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Raptiva (Genentech Inc)

Raptiva (Genentech Inc) - General Information

Humanized IgG1 kappa isotype monoclonal antibody that binds to human CD11a. Raptiva (Genentech Inc) has a molecular weight of approximately 150 kilodaltons and is produced in a Chinese hamster ovary mammalian cell expression system in a nutrient medium containing the antibiotic gentamicin.

 

Pharmacology of Raptiva (Genentech Inc)

Lymphocyte activation and trafficking to skin play a role in the pathophysiology of chronic plaque psoriasis. In psoriatic skin, ICAM-1 cell surface expression is upregulated on endothelium and keratinocytes. Raptiva inhibits the binding of LFA-1 to the intercellular adhesion molecule-1 (ICAM-1), thereby inhibiting the adhesion of leukocytes to other cell types.

 

Raptiva (Genentech Inc) for patients

RAPTIVA (Rap-TEE-vah)
(efalizumab)
for injection, subcutaneous

Read the Patient Information that comes with RAPTIVA® (efalizumab) before you start using it and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment. It is important to remain under a healthcare provider's care while using RAPTIVA Do not change or stop treatment without first talking with your healthcare provider. Talk to your healthcare provider or pharmacist if you have any questions about RAPTIVA.

WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT RAPTIVA?

RAPTIVA can decrease the activity of your immune system.

Therefore, people using RAPTIVA may have an increased chance of getting:

�  Serious infections. Some infections could become serious and in rare cases may lead to death. If you have an infection, tell your healthcare provider before you start using RAPTIVA. If you get an infection that does not go away while taking RAPTIVA, tell your healthcare provider right away.

�  Cancers. Many drugs that decrease the activity of the immune system can increase the risk of cancer. If you have had cancer you should tell your healthcare provider before you start taking RAPTIVA. The role of RAPTIVA in the development of cancer is not known.

� Low platelet counts (thrombocytopenia). Platelets help your blood clot. Low platelets give you a higher chance for bleeding. Call your doctor right away if you have increased bruising or bleeding. Your healthcare provider may do regular blood tests to check your platelets while you are taking RAPTIVA.

� Low blood counts (anemia). RAPTIVA may increase the breakdown of your red blood cells and cause very low blood counts. Call your doctor right away if you feel weak and lightheaded, your skin and eyes turn yellow in color or your urine turns red or dark.

� Worsening of psoriasis. Some patients have had severe worsening or new forms of psoriasis while taking RAPTIVA or after stopping RAPTIVA. Tell your healthcare provider right away if your psoriasis gets worse or if you see any new rashes during or after treatment with RAPTIVA.

� Arthritis. Some patients have had worsening or new arthritis while taking RAPTIVA or after stopping RAPTIVA. Tell your health care provider if you have severe redness, pain, swelling, or stiffness of joints such as hands, knees, ankles, etc.

You should not receive vaccines while using RAPTIVA. RAPTIVA may prevent a vaccine from working. Talk to your healthcare provider if you need to receive a vaccine while using RAPTIVA.

WHAT IS RAPTIVA?

RAPTIVA is a medicine used to treat adult patients with moderate to severe plaque psoriasis who can be treated with medicines that affect the whole body (systemic therapy) or with phototherapy.

RAPTIVA is a man-made protein that is like proteins made in the body called antibodies. Antibodies fight disease in the human body. RAPTIVA may decrease the skin changes in the body that are the main problems of moderate to severe plaque psoriasis.

RAPTIVA has not been studied in children under 18 years of age.

WHO SHOULD NOT USE RAPTIVA?

Do not use RAPTIVA if you have ever had an allergic reaction to RAPTIVA.

Before using RAPTIVA, tell your healthcare provider

1. about the following medical conditions:

� If you are pregnant, planning to become pregnant, or become pregnant while using RAPTIVA. It is not known if RAPTIVA can harm your unborn baby. If you become pregnant while taking RAPTIVA, notify your healthcare provider immediately. You and your healthcare provider will have to decide if RAPTIVA is right for you during pregnancy. If you use RAPTIVA when you are pregnant, call 1-877-RAPTIVA (1-877-727-8482) to ask how you can be included in the RAPTIVA Pregnancy Registry.

