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Consumer Medicine Information

RAPTIVA^® for Injection

Efalizumab (rch) 125 mg Powder for Injection

What is in this leaflet

This leaflet answers some common questions about RAPTIVA.

It does not contain all of the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines have benefits and risks. Your doctor has weighed the risks of you using RAPTIVA against the benefits it will have for you.

If you have any concerns about using this medicine, ask your doctor or pharmacist.

Keep this information with your medicine. You may want to read it again later.

What is RAPTIVA used for?

RAPTIVA is a medicine containing efalizumab, made by means of biotechnology, used for the treatment of plaque psoriasis. Psoriasis is a chronic skin condition. The safety and efficacy of the use of this product beyond 12 months is not established.

In psoriasis, certain immune system cells are triggered and become overactive where skin grows too quickly and cannot be shed fast enough, typically leading to inflamed, swollen and scaly patches of skin. Plaque psoriasis, the most common form, is characterised by such inflamed patches of skin ("lesions") topped with silvery white scales. Psoriasis may be limited to a few plaques or involve moderate-to-extensive areas of skin, appearing most commonly on the scalp, knees, elbows and trunk. Patients with 10% or more of their body surface area (the palm of the hand is approximately 1%) covered by plaques are classified as having moderate-to-severe psoriasis. Although it is highly visible, psoriasis is not a contagious disease.

RAPTIVA is used to treat adults who have moderate to severe chronic plaque psoriasis (the most common type). Patients should be suitable for phototherapy or systemic therapy.

RAPTIVA is an antibody that prevents certain activated immune cells called T cells, from entering tissues such as the skin.

T cells are a type of white blood cell in the body. In psoriasis, once T cells are mistakenly activated, they can trigger other immune responses and inflammation and activate the development of psoriasis lesions.

Your doctor may prescribe RAPTIVA for another reason. Ask your doctor if you have any questions about why RAPTIVA has been prescribed for you.

RAPTIVA is not addictive. This medicine does not interfere with your ability to drive a car or operate machinery.

This medicine is available only on a doctor's prescription.

Before you use RAPTIVA

Do not use RAPTIVA if:

• You have a history of allergic reactions to any of the ingredients listed at the end of this leaflet;
• You have cancer, including skin cancer;
• You have tuberculosis or any serious infections.

Before you start to use RAPTIVA

Tell your doctor if you have or have had any medical conditions, especially the following:

• An active infection or a history of major infections.
• You have recently had a vaccination or are going to have a vaccination;
• You are pregnant, or intend to become pregnant;
• You are breastfeeding or intend to breastfeed;
• You have any allergies to any other medicines or any other substances such as foods, preservatives or dyes;
• You have a pre-existing neurological condition;
• You have history of kidney or liver disease.

Make sure you tell your doctor about any of the above before you use RAPTIVA.

Taking other medicines

Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop or any other source.

It is important that you tell your doctor if you are using other medicines:

• For psoriasis, such as cyclosporin or methotrexate;
• To treat cancer, some types of arthritis or kidney disease or to prevent rejection in organ transplantation.

Your doctor or pharmacist has more information on medicines to be careful with or to avoid while using RAPTIVA.

When you get your RAPTIVA

Do not use RAPTIVA after the expiry date (month/year) on the packaging has passed.

If your medicine has expired or is damaged, return it to your pharmacist.

Do not use RAPTIVA if the packaging is torn or shows signs of tampering.

If you are not sure about using RAPTIVA, talk to your doctor.

How RAPTIVA is given

Treatment with RAPTIVA should be started under the supervision of a doctor.

Follow all directions given to you by your doctor or pharmacist carefully.

They may differ from the information contained in this leaflet.

RAPTIVA is given once a week by injection, just under the skin.

RAPTIVA should not be given in the same injection with other drugs.

How to inject

If your doctor decides that you or your partner can give the injection, the doctor or a nurse will teach you the injection technique.

Do not self-inject until you are sure of how to do it.

