12 mg solution
for injection
businesses
What Spinraza is and what it is used for
Spinraza contains the active substance businesses which belong to a group of medicines called antisense oligonucleotides. Spinraza is used to treat a genetic disease called spinal muscular atrophy (SMA).
Spinal muscular atrophy is caused by a lack of a protein called survival motor neuron, (SMN) in the body. This results in loss of nerve cells in the spine, leading to muscle weakness in the shoulders, hips, thighs, and upper back. It can also weaken the muscles used for breathing and swallowing.
Spinraza works by making it easier for the body to produce more of the SMN protein that people with SMA lack. This reduces the loss of nerve cells and can improve muscle strength.
What you need to know before you or your child is given Spinraza
Spinraza must not be given:
- If you or your child are allergic to businesses 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 giving you or your child Spinraza.
Warnings and precautions
There is a risk of side effects occurring after Spinraza is given by lumbar puncture (see section 3). These can include headaches, vomiting, and back pain. There may also be difficulties in giving drugs through this method in very young patients and those with scoliosis (twisted and curved spine).
Other drugs that are part of the same drug group as Spinraza have been shown to affect the blood cells that cause the blood to clot. Before you or your child are given Spinraza, your doctor may order blood tests to check whether your or your child’s blood is clotting properly. This may not be needed every time you or your child is given Spinraza.
Other drugs in the same drug group as Spinraza have been shown to affect the kidneys. Before you or your child is given Spinraza, your doctor may order urine samples to check whether your or your child’s kidneys are working normally. This may not be needed every time you or your child is given Spinraza.
There have been a small number of reports of patients developing hydrocephalus (an accumulation of too much fluid around the brain) after receiving Spinraza. Some of these patients needed to have a so-called ventriculoperitoneal shunt implanted to treat hydrocephalus. If you notice any symptoms of increased head circumference, decreased consciousness, persistent nausea, vomiting or headache, or other symptoms that worry you, tell your or your child’s doctor to get the necessary treatment. The benefits and risks of continuing treatment with Spinraza concurrently with an inoperable ventriculoperitoneal shunt are currently unknown.
Talk to your doctor before giving you or your child Spinraza.
Other medicines and Spinraza
Tell the doctor if you or your child are taking, have recently taken, or might be taking other medicines.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before being given this medicine. The use of Spinraza should be avoided during pregnancy and breastfeeding.
Driving ability and use of machinery
Spinraza has no or negligible effect on the ability to drive and use machines.
Spinraza contains a small amount of sodium and potassium
This medicine contains less than 1 mmol (23 mg) of sodium per 5 ml vial, i.e. it is almost “sodium-free” and can be used by patients who have been prescribed a low-salt diet.
This medicine contains less than 1 mmol of potassium (39 mg) per 5 ml vial, i.e. it is almost “potassium-free”.
How Spinraza is given
The normal dose of Spinraza is 12 mg.
How Spinraza is given:
- On the first day of treatment, day 0.
- Then around day 14, day 28, and day 63.
- Then once every 4 months.
Spinraza is given as an injection into the lower back. This injection, called a lumbar puncture, is performed by inserting a cannula into the space around the spinal cord. This is done by a doctor who is experienced in performing lumbar punctures. You or your child may also be given medicine to make you relax or sleep during the procedure.
How long Spinraza is used
Your doctor will tell you how long you or your child will need to receive Spinraza. Do not stop treatment with Spinraza unless your doctor advises you to do so.
If you or your child miss an injection
If you or your child have missed a dose of Spinraza, talk to your doctor to make sure Spinraza can be given as soon as possible.
If you have any questions about how Spinraza is given, ask your doctor.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects related to lumbar puncture may occur when Spinraza is given or shortly thereafter. Most of these side effects have been reported within 72 hours of the procedure.
Very common (may affect more than 1 in 10 people)
- Back pain
- Headache
- Vomiting
Other side effects are
Frequency not known (cannot be estimated from available data)
- Serious infection related to lumbar puncture (eg, meningitis )
- Hydrocephalus (an accumulation of too much fluid around the brain)
- Meningitis is not caused by an infection ( inflammation of the membranes around the spinal cord and brain, which can manifest as a stiff neck, headache, fever, nausea, and vomiting)
- Hypersensitivity (an allergic or allergy-like reaction that may cause swelling of the face, lips, or tongue, rash, or itching )
How to store Spinraza
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the vial and carton after “EXP”. The expiration date is the last day of the specified month.
Store in a refrigerator (2 °C to 8 °C). Do not freeze.
Store the vial in the outer carton. Light sensitive.
If a refrigerator is not available, Spinraza should be stored in its original carton, protected from light, at or below 30°C for a maximum of 14 days.
Unopened vials of Spinraza can be removed from and returned to the refrigerator as needed. If the vial is removed from the original carton, the total time outside the refrigerator must not exceed 30 hours, at a temperature not exceeding 25 °C.
Contents of the packaging and other information
Contents declaration
- The active substance is businesses.
- Each 5 ml vial contains nusinersen sodium equivalent to 12 mg businesses.
- Each ml contains 2.4 mg of business.
- The other ingredients are sodium dihydrogen 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.
Appearance and package sizes of the medicine
Spinraza is a clear, colorless solution for injection.
Each carton of Spinraza contains one vial.
Each vial is intended for single use.
Marketing Authorisation Holder
Biogen Netherlands BV
Prins Mauritslaan 13
1171 LP Badhoevedorp
Netherlands
Manufacturer
FUJIFILM Diosynth Biotechnologies Denmark ApS
Biotek Allé 1
DK – 3400 Hillerød
Denmark
or
Biogen Netherlands BV
Prins Mauritslaan 13
1171 LP Badhoevedorp
Netherlands
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