Efalizumab Injection (patient information)

Why this medication is prescribed

Efalizumab is used to treat chronic (long-lasting) plaque psoriasis (a skin disease in which red scaly patches form on some areas of the body) in patients who cannot be treated with medications that are applied to the skin. Efalizumab is in a class of medications called immunosuppressants. It works by stopping the action of cells in the body that cause the symptoms of psoriasis.

How this medication should be used

Efalizumab comes as a powder to mix with sterile water and inject subcutaneously (under the skin). It is usually injected once a week. You should inject efalizumab on the same day every week. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use efalizumab exactly as directed. Do not use more or less of it or use it more often or for a longer period of time than prescribed by your doctor.

Your doctor will probably start you on a low dose of efalizumab and increase your dose after 1 week.

Efalizumab controls chronic plaque psoriasis but does not cure it. It may take several weeks before you feel the full benefit of efalizumab. Do not stop taking efalizumab without talking to your doctor.

You can inject efalizumab yourself or have a friend or relative give the injections. Your doctor will train the person who will be injecting the medication, and will test him to be sure he can give the injections correctly. Be sure that you and the person who will be giving the injections read the manufacturer's information for the patient that comes with efalizumab before you use it for the first time at home.

If you are injecting efalizumab yourself, you can inject it anywhere on your thighs or stomach. If someone else will be giving you your injections, he or she can also inject the medication anywhere on the back of your upper arms or buttocks. To reduce the chances of soreness or redness, choose a different area for each injection. If your doctor has told you to use two injections for each dose, choose two spots that are at least 1 inch apart. Do not inject efalizumab near a vein that you can see through the surface of the skin. Try to inject efalizumab in skin that is free of symptoms of psoriasis.

Never reuse needles, syringes, vials of efalizumab, or syringes of sterile water. You can throw away used alcohol pads, needle caps, and vials in the trash. Throw away used needles and syringes in a puncture-resistant container out of the reach of children. Talk to your doctor or pharmacist about what to do with the puncture-resistant container when it is full.

Never mix efalizumab powder with any liquid other than the sterile water provided. Never add any other medications to the syringe you will use to inject efalizumab.

To prepare and inject efalizumab, follow these steps:

1. Take one or two blister trays of efalizumab and supplies out of the refrigerator and place the tray(s) on a clean, well-lit, flat work surface. You will need one tray if your doctor has told you to inject 1.25 mL or less each week or two trays if your doctor has told you to inject more than 1.25 mL each week. You will also need to prepare sterile gauze and an adhesive bandage.
2. Wash your hands well with soap and warm water.
3. Open the blister tray(s) and place the contents on the work surface. Each tray should contain one vial of efalizumab, one prefilled syringe of sterile water, two alcohol pads, and two needles. The vial(s) of efalizumab and syringe(s) of sterile water should be marked with expiration dates that have not passed. Call your pharmacist if your tray(s) do not contain all of these supplies or if your medication or water has expired.
4. Wait to allow the medication and water to warm to room temperatureSteps 5-14 tell how to mix efalizumab with sterile water. If your dose is more than 1.25 mL, you will need to follow these directions twice to prepare two separate vials of efalizumab.
5. Remove the plastic cap from the vial of efalizumab and wipe the rubber stopper with an alcohol pad. When you handle the vial, be careful not to touch the rubber stopper with your fingers.
6. Remove one of the needles from its package, but do not remove the cap.
7. Remove the cap from the tip of the prefilled syringe, and place the capped needle onto the syringe tip. Twist the needle cap to secure it into place.
8. Remove the cap from the needle but be careful not to touch the needle with your fingers.
9. Place the vial of efalizumab upright on a firm surface and slowly push the needle through the rubber stopper.
10. Aim the tip of the needle toward the wall of the vial and slowly push down on the plunger to inject all of the sterile water into the vial. The powder in the vial may foam when you inject the water.
11. Leave the needle and syringe in the vial stopper. Pick up the vial and swirl it gently to mix the medication. Do not shake the vial.
12. Wait 5 minutes to allow the medication to dissolve.
13. Look at the vial to be sure it contains a clear or pale yellow liquid. Call your pharmacist and do not use the liquid if it is cloudy, contains particles, or is a different color.Steps 14-29 tell how to fill the syringe with the correct amount of medication and inject the medication. If your dose is more than 1.25 mL, you will need to follow these steps twice to fill and inject two syringes that each contain half of your dose.
14. Pick up the vial and turn it upside down without removing the needle. The entire tip of the needle should be covered by the liquid in the vial.
15. Pull back the plunger to fill the syringe with the amount of medication your doctor told you to use. (If your dose is more than 1.25 mL, you will fill the syringe with half the amount of medication your doctor told you to use and then prepare a second syringe containing the other half of your dose.) Line up the plunger with the right number on the side of the syringe to fill the syringe with the right amount of medication.
16. Remove the needle and syringe from the vial. Place the needle cap on a flat surface and slide the needle into the cap. Push the cap all the way down over the needle.
17. Hold the syringe upright and tap it to push any air bubbles to the top. Gently push in the plunger to push the air bubbles out.
18. Check that the syringe contains the right amount of medication. If the amount of liquid in the syringe goes past the line that matches your dose, push the plunger up slowly to release the extra medication.
19. Twist the capped needle off of the syringe and throw it away in a puncture-resistant container.
20. Hold the plastic cover of the second needle and remove the needle from the package. Be careful not to touch the uncovered end of the needle.
21. Place the capped needle on the syringe tip and twist it in place. Put the syringe and needle on a flat surface.
22. Wash your hands and the skin in the area where you plan to inject the medication with soap and warm water.
23. Let the skin in the area where you will inject efalizumab air dry, then clean it with an alcohol pad or alcohol-soaked cotton ball using a circular motion. Allow the skin to air dry again and do not touch it with your fingers until after you are finished injecting your medication.
24. Pick up the syringe and remove the needle cap by twisting and pulling it. Be careful not to touch the needle to your fingers or any surface.
25. Hold the syringe firmly between your thumb and fingers with one hand and use your other hand to pinch a fold of skin in the area where you will inject your medication.
26. Push the needle straight into your skin at a 90-degree angle.
27. Let go of the pinched fold of skin and use that hand to slowly push down on the plunger until it stops.
28. Remove the needle from your skin and throw it away in a puncture-resistant container. Do not recap the needle.
29. Use a dry sterile gauze pad to press down on the spot where you injected efalizumab. Do not use an alcohol wipe. You may cover the spot with a small bandage if needed.

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Special precautions

Before using efalizumab:

• tell your doctor and pharmacist if you are allergic to efalizumab or any other medications.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: other medications for psoriasis; oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), and prednisone (Deltasone); and medications that suppress the immune system such as azathioprine (Imuran), cancer chemotherapy medications, cyclosporine (Neoral, Sandimmune), methotrexate (Rheumatrex), sirolimus (Rapamune), and tacrolimus (Prograf). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you or any of your close relatives have or have ever had cancer or if you have or have ever had any disease that affects your immune system such as human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS), or severe combined immunodeficiency syndrome (SCID), or if you have liver or kidney disease. Also tell your doctor if you have any type of infection, including infections that come and go (such as cold sores) and chronic infections that never go away, or if you frequently get any type of infection (such as urinary tract or bladder infections).
• tell your doctor if your psoriasis is being treated with phototherapy (a treatment for psoriasis that involves exposing the skin to ultraviolet light).
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using efalizumab or within 6 weeks after you stop using efalizumab, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are using efalizumab.
• do not have any vaccinations (shots to prevent diseases) without talking to your doctor.
• you should know that efalizumab may decrease your ability to fight infection and increase the risk that you will develop a serious infection. Stay away from people who are sick and wash your hands often while you are using this medication.
• you should know that your psoriasis may worsen or you may develop a new type of psoriasis during or after your treatment with efalizumab. Call your doctor if you notice a new or worsening rash during or after your treatment.
• tell your doctor if you gain or lose weight while you are using efalizumab. Your doctor may have to change the dose of your medication if your weight changes. Do not change the dose of your medication without talking to your doctor.

Special dietary instructions

Unless your doctor tells you otherwise, continue your normal diet.

What to do if you forget a dose

Call your doctor to find out when you should inject your next dose and what schedule you should follow after that. Never inject a double dose to make up for a missed one.

Side effects

Minor side effects

Efalizumab may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache, fever, chills, upset stomach, vomiting, and muscle pain within 48 hours of injecting the first two doses.
• back pain
• acne

Severe side effects

Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:

• sore throat, fever, chills, cough, or other signs of infection
• flu-like symptoms
• easy bruising or bleeding
• bleeding gums
• tiny red spots under surface of skin
• weakness
• lightheadedness
• dark or red urine
• yellowing of the skin or eyes
• red, stiff, swollen, or painful joints
• hives
• itching
• difficulty breathing or swallowing
• wheezing
• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• hoarseness
• rash or blisters
• unusual skin changes or sores on the skin
• new lumps or masses anywhere in your body

Efalizumab may increase the risk that you will develop cancer. Talk to your doctor about the risks of using this medication.

Efalizumab may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/report.htm] or by phone [1-800-332-1088].

Storage conditions needed for this medication

Keep this medication in the carton it came in, tightly closed, away from light, and out of reach of children. Store unopened blister trays of efalizumab in the refrigerator, but do not freeze them. You may store mixtures of efalizumab and sterile water for up to 8 hours at room temperature. Throw away mixtures of efalizumab and sterile water after 8 hours have passed and throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

• severe vomiting

Other information

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to efalizumab.

Before having any laboratory tests, tell your doctor and the laboratory personnel that you are using efalizumab.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

Brand names

• Raptiva®