Spinraza 12 mg solution for injection

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

What is in this leaflet

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

Spinraza must not be given:

• If you or your child are allergic to nusinersen or any of the other ingredients of this medicine (listed in section 6).

If you are not sure, talk to your doctor or nurse before you or your child are given Spinraza.

Warnings and precautions

There is a risk of side effects occuring after Spinraza is given by a lumbar puncture procedure (see section 3). This can include headaches, vomiting and back pain. There may also be difficulties with giving a medicine by this method in very young patients and those with scoliosis (twisted and curved spine).

Other products that are in the same group of medicines as Spinraza have been shown to affect the cells in the blood which help clotting. Before you or your child are given Spinraza your doctor may decide to do a blood test to check that your or your child’s blood can clot properly. This may not be required every time you or your child are given Spinraza.

Other products that are in the same group of medicines as Spinraza have been shown to affect the kidneys. Before you or your child are given Spinraza your doctor may decide to do a urine test to check that your or your child’s kidneys are working normally. This may not be required every time you or your child are given Spinraza.

There have been a small number of reports of patients developing hydrocephalus (a build-up of too much fluid around the brain) after Spinraza is given.  Some of these patients had needed to have a device called a ventriculo-peritoneal shunt implanted to treat the hydrocephalus.  If you notice any symptoms of increase in head size, decreased consciousness, persistent nausea, vomiting or headache; or other symptoms that cause you concern, please inform your or your child’s doctor to seek necessary treatment. The benefits and risks of continuing Spinraza whilst having a "ventriculo-peritoneal shunt" in place are not known at present.

Talk to your doctor before you or your child are given Spinraza.

Other medicines and Spinraza

Tell your doctor if you or your child are taking, have recently taken any, or might take any other medicines in future.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before being given this medicine. It is preferable to avoid the use of Spinraza during pregnancy and breast-feeding.

Driving and using machines

Spinraza has no or negligible influence on the ability to drive and use machines.

Spinraza contains a small amount of sodium

This medicine contains less than 1 mmol sodium (23 mg) per 5 ml vial, that is to say itt is essentially ‘sodium-free’ and can be used by people on a sodium-restricted 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’. 

How long to use Spinraza

Your doctor will tell you how long you or your child need to receive Spinraza. Don’t stop treatment with Spinraza unless your doctor tells you to.

If you or your child misses an injection

If you or your child miss a dose of Spinraza, speak with your doctor so that Spinraza can be given as soon as possible.

Side effects related to the lumbar puncture may occur while Spinraza is being given or afterwards. The majority 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

Additional side effects 

Not known (frequency cannot be estimated from the available data)

• Serious infection related to lumbar puncture (e.g. meningitis)
• Hydrocephalus (a build-up of too much fluid around the brain)
• Meningitis not caused by an infection (inflammation of the membrane around the spinal cord and brain, which may present as neck stiffness, headache, fever, nausea and vomiting).
• Hypersensitivity (an allergic or allergic-like reaction that may include swelling of your face, lips or tongue, rash, or itching)

Reporting of side effects

If you or your child get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via:

Ireland

United Kingdom (Northern Ireland) 
Yellow Card Scheme 
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

By reporting side effects you can help provide more information on the safety of this medicine.

What Spinraza contains

• The active substance is nusinersen.
• Each 5 ml vial contains nusinersen sodium equivalent to 12 mg nusinersen.
• Each ml contains 2.4 mg of nusinersen.
• The other ingredients are sodium dihydrogen phosphate dihydrate, disodium phosphate, sodium chloride, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate, sodium hydroxide, hydrochloric acid, water for injections.

What Spinraza looks like and contents of the pack

Spinraza is a clear colourless solution for injection.

Each carton of Spinraza contains one vial.

Each vial is for single use.

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