Spinraza 12 mg solution for injection
▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
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 contains the active substance nusinersen which belongs to a group of medicines known as antisense oligonucleotides. Spinraza is used to treat a genetic disease called spinal muscular atrophy (SMA).
Spinal muscular atrophy is caused by a shortage of a protein called survival motor neuron (SMN) in the body. This results in the loss of nerve cells in the spine, leading to weakness of the muscles in the shoulders, hips, thighs and upper back. It may also weaken the muscles used for breathing and swallowing.
Spinraza works by helping the body to produce more of the SMN protein that people with SMA are lacking. This reduces the loss of nerve cells and so may improve muscle strength.
If you are not sure, talk to your doctor or nurse before you or your child are given Spinraza.
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.
Tell your doctor if you or your child are taking, have recently taken any, or might take any other medicines in future.
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.
Spinraza has no or negligible influence on the ability to drive and use machines.
Each dose of Spinraza contains less than 1 mmol (23 mg) sodium. It is essentially ‘sodium-free’ and can be used by people on a sodium-restricted diet.
The usual dose of Spinraza is 12 mg.
Spinraza is given;
Spinraza is given by injection into the lower back. This injection, called a lumbar puncture, is done by inserting a needle into the space around the spinal cord. This will be done by a doctor experienced in doing lumbar punctures. You or your child may also be given a medicine to make you relax or sleep during the procedure.
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 miss a dose of Spinraza, speak with your doctor so that Spinraza can be given as soon as possible.
If you have any questions about how Spinraza is given, ask your doctor.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects related to the lumbar puncture may occur while Spinraza is being given or shortly 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)
Additional side effects not seen in clinical trials:
Not known (frequency cannot be estimated from the available data)
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:
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.
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 carton after “EXP”. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C to 8°C). Do not freeze.
Keep the vial in the outer carton in order to protect from light.
If no refrigeration is available, Spinraza may be stored in its original carton, protected from light at or below 30°C for up to 14 days.
Unopened vials of Spinraza can be removed from and returned to the refrigerator if necessary. If removed from the original carton, the total time out of refrigeration should not exceed 30 hours, at a temperature that does not exceed 25°C.
Spinraza is a clear colourless solution for injection.
Each carton of Spinraza contains one vial.
Each vial is for single use.
Biogen Netherlands B.V.
Prins Mauritslaan 13
1171 LP Badhoevedorp
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: