Patient leaflet - Raptiva
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 not sure.
Dosing for adults (18–64 years) and the elderly ( > 65 years)
The usual dose is an initial single injection of 0.7 mg/kg followed by weekly injections of 1.0 mg/kg. Your doctor will tell you how much you should inject. The duration of therapy is 12 weeks. 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 by step:
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 you need:
o one vial containing the Raptiva powder
o one pre-filled syringe containing the solvent
o one EasyMIX adapter for reconstitution
o two alcohol swabs
o one needle for subcutaneous injection, and
o a 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 alcohol swab.
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 this area.
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 the vial.
Ensure the EasyMIX adapter is firmly attached to the vial, before removing the outer cover.
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 the solven
Do not shake (Shaking will cause foaming of the Raptiva solution).
erally reconstitution takes less ion for particles and
nd free of particles. No other
than 5 minutes. 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 syringe tip.
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 upper arm.
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 forgotten dose.
Please contact your doctor if you forget to take 2 or more doses of Raptiva.
If you stop usin
If you discontinu significantly wor
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 gets them.
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 been used:
- Very common: Side effects that may occur in more than 1 out of 10 patients;
- Common: Side effects that may occur in 1 to 10 out of 100 patients;
- Uncommon: Side effects that may occur in 1 to 10 out of 1,000 patients;
- Rare: Side effects that may occur in 1 to 10 out of 10,000 patients;
- Very rare: Side effects that may occur in less than 1 out of 10,000 patients;
Raptiva may cause mild to moderate flu-like symptoms including headache, chills, nausea, musc aches and occasionally fever within 48 hours 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 if you:
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, s pinpoint 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 with n
the beginning of the treatment. Are diagnosed with cancer. Develop a diffuse skin rash or
y bleeding from the gums, bruising or mon.
of weakness in legs or arms or new or g, walking or vision.
al rigidity. This may occur rarely in particular at
Back pain, joints pain effects have not be Your doctor Fever or potentia are very
Tell your doctor and discuss wi
A re
- x1
with
your general health if you notice any of the following:
, vomiting, weakness, fatigue or rash. These common side y associated with Raptiva but have been observed when using it.
to examine you more closely and ask you to have blood tests.
hat you have an infection. Raptiva acts on the immune system, which may our risk of infectious diseases or may reactivate old infections. Infections
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.
hortness of breath or any persistent respiratory difficulties.
igns of facial paralysis usually on one side of the face (such as weakness of face muscles and dribbling) possibly preceded by pain in the ear area. Generally patients with facial paralysis recover within a few weeks without any specific treatment.
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 blood tests.
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 from light.
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 that month.
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 125 mg efalizumab.
- The other ingredients are polysorbate 20, histidine, histidine hydrochloride monohydrate and
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 1 vial of powder, 1 pre-filled syringe of solvent, 1 EasyMIX adapter for reconstitution, 1 needle for injection; in packs of 4 vials of powder, 4 pre-filled syringes of solvent, 4 EasyMIX adapters for reconstitution, 4 needles for injection and in packs of 12 vials of powder, 12 pre-filled syringes of solvent, 12 EasyMIX adapters for reconstitution and 12 needles 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.
België/Belgique/Belgien
MERCK NV/SA Brusselsesteenweg 288 B-3090 Overijse
Tél/Tel: +32–2–686 07 11
Luxembourg/Luxemburg
MERCK NV/SA
Brusselsesteenweg 288
B-3090 Overijse, 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 1 560 3 800
Česká republika
Merck spol.s.r.o
Zděbradská 72
CZ-251 01 Říčany- Jažlovice
Tel. +420 323619211
Magyarország
Merck Kft.
Bocskai út 134–146.
H-1113 Budapest Tel: +36–1–463–8100
Malta
Cherubino Ltd
Delf Building
Sliema Road
MT-GZR 06 Gzira Malta
Tel: +356–21–343270/1/2/3/
Danmark
E. Merck AB
Strandvejen 102 B, 4th
DK-2900 Hellerup
Tlf: +45 35253550
Deutschland
Serono GmbH
Alsfelder Straße 17
D-64289 Darmstadt
Tel: +49–6151–6285–0
Eesti
Merck Serono
Esindaja
C/o Ares Trading SA Baltic
Zamenhofo 11–3, LT-44
Kaunas, Leedu
Tel: +370 37320603
0–210–61 65 100
EÀÀàôa Merck A. Kupicí GR-1
45, KTípio B apoúci
l-Rijk
Norg
Merck Serono Norge
Nederland
Serono Benelux Tupolevlaan 41 NL-1119
Tel: +31–2
Tlf: +47 67 90 35 90
Österreich
Merck GesmbH.
Zimbagasse 5
A-1147 Wien
Tel: +43 1 57600–0
Polska
Merck Sp. z o.o.
Al. Jerozolimskie 178 02–486 Warszawa Polska
Tel.: +48 22 53 59 700
España
Merck Farma y Química, S.L.
María de Molina, 40
E-28006 Madrid
Línea de Información: 900 200 400
Tel: +34–91–745 44 00
Portugal
Merck, s.a.
Rua Alfredo da Silva, 3-C
P-1300–040 Lisboa
Tel: +351–21–361 35 00
France
Merck Lipha Santé s.a.s.
37, rue Saint-Romain
F-69379 Lyon cedex 08
Tél.: +33–4–72 78 25 25
Numéro vert : 0 800 888 024
Ireland
Merck Serono Ltd
Bedfont Cross, Stanwell Road
Feltham, Middlesex TW14 8NX
United Kingdom
Tel: +44–20 8818 7200
Ísland
Gróco ehf.
Pverholti 14
IS-105 Reykjavík
Sími: +354–568–8533
Italia
Merck Serono S.p.A.
Via Casilina 125
I-00176 Roma
Tel: +39–06–70 38 41
Kùnpoç
Akis Panayiotou & Son Ltd riávvou KpaviSiÓTn 4 CY-225 78, ÂeuKœoia Tql: +357–22677038
România
MERCK d.o.o.,
Dunajska cesta 119
SI-1000 Lubliana, Slovenia
Tel: +386 1 560 3 800
Slovenija
MERCK d.o.o.
Dunajska cesta 119
SI-1000 Ljubljana
Tel: +386 1 560 3 800
Slovenská rep Merck spol. s r Tuhovská 3 SK-831 06 Bra
islava
49 267 111
Tel: +
Sverige
E. Merck AB
S-195 87 Stockholm
Tel: +46–8–562 445 00
omi /Finland
erck Oy
Pihatörmä 1 C
FI-02240 Espoo
Puh/Tel: +358–9–8678 700
Latvija
Merck Ser Pärstävni C/o
e
a
ding SA Baltic States o 11–3,
87 Kauna, Lietuva
+370 37320603
Lietuva
Merck Serono
Atstovybe
C/o Ares Trading SA Baltic States
Zamenhofo 11–3, LT-44287 Kaunas
Tel: +370 37320603
United Kingdom
Merck Serono Ltd
Bedfont Cross, Stanwell Road
Feltham, Middlesex TW14 8NX
Tel: +44–20 8818 7200
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