2. What should I know before I use SPINRAZA?
Do not use if you have ever had an allergic reaction to SPINRAZA or any of the ingredients
listed at the end of the CMI.
Talk to your doctor or nurse if you or your child have any other medical conditions,
take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with SPINRAZA and affect how it works.
4. How do I use SPINRAZA?
The usual dose of SPINRAZA is 12 mg administered by an experienced doctor, and given
as a continuous injection (over 1 to 3 minutes) into the lower back by lumbar puncture.
Your doctor may give you or your child a medicine to make you or your child relax
or sleep (sedation) before giving SPINRAZA.
5. What should I know while using SPINRAZA?
|
Things you should do
|
Keep all of your or your child's hospital, doctor and physiotherapy appointments so
that you or your child's progress can be checked.
Remind any doctor, dentist, nurse or pharmacist you or your child visit that you are
receiving SPINRAZA.
|
|
Things you should not do
|
Do not stop receiving this medicine without consulting your doctor.
|
|
Driving or using machines
|
Be careful before you drive or use any machines or tools until you know how SPINRAZA
affects you.
|
|
Drinking alcohol
|
Tell your doctor if you drink alcohol.
|
|
Looking after your medicine
|
SPINRAZA is usually stored in the hospital pharmacy until it is time for it to be
given to you or your child.
|
6. Are there any side effects?
Side effect may include infections, allergic reactions, gut, skin or breathing related
effects. You or your child might experience side effects caused by the lumbar puncture
procedure.
Active ingredient(s):
nusinersen (as heptadecasodium) 12mg/5mL solution for injection
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using SPINRAZA. You should also speak to your doctor, nurse or pharmacist if you would like further
information or if you have any concerns or questions about using SPINRAZA.
Where to find information in this leaflet:
1. Why am I using SPINRAZA?
SPINRAZA contains the active ingredient nusinersen (as heptadecasodium). SPINRAZA is a type of medicine called an anti-sense oligonucleotide (ASO).
SPINRAZA is used to treat the genetic disease called Spinal Muscular Atrophy (SMA).
Spinal Muscular Atrophy (SMA) is a genetic disease caused by a shortage of a protein
called survival motor neuron (SMN). 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 causing the body to produce more SMN protein.
SPINRAZA has only been proven to work in a type of SMA known as 5q SMA.
Ask your doctor if you have any questions about why this medicine has been prescribed
for you or your child.
Your doctor may have prescribed it for another reason.
There is limited information on the use of SPINRAZA in people over 18 years of age.
This medicine is not addictive.
It is available only with a doctor's prescription.
This medicine is given to you or your child by a doctor.
2. What should I know before I use SPINRAZA?
Warnings
Do not use SPINRAZA if:
you or your child have an allergy to:
Nusinersen, or any of the ingredients listed at the end of this leaflet.
Always check the ingredients to make sure you can use this medicine.
Some of the symptoms of an allergic reaction may include:
shortness of breath.
wheezing or difficulty breathing.
swelling of the face, lips, tongue or other parts of the body.
rash, itching or hives on the skin.
If any of these signs occur, stop using SPINRAZA and notify your doctor, nurse or
pharmacist immediately.
Do not receive this medicine after the expiry date printed on the vial or if the packaging
is torn or shows signs of tampering.
If you receive it after the expiry date has passed, it may not work as intended.
Do not receive SPINRAZA if the medicine is cloudy, contains particles or is discoloured.
It should be clear and colourless.
If you are not sure whether you or your child should start receiving this medicine,
talk to your doctor.
Check with your doctor if you or your child:
have bleeding problems, problems with blood clotting, or low platelet counts.
Tell your doctor if you or your child have kidney problems.
Tell your doctor if you or your child have allergies to any other medicines, foods,
preservatives or dyes.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Tell your doctor if you are pregnant or intend to become pregnant.
There is no information on the use of SPINRAZA during pregnancy. Your doctor will
discuss the risks and benefits of receiving it if you are pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
It is not known whether SPINRAZA passes into breast milk. Your doctor will discuss
the risks and benefits of receiving it if you are breast-feeding.
3. What if I am taking other medicines?
Tell your doctor, nurse or pharmacist if you are taking any other medicines, including
any medicines, vitamins or supplements that you buy without a prescription from your
pharmacy, supermarket or health food shop.
Your doctor and nurse have more information on medicines to be careful with or avoid
while taking this medicine.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect SPINRAZA.
4. How do I use SPINRAZA?
How much to use
The usual dose of SPINRAZA is 12 mg, given as a continuous injection into the lower
back (over 1 to 3 minutes) by lumbar puncture.
When to use SPINRAZA
You or your child will usually be given SPINRAZA on the first day of treatment then
again approximately 14, 28 and 63 days later. After this, SPINRAZA is given once every
4 months.
