Pronunciation:

a-LE-fa-sept, WA-ter, STARE-il

Uses of This Medicine:

Alefacept is used in adult patients to treat moderate to severe psoriasis. This medicine is for patients who have used other medicines that have not worked for their psoriasis.

This medicine is available only with your doctor's prescription.

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—

Studies on this medicine have been done only in adult patients, and there is no specific information comparing the use of alefacept in children with use in other age groups.

Older adults—

Many medicines have not been studied specifically in older people and it may not be known if they work the same way they do in younger adults. Elderly people may have more age related problems than younger people and may need less of this medicine.

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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:

• Human immunodeficiency virus (HIV) infection—This medicine should not be used in patients who have HIV infection.

• Infection, moderate to severe—Alefacept could make your infections worse; your doctor may want to stop this medicine if you get an infection.

• Lymphopenia (small amount of white blood cells)—This medicine could make this condition worse; your doctor may want to stop this medicine if your white blood cell counts are too low.

• Cancer, history of—This medicine should not be used in patients with a history of cancer and it should be used with caution in patients at risk for cancer.

Proper Use of This Medicine:

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For parenteral dosage form
  • Psoriasis
    • Adults—15 milligrams (mg) injected into a muscle once a week for 12 weeks OR 7.5 milligrams (mg) injected into a vein once a week for 12 weeks
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check you at regular visits for any blood problems or any other side effects that may be caused by this medicine.

It is important to check with your doctor if you have any symptoms of an infection such as fever or chills, cough or hoarseness, lower back or side pain, painful or difficult urination. If your symptoms do not improve within a few days or if they become worse, check with your doctor.

You should contact your doctor right away if you develop persistent nausea, anorexia, fatigue, vomiting, abdominal pain, jaundice (yellow eyes and/or skin), easy bruising, dark urine, or pale stools.

It is important to tell your doctor if you become pregnant. Your doctor may want you join a pregnancy registry for patients taking this medicine.

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 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 throat

infections, serious

runny nose

tender, swollen glands in neck

trouble in swallowing

voice changes

Rare

Arm, back or jaw pain

cardiovascular events

chest pain or discomfort

chest tightness or heaviness

fast or irregular heartbeat

nausea

pain or discomfort in 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

Injection site reactions, including pain, swelling, bleeding, skin rash or lumps

Less common

Difficulty in 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.