SPINRAZA 12 mg Инъекционный Раствор

Содержание инструкции

1. Spinraza 12 mg injectable solution
   1. What is Spinraza and what is it used for
   2. What you need to know before you or your child receive Spinraza
   3. How Spinraza is administered
   4. Possible side effects
   5. How to store Spinraza
   6. Contents of the pack and other information

Spinraza 12 mg injectable solution

nusinersen

Read this leaflet carefully before you or your child receive this medicine because
it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you or your child gets any side effects, even those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet

• 1. What Spinraza is and what it is used for
• 2. What you need to know before you or your child receive Spinraza
• 3. How Spinraza is administered
• 4. Possible side effects
• 5. How to store Spinraza
• 6. Contents of the pack and other information

1. What is Spinraza and what is it used for

Spinraza contains the active substance nusinersen, which belongs to a group of medicines known as

antisense oligonucleotides. Spinraza is used for the treatment of a genetic disease called

spinal muscular atrophy(SMA).
Spinal muscular atrophyis caused by a deficiency of a protein called survival of motor neuron

(SMN) in the body, which leads to the loss of nerve cells in the spinal cord, resulting in weakness of the muscles of the shoulders, hips, thighs, and upper back. It can also weaken the muscles used for breathing and swallowing.
Spinraza works by helping the body to produce a greater amount of SMN protein, which people with SMA are lacking. This reduces the loss of nerve cells and may thus improve muscle strength.

2. What you need to know before you or your child receive Spinraza

Spinraza must not be administered

• if you or your child is allergic to nusinersenor to any of the other ingredients of this medicine (listed in section 6).

If you have any doubts, consult your doctor or nurse before you or your child receive Spinraza.

Warnings and precautions
There is a risk of adverse effects occurring after the administration of Spinraza with a
lumbar puncture procedure (see section 3). These may include headache, vomiting and back
pain. There may also be difficulties in administering a medicine using this method
in very young patients and in those with scoliosis (rotation and curvature of the spine).
Other medicines belonging to the same group as Spinraza have shown an effect on blood
cells that promote coagulation. Before you or your child receive Spinraza, the doctor
may decide to perform a blood test to check correct coagulation. This test
may not be necessary every time you or your child receive Spinraza.
Other medicines belonging to the same group as Spinraza have shown an effect on the kidneys.
Before you or your child receive Spinraza, the doctor may decide to perform a urine test
to check the correct functioning of the kidneys. This test may not be necessary every
time you or your child receive Spinraza.
There have been a small number of reports of patients who have developed hydrocephalus (accumulation of
excess fluid around the brain) after the administration of Spinraza. For some
of these patients, treatment of hydrocephalus has required the implantation of a device called a
ventriculoperitoneal shunt. If you notice symptoms of increased head size, decreased
level of consciousness, nausea, vomiting or persistent headache, or other symptoms that cause
concern, inform your doctor or your child's doctor to receive the necessary treatment. The
benefits and risks of continuing treatment with Spinraza after implantation of a
“ventriculoperitoneal shunt” are not known at this time.
Consult your doctor before you or your child receive Spinraza.

Other medicines and Spinraza
Tell your doctor if you or your child are taking, have recently taken or might take
any other medicine.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant or are breastfeeding
with breast milk, ask your doctor for advice before receiving this medicine. It is preferable to avoid
using Spinraza during pregnancy and breastfeeding.

Driving and using machines
Spinraza does not or negligibly alters the ability to drive vehicles and use machines.

Spinraza contains a small amount of sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 5 ml vial, i.e.
essentially ‘sodium-free’ and can be used by people following a low-sodium diet.

Spinraza contains a small amount of potassium
This medicine contains potassium, less than 1 mmol (39 mg) per 5 ml vial, i.e.
essentially ‘potassium-free’.

3. How Spinraza is administered

The usual dose of Spinraza is 12 mg.
Spinraza is administered:

• On the first day of treatment, day 0
• Then around day 14, day 28 and day 63
• Then once every 4 months.

Spinraza is administered by injection into the lower back. This injection,
called a lumbar puncture, is performed by inserting a needle into the space surrounding the spinal cord.
This is done by a doctor experienced in performing lumbar punctures. You or your child may
also be given a medicine to help you relax or sleep during the procedure.

Duration of treatment with Spinraza
The doctor will tell you how long it is necessary for you or your child to receive Spinraza. Do not interrupt the
treatment with Spinraza unless instructed by your doctor.

If you or your child miss an injection
If you or your child miss a dose of Spinraza, consult your doctor so that Spinraza can be
administered as soon as possible.
If you have any questions about how Spinraza is administered, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Side effects related to the lumbar puncture may occur during the administration of
Spinraza or subsequently. Most of these side effects are reported within
72 hours of the procedure.
Very common (may affect more than 1 in 10 people)

• Back pain
• Headache
• Vomiting

Not known (frequency cannot be estimated based on available data)

• Serious infection related to lumbar puncture (e.g. meningitis)
• Hydrocephalus (accumulation of an excessive amount of fluid around the brain)
• Meningitis not caused by an infection (inflammation of the membrane surrounding the spinal cord and brain, which may manifest as neck stiffness, headache, fever, nausea and vomiting)
• Hypersensitivity (an allergic or allergy-like reaction that may include swelling of the face, lips or tongue, rash or itching)
• Arachnoiditis (inflammation of a membrane surrounding the brain and spinal cord), which can cause pain in the lower back or pain, numbness or weakness in the legs

Reporting of side effects
If you or your child experiences any side effect, including those not listed in this
leaflet, consult your doctor or nurse.You can also report side effects directly
through the national reporting system as reported in Annex V. By reporting side
effects you can help provide more information on the safety of this medicine.