� If you are breast feeding. It is not known if RAPTIVA passes into your milk. It may harm your baby. You will need to decide whether to use RAPTIVA or breast feed, but you may not do both.

� If you have any infections.

� If you have immune system problems

2. about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

It is not known if RAPTIVA and other medicines affect each other.

Especially, tell your healthcare provider if you are using:

� Other medicines or treatments for your psoriasis

� Medicines called immunosuppressives or any medicine that affects your immune system. Ask your healthcare provider or pharmacist if you are not sure if any of your medicines are immunosuppressives.

HOW SHOULD I USE RAPTIVA?

� RAPTIVA is an injection that you give yourself once a week.

� See the end of this leaflet for instructions on how to prepare and inject RAPTIVA (HOW DO I PREPARE AND GIVE A RAPTIVA INJECTION?). Ask your healthcare provider or pharmacist if you have any questions about using RAPTIVA.

� Use RAPTIVA exactly as prescribed by your healthcare provider. Your dose of RAPTIVA is based on your body weight. Tell your healthcare provider if your weight changes. Do not change your dose without talking to your healthcare provider. Do not stop using RAPTIVA without talking to your healthcare provider.

� RAPTIVA is injected under the skin (subcutaneous) of your upper leg (thigh), upper arm, abdomen, or buttocks once a week. Change (rotate) your skin injection site with each injection.

� Use RAPTIVA the same day each week. If you miss your dose of RAPTIVA, contact your healthcare provider to find out when to take your next dose of RAPTIVA and what schedule to follow after that.

� If you take more than your regular dose of RAPTIVA, call your healthcare provider right away.

� See your healthcare provider regularly while using RAPTIVA. Do not miss your appointments. Your healthcare provider may do blood tests, including platelet counts, before and during treatment with RAPTIVA to check its affect on your body.

WHAT SHOULD I AVOID WHILE USING RAPTIVA?

Unless directed by your healthcare provider, do not:

� take other medicines called immunosuppressives.

� take treatments called phototherapy.

You should not receive vaccines while using RAPTIVA. Talk to your healthcare provider if you need to receive a vaccine while taking RAPTIVA.

WHAT ARE THE POSSIBLE SIDE EFFECTS OF RAPTIVA? RAPTIVA can cause serious side effects including the following:

RAPTIVA can affect your immune system and might cause:

� Serious infections

� Cancers

� Low platelet counts (thrombocytopenia)

� Low blood counts (anemia)

� Worsening of psoriasis

� New or worsening arthritis

The most common side effects of RAPTIVA include headache, chills, fever, nausea, and muscle aches. These reactions usually happen within the first 48 hours following RAPTIVA injection, and often decrease after the first few weeks of use of RAPTIVA.

Other side effects that can also happen with RAPTIVA include back pain or swelling of the arms or legs (peripheral edema). Talk to your healthcare provider about any symptoms that bother you.

If you get any side effect that concerns you or if you get an infection, call your healthcare provider.

These are not all the side effects of RAPTIVA. For more information, ask your healthcare provider or pharmacist.

HOW SHOULD I STORE RAPTIVA?

� Store RAPTIVA vials in the refrigerator at 36° to 46°F (2° to 8°C) until you are ready to prepare your injection. Do not freeze or store at room temperature. Once RAPTIVA has been mixed with sterile water, you should use it right away to inject yourself. If you are unable to inject the drug after mixing, the mixture can stay at room temperature for up to 8 hours. Do not use RAPTIVA that was mixed more than 8 hours earlier.

If you are traveling, be sure to store RAPTIVA at the right temperature. If you have any questions, ask your healthcare provider or pharmacist.

� Protect RAPTIVA vials from light while stored.

� Throw away RAPTIVA vials that are out of date.

� Keep RAPTIVA and all medicines out of the reach of children.

GENERAL INFORMATION ABOUT RAPTIVA

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use RAPTIVA for a condition for which it was not prescribed. Do not give RAPTIVA to other people, even if they have the same symptoms you have. It may harm them.

This leaflet summarizes the most important information about RAPTIVA. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about RAPTIVA that is written for health professionals. For more information, you can also call 1-877-RAPTIVA (toll free).

HOW DO I PREPARE AND GIVE A RAPTIVA INJECTION?

If your dose amount is more than 1.25 mL, you will need to use 2 RAPTIVA blister trays, and you will give yourself 2 injections of RAPTIVA.