Alternatively, your doctor or a nurse may give you these injections.

Where to inject

RAPTIVA is given as a subcutaneous (under your skin) injection in the thigh, abdominal area or upper arm.

Do not inject into any areas in which you feel lumps, firm knots, depressions, pain or discolouration.

Talk to your doctor if you find anything unusual when injecting.

How much is injected

RAPTIVA should be administered as a single conditioning dose of 0.7 mg/kg followed by weekly injections of 1.0 mg/kg. The maximum single dose should not exceed a total of 200 mg.

Your doctor will determine the dose of RAPTIVA to inject. The dose will depend on your body weight.

Each vial is for single use only.

If you forget to inject RAPTIVA

If you forget to inject RAPTIVA on your usual day of the week. Inject the RAPTIVA, as soon as you remember. Do not inject a double dose to make up for forgotten individual doses.

If you have forgotten your injection for more than one week, contact your doctor for advice on how to proceed.

If you are concerned that you have given yourself too much RAPTIVA

Immediately contact your doctor or the Poisons Information Centre (In Australia telephone 131 126. In New Zealand telephone 0800 POISON or 0800 764 766).

While you are using RAPTIVA

Things you must do

If you are about to be started on any new medicine, tell your doctor and pharmacist that you are using RAPTIVA.

Tell all the doctors, dentists and pharmacists who are treating you that you are using RAPTIVA.

Things you must NOT do

• Stop using RAPTIVA without first talking to your doctor, as stopping suddenly can make your psoriasis worse;
• Change the dose unless your doctor tells you to. Changing your dose without advising your doctor can increase your risk of unwanted side effects or prevent the drug from working properly;
• Give this medicine to anyone else, even if their symptoms seem similar to yours or if they have the same condition as you.

Side effects

Tell your doctor as soon as possible if you do not feel well while using RAPTIVA.

All medicines can have side effects. Sometimes they are serious but most of the time they are not.

If you get side effects do not stop using RAPTIVA without first talking to your doctor.

Ask your doctor or pharmacist to answer any questions you may have.

RAPTIVA can change the way your body prevents infection or cancer.

Tell your doctor if:

• You develop a fever or think you may have an infection. Your doctor will monitor you to see whether you need to stop using RAPTIVA.

Stop using RAPTIVA and tell your doctor if:

• You develop cancer, including skin cancer.

Tell your doctor if you notice any of the following and they worry you:

• Moderate flu-like symptoms including headache, chills, nausea, muscle aches and occasional fever. These may be relieved if paracetamol or other analgesics are taken prior to the injection being given. These symptoms occur most often after the first dose and decrease with time.
• Abdominal pain
• Back pain
• Chest pain
• Migraine
• Swelling of the hands, ankles or feet
• Joint pain
• Worsening or changing of your psoriasis
• Unusual tiredness or weakness
• Acne
• Looking pale and yellowing of the skin and/or eyes
• Weakness or tingling in the legs or arms
• Weakness of face muscles and dribbling
• New or sudden changes in thinking, balance, strength, talking, walking or vision

If any of the following happen, stop using RAPTIVA and tell your doctor immediately or go to the accident and emergency department at your nearest hospital:

• Swelling of the face, lips, tongue or other parts of the body;
• Shortness of breath, wheezing or difficulty breathing;
• Severe skin rash, itching or hives;
• Spontaneous bruising or bleeding from gums;
• Stiffness of the neck and extreme sensitivity to bright light.

These reactions can be life threatening.

Other side effects not listed above may also occur in some patients. Tell your doctor if you notice anything else that is making you feel unwell.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

After using RAPTIVA

Storage

Prior to dissolving, keep the RAPTIVA vial at 2°C to 8°C. (Refrigerate. Do not freeze.) RAPTIVA should be stored in its original container and protect from light.

Once the RAPTIVA powder is dissolved with the diluent provided it should be injected immediately. Although it is not recommended, the solution may be stored at 2°C to 8°C (Refrigerate. Do not Freeze) for up to 24 hours. This is due to the diluent not containing preservative. Any left over solution must be discarded.
RAPTIVA is for single patient use only.

