Evrysdi®
Consumer Medicine Information (CMI) summary
The full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
This medicine is new or being used differently. Please report side effects. See the
full CMI for further details.
Evrysdi contains the active ingredient risdiplam. Evrysdi is used to treat spinal
muscular atrophy (SMA). For more information, see Section 1. Why am I using Evrysdi? in the full CMI.
Do not use if you have ever had an allergic reaction to risdiplam or any of the ingredients
listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant, or are breastfeeding. If you are female, your doctor may do a pregnancy test to confirm you are not pregnant.
If you are male and planning to donate sperm or have children, talk to your doctor. For more information, see Section 2. What should I know before I use Evrysdi? in the full CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant, or are breastfeeding. If you are female, your doctor may do a pregnancy test to confirm you are not pregnant.
If you are male and planning to donate sperm or have children, talk to your doctor. For more information, see Section 2. What should I know before I use Evrysdi? in the full CMI.
Tell your doctor 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. For more information, see Section 3. What if I am taking other medicines? in the full CMI.
Take Evrysdi orally (by mouth or through a feeding tube) once a day, at approximately
the same time each day, after a meal, using only the oral syringes provided in the
pack.
The recommended dose in adults and adolescents is 5 mg (6.6 mL) a day. Your doctor
will decide the dose for infants and children based on their age and body weight.
More information can be found in Section 4. How do I use Evrysdi? in the full CMI and in the Instructions for use leaflet provided in the pack.
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Things you should do
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Men and women should use contraception during treatment and for at least 1 month (women)
or for at least 4 months (men) after stopping treatment (women).
If you do become pregnant during treatment with Evrysdi, tell your doctor straight
away.
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Things you should not do
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Do not stop treatment with Evrysdi unless your doctor tells you to.
Avoid getting Evrysdi on your skin. If Evrysdi gets on your skin, wash the area with
soap and water.
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Driving or using machines
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Evrysdi is unlikely to affect your ability to drive and use machines.
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Looking after your medicine
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Store the oral solution at 2°C to 8°C (refrigerate, do not freeze) in the original
bottle. Discard the medicine after the expiry date printed on the bottle label or
after 64 days (refer to the “Discard contents after” date written on the bottle label).
If necessary, you or your caregiver may store the oral solution at room temperature
(below 40°C) for no more than a total combined time of 5 days.
Keep the bottle closed tightly and in an upright position.
Once transferred to the oral syringe, use right away. Do not store the solution in
the syringe.
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For more information, see Section 5. What should I know while using Evrysdi? in the full CMI.
Serious side effects include difficulty breathing, rapid breathing or shortness of
breath; increased heart rate; blue lips, fingertips or skin; watery or bloody diarrhea;
bleeding into the skin causing small red or reddish-blue to purple spots or net-like
patterns on the skin; skin hives or skin ulcers; joint dislocation.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.
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.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems .
Evrysdi®
Active ingredient:
risdiplam
Consumer Medicine Information (CMI)
This leaflet provides important information about using Evrysdi. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using Evrysdi.
Where to find information in this leaflet:
Evrysdi contains the active ingredient risdiplam. Risdiplam is a selective survival of motor neuron 2 (SMN2) gene splicing modifier.
Evrysdi is used to treat spinal muscular atrophy (SMA).
SMA is a genetic condition people can be born with, that is caused by a shortage of
a protein called “survival of motor neuron” (SMN) in the body. The SMN protein is
needed for nerves to function properly. Not having enough SMN protein results in the
loss of motor neurons, leading to muscle weakness and muscle wasting. Basic activities
such as head and neck control, sitting, crawling and walking may be affected. The
muscles used for breathing and swallowing may also be affected.
Evrysdi works by helping the body make more SMN protein and maintain SMN protein levels
throughout the body with continued use. This reduces the loss of nerve cells and may
improve muscle strength and function in a broad range of ages and SMA types.
In infants with SMA, Evrysdi improves survival, preserves swallowing, improves likelihood
of achieving motor milestones, and reduces the need for hospitalisation and ventilator
supported breathing. In children (infants to adolescents) and adults, Evrysdi may
maintain or improve motor function over time.
Do not take Evrysdi if:
you are allergic to risdiplam, or any of the ingredients listed at the end of this
leaflet.
Always check the ingredients to make sure you can use this medicine.
Check with your doctor if you:
have any other medical conditions
have a kidney or liver disorder
take any medicines for any other condition
are female and pregnant or plan to become pregnant, or are breastfeeding or plan to
breastfeed (see Pregnancy)
are male and planning to donate sperm or have children (see Male fertility)
have any issues with the structure of your eye
have been diagnosed with Type 0 or IV SMA
are older than 60 years or if your baby is younger than 16 days
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?
