Pronunciation:

a-LEF-a-sept

Brand Names:

• Amevive

Uses of This Medicine:

Alefacept injection is used to treat chronic plaque psoriasis, which is a skin disease with red and white scales that don't go away. This medicine is given to patients who have used other medicines that did not work well.

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

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

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Alefacept injection is not to be used in children. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of alefacept injection in the elderly. However, elderly patients are more likely to have cancers or infections, which may require caution in patients receiving alefacept injection.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alfentanil
• Anifrolumab-fnia
• Astemizole
• Cisapride
• Cyclosporine
• Dihydroergotamine
• Ergotamine
• Fentanyl
• Infliximab
• Pimozide
• Quinidine
• Sirolimus
• Tacrolimus
• Terfenadine
• Warfarin

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Cancer, history of or
• HIV infection or AIDS—Should not be used in patients with these conditions.

• Infection, active or
• Liver disease (including cirrhosis) or
• Lymphopenia (low white blood cells)—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given as a shot into one of your muscles.

This medicine is usually given once a week for 12 weeks. If your 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, talk with 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 medicine.

This medicine comes with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits for any problems or unwanted effects that may be caused by this medicine. Blood tests may be needed to check for unwanted effects.

You may get infections more easily while you are receiving this medicine. Avoid people who are sick or have infections. Call your doctor right away if you start to have signs of an infection such as a cough or hoarseness, lower back or side pain, painful or difficult urination, fever or chills, shortness of breath, or flu-like symptoms such as a runny or stuffy nose, headache, or feeling generally ill.

A small number of people who used this medicine developed cancer. This was rare and most of the cases were skin cancer. Make sure your doctor knows if you have had cancer before. Talk about this risk with your doctor.

This medicine may cause serious allergic reactions such as anaphylaxis, angioedema (swelling), and severe itching. These reactions can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, hives or welts, itching, hoarseness, redness of the skin, trouble breathing, trouble swallowing, or any swelling of your hands, face, mouth, or throat after you receive the medicine.

You should contact your doctor right away if you develop constant nausea, a loss of appetite, unusual tiredness or weakness, vomiting, abdominal or stomach pain, yellow eyes or skin, easy bruising, dark urine, or pale stools. These could be symptoms of a serious liver problem.

Female patients: Tell your doctor if you become pregnant while you are receiving this medicine or within 8 weeks after your last dose.

While you are being treated with alefacept injection and after you stop using it, do not have any immunizations (vaccines) without your doctor's approval. Alefacept may lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent.

Make sure your doctor knows if you are using a medicine that weakens your immune system, such as a steroid or cancer medicine. Make sure your doctor knows if you are also receiving phototherapy (light or laser therapy) for your psoriasis.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

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 with swallowing

voice changes

Rare

Arm, back, or jaw pain

chest pain or discomfort

chest tightness or heaviness

fast or irregular heartbeat

nausea

pain or discomfort in the arms, jaw, back, or neck

shortness of breath

sweating

vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

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

Less common

Difficulty with moving

dizziness

itching skin

joint pain

muscle aching or cramping

muscle pains or stiffness

swollen joints

Rare

Headache

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.