Continue receiving your medicine for as long as your doctor tells you.
Your doctor will tell you how long you or your child needs to keep having SPINRAZA.
How to give SPINRAZA
SPINRAZA is given by injection into the lower back. This injection, called a lumbar
puncture, is done by inserting a needle in the space around the spinal cord (intrathecal
space). This will be done by a doctor experienced in doing lumbar punctures. Your
doctor may give you or your child a medicine to make you or your child relax or sleep
(sedation) before giving SPINRAZA.
If you or your child forget to use SPINRAZA
SPINRAZA should be used regularly. If you or your child miss your dose at the usual
time, talk to your doctor or nurse as soon as possible.
If you or your child are unable to receive SPINRAZA as planned, speak with your doctor
to ensure that SPINRAZA can be given as soon as possible.
If you use too much SPINRAZA
There have been no reported overdoses of SPINRAZA.
Your doctor is trained to calculate the correct dose and administer your medicine.
If you think that you or your child have been given too much SPINRAZA, you may need
urgent medical attention.
You should immediately:
phone the Australian Poisons Information Centre (by calling
13 11 26), or the New Zealand National Poisons Information Centre (by calling
0800 POISON or 0800 764 766), or
contact your doctor, or
go to the Emergency Department at your nearest hospital
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while using SPINRAZA?
Things you should do
Keep all of your or your child's hospital, doctor and physiotherapy appointments so
that you or your child's progress can be checked.
Remind any doctor, nurse, dentist or pharmacist you visit that you or your child are
using SPINRAZA.
Things you should not do
Do not stop using this medicine without consulting your doctor.
Do not give your or your child's medicine to anyone else, even if they appear to have
the same condition as you.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how SPINRAZA
affects you.
Drinking alcohol
Tell your doctor if you drink alcohol.
Looking after your medicine
SPINRAZA is usually stored in the hospital pharmacy until it is time for it to be
given to you or your child.
However, if you need to store SPINRAZA:
Follow the instructions in the carton on how to take care of your medicine properly.
Keep SPINRAZA in the original carton until it is time for it to be given.
Keep it in the refrigerator, between 2°C and 8°C. Do not freeze. Protect from light.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
Each vial of SPINRAZA should be used once only. The doctor, nurse or pharmacist will
discard any unused portion.
Do not use this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor, nurse or pharmacist
if you have any further questions about side effects.
In studies with SPINRAZA the side effects are consistent with the signs and symptoms
of SMA or are side effects which can occur when medications are given by lumbar puncture.
There is a risk of side effects occurring after SPINRAZA is given by a lumbar puncture
procedure.
This can include headaches, vomiting, back pain and infection. There may also be difficulties
with giving a medicine by this method in very young patients and those with scoliosis
(twisted and curved spine). Medical imaging techniques may be used to guide delivery
of Spinraza if you have scoliosis.
You or your child may be at risk of bleeding complications whilst receiving treatment
with SPINRAZA. 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.
Your doctor may decide to repeat this test from time to time whilst you or your child
are given SPINRAZA.
SPINRAZA may 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.
You or your child should be aware that symptoms and signs of SMA may still occur when
being treated with SPINRAZA, e.g. breathing problems, muscle weakness, joint and bone
problems, or digestive problems.
Less serious side effects
Serious side effects
Tell your doctor, nurse or pharmacist if you notice anything else that may be making
you or your child feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What SPINRAZA contains
|
Active ingredient
(main ingredient)
|
nusinersen (as heptadecasodium)
|
|
Other ingredients
(inactive ingredients)
|
sodium chloride
potassium chloride
calcium chloride dihydrate
magnesium chloride hexahydrate
dibasic sodium phosphate
sodium phosphate monobasic dihydrate
sodium hydroxide
hydrochloric acid
water for injection
|
|
Potential allergens
|
None
|
Do not take this medicine if you are allergic to any of these ingredients.
What SPINRAZA looks like
SPINRAZA comes as a clear and colourless solution in a glass vial. Each pack of SPINRAZA
contains 12mg nusinersen (as heptadecasodium) in 5mL of solution in a single 5mL vial.
SPINRAZA is only available in one pack size.
SPINRAZA is usually drawn up into a syringe ready for your or your child's dose to
be given by a doctor.
SPINRAZA - AUST R 282522.
Further information
You can obtain more information from your doctor, pharmacist or nurse or by telephoning
1800 852 289 in Australia or 0800 852 289 in New Zealand.
Who distributes SPINRAZA
SPINRAZA is supplied in Australia by:
Biogen Australia Pty Ltd
Level 4, 2 Banfield Road
Macquarie Park, NSW 2113
Australia
SPINRAZA is supplied in New Zealand by:
Biogen NZ Biopharma Limited
155 Fanshawe Street
Auckland
New Zealand
This leaflet was prepared in May 2025.