Efalizumab (Subcutaneous Route)

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 .

This product is available in the following dosage forms:

• Powder for Solution

Before Using

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.

Pediatric

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.

Geriatric

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

Breastfeeding

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.

Drug Interactions

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)a€”Use with caution. May make these conditions worse.

• Cancer, history ofa€”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 severea€”May make your infection worse. Your doctor may want to stop this medicine if you get an infection.

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

Proper Use

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:
    
    
    
    • Adultsa€”The dose is based on your body weight and must be determined by your doctor .
    
    
    • Childrena€”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

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

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.