvement* in their psoriasis
    • — Only 5% saw improvement when given placebo
  • 42% of patients saw a 50% improvement* in their psoriasis
    • — In comparison, 18% saw the same results with placebo

*Improvement was measured using a scale called PASI (Psoriasis Area and Severity Index), a standard measure in psoriasis clinical studies.
†What is a placebo? Placebo is a pill, liquid, or powder that looks like active medication but contains no drug. In clinical trials, it is often used as a comparison to assess the effectiveness of an active drug or treatment.

Back to top   Click here to see Important Safety Information

How soon can I expect results?

Amevive may take time to work, so it’s important to be patient. If you respond to Amevive, it may take 8 weeks or longer to see any noticeable changes. That's why it's so important to complete the entire 12 weeks of treatment. In clinical trials, some patients who responded actually experienced their best response after their 12-week treatment ended (maximum skin improvement occurred 6 weeks after the last dose of Amevive).[1,2] Your results may vary.

Back to top

How long can results last?

If you respond, Amevive may keep working while you get 12 weeks—or more—off therapy.[1] Some patients who responded actually experienced their best response after their 12-week treatment ended (maximum skin improvement occurred 6 weeks after the last dose of Amevive).[1,2] Your results may vary. Also, if you and your doctor decide that a second course of Amevive is right for you, your treatment break may last even longer.[4,5]

Back to top   Click here to see Important Safety Information

You should be aware that there are risks associated with taking Amevive for the treatment of moderate-to-severe psoriasis. Commonly reported side effects that occurred in clinical studies with Amevive included sore throat, dizziness, cough, nausea, itching, muscle aches, chills, injection site reactions, and accidental injury.[1] These side effects didn’t stop patients from receiving treatment.

Also, there was a low incidence of serious side effects in clinical trials which did not increase with an additional course of Amevive. Some patients who received Amevive in clinical studies were found to have cancers. Most of these cases were skin cancers. There were also other types of cancer and lymphomas. Some patients developed serious infections, including wound infections and pneumonia.[1,6] Remember to always discuss any side effects you experience with your doctor.

Back to top   Click here to see Important Safety Information

Will my health insurance cover the cost of Amevive?

Amevive is currently covered by many insurance plans. The Amevive Start Assistance Program (ASAP), along with our reimbursement support services, can help you understand the extent of your insurance coverage. For more information, contact Astellas Reimbursement Servicessm at 1-866-263-8483 or visit www.astellasreimbursement.com.

Back to top

What happens if I change insurers?

If such a change occurs, contact Astellas Reimbursement Servicessm at 1-866-263-8483 or visit www.astellasreimbursement.com. A reimbursement specialist will immediately initiate the insurance verification process with your new plan to help facilitate the transition and minimize interruptions in your course of therapy.

Back to top

Will Medicare cover treatment with Amevive?

Medicare typically covers Amevive when it is used for its approved indication. A reimbursement specialist at Astellas Reimbursement Servicessm (1-866-263-8483) will be able to help you answer specific questions regarding your coverage.

Back to top

I am an uninsured patient. Is there an option for me to receive treatment with Amevive?

Astellas is committed to helping uninsured patients receive appropriate assistance. If you are a candidate for treatment with Amevive but are without health insurance or your health insurance does not provide coverage for Amevive, please contact a reimbursement specialist at Astellas Reimbursement Servicessm (1-866-263-8483).

Amevive may be provided at no cost to eligible, uninsured patients. Eligibility requirements include being a permanent US resident or citizen, meeting the financial criteria, and using Amevive for its approved indication.

Back to top

Are there resources for patients who cannot afford their insurance co-payments and/or deductibles?

Independent foundations may be a resource for underinsured patients. These nonprofit organizations offer financial assistance to qualified patients, and also provide disease and treatment information. A reimbursement specialist can provide you with contact information for other independent foundations with chronic plaque psoriasis disease funds. Call Astellas Reimbursement Servicessm at 1-866-263-8483 for more information.

Back to top

What are the independent foundations that may be able to assist underinsured patients, and how can I contact them?

There are currently three independent foundations that offer assistance to underinsured patients with chronic plaque psoriasis:

Back to top

References
  • 1. Amevive® (alefacept) prescribing information, Astellas Pharma US, Inc.
  • 2. Lebwohl M, Christophers E, Langley R, et al. An international, randomized, double-blind, placebo-controlled phase 3 trial of intramuscular alefacept in patients with chronic plaque psoriasis. Arch Dermatol. 2003;139:719-727.
  • 3. Ortonne JP, Lebwohl M, Griffiths CE. Alefacept-induced decreases in circulating blood lymphocyte counts correlate with clinical response in patients with chronic plaque psoriasis. Eur J Dermatol. 2003;13:117-123.
  • 4. Gordon KB, Langley RG. Remittive effects of intramuscular alefacept in psoriasis. J Drugs Dermatol. 2003;2:624-628.
  • 5. Data on file, Astellas Pharma US, Inc.
  • 6. Goffe B, Papp K, Gratton D, et al. An integrated analysis of thirteen trials summarizing the long-term safety of alefacept in psoriasis patients who have received up to nine courses of therapy. Clin Ther. 2005;27:1912-1921.

Back to top

Amevive is approved for the treatment of moderate to severe chronic plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
Important Safety Information
  • Amevive reduces the number of certain T cells. That is part of how it is thought to treat psoriasis. This reduction could increase the possibility of getting an infection or cancer. Before taking Amevive, be sure to tell your doctor if you have had a serious infection or cancer. Amevive should not be taken if you are HIV positive.
  • Because Amevive reduces the number of T cells, you should have a blood test every 2 weeks during the dosing period to check your T-cell levels. If your T-cell levels are too low, your doctor will check your blood weekly and will either postpone or stop treatment with Amevive.
  • Some patients who received Amevive in clinical studies were found to have cancers. Most of these cases were skin cancers. There were also other types of cancer and lymphomas. Some patients developed serious infections, including wound infections and pneumonia.
  • During and after taking Amevive, if you notice anything unusual about your health or any signs of infections such as swollen glands, fever, or chills, notify your doctor right away.
  • Amevive should not be taken if you are known to be allergic to Amevive or any of its components, since serious allergic reactions such as hives, with or without swelling of the mouth and tongue, have been seen.
  • Some patients treated with Amevive have had serious liver injury. If your skin or the whites of your eyes become yellow, if you start to bruise easily, or if you have persistent loss of appetite or vomiting, you should call your doctor right away.
  • Commonly reported side effects that occurred in clinical studies with Amevive included sore throat, dizziness, cough, nausea, itching, muscle aches, chills, injection site reactions, and accidental injury.

If you become pregnant during treatment with Amevive, tell your doctor and consider enrolling in the Pregnancy Registry by calling 1-866-834-7223. Information collected in this program is kept confidential.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit fda.gov/medwatch or call 1-800-FDA-1088.

Please see the full prescribing information and talk to your doctor for more information.