Do not use the dissolved solution if it contains particles or is not clear.

Do not store RAPTIVA in the bathroom or near a sink.

Do not leave RAPTIVA in the car.

Keep RAPTIVA where children cannot reach it.

Disposal

If you are self-injecting, you should discard all sharps in a sharps container.

Each vial of medicine is for single patient use only. Any medicine left over after injecting should be discarded.

Product description

What it looks like

RAPTIVA is a sterile white powder in a vial. Each vial of RAPTIVA contains 125 mg efalizumab.

RAPTIVA is supplied as a kit, containing a single tray. Each single tray contains 4 vials of 125 mg of efalizumab white powder and 4 pre-filled syringes each containing 1.3 mL Sterile Water for Injections and 8 needles.

Ingredients

Active ingredient:

• Efalizumab (rch)

Inactive ingredients:

• Polysorbate 20
• Histidine
• Histidine-hydrochloride
• Sucrose
• Water for Injections

RAPTIVA is supplied in Australia by:
Merck Serono Australia Pty Ltd
3-4/25 Frenchs Forest Road
Frenchs Forest NSW 2086

RAPTIVA is supplied in New Zealand by:
Healthcare Logistics
58 Richard Pearse Drive
Airport Oaks, Auckland

The Australian Registration number for RAPTIVA is AUST R 100484

For enquiries call: 1800 633 463

This leaflet was prepared in November 2008.

© Copyright 2004

HOW TO SELF-INJECT RAPTIVA

RAPTIVA is given by injection under the skin. Each vial is for single use only.

Sometimes the injection will be given to you by a doctor or nurse, or you or your partner may be trained to give the injection at home.

If you administer RAPTIVA to yourself, please carefully read the following instructions:

Step 1. Getting Ready

1. Wash your hands. It is important that your hands and the items you use be as clean as possible.
2. Assemble everything you need. Find a clean area and lay out everything:
   • one vial containing the RAPTIVA powder,
   • one pre-filled syringe containing the diluent,
   • two needles, and
   • a sharps container.
3. Remove the protective cap from the RAPTIVA vial and from the diluent pre-filled syringe.

Step 2. Preparing for your Injection

1. Attach a needle to the pre-filled syringe and slowly inject all the diluent into the RAPTIVA vial.
   
   
2. Swirl the vial with a gentle rotation motion without removing the syringe. Do not shake (Shaking will cause foaming of the RAPTIVA solution). Generally dissolution takes less than 5 minutes. The reconstituted solution should be clear and colourless to pale yellow.
   
   Note:
   • After the powder has dissolved, check the solution for particles and discolouration. The solution should not be used if discoloured or cloudy or contains particles.
   • No other medications should be added to the solution containing RAPTIVA and RAPTIVA should not be reconstituted with other diluents.

   
   

3. Turn the vial upside down, taking care to keep the needle below the level of the liquid;
4. Withdraw the solution into the syringe, removing from the vial only the dose to be given. Some foam or bubbles may remain in the vial
   
   
5. Change the needle and remove any air bubbles;
6. If you see air bubbles in the syringe, hold the syringe with the needle pointing upwards and gently flick the syringe until the air bubbles are gone.

Step 3. Self-Injecting

Immediately inject the solution: Your doctor or nurse will have already advised you where to inject. Sites for self-injection include thigh, abdomen or upper arm. The injection sites should be rotated.

1. Firmly pinch the skin together and insert the needle at a 45° or 90° angle using a dart-like motion. Inject under the skin, as you were taught;
2. Do not inject directly into a vein;
3. Inject the solution by pushing gently on the plunger. Take as much time as you need to inject all the solution. Immediately withdraw the needle.

After Your Injection

Dispose of all used items: Once you have finished your injection, immediately discard all needles and empty glass containers in a sharps container. Any unused solution must be discarded.