5. How to store Spinraza

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the vial and the carton after
“Exp”. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C-8°C). Do not freeze.
Keep the vial in the outer packaging to protect the medicine from light.
If refrigeration is not available, Spinraza can be stored in its original packaging, protected from
light or at a temperature equal to or below 30°C for up to 14 days.
If necessary, intact vials of Spinraza can be removed from the refrigerator and returned. If
removed from the original packaging, the total storage time at room temperature must not
exceed 30 hours, at a temperature not exceeding 25°C.

6. Contents of the pack and other information

What Spinraza contains

• The active substance is nusinersen.
• Each 5 ml vial contains nusinersen sodium equivalent to 12 mg of nusinersen.
• Each ml contains 2.4 mg of nusinersen.
• The other components are disodium hydrogen phosphate dihydrate, disodium phosphate, sodium chloride (see section 2 “Spinraza contains a small amount of sodium”), potassium chloride (see section 2 “Spinraza contains a small amount of potassium”), calcium chloride dihydrate, magnesium chloride hexahydrate, sodium hydroxide, hydrochloric acid, water for injections.

Description of Spinraza and contents of the pack
Spinraza is a clear and colourless injectable solution.
Each pack of Spinraza contains one vial.
Each vial is for single use.

Marketing Authorisation Holder and Manufacturer
Biogen Netherlands B.V.
Prins Mauritslaan 13
1171 LP Badhoevedorp
Netherlands
For further information on this medicinal product, contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
Biogen Belgium N.V./S.A.
Tél/Tel: +32 2 219 12 18

Lietuva
Biogen Lithuania UAB
Tel: +370 5 259 6176

България
ТП ЕВОФАРМА
Teл.: +359 2 962 12 00

Luxembourg/Luxemburg
Biogen Belgium N.V./S.A.
Tél/Tel: +32 2 219 12 18

Česká republika
Biogen (Czech Republic) s.r.o.
Tel: +420 255 706 200

Magyarország
Biogen Hungary Kft.
Tel.: +36 1 899 9880

Danmark
Biogen (Denmark) A/S
Tlf.: +45 77 41 57 57

Malta
Pharma MT limited
Tel: +356 213 37008/9

Deutschland
Biogen GmbH
Tel: +49 (0) 89 99 6170

Nederland
Biogen Netherlands B.V.
Tel: +31 20 542 2000

Eesti
Biogen Estonia OÜ
Tel: + 372 618 9551

Norge
Biogen Norway AS
Tlf: +47 23 40 01 00

Ελλάδα
Genesis Pharma SA
Τηλ: +30 210 8771500

Österreich
Biogen Austria GmbH
Tel: +43 1 484 46 13

Polska
Biogen Poland Sp. z o.o.
Tel.: +48 22 351 51 00

France
Biogen France SAS
Tél: +33 (0)1 41 37 95 95

España
Biogen Spain SL
Tel: +34 91 310 7110

Portugal
Biogen Portugal
Tel.: +351 21 318 8450

Hrvatska
Biogen Pharma d.o.o.
Tel: +385 (0) 1 775 73 22

România
Ewopharma România SRL
Tel: + 40 21 260 13 44

Ireland
Biogen Idec (Ireland) Ltd.
Tel: +353 (0)1 463 7799

Slovenija
Biogen Pharma d.o.o.
Tel.: +386 1 511 02 90

Ísland
Icepharma hf
Sími: +354 540 8000

Slovenská republika
Biogen Slovakia s.r.o.
Tel.: +421 2 323 340 08

Italia
Biogen Italia s.r.l.
Tel: +39 02 584 9901

Suomi/Finland
Biogen Finland Oy
Puh/Tel: +358 207 401 200

Κύπρος
Genesis Pharma Cyprus Ltd
Τηλ: +357 22765715

Sverige
Biogen Sweden AB
Tel: +46 8 594 113 60

Latvija
Biogen Latvia SIA
Tel: + 371 68 688 158

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency, https://www.ema.europa.eu
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The following information is intended exclusively for healthcare professionals:

• 1. The Spinraza vial must be inspected before administration for the presence of particles. If particles are observed and/or if the liquid is not clear and colourless, the vial must not be used.
• 2. Aseptic technique must be used when preparing the Spinraza solution for intrathecal administration.
• 3. Before administration, the vial must be removed from the refrigerator and allowed to warm to room temperature (25°C) without the use of external heat sources.
• 4. If the vial remains intact and the solution is not used, it must be returned to the refrigerator.

• 5. Immediately before administration, remove the plastic closure cap and insert the syringe needle into the vial through the centre of the seal, to withdraw the appropriate volume. Spinraza must not be diluted. The use of external filters is not required.
• 6. Spinraza is administered by intrathecal bolus injection over 1-3 minutes, using a spinal anaesthesia needle.
• 7. The injection should not be given in areas of skin where there are signs of infection or inflammation.
• 8. It is recommended to remove a volume of CSF equivalent to the volume of Spinraza to be injected, before administering Spinraza.
• 9. Once drawn into the syringe, the solution must be discarded if not used within 6 hours.
• 10. Unused medicinal product or waste material derived from such medicinal product should be disposed of in accordance with local regulations.