Raptiva - patient leaflet, side effects, dosage | Patient info (2025)

3. HOW TO USE RAPTIVA

Always take Raptiva exactly as your doctor has told you. You should check with your doctor or pharmacist if you are notsure.

Dosing for adults (18–64 years) and the elderly ( > 65years)

The usual dose is an initial single injection of 0.7mg/kg followed by weekly injections of 1.0mg/kg. Your doctor will tell you how much you should inject. The duration of therapy is 12weeks. Therapy may be continued only in patients who responded to treatment, your doctor will discuss with you the extent of your response to treatment.

Method and route of administration

Raptiva is injected just under the skin (subcutaneous). It is for single use only. The injection can be self-administered or given by another person, for example a family member or your doctor. You should continue to inject Raptiva as long as instructed to do so by your doctor.

The vial of powder is designed to be reconstituted (mixed) with the solvent.

If you administer Raptiva, please read the following instructions carefully and follow then step bystep:

Wash your hands. It is important that your hands and items you use be as clean as possible. Take the Raptiva out of the refrigerator and lay out on a clean surface everything youneed:

oone vial containing the Raptiva powder

oone pre-filled syringe containing the solvent

oone EasyMIX adapter for reconstitution

otwo alcohol swabs

oone needle for subcutaneous injection, and

oa sharps container

Remove the protective cap from the Raptiva vial and from the solvent pre-filled syringe. Wipe the top of the vial with an alcoholswab.

Holding the EasyMIX outer cover, carefully peel back and remove the protective film using the tab. This will expose a plastic spiked end that you will use to pierce the vial. You should not touch thisarea.

Holding the EasyMIX outer cover, place it on top of the vial, then press down so that the plastic spiked end pierces the rubber stopper on thevial.

Ensure the EasyMIX adapter is firmly attached to the vial, before removing the outercover.

Pull off the cap covering the pre-filled syringe tip.

Attach the pre-filled syringe containing the solvent to the EasyMIX adapter with a ‘push and twist’ action.

Very slowly push down on the syringe plunger to inject all the solvent into the Raptiva vi Without removing the syringe, gently rotate the vial to dissolve the medicine in thesolven

Do not shake (Shaking will cause foaming of the Raptiva solution).

than 5minutes. After the powder has dissolved, check the resulting discoloration. The reconstituted solution should be clear to pale ye medicines should be added to the solution containing Raptiva and with other solvents.

Raptiva should not be reconstituted

Turn the vial upside down, with the syringe still attached. Withdraw the solution slowly into the syringe, taking more than the dose you need. Some foam or bubbles may remain in the vial. With the syringe still attached to the vial, check the syringe for air bubbles.

Gently tap the syringe to make any bubbles rise to the top of the syringe.

Gently push the plunger up until the dose to be given remains in the syringe. This will also push the bubbles out of the syringe and into the vial. If you eject too much Raptivaback into the vial, simply repeat the drawing up process and continue.

Check you have the right dose, then remove the syringe from the EasyMIX adapter using a ‘twist and pull’ action.

You are now ready to attach the injection needle.

• Take the injection needle and, with its shield still in place, carefully screw it on to the syringetip.

You are now ready to select and prepare your injection site. Your doctor or nurse will have already advised you where to inject. Sites for self-injection include the buttocks, thigh, abdomen or upperarm.

The injection sites should be rotated.

• Wipe the chosen area with an alcohol swab. Remove the shield from the injection needle.
• Immediately inject the solution as follows: Firmly pinch the skin together and insert the needle at a 45° to 90° angle using a dart-like motion. Inject under the skin, as you were taught. Do not inject directly into a vein. Pull back the plunger very slightly. If blood comes into the syringe, the needle has entered a blood vessel. Do not inject but withdraw the needle and repeat the injection procedure. 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 and clean the skin with an alcohol swab using a circular motion.

Dispose of all used items: Once you have finished needles and empty glass containers in a sharps co discarded.

If you use more Raptiva than you should

If you have injected more Raptiva than told by your doctor, please contact your doctor or pharmacist. It is recommended that you are monitored for any signs or symptoms of adverse effects and that you are given appropriate symptomatic treatment immediately.

If you forget to use Raptiva

Do not take a double dose to make up for a forgottendose.

Please contact your doctor if you forget to take 2or more doses of Raptiva.

atment with Raptiva without substitution treatment, your psoriasis may (See “Take special care with Raptiva”)

In case re-treatment with Raptiva is needed you should follow the guidance of your doctor. Retreatment may be associated with lower or inadequate response to Raptiva than in the earlier treatment periods. Therapy should be continued only when adequate response is observed. Your doctor will advise you what to do when insufficient response to treatment or worsening of your disease is observed. (See also under Take Special Care with Raptiva)

If you have any further questions on the use of the product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Raptiva can cause side effects, although not everybody getsthem.

The side effects in this section are given with an estimation of the frequency with which they may occur. For this purpose the following classification has beenused:

• Very common: Side effects that may occur in more than 1out of 10patients;
• Common: Side effects that may occur in 1to 10out of 100patients;
• Uncommon: Side effects that may occur in 1to 10out of 1,000patients;
• Rare: Side effects that may occur in 1to 10out of 10,000patients;
• Very rare: Side effects that may occur in less than 1out of 10,000patients;

Raptiva may cause mild to moderate flu-like symptoms including headache, chills, nausea, musc aches and occasionally fever within 48hours of an injection of Raptiva. These symptoms are ve common and occur most often after the first two doses and decrease with continued use. If any of these symptoms are severe or persist, you should contact your doctor. In clinical trials, visible side effects at the injection site and injection site pain were uncommon.