Setting Up the Equipment

1. Take the RAPTIVA® (efalizumab) blister tray out of the refrigerator, and place it on a flat, well-lit, clean work surface.

2.  Wash your hands with soap and water before opening the blister tray.

3.  Open the tray and lay out the contents. Allow the contents to come to room temperature.

As shown below, the tray contains:

� One RAPTIVA vial

� One 1.3-mL prefilled syringe of sterile water

� Two 25-gauge needles

� Two alcohol prep pads

Contact your healthcare provider or pharmacist if you are missing any of the items listed above.

4. Check the expiration (Exp.) date on the RAPTIVA vial label and prefilled syringe label. If the expiration date has passed, do not use the RAPTIVA vial or the prefilled syringe containing the sterile water. Contact your healthcare provider.

5. Partially peel open the needle pack and place it on a clean surface. Be sure to grasp the needle by the plastic cover and avoid touching the end of the syringe and the needle.

6.  Remove the plastic cap protecting the rubber stopper of the RAPTIVA vial. Open one alcohol prep pad package and wipe the rubber stopper with an alcohol prep pad. Do not touch the top of the vial after wiping.

7.  Remove the cap covering the prefilled syringe tip. Remove one of the 25-gauge needles from its package by grasping the needle by the plastic cover and without touching the end of the needle. Carefully place the capped 25-gauge needle onto the syringe tip. Twist needle to secure.

Mixing RAPTIVA

1. Remove the needle cap. Do not touch the needle. Keep the RAPTIVA vial upright on a firm surface, and slowly puncture the rubber stopper with the needle. Slowly push down on the syringe plunger to inject all of the 1.3 mL of sterile water onto the side wall of the vial to cause less foaming. Some foaming may happen; this is normal.

2. With the needle and syringe still in the vial stopper, gently swirl the vial to mix. Wait 5 minutes for the medicine to completely dissolve. To avoid excess foaming, do not shake the vial. The RAPTIVA solution should be clear to pale yellow. Do not use the solution if it is discolored or cloudy or if particles (solid matter) are in the solution.

Preparing the RAPTIVA Dose for Injection

If you need more than one vial of RAPTIVA for the correct dose (dose amount is greater than 1.25 mL), repeat Steps 1-7 of this section using a second RAPTIVA blister tray, and divide your dose between two syringes.

1.  Turn the vial upside down, keeping the needle in the vial. (The needle will now be pointing upward.) Make sure the tip of the needle is covered all the way by the medicine in the vial. Pull back the syringe slightly if necessary. This will make it easier to get the medicine into the syringe.

2.  Pull back on the plunger to fill the syringe. Withdraw the correct dose of medicine by reading the numbers on the syringe. Remove the syringe from the vial.

3. Slide the needle into the cap on a flat surface to pick up the needle cap. To lower the chance of a needlestick injury, do not touch the cap until it covers the needle all the way. Push the cap all the way down over the needle

4.  Hold the syringe upright and tap the side of the syringe to let air bubbles rise to the top. Gently push in the plunger of the syringe to push the air bubbles out.

5.  After removing the bubbles, recheck the dose of medicine in the syringe. If necessary, push the plunger again to remove any amount of medicine beyond the line that indicates your dose. Make sure you have the right dose as instructed by your healthcare provider. Twist the capped needle off the syringe and discard it in a puncture-resistant container. Never reuse a needle or syringe.

6.  Remove the other 25-gauge needle from its package by grasping the needle by the plastic cover and without touching the end of the needle. Carefully place the capped 25-gauge needle onto the syringe tip. Twist to secure. Put the syringe down while preparing your skin for injection.

Selecting and Preparing the Injection Site

1. Wash your hands well with soap and water.

2. Choose an area of the body for the injection. Avoid, if possible, skin involved with psoriasis. Possible injection sites include the following:

� Outer area of the upper legs (thighs)

� Stomach area around the belly button

If someone else is giving you an injection, you can also use:

� Back of upper arms

� Buttocks

3.  It is important to change (rotate) the injection site each time you take RAPTIVA to lower your chances of soreness and redness at the injection site. Changing the injection site will also improve absorption of the medication. Repeat injections given in the same area should be at least 1 inch apart. Do not give an injection close to a vein that you can see under the surface of your skin.

