Spinraza 12 mg soluciÓn inyectable

Prescribing Information for the User

Spinraza 12 mg Injectable Solution

nusinersén

Read this entire prescribing information carefully before you or your child receives this medication, as it contains important information for you.

• Keep this prescribing information, as you may need to read it again.

• If you have any questions, consult your doctor or nurse.

• If you or your child experience any adverse effects, consult your doctor or nurse, even if they are not listed in this prescribing information. See section 4.

1. What you need to know before Spinraza is administered to you or your child
2. How to administer Spinraza
3. Possible adverse effects

1. Storage of Spinraza
2. Contents of the package and additional information

Spinraza contains the active ingredientnusinersénwhich belongs to a group of medications calledantisense oligonucleotides. Spinraza is used to treat a genetic disease calledspinal muscular atrophy(SMA).

The cause ofspinal muscular atrophyis a deficiency of a protein calledsurvival motor neuron(SMN) in the body. This deficiency leads to the loss of neurons in the spinal cord, resulting in the weakening of the muscles of the shoulders, hips, thighs, and upper back. It may also weaken the muscles used for breathing and swallowing.

Spinraza helps the body to produce more SMN protein that is lacking in people with SMA. This reduces the loss of neurons and may improve muscle strength.

You should not receive Spinraza

• if you or your child isallergic to nusinersenor to any of the other components of this medication (listed in section 6).

Consult your doctor or nurse if you are unsure before you or your child receives Spinraza.

Warnings and precautions

There is a risk of presenting adverse effects after the administration of Spinraza through a lumbar puncture procedure (see section 3). These adverse effects may include headaches, vomiting, and back pain. Difficulties may also be encountered in administering a medication through this method in very young patients and in patients with scoliosis (curvature and deviation of the spine).

It has been demonstrated that other medications in the same group as Spinraza affect the blood cells that help with coagulation. Before Spinraza is administered to you or your child, your doctor may decide to perform a blood test to check that your blood or your child's blood can clot properly. It may not be necessary to perform this test every time Spinraza is administered to you or your child.

It has been demonstrated that other medications in the same group as Spinraza affect the kidneys. Before Spinraza is administered, your doctor may decide to perform a urine test to check that your kidneys are functioning properly. It may not be necessary to perform this test every time Spinraza is administered to you or your child.

A small number of cases have been reported of patients who developed hydrocephalus (accumulation of too much fluid around the brain) after receiving Spinraza. Some of these patients required the placement of a device called a ventriculoperitoneal shunt to treat the hydrocephalus. If you observe any symptoms such as increased head size, decreased level of consciousness, nausea, vomiting, or persistent headaches or other symptoms that concern you, inform your doctor or your child's doctor to receive the necessary treatment. At present, the risks and benefits of continuing treatment with Spinraza in patients with a ventriculoperitoneal shunt are unknown.

Consult your doctor before Spinraza is administered to you or your child.

Other medications and Spinraza

Inform your doctor if you or your child is taking, has taken recently, or may need to take any other medication in the future.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor before this medication is administered. It is preferable to avoid the use of Spinraza during pregnancy and breastfeeding.

Driving and operating machinery

The influence of Spinraza on the ability to drive and operate machinery is negligible or insignificant.

Spinraza contains a small amount of sodium

This medication contains less than 1 mmol of sodium (23 mg) per 5 ml vial; it is essentially "sodium-free" and can be used in people with low-sodium diets.

Spinraza contains a small amount of potassium

This medication contains less than 1 mmol of potassium (39 mg) per 5 ml vial, so it is essentially "potassium-free".

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 in the lower back. This injection, called a lumbar puncture, is performed by introducing a needle into the space surrounding the spinal cord. A doctor experienced in lumbar punctures will administer the injections. They may also administer a medication to you or your child to relax or fall asleep during the procedure.

For how long Spinraza should be used

Your doctor will tell you for how long you or your child needs to receive Spinraza. Do not stop treatment with Spinraza unless your doctor tells you to.

If you or your child forgets an injection

If you or your child forgets a dose of Spinraza, talk to 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.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Adverse effects associated with lumbar puncture may appear while Spinraza is being administered or after administration. Most of these adverse effects are reported within 72 hours following the procedure.

Very common (may affect more than 1 in 10 people)

• Back pain.

• Headache.

• Vomiting.

Frequency not known (cannot be estimated from available data)

• Severe infection associated with lumbar puncture (e.g., meningitis).

• Hydrocephalus (accumulation of too much fluid around the brain).

• Meningitis not caused by infection (inflammation of the membrane surrounding the spinal cord and brain, which may present as neck stiffness, headache, fever, nausea, and vomiting).
• Hypersensitivity (an allergic or allergic-type reaction that may include facial swelling, lip or tongue swelling, skin rash, or itching).
• Arachnoiditis (inflammation of a membrane surrounding the brain and spinal cord), which may cause lower back pain, or pain, numbness, or weakness in the legs.

Reporting Adverse Effects

If you or your child experience any type of adverse effect, consult your doctor or nurse,even if it is a possible adverse effect not listed in this prospectus.You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.

By reporting adverse effects, you can contribute to providing moreinformation on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the vial and on the box after “CAD”. The expiration date is the last day of the month indicated.

Store in refrigerator (between 2°C and 8°C). Do not freeze.

Store the vial in the outer packaging to protect it from light.

If it is not possible to store it in the refrigerator, Spinraza can be stored in the original box, protected from light or at a temperature equal to or less than 30°C for a maximum of 14 days.

Spinraza vials that have not been opened can be removed and reinserted into the refrigerator as needed. If removed from the original box, the total time the medication is out of the refrigerator should not exceed 30 hours, at a temperature not exceeding 25°C.

Spinraza Composition

• The active ingredient 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 dihydrogen phosphate sodium dihydrate, hydrogen phosphate sodium, 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, and water for injectable preparations.

Product Appearance and Packaging Contents

Spinraza is a clear and colorless injectable solution.

Each Spinraza box contains one vial.

Each vial is for single use only.

Marketing Authorization Holder and Responsible Manufacturer

Biogen Netherlands B.V.

Prins Mauritslaan 13

1171 LP Badhoevedorp

Netherlands

For more information about this medication, please contact the local representative of the marketing authorization holder:

Last Review Date of this SmPC:01/2025

Other sources of information

The detailed information about this medication is available on the European Medicines Agency website: https://www.ema.europa.eu.

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This information is intended solely for healthcare professionals:

1. The vial of Spinraza should be visually inspected for particles before administration. If particles are observed and/or the liquid in the vial is not transparent and colorless, the vial should not be used.

1. Aseptic technique should be followed when preparing the Spinraza solution for intrathecal administration.

1. Before administration, the vial should be removed from the refrigerator and allowed to reach room temperature (25°C), without using external heat sources.

1. If the vial remains unopened and the solution has not been used, it should be returned to the refrigerator.

1. Just before administration, remove the plastic closure cap and insert the needle of the syringe into the vial through the center of the stopper to withdraw the required volume. Spinraza should not be diluted. External filters are not necessary.

1. Spinraza is administered as an intrathecal bolus injection over 1 to 3 minutes using a spinal anesthesia needle.

1. The injection should not be administered in areas of the skin with signs of infection or inflammation.

1. It is recommended to withdraw the volume of cerebrospinal fluid (CSF) equivalent to the volume of Spinraza to be administered before administering Spinraza.

1. Once the solution has been withdrawn into the syringe, if it is not used within 6 hours, it should be discarded.

1. The unused medication and all materials that have come into contact with it should be disposed of in accordance with local regulations.