Pronunciation:

e-fa-li-ZOO-mab

Brand Names:

• Raptiva

Dosage Forms:

• Powder for Solution

Classifications:

Therapeutic—

Immune Suppressant

Pharmacologic—

Monoclonal Antibody

Uses of This Medicine:

Efalizumab is used in adult patients to treat moderate to severe 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 efalizumab 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	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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:

• 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.

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

• Thrombocytopenia (not enough platelets in your blood)—May give you a higher chance for bleeding; your doctor may want to stop this medicine if you have a low platelet count.

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

Missed dose—

Call your doctor or pharmacist for instructions.

Storage—

Store in the refrigerator. Do not freeze.

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.

While you are being treated with efalizumab, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. Efalizumab may lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent. In addition, the other persons living in your household should not take oral polio vaccine since there is a chance they could pass the polio virus 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 protective mask that covers the nose and mouth.

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.

Check with you doctor immediately if you notice an unusual bleeding or bruising, 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 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:

Less common

Accumulation of pus

chest pain

cough

cough producing mucus

diarrhea

difficulty in breathing or swallowing

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 tenderness around 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

difficulty in moving

general tiredness and weakness

hearing loss

light-colored stools

muscle pain

pain, swelling, or redness in 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

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

Difficulty in moving

general feeling of 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 loss of strength

pimples

swelling of hands, ankles, feet, or lower legs

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