Alefacept Intramuscular

Mild pain/swelling/bleeding at the injection site and chills may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor immediately if any of these unlikely but serious side effects occur: symptoms of liver damage (e.g., severe nausea/vomiting, stomach/abdominal pain, dark urine, yellowing eyes/skin).Rarely, this medication may increase the risk of developing cancer. Tell your doctor immediately if you develop symptoms such as: unusual lumps, swollen glands, skin sores/spots that are new or change appearance.This medication can lower the body's ability to fight an infection. Tell your doctor promptly if you develop any signs of an infection such as fever, muscle aches, or persistent sore throat.A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

In the U.S.

• Amevive

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Immune Suppressant

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 alefacept, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to alefacept 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.

Pediatric

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

Geriatric

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.

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.

Interactions with 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 alefacept, 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 alefacept 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
• Astemizole
• Cisapride
• Cyclosporine
• Dihydroergotamine
• Ergotamine
• Fentanyl
• Pimozide
• Quinidine
• Sirolimus
• Tacrolimus
• Terfenadine
• Warfarin

Interactions with Food/Tobacco/Alcohol

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 alefacept. 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.

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

alefacept 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 alefacept.

alefacept 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.

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

You may get infections more easily while you are receiving alefacept. 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 alefacept 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.

alefacept 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 alefacept 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.

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.