Tell your doctor or go to the local casualty and stop using Raptiva immediately ifyou:

Notice serious hypersensitivity or allergic reactions, such as anaph allergic reaction are common and generally include overall bod rash. Anaphylaxis is a more serious allergic reaction that ma blood pressure, and difficulty with breathing. Prompt me allergic reactions may be potentially life-threatening.

is. Symptoms of an ing, hives, skin flushing or dizziness, vomiting, low is needed since serious

n your oral cavity.

Notice symptoms of low blood platelet counts, spinpoint red spots on the skin. These symptoms Notice signs of nerve disorder such as tinglin sudden change in thinking, balance, stren Notice severe headache accompanied withn

the beginning of the treatment. Are diagnosed with cancer. Develop a diffuse skin rashor

Back pain, joints pain effects have not be Your doctor Fever or potentia arevery

Tell your doctor and discuss wi

strong worsening of psoriasis or red, inflamed psoriatic plaques, sometimes welling of your arms or legs or joint inflammation, especially after stopping Raptiva. side effects are common.

Certain laboratory tests may change, such as the number of white or red blood cells (including leukocytes and lymphocytes) as well as alkaline phosphatase and ALT values (blood laboratory values). These changes, which may be associated with the use of Raptiva, can usually only be detected with bloodtests.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE RAPTIVA

Keep out of the reach and sight of children.

Store in a refrigerator (2°C– 8°C). Do not freeze.

Store in the original package in order to protect fromlight.

Do not use Raptiva after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of thatmonth.

Do not use if you notice that the solution is not clear or contains particles.

To maintain sterility, Raptiva must be used immediately after first opening and reconstitution.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

• 6.FURTHER INFORMATION

What Raptiva contains

• The active substance is efalizumab, each vial contains a deliverable dose of 125mg efalizumab.
• The other ingredients are polysorbate 20, histidine, histidine hydrochloride monohydrateand

sucrose.

• Each pre-filled syringe of solvent contains sufficient water for injections to make up the solution for injection.

What Raptiva looks like and contents of the pack

Raptiva is presented as a powder and solvent for solution for injection. The powder is a white to off-white cake and the solvent is a colourless liquid. The product is supplied in packs of 1vial of powder, 1pre-filled syringe of solvent, 1EasyMIX adapter for reconstitution, 1needle for injection; in packs of 4vials of powder, 4pre-filled syringes of solvent, 4EasyMIX adapters for reconstitution, 4needles for injection and in packs of 12vials of powder, 12pre-filled syringes of solvent, 12EasyMIX adapters for reconstitution and 12needles for injection. Not all pack sizes may be available in each country.

Italy

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

Luxembourg/Lu­xemburg

MERCK NV/SA

Brusselsesteenweg 288

B-3090Overijse, Belgique/Belgien

Tél/Tel: +32–2–686 07 11

Efc^rapufl

MERCK d.o.o.

Dunajska cesta 119

SI 1000 ^roo.iííHa, CnoBeHua

Ten: +386 1560 3800

Česká republika

Merck spol.s.r.o

Zděbradská 72

CZ-251 01Říčany- Jažlovice

Tel. +420323619211

Magyarország

Merck Kft.

Bocskai út 134–146.

H-1113Budapest Tel: +36–1–463–8100

Malta

Cherubino Ltd

Delf Building

Sliema Road

MT-GZR 06Gzira Malta

Tel: +356–21–343270/1/2/3/

Danmark

E. Merck AB

Strandvejen 102B, 4th

DK-2900Hellerup

Tlf: +4535253550

Deutschland

Serono GmbH

Alsfelder Straße 17

D-64289Darmstadt

Tel: +49–6151–6285–0

0–210–61 65100

EÀÀàôa Merck A. Kupicí GR-1

45, KTípio B apoúci

Nederland

Serono Benelux Tupolevlaan 41NL-1119

Tel: +31–2

Tlf: +47 67 90 35 90

Österreich

Merck GesmbH.

Zimbagasse 5

A-1147Wien

Tel: +43 157600–0

Polska

Merck Sp. zo.o.

Al. Jerozolimskie 178 02–486 Warszawa Polska

Tel.: +48 22 53 59700

España

Merck Farma y Química, S.L.

María de Molina, 40

E-28006Madrid

Línea de Información: 900200400

Tel: +34–91–745 44 00

France

Merck Lipha Santé s.a.s.

37, rue Saint-Romain

F-69379Lyon cedex 08

Tél.: +33–4–72 78 25 25

Numéro vert : 0800888024

Ísland

Gróco ehf.

Pverholti 14

IS-105Reykjavík

Sími: +354–568–8533

Italia

Merck Serono S.p.A.

Via Casilina 125

I-00176Roma

Tel: +39–06–70 38 41

Kùnpoç

Akis Panayiotou & Son Ltd riávvou KpaviSiÓTn 4CY-225 78, ÂeuKœoia Tql: +357–22677038

România

MERCK d.o.o.,

Dunajska cesta 119

SI-1000Lubliana, Slovenia

Tel: +386 1560 3800

Slovenija

MERCK d.o.o.

Dunajska cesta 119

SI-1000Ljubljana

Tel: +386 1560 3800

Slovenská rep Merck spol. sr Tuhovská 3SK-831 06Bra

omi /Finland

erck Oy

Pihatörmä 1C

FI-02240Espoo

Puh/Tel: +358–9–8678700

e

a

ding SA Baltic States o11–3,

87Kauna, Lietuva

+37037320603

Lietuva

Merck Serono

Atstovybe

C/oAres Trading SA Baltic States

Zamenhofo 11–3, LT-44287Kaunas

Tel: +37037320603

United Kingdom

Merck Serono Ltd

Bedfont Cross, Stanwell Road

Feltham, Middlesex TW14 8NX

Tel: +44–2088187200

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