Amevive

Amevive is a prescription medication used to treat moderate to severe chronic plaque psoriasis in adults. Amevive belongs to a group of drugs called immunosuppressants. It is thought to work by blocking the actions of certain cells of the immune system.

Amevive comes in an injectable form to be given directly into a muscle by a healthcare provider. It is usually given once a week, for 12 weeks.

Common side effects include sore throat, dizziness, and cough. Do not drive or operate heavy machinery until you know how Amevive affects you.

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.

• Astellas Pharma US, Inc.

Amevive can cause serious side effects. See “Drug Precautions”.

Common side effects of Amevive include:

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

Tell your doctor if you have any side effect that bothers you or that does not go away.

This is not a complete list of Amevive drug interactions. Ask your doctor or pharmacist for more information.

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 take other medicines that affect your immune system such as cyclosporine (Neoral, Sandimmune); oral steroids such as prednisone (Deltasone), dexamethasone (Decadron, Dexone), and methylprednisolone (Medrol); azathioprine (Imuran); cancer chemotherapy; sirolimus (Rapamune); and tacrolimus (Prograf).

This is not a complete list of Amevive drug interactions. Ask your doctor or pharmacist for more information.

Amevive can increase your risk for certain types of cancer by its effects on the immune system. Before receiving Amevive, tell your doctor if you have ever had any type of cancer.

Amevive can increase your risk of getting serious infections by lowering the number of certain white blood cells in your body. This can affect the ability of your immune system to fight infections. Your doctor will likely do a blood test before you receive Amevive and every 2 weeks while you receive treatment to check your white blood cell counts. Depending on the blood test results, your doctor may need to either delay or stop your treatment with Amevive. Before receiving Amevive, tell your doctor if you have any kind of infection.

Serious allergic reactions can happen during treatment with Amevive. Call your doctor right away if you get any of the following symptoms of an allergic reaction
with Amevive:

• red-itchy welts (hives) on your skin
• swelling or tingling of your lips, tongue, or inside your mouth

Serious Liver problems. Some patients treated with AMEVIVE develop serious liver
problems, including liver injury. Call your doctor right away if you get any of the following signs and symptoms of serious liver problems:

• yellowing of your skin or the whites of your eyes
• you start to bruise easily
• tiredness
• loss of appetite or vomiting that does not go away, or abdominal pain
• dark urine
• pale stool

Do not use Amevive if you have HIV infection.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Amevive there are no specific foods that you must exclude from your diet when receiving Amevive.

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.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Amevive falls into category B. Animal studies have not shown harm to babies born to pregnant animals. However, animal studies are not always predictive of human response and there are no good studies in pregnant women. Because the risk to the unborn baby is unknown, Amevive should be used during pregnancy only if clearly needed. If pregnancy occurs while taking Amevive, continued use of the drug should be assessed.

Tell your doctor if you 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.

• 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.

The recommended dose of Amevive is 15 mg intramuscularly (in the muscle) once weekly for 12 weeks. An additional 12-week course may be done if at least 12 weeks have passed since the previous treatment course and certain cell counts (CD4+ T lymphocytes) are normal.

Amevive is usually administered by a healthcare provider in a medical setting making it unlikely for an overdose to occur. However, if overdose is suspected, seek emergency medical attention.

Keep all medical and laboratory appointments. It is important that you receive Amevive on schedule to get the most benefit. During treatment, your doctor will ask that you have blood tests to monitor progress and side effects. It is important to have regular monitoring of white blood cell (lymphocyte) counts during therapy with Amevive. The reduction in lymphocytes could increase your chances of developing an infection or a malignancy.