Amevive
What is Amevive?
Amevive (also known by its generic name alefacept) is a biologic medication approved in January 2003 by the U.S. Food and Drug Administration (FDA) for treating moderate to severe plaque psoriasis. For more information about biologics as a class of treatment, please see the biologics section.
Key features
- FDA-approved for treating psoriasis
- Given by intramuscular injection in a doctor's office once per week for 12 weeks
- Additional 12-week treatment cycles might be necessary or recommended
- Blood tests required every two weeks during treatment to monitor immune cell counts
- Long-term side effects still being monitored
How does it work?
Amevive works by blocking the activation of certain immune cells called T cells. T cells are a type of white blood cell in the body; in psoriasis, once T cells are mistakenly activated, they can trigger inflammation and other immune responses and fuel the development of psoriasis lesions.
By blocking T-cell activation and reducing the number of activated T cells in the body, Amevive interrupts the cycle of psoriasis, leading to improvement in symptoms for many people who take it.
Who is a candidate?
Amevive is prescribed for adults with moderate to severe plaque psoriasis who are candidates for phototherapy or other systemic (oral or injected) treatments.
Who should not take Amevive?
- People with a history of malignancy or recurrent infections
- Children—the medication has not been approved for children
Caution is advised for the elderly, due to the already increased risk of infection for this age group.
The impact of Amevive on pregnant women or developing fetuses is not known, nor is it known if
the medication passes into breast milk in nursing women. Amevive should only be given to pregnant
or nursing women if there is a clear medical need, and if this decision is reached by a patient and doctor together. Pregnant women using Amevive should talk to their doctor about enrolling in a pregnancy registry.
How is it used?
Amevive injections are given in a doctor's office into the muscle. Patients receive one injection per week for 12 weeks. Additional 12-week cycles of Amevive treatment may be given, depending on how patients respond the first time, but they must wait at least 12 weeks between cycles. More patients reached the 75 percent and 50 percent improvement targets after two cycles of treatment than after one, indicating there is a cumulative benefit of the medication for some people.
What are the side effects?
The most common side effects reported in clinical studies were:
- sore throat
- dizziness
- increased cough
- itching
- nausea
- muscle aches
- chills
- injection site reaction (pain and inflammation)
These side effects were generally mild and did not cause most patients to stop taking Amevive. These events happened most often after the first dose of Amevive and may decrease after additional doses.
As mentioned earlier, Amevive works by blocking and actually eliminating a specific kind of T cell, which normally helps us fight infections. People who have psoriasis and psoriatic arthritis have far too many of these types of T cells, and Amevive reduces the amount of them in the body. In some patients this causes lymphopenia, a medical term for the reduction of white blood cell counts below normal levels. T-cell counts are monitored weekly while taking Amevive, and if they drop too low your doctor may temporarily stop the treatment to avoid the possible risk of a serious infection. A temporary discontinuation of treatment due to low T-cell counts occurred in about one out of 25 patients (4 percent) in the clinical studies.
Those taking Amevive may have an increased chance of infection or malignancy. Patients taking Amevive in the clinical studies did not experience a significant increase in infections, but those at a high risk for malignancy or with a history of recurrent infections are advised to use caution when considering taking Amevive. People who develop a malignancy or serious infection while on Amevive should stop taking the medication.
Amevive should not be used in patients who have HIV because it may speed up progression of the virus or cause more complications.
Amevive's safety and side effects continue to be montiored by Biogen Idec, and the FDA.
For detailed information on side effects and safety, talk to your doctor.
How do I get Amevive?
Amevive is available by prescription, primarily from dermatologists. Some rheumatologists are prescribing it for psoriatic arthritis. Once a person and his or her doctor make the decision that Amevive is an appropriate treatment, a determination of insurance coverage will need to be made, and preauthorization from the insurance company will likely be needed.
Biogen Idec has a special program where patients and doctors can get help with insurance questions and other issues. For more information, call 866.AMEVIVE (866.263.8483) or visit www.amevive.com.
How much does it cost?
In general, biologics tend to be expensive; the cost of each drug can vary between $10,000 and $25,000 per year (or more), based on the dosage and treatment regimen prescribed by your doctor. Most insurance companies cover this medication for its approved indication: psoriasis. If a person's health insurance will cover Amevive, the exact amount will vary. Some patients will be fully covered for Amevive; others may be partially covered or, in some cases, may have to pay a percentage of the total cost out of pocket. For patients with psoriatic arthritis, insurance coverage may be more difficult to get, because Amevive is not FDA-approved for this disease.
Biogen Idec has a patient assistance program to help provide discounted medications to people who
qualify, based on income levels and other factors. Patients with psoriatic arthritis may not qualify for Amevive's patient assistance program, because Amevive is not FDA-approved for psoriatic arthritis. This program can be reached by calling 866.AMEVIVE (866.263.8483).
Updated March 2008
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