Amevive is a protein that reduces specific actions of the immune system that are involved in causing psoriasis.

Amevive is used to treat plaque psoriasis (raised, silvery flaking of the skin) in adults.

Amevive may also be used for purposes not listed in this medication guide.

You should not use Amevive if you are allergic to alefacept, or if you have HIV (human immunodeficiency virus).

Before using Amevive, tell your doctor if you have an active or chronic infection, liver disease, a history of cancer, or if you are receiving phototherapy or using drugs that weaken the immune system.

Do not receive a "live" vaccine while using Amevive. Live vaccines include measles, mumps, rubella (MMR), Bacillus Calmette-Guérin (BCG), oral polio, rotavirus, smallpox, typhoid, yellow fever, varicella (chickenpox), H1N1 influenza, and nasal flu vaccine.

Amevive can lower blood cells that help your body fight infections. Your blood may need to be tested often. Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Using Amevive may increase your risk of developing certain types of cancer. Talk with your doctor about your specific risk.

Serious and sometimes fatal infections may occur during treatment with Amevive. Call your doctor right away if you have signs of infection such as: fever, chills, flu symptoms, mouth sores, swelling or warmth, skin redness or oozing, stabbing chest pain, feeling short of breath, or cough with yellow or green mucus.

Use Amevive exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Amevive is usually given once every week for 12 weeks. Follow your doctor's dosing instructions very carefully.

Amevive is injected into a muscle. You may be shown how to use injections at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

Amevive is a powder medicine that must be mixed with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medicine.

Do not shake the mixed medicine or it may foam. Prepare your dose in a syringe only when you are ready to give yourself an injection. Do not use the medication if it has changed colors or has particles in it. Call your pharmacist for new medication.

After mixing Amevive with a diluent, store in the refrigerator and use it within 4 hours. Do not freeze.

Your care provider will show you the best places on your body to give your injection (shot). Give each shot at least 1 inch away from where the last shot was injected. Do not inject into the same place two times in a row. Do not inject Amevive into skin that is tender, bruised, red, or hard (including an active psoriasis lesion).

Use a disposable needle only once. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

Each single-use vial (bottle) of Amevive is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.

Amevive can lower blood cells that help your body fight infections and help your blood to clot. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Serious and sometimes fatal infections may occur during treatment with Amevive. Your blood may need to be tested often. Visit your doctor regularly.

Store Amevive in its original container in the refrigerator. Do not freeze. Protect from light.

Usual Adult Dose of Amevive for Psoriasis:

7.5 mg once a week as an IV bolus or 15 mg once a week as an IM injection.

The recommended regimen is a course of 12 weekly injections. Retreatment with an additional twelve week course may be initiated provided that CD4+ T lymphocyte counts are within the normal range, and a minimum of a twelve week interval has passed since the previous course of treatment. Data on retreatment beyond two cycles are limited.

The CD4+ T lymphocyte counts of patients receiving alefacept should be monitored weekly before initiating dosing and throughout the course of the twelve week dosing regimen. Dosing should be withheld if CD4+ T lymphocyte counts are below 250 cells/microliter. The drug should be discontinued if the counts remain below 250 cells/microliter for one month.

You should not use Amevive if you are allergic to alefacept, or if you have HIV (human immunodeficiency virus).

To make sure you can safely take Amevive, tell your doctor if you have other medical conditions, especially:

• an active or chronic infection;

• a history of cancer;

• liver disease;

• if you are receiving phototherapy (light therapy); or

• if you use drugs that weaken the immune system (such as cancer medicine, steroids, and medicine to prevent organ transplant rejection).

Using Amevive may increase your risk of developing certain types of cancer. Talk with your doctor about your specific risk.

FDA pregnancy category B. Amevive is not expected to harm an unborn baby. However, tell your doctor if you become pregnant during treatment or within 8 weeks after you stop using Amevive.

It is not known whether alefacept passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using Amevive.

Call your doctor for instructions if you miss a dose of Amevive.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe forms of some of the side effects listed in this medication guide.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Do not receive a "live" vaccine while using Amevive. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), Bacillus Calmette-Guérin (BCG), oral polio, rotavirus, smallpox, typhoid, yellow fever, varicella (chickenpox), H1N1 influenza, and nasal flu vaccine.

Get emergency medical help if you have any of these signs of an allergic reaction to Amevive: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using Amevive and call your doctor at once if you have a serious side effect such as:

• fever, chills, body aches, flu symptoms, sores in your mouth and throat;

• cough with yellow or green mucus, stabbing chest pain, wheezing, feeling short of breath;

• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• swelling, warmth, redness, itching, or oozing from the skin;

• new skin lesions, or a sunburn-like skin rash; or

• worsening or no improvement of your skin condition.

Less serious Amevive side effects may include:

• sore throat, cough;

• dizziness;

• mild nausea;

• headache;

• itching;

• muscle pain;

• pain or swelling where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all other medicines you use, especially:

• a blood thinner such as warfarin (Coumadin, Jantoven);

• cyclosporine (Gengraf, Neoral, Sandimmune);

• digoxin (digitalis, Lanoxin, Lanoxicaps);

• fentanyl (Abstral, Actiq, Fentora, Duragesic, Lazanda, Onsolis);

• levothyroxine (Synthroid, Levothroid);

• lithium (Eskalith, Lithobid);

• pimozide (Orap);

• sirolimus (Rapamune) or tacrolimus (Prograf);

• theophylline (Elixophyllin, Theo-24, Theochron, Uniphyl);

• ergot medicine such as ergotamine (Ergomar, Cafergot) or dihydroergotamine (D.H.E. 45, Migranal Nasal Spray);

• seizure medication such as carbamazepine (Carbatrol, Equetro, Tegretol), divalproex (Depakote), ethosuximide (Zarontin), phenytoin (Dilantin), or valproic acid (Depakene, Stavzor); or

• heart rhythm medication such as disopyramide (Norpace), procainamide (Procan, Pronestyl), or quinidine (Quin-G).

This list is not complete and other drugs may interact with Amevive. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.