Amevive

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

Stop using alefacept 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 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.

The most common side effects of alefacept are:

• sore throat,
• dizziness,
• cough,
• nausea,
• itching,
• muscle aches,
• chills,
• injection site pain and
• injection site redness and swelling.

The most serious side effects are

• a reduction in the number of immune cells,
• liver failure,
• serious opportunistic infections (for example, fungal infections),
• cancer and
• allergic reactions.

Alefacept should not be used by individuals whose blood lymphocyte counts are less than 250/ml.

AMEVIVE® (alefacept) is a CD2-directed LFA-3/Fc fusion protein that consists of the extracellular CD2-binding portion of the human leukocyte function antigen-3 (LFA-3) linked to the Fc (hinge, CH2 and CH3 domains) portion of human IgGl. Alefacept is produced by recombinant DNA technology in a Chinese Hamster Ovary (CHO) mammalian cell expression system. The molecular weight of alefacept is 91.4 kilodaltons.

AMEVIVE® is supplied as a sterile, white-to-off-white, preservative-free, lyophilized powder for intramuscular administration. After reconstitution with 0.6 mL of the supplied Sterile Water for Injection, USP, the solution of AMEVIVE® is clear, with a pH of approximately 6.9.

AMEVIVE® for intramuscular injection contains alefacept (15 mg), citric acid monohydrate (0.06 mg), glycine (5 mg), sodium citrate dehydrate (3.6 mg), and sucrose (12.5 mg) per 0.5 mL of reconstituted solution.

Amevive is a prescription medication used to treat adults with moderate to severe plaque psoriasis that keeps coming back. Psoriasis is a disease in which rough, red patches form on the skin.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Before starting Amevive, tell your doctor if you think you have an infection or have symptoms of an infection such as:

• swollen glands.
• fever, sweats or chills.
• cough.
• muscle aches.
• shortness of breath.
• blood in your phlegm.
• warm, red, or painful skin or sores on your body.
• burning when you urinate or urinate more often than normal.
• feel very tired.
• get a lot of infections or have infections that keep coming back.

After starting Amevive, call your doctor right away if you have any symptoms of an infection (see above).

Before receiving Amevive, tell your doctor if you:

• are receiving phototherapy for your psoriasis.
• are allergic to Amevive or any of its ingredients. See "Forms of Medication."
• have any other medical conditions.
• are pregnant or plan to become pregnant. It is not known if Amevive will harm your unborn baby. Tell your doctor right away if you become pregnant while receiving Amevive or within 8 weeks after receiving your last dose of Amevive.
• are breastfeeding or plan to breastfeed. It is not known if Amevive passes into your breast milk. You and your doctor should decide if you will take Amevive or breastfeed. You should not do both.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Especially tell your doctor if you receive phototherapy or take any other medicines that affect your immune system, including other medicines for treatment of your plaque psoriasis.

Storage

Parenteral

2–8°C.1 Protect from light; retain dose tray in carton until time of use.1

Store reconstituted solution in vial at 2–8°C; use within 4 hours.1

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

The highest dose tested in humans (0.75 mg/kg intravenous) was associated with chills, headache, arthralgia, and sinusitis within one day of dosing. 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.

Amevive® (alefacept) is a sterile, white to off-white, preservative-free lyophilizate (15 mg/vial) for intramuscular administration provided in single-use glass vials with a bromobutyl rubber stopper and an aluminum overseal. Each vial contains 15 mg of alefacept.

Amevive® is available as follows:

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

Your pharmacist can provide more information about alefacept.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 4.01. Revision date: 9/12/2012.

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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.

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.