Amevive

Amevive injection is used to treat chronic plaque psoriasis, which is a skin disease with red and white scales that don’t go away. This medication is given to patients who have used other medications that did not work as well.

Alefacept is an immunosuppressant. It works on the immune system to treat the symptoms of plaque psoriasis.

This medication is to be given only by or under the direct supervision of a doctor.

This product is available in the following forms:

• Powder for Solution

As with all medicines, the risks of using Amevive must be compared to how much this medication will help you. This is a decision that you and your doctor will make together.

For this medication, there are many things that need to be considered:

Allergies

Inform your doctor if you have ever had an allergic reaction to Doxorubicin or to any other medications. It is also important to inform your doctor of any non-medicine allergies such as foods, dyes, preservatives or animals.

Pediatric

This medication is not to be used in children. Safety and efficacy have not been established.

Geriatric

Up-to-date studies have not shown any problems specific to the elderly that would limit the use of this medication in the elderly population.

Pregnancy

This medication is listed as Pregnancy Category B. This means that animal studies have revealed no evidence of harm to the unborn baby, however there are no studies in pregnant women OR animal studies have showed an adverse affect to the unborn baby, but studies in pregnant women have not shown a risk to the unborn baby.

Breastfeeding

There are no up-to-date studies in women for determining infant risk when using this medication while breastfeeding. Weigh the potential risks with the benefits before taking this medication while breastfeeding.

Drug Interactions

Certain medications should not be used together. However, in certain cases, two medications may be used together, even if an interaction might occur. In these cases, your doctor may want to change your dose or take other precautions.

When taking this medication, it is important that you inform your doctor if you are taking any of the medications listed below. The following interactions were selected on the basis of potential significance and are not all-inclusive.

Using this medication with any of the following medication is not recommended, but may be unavoidable in some cases. Your doctor may make the decision not to treat you with this medication or change some of the other medications you take:

• Alfentanil
• Astemizole
• Cisapride
• Cyclosporine
• Dihydroergotamine
• Ergotamine
• Fentanyl
• Pimozide
• Quinidine
• Sirolimus
• Tacrolimus
• Terfenadine
• Warfarin

Other Interactions

Certain medications should not be used while eating, or while eating certain foods in case of negative interactions. Using alcohol or tobacco with certain mediations may also cause negative interactions. Talk with your doctor about the use of your medication with food, alcohol or tobacco.

Other Medical Problems

Pre-existing medical problems may affect the use of this medication. Be sure to tell your doctor if you have any other medical problems, especially:

• Cancer
• HIV or AIDS - Should not be used in patients with these conditions.
• Infection
• Liver disease
• Lymphopenia (low white blood cell count) - Use with caution. May make these conditions worse.

A nurse or other trained health professional will give you Amevive in a hospital. This medication is given as a shot into one of your muscles (intramuscular).

This medication is normally given once a week for 12 weeks. If you doctor decides that you need a second set of injections, you must wait at least 12 weeks before starting the dosing cycle again.

If you have questions, ask your doctor.

You may not see improvement in your skin right away. Your psoriasis may continue to get better even after you have stopped receiving this medication.

This medication comes with a medication guide. It is very important that you read and understand this information. Ask your doctor if you have any questions.

It is very important that your doctor checks in with you often while you are receiving this medication to make sure that it is working properly. Blood tests may be needed to check for unwanted effects.

You may get infections more easily while you receive this medication. Avoid people who are sick or have infections.

Call your doctor immediately if you have signs of infection such as

• Cough or hoarseness
• Lower back or side pain
• Painful or difficult urination
• Fever or chills
• Shortness of breath
• Flu-like symptoms such as runny or stuffy nose
• Headache
• General feeling of illness (malaise)

A small population of patients who received this medication developed cancer. This was rare and most of the cases were skin cancer. Inform your doctor if you have had cancer before. Discuss this risk with your doctor.

This medication may cause serious allergic reactions such as anaphylaxis, angioedema (swelling) and severe itching. These reactions can be life-threatening and require immediate medical attention.

Inform your doctor immediately if you have

• Rash
• Hives or welts
• Itching
• Hoarseness
• Redness of the skin
• Trouble breathing
• Trouble swallowing
• Any swelling of your hands, face, mouth or throat after receiving this medication

Contact your doctor immediately if you develop

• Constant nausea
• Loss of appetite
• Unusual fatigue or weakness
• Vomiting
• Abdominal or stomach pain
• Yellow eyes or skin (jaundice)
• Easy bruising
• Dark urine or pale stool

These could be symptoms of a serious liver problem.

While being treated with this medication and after you stop using it, do not have any vaccines without your doctor’s approval. This medication may lower your body’s resistance and there is a chance you may get the infection the vaccine is meant to prevent.

Inform your doctor if you are using a medication that weakens the immune system, such as a steroid or cancer medication. Inform your doctor if you are receiving phototherapy for your psoriasis.

Amevive may produce unwanted effects along with the intended effects. Although not all of these side-effects may occur, if they do occur, they may need medical attention.

Check with your doctor immediately if you experience any of the following side-effects:

More Common:

• Chills
• Cough
• Fever
• Hoarseness
• Lower back or side pain
• Painful or difficult urination

Less Common:

• Body aches or pain
• Congestion
• Dryness or soreness of the throat
• Runny nose
• Tender, swollen glands in the neck
• Trouble swallowing
• Voice changes

Rare:

• Arm, back, or jaw pain
• Chest pain or discomfort
• Chest tightness or heaviness
• Fast or irregular heartbeat (tachycardia)
• Nausea
• Pain or discomfort in the arms, jaw, back, or neck
• Shortness of breath
• Sweating
• Vomiting

Some side effects that may occur do not normally need medical attention. These may leave as your body becomes accustomed to treatment. Ask your doctor about ways to prevent or reduce some of these side effects. Talk to your doctor if any of the following side effects continue or are bothersome, or if you have questions:

More Common:

• Pain, swelling, bleeding, skin rash or lumps at the injection site

Less Common:

• Difficulty moving
• Dizziness
• Itching skin
• Joint pain
• Muscle aching or cramping
• Muscle pains or stiffness
• Swollen joints

Rare:

• Headache

Some patients may experience other side effects that are not listed. Check with your doctor if you notice any other side effects. Ask your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088.