efalizumab

Serious, even fatal, infections have been reported to occur during treatment with efalizumab. Contact your doctor immediately if you develop signs of infection such as fever or chills; sore throat, coughing, congestion or other signs of infection; redness, pain, or swelling of a skin wound; or burning or difficult urination.

Treatment with an immunosuppressant such as efalizumab may increase the risk of developing certain types of cancer (e.g., lymphoma). Talk to your doctor about the risks and benefits of using this medication.

Efalizumab may cause a decreased number of platelets in the blood, which could result in bleeding. Contact your doctor immediately if you develop symptoms of low platelets such as unusual bruising or bleeding, pinpoint red spots under the skin, easy bleeding from the gums, nosebleeds, or black, bloody or tarry stools.

The use of efalizumab has been associated with new or worsening cases of psoriasis. Contact your healthcare provider if you develop a rash, skin condition, or worsening psoriasis during treatment with efalizumab.

Efalizumab is an immunosuppressant. Immunosuppressants decrease the actions of the body's immune system.

Efalizumab is used in the treatment of psoriasis.

Efalizumab may also be used for purposes other than those listed in this medication guide.

Before using efalizumab, tell your doctor if you

• have any active or chronic viral, bacterial, or fungal infection;
• are receiving phototherapy; or
• have a suppressed immune system or take medications that may suppress the immune system (e.g., medicines to prevent rejection of a transplanted organ, some cancer medicines, others).

You may not be able to use efalizumab, or you may require a dosage adjustment or special monitoring if you have any of the conditions listed above.

Efalizumab is in the FDA pregnancy category C. This means that it is not known whether efalizumab will be harmful to an unborn baby. Do not use this medication without first talking to your doctor if you are pregnant or could become pregnant during treatment. Contact your doctor immediately if you become pregnant during, or in the six weeks following, treatment with efalizumab. If pregnancy occurs, your doctor may encourage enrollment in the Raptiva Pregnancy Registry which gathers information about women who become pregnant during or immediately following treatment with efalizumab.

It is not known whether efalizumab passes into breast milk. Do not use efalizumab without first talking to your doctor if you are breast-feeding a baby.

Use efalizumab exactly as directed by your doctor. If you do not understand these directions, ask your doctor, nurse, or pharmacist to explain them to you.

Efalizumab is administered as an injection. Your healthcare provider will give you detailed instructions regarding preparation, administration, and storage of the medication.

Efalizumab is injected subcutaneously (under the skin) into the thigh, upper arm, abdomen, or buttocks. Rotate the injection site as directed by your healthcare provider.

Efalizumab is usually administered once a week. Follow your doctor's instructions.

The dose of efalizumab prescribed is based on body weight. Contact your doctor if your weight changes. Do not change your dose without first talking to your healthcare provider. Do not stop using efalizumab without first talking to your healthcare provider.

After adding the diluent (liquid) to the powder, the vial should be gently swirled, not shaken, to mix the solution. After mixing, the solution should be used right away. If the injection cannot be administered immediately, the mixture can stay at room temperature for up to 8 hours. If it is not used within 8 hours, it must be thrown away.

Never reuse a needle or syringe. Discard needles in an appropriate puncture-resistant container.

It is important to use efalizumab regularly to get the most benefit.

Your doctor may want you to have blood tests or other medical evaluations during treatment with efalizumab to monitor progress and side effects.

Store efalizumab in the refrigerator between 36 to 46 degrees Fahrenheit (2 to 8 degrees Celsius). Do not store the medication at room temperature or allow it to freeze. Protect the vials from light and the reach of children. Throw away unused medication on the expiration date.

Contact your doctor if you miss a dose of efalizumab.

Seek emergency medical attention if an overdose is suspected.

Symptoms of a efalizumab overdose may include nausea or vomiting.

Do not receive vaccines during treatment with efalizumab without first talking to your doctor. Vaccines may not be effective, or may be harmful, if received during treatment with efalizumab. In addition, avoid contact with individuals who have recently been vaccinated with a "live" vaccine (e.g. oral polio vaccine, nasal influenza vaccine). There is a chance that the virus can be passed on to you.

Efalizumab can lower the activity of the immune system making you susceptible to infections. Avoid contact with people who have colds, the flu, or other contagious illnesses. Contact your doctor immediately if you develop any signs of illness or infection.

Tell your doctor and dentist that you are taking this medication before having surgery and before starting any other medicines.

Serious, even fatal, infections have been reported to occur during treatment with efalizumab. Contact your doctor immediately if you develop signs of infection such as fever or chills; sore throat, coughing, congestion or other signs of infection; redness, pain, or swelling of a skin wound; or burning or difficult urination.

Treatment with an immunosuppressant such as efalizumab may increase the risk of developing certain types of cancer (e.g., lymphoma). Talk to your doctor about the risks and benefits of using this medication.

Efalizumab may cause a decreased number of platelets in the blood, which could result in bleeding. Contact your doctor immediately if you develop symptoms of low platelets such as unusual bruising or bleeding, pinpoint red spots under the skin, easy bleeding from the gums, nosebleeds, or black, bloody or tarry stools.

The use of efalizumab has been associated with new or worsening cases of psoriasis. Contact your healthcare provider if you develop a rash, skin condition, or worsening psoriasis during treatment with efalizumab.

If you experience a serious allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives) to efalizumab, seek emergency medical attention.

The most common side effects from efalizumab include headache, chills, fever, nausea, and muscle aches. These side effects usually occur within the first 48 hours after an injection, and often decrease after the first few weeks of use.

Other, less serious side effects may also occur. Continue to take efalizumab and notify your doctor if you experience

• back pain;
• joint pain; or
• swelling of the hands, feet, arms, or legs (peripheral edema).

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

Do not receive vaccines during treatment with efalizumab without first talking to your doctor. Vaccines may not be effective, or may be harmful, if received during treatment with efalizumab. In addition, avoid contact with individuals who have recently been vaccinated with a "live" vaccine (e.g. oral polio vaccine, nasal influenza vaccine). There is a chance that the virus can be passed on to you.

Before using efalizumab, tell your doctor if you are taking any other medicines, especially those that may affect the immune system such as:

• medicines to prevent the rejection of a transplanted organ;
• certain cancer medicines;
• medicines for other immune system disorders; or
• phototherapy.

You may not be able to use efalizumab, or you may require a dosage adjustment or special monitoring if you are taking any of the medicines listed above.

Drugs other than those listed here may also interact with efalizumab. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.

Your pharmacist has additional information about efalizumab written for health professionals that you may read.

Efalizumab is available with a prescription under the brand name Raptiva as an injection. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.