Pronunciation:

ef-a-LIZ-oo-mab

Brand Names:

• Raptiva

Dosage Forms:

• Powder for Solution

Warnings:

• Risk of Progressive Multifocal Leukoencephalopathy (PML):
  • Efalizumab increases the risk for PML, a rapidly progressive viral infection of the central nervous system that has no known treatment and that leads to death or severe disability. The risk of PML may markedly increase with longer duration of efalizumab exposure. The time dependent threshold when the risk for PML increases is unknown.
  • Patients on efalizumab should be monitored frequently to ensure they are receiving significant clinical benefit, to ensure they understand the significance of the risk of PML, and for any sign or symptom that may be suggestive of PML.
  • Efalizumab dosing should be withheld immediately at the first sign or symptom suggestive of PML. For diagnosis, brain magnetic resonance imaging (MRI) and, when indicated, cerebrospinal fluid analysis for JC viral DNA are recommended.
• Risk of Serious Infections:
  • Infections, including serious infections leading to hospitalizations or death, have been observed in patients treated with efalizumab. These infections have included bacterial sepsis, viral meningitis, invasive fungal disease and other opportunistic infections. Patients should be educated about the symptoms of infection and be closely monitored for signs and symptoms of infection during and after treatment with efalizumab. If a patient develops a serious infection, efalizumab should be discontinued and appropriate therapy instituted .

Efalizumab increases the risk for progressive multifocal leukoencephalopathy (PML). The risk of PML may markedly increase with longer duration of efalizumab exposure. Monitor patients for signs and symptoms of PML and discontinue therapy if any sign or symptom of PML develops. Serious infections, some leading to hospitalizations or death, have been observed in patients treated with efalizumab and include bacterial sepsis, viral meningitis, invasive fungal disease and other opportunistic infections. Educate patients about the symptoms of infection and monitor for signs and symptoms of infection during and after treatment. Discontinue efalizumab if a serious infection develops .

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 was available only with your doctor's prescription.

Genentech announced on April 8, 2009 that all products containing efalizumab will no longer be available on the market after June 8, 2009, because it may cause a rare but serious side effect.

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

Appropriate studies have not been performed on the relationship of age to the effects of efalizumab in the pediatric population. 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 efalizumab in the elderly. However, elderly patients are more likely to have infections, which may require caution in patients receiving efalizumab.

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:

• Arthritis or
• Thrombocytopenia (low platelet count) Use with caution. May make these conditions worse.

• 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 May make your infection worse. Your doctor may want to stop this medicine if you get an infection.

• Progressive multifocal leukoencephalopathy (PML) Should not be used in patients with this condition.

Proper Use of This Medicine:

This medicine is given as a shot under your skin. Your doctor will teach you how to prepare and inject the medicine. Be sure that you understand exactly how the medicine is prepared and injected.

This medicine comes with a medication guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

You will be shown the body areas where this shot can be given (e.g., the thigh or upper leg, upper arm, abdomen, or buttocks). Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems from the injections.

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 injection dosage form:
  • For treatment of psoriasis:
    • Adults The dose is based on your body weight and must be determined by your doctor.
    • 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.

Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

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 tell your doctor if you become pregnant. Your doctor may want you to join a pregnancy registry for patients taking 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.

This medicine may increase your risk of developing infections, including a serious brain infection called progressive multifocal leukoencephalopathy. Check with your doctor right away if you are having more than one of these symptoms: back pain; blurred vision; confusion; convulsions; dizziness; drowsiness; fever; headache; or unusual tiredness or weakness.

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 your doctor right away if you start having numbness, tingling, or weakness in your arms, legs, or face; or problems with thinking, balance, talking, walking, or vision. These could be symptoms of a nervous system disorder.

Check with you doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.

When you first start using this medicine, you may have a headache, fever, muscle aches, nausea, and vomiting, especially after your first dose. These symptoms usually clear up once you are using the medicine regularly.

Tell your doctor if you want to stop using this medicine. Your psoriasis may become worse if you miss a dose or stop using the medicine altogether.

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

increased bone pain in vertebrae

itching, pain, redness, swelling, tenderness, or warmth on the skin

loss of appetite

muscle or joint stiffness, tightness, or rigidity

nausea

pain or tenderness around the 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 the face, throat, or tongue

swollen, red, or tender area of infection

tightness in the chest

vomiting

weakness

wheezing

Rare

Back pain

black, tarry stools

bleeding gums

blood in the urine or stools

dark urine

difficulty in moving

general tiredness and weakness

hearing loss

light-colored stools

muscle pain

pain, swelling, or redness in the joints

pinpoint, red spots on the skin

small usually colored spots on the skin

spots on your skin resembling a blister or pimple

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

Incidence not known

Back pain, sudden and severe

blistering, peeling, or loosening of the skin

blurred vision

cold or flu-like symptoms

confusion

convulsions

dizziness

drowsiness

general feeling of illness

headache

inability to move arms and legs

increased sensitivity of the skin to sunlight

lower back or side pain

muscle weakness, sudden and progressing

numbness, tingling, pain, or weakness in the hands or feet

painful or difficult urination

red skin lesions, often with a purple center

red, irritated eyes

redness or other discoloration of the skin

severe sunburn

skin rash

sores, ulcers, or white spots in the mouth or on the lips

sudden numbness and weakness in the arms and legs

swollen glands

unusual tiredness or weakness

weakness of the muscles in your face

weight loss

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

Less common

Blemishes on the skin

lack or loss of strength

pimples

swelling of the 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.

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