EFALIZUMAB (Systemic)?

Some commonly used brand names are:

In the U.S.?

• Raptiva

? Not commercially available in Canada.

Category

• Antipsoriatic
• Immunosuppressant

Description

Efalizumab (e-fa-li-ZOO-mab) is used in adult patients to treat moderateto severe psoriasis.

This medicine is available only with your doctor's prescription, in thefollowing dosage forms:

Parenteral
• Subcutaneous injection (U.S.)

Before Using This Medicine

In decidingto use a medicine, the risks of taking the medicine must be weighed againstthe good it will do. This is a decision you and your doctor will make. Forefalizumab, the following should be considered:

Allergies?Tell your doctor if you have ever had any unusualor allergic reaction to efalizumab. Also tell your doctor and pharmacist ifyou are allergic to any other substances, such as foods, preservatives, ordyes.

Pregnancy?Efalizumab has not been studied in pregnant women.Efalizumab has not been shown to cause birth defects or other problems inanimal studies. Efalizumab should be used with caution in pregnant women andshould be used only if clearly needed. Discuss this with your doctor.

Breast-feeding?It is not known whether efalizumab passes intobreast milk. However, in animals efalizumab has been shown to cause adverseeffects in nursing babies. It may be necessary for you to take another medicineor stop breast-feeding during treatment. Be sure you have discussed the risksand benefits of the medicine with your doctor.

Children?Studies on this medicine have been done only inadult patients, and there is no specific information comparing the use ofefalizumab in children with use in other age groups.

Older adults?Many medicines have not been studied specificallyin older people and it may not be known if they work the same way they doin younger adults. Elderly people may have more age-related problems thanyounger people and may need less of this medicine.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takingefalizumab, it is especially important that your doctor and pharmacist knowif you are taking any of the following:

• Immunosuppressive agents (medicines used to lower the body's naturalimmunity)?These can cause your immune system to be weakened and shouldnot be used at the same time as efalizumab.

Other medical problems?The presence of other medicalproblems may affect the use of efalizumab. Make sure you tell your doctorif you have any other medical problems, especially:

• Cancer, history of?This medicine should not be used in patientswith a history of cancer and it should be used with caution in patients atrisk for cancer

• Infection, moderate to severe?Efalizumab could make your infectionworse; your doctor may want to stop this medicine if you get an infection

• Thrombocytopenia (not enough platelets in your blood)?May giveyou a higher chance for bleeding; your doctor may want to stop this medicineif you have a low platelet count

Proper Use of This Medicine

Dosing?The dose of efalizumab will be different for different patients. Follow your doctor's orders or the directions on thelabel. The following information includes only the average doses ofefalizumab. If your dose is different, do not changeit unless your doctor tells you to do so.

• For parenteral dosage form
  • Psoriasis
    • Adults?The dose is based on your body weight and must be determinedby your doctor. This medicine is injected under your skin of your upper leg(thigh), upper arm, abdomen or buttocks once a week. Change (rotate) yourskin injection site with each injection.
    • Children?Use and dose must be determined by your doctor.

Missed dose?If you miss a dose, contact your healthcare providerto find out when to take your next dose of efalizumab and what schedule tofollow after that.

Storage?To store this medicine:

• Keep out of the reach of children.
• Protect from light.
• Store in the refrigerator. However, keep the medicine from freezing.
• Do not keep outdated medicine or medicine no longer needed. Ask yourhealth care professional how you should dispose of any medicine you do notuse. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

It is very important that your doctor check you at regularvisits for any blood problems or any other side effects that may becaused by this medicine.

While you are being treated with efalizumab, and after you stop treatmentwith it, do not have any immunizations (vaccinations)without your doctor's approval. Efalizumab may lower your body's resistanceand there is a chance you might get the infection the immunization is meantto prevent. In addition, the other persons living in your household shouldnot take oral polio vaccine since there is a chance they could pass the poliovirus on to you. Also avoid persons who have recently taken oral polio vaccine.Do not get close to them or stay in the same room with them for very long.If you cannot take these precautions, you should consider wearing a protectivemask that covers the nose and mouth.

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

Check with you doctor immediately if you noticean unusual bleeding or busing, black, tarry stools, blood in urine, or stools,or pinpoint red spots on your skin

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

Side Effects of This Medicine

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

Check with your doctorimmediately if any of the following side effects occur:

Less common

Accumulation of pus; chest pain; cough; cough producing mucus; diarrhea ; difficulty in breathing orswallowing; fast heartbeat; fever or chills; headache; increase bone pain in vertebrae; itching, pain, redness,swelling, tenderness, warmth on skin; loss of appetite; muscle or joint stiffness, tightness, or rigidity; nausea; pain or tendernessaround eyes and cheekbones; rash or redness; shortness of breath; skin itching; sneezing; sore throat; stiff neck or back; stomach pain; stuffy or runny nose; swelling of face,throat, or tongue; swollen, red, tender area of infection; tightness in chest; vomiting; weakness; wheezing

Rare

Back pain; black, tarry stools; bleeding gums; blood in urine or stools; dark urine; difficultyin moving; general tiredness and weakness; hearing loss; light-colored stools; muscle pain; pain, swelling, or rednessin joints; pinpoint red spots on skin; spots on your skin resembling a blister or pimple; small usually colored spots on skin; sudden and severe muscle weakness, sudden and progressing; swollen salivary glands; unusual bleeding or bruising; unusual lumps or skin changes; upper right abdominal pain; yellow eyes and skin

Other side effects may occur that usually do not need medical attention.These side effects may go away during treatment as your body adjusts to themedicine. However, check with your doctor if any of the following side effectscontinue or are bothersome.

More common

Difficulty in moving; general feelingof discomfort or illness; joint pain; loss of appetite; muscle cramping; shivering; sweating; swollen joints; trouble sleeping; unusual tiredness or weakness

Less common

Blemishes on the skin; lack or lossof strength; pimples; swellingof hands, ankles, feet, or lower legs

Other side effects not listed above may also occur insome patients. If you notice any other effects, check with your doctor.