4.  Wash the skin at the site of injection with soap and water. Let it air dry.

5.  Cleanse the skin at the injection site with an alcohol prep pad using a circular motion. Let the area air dry all the way. Do not touch this area again before giving the injection.

Giving the RAPTIVA Injection under the Skin

Your healthcare provider will teach you how to inject RAPTIVA. Do not inject RAPTIVA unless you have been taught the right way to give the injection.

1. Hold the syringe and remove the needle cover. Twisting the needle cover while pulling will help in the removal. Do not touch the needle or allow the needle to touch anything.

2.  Hold the syringe in the hand you use to inject yourself. Use your other hand to pinch a patch of skin at the clean injection site. Do not lay the syringe down or allow the needle to touch anything.

3.  Hold the syringe firmly between your thumb and fingers so that you have steady control. Insert the needle straight down at a 90-degree angle. This is important to make sure the medicine is injected into fatty tissue.

4.  After the needle is inserted all the way into the skin, you can gently let go of the pinched skin. Be sure the needle stays in your skin. Slowly and smoothly push the plunger down into the syringe until it stops.

5.  When all of the medicine has been injected, remove the needle and do not re-cap it. Discard the used syringe with the attached needle into a puncture resistant container. Never reuse a needle or syringe. Press a dry, sterile gauze (not provided) over the injection site. Do not

use the alcohol prep pad. A small bandage may be put over the injection site.

6. If your dose amount is more than 1.25 mL, you will need to give a second injection. Choose the second injection site at least 1 inch from the first injection site.

DISPOSAL OF THE SYRINGE, NEEDLES, AND SUPPLIES

1. As stated earlier, place the used syringe with the attached needle in a puncture-resistant container, like a sharps container. You can buy a sharps container at your local pharmacy.

2.  Talk to your healthcare provider about how to properly dispose of a filled container of your used syringes and needles. There may be special local and state laws for disposing of used needles and syringes.

Do not throw the filled container in the household trash and do not recycle.

3.  The needle cap, alcohol prep pads, and other used supplies can be thrown out with your regular trash.

4.  Always keep syringes, injection supplies, and disposal containers out of the reach of children.

5.  Do not reuse these single-use syringes or needles.

 

Raptiva (Genentech Inc) Interactions

No formal drug interaction studies have been performed with RAPTIVA. RAPTIVA should not be used with other immunosuppressive drugs.

Acellular, live and live-attenuated vaccines should not be administered during RAPTIVA treatment.

Drug/Laboratory Test Interactions

Increases in lymphocyte counts related to the pharmacologic mechanism of action are frequently observed during RAPTIVA treatment.

 

Raptiva (Genentech Inc) Contraindications

RAPTIVA should not be administered to patients with known hypersensitivity to RAPTIVA or any of its components.

 

Additional information about Raptiva (Genentech Inc)

Raptiva (Genentech Inc) Indication: For the treatment of adult patients with moderate to severe chronic plaque psoriasis, who are candidates for phototherapy or systemic therapy.
Mechanism Of Action: Raptiva (Genentech Inc) binds to CD11a, a subunit of leukocyte function antigen-1 (LFA-1), which is expressed on all leukocytes. As a result efalizumab decreases cell surface expression of CD11a.
Drug Interactions: Ergonovine The antiretroviral agent may increase the ergot derivative
Food Interactions: Not Available
Generic Name: Efalizumab
Synonyms: Raptiva; anti alphaL integrin; antiCD11 alpha; hu1124
Drug Category: Immunomodulatory Agents; Immunosuppressive Agents
Drug Type: Biotech; Approved; Investigational

Other Brand Names containing Efalizumab: Raptiva (Genentech Inc);
Absorption: Average efalizumab bioavailability following subcutaneous administration was estimated at 30 to 50%.
Toxicity (Overdose): Not Available
Protein Binding: Not Available
Biotransformation: Not Available
Half Life: 5 days
Dosage Forms of Raptiva (Genentech Inc): Powder, for solution Subcutaneous
Chemical IUPAC Name: Humanized anti-CD11a antibody
Chemical Formula: Not Available
Efalizumab on Wikipedia: https://en.wikipedia.org/wiki/Efalizumab
Organisms Affected: Humans and other mammals