Contraception
For women: You should use highly effective contraception during treatment and for at least 1 month after you stop treatment with Evrysdi.
For men: If your female partner is of childbearing potential, you and your partner should
both use highly effective contraception during treatment and for at least 4 months after you stop taking Evrysdi.
Talk to your healthcare provider about reliable methods of contraception that should
be used.
Pregnancy
Evrysdi could harm your unborn baby. If you are pregnant, think you may be pregnant
or are planning to have a baby, ask your doctor for advice before taking this medicine.
Your doctor will consider the benefit of you taking Evrysdi against the risk to your
baby.
Before you start treatment with Evrysdi, your doctor may do a pregnancy test to confirm
you are not pregnant.
If you do become pregnant during treatment with Evrysdi, tell your healthcare provider
doctor straight away. You and your doctor will decide what is best for you and your
unborn baby.
Breastfeeding
Do not breastfeed while taking this medicine. This is because Evrysdi may pass into
breast milk and may harm your baby.
Discuss with your doctor if you should stop breastfeeding or if you should stop taking
Evrysdi.
Male fertility
Evrysdi may affect fertility in men.
Do not donate sperm during your treatment and for at least 4 months after you stop
taking Evrysdi.
For your family planning, ask your doctor for advice.
Tell your doctor 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.
Keep a list of them to show your healthcare provider and pharmacist when you get a
new medicine.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these could affect Evrysdi.
Evrysdi may increase the effect of:
metformin
fexofenadine
Evrysdi may affect your eye. Tell your doctor if you are taking other medicines that
affect the eye while taking Evrysdi.
Evrysdi is a liquid, and is referred to as a ‘solution’ or ‘medicine’ in this leaflet.
How much to take
Adolescents and adults: The daily dose of Evrysdi is 5 mg (6.6 mL of the 750 microgram/mL oral solution).
Infants and children: Your doctor will determine the daily dose of Evrysdi based on your child’s age and
weight.
You must take your daily dose as instructed by your doctor. Do not change the dose
without speaking to your doctor.
If you do not swallow the full dose, or vomit after taking a dose of Evrysdi, do not
take an extra dose. Instead, just take the next dose at the usual time the next day.
When to take Evrysdi
Take Evrysdi once daily at approximately the same time each day. This will help you
remember when to take your medicine.
You should take Evrysdi after a meal.
If your baby is being breastfed, you can give your baby Evrysdi after breastfeeding.
How to take Evrysdi
Always take this medicine exactly as your healthcare provider has told you. Check
with your healthcare provider if you are not sure.
Read carefully and follow the “Instructions for use” leaflet enclosed in the pack on how to take or give Evrysdi.
You should receive Evrysdi from your healthcare provider as a liquid for oral administration
that can be given by mouth or through a feeding tube. Do not mix Evrysdi with formula
or milk.
Use only oral syringes provided.
It is important that you only use the oral syringe provided in the pack to measure
your or your child’s dose of Evrysdi as they are specially designed to protect the
medicine from light.
If your oral syringes are lost or damaged, contact your healthcare provider and they
will advise you on how to continue to take your medicine.
If you forget to take Evrysdi
Evrysdi should be used regularly at the same time each day. If you miss your dose
at the usual time:
If it is within 6 hours of when you normally take Evrysdi, take the missed dose as
soon as you remember.
If it is over 6 hours from when you normally take Evrysdi, skip the missed dose and
then take your next dose at the usual time.
Do not take a double dose to make up for the dose you missed.
If you use too much Evrysdi
If you think that you have taken too much Evrysdi, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling 13 11 26), or
(by calling 13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
Take the medicine pack and this leaflet with you.
You should do this even if there are no signs of discomfort or poisoning.
Things you should do
Use contraception during treatment (men and women) and for at least 1 month after
stopping treatment (women), or for at least 4 months after stopping treatment (men)
(see Contraception).
If you do become pregnant during treatment with Evrysdi, tell your healthcare provider
doctor straight away (see
Pregnancy).
Inform any other doctor or health professional you visit that you are using Evrysdi.
Things you should not do
Do not stop treatment with Evrysdi unless your doctor tells you to.
Avoid getting Evrysdi on your skin. If Evrysdi gets on your skin, wash the area with
soap and water.
Looking after your medicine
Store the oral solution in the refrigerator at 2°C to 8°C (refrigerate, do not freeze).
If necessary, you or your caregiver may store the oral solution at room temperature
(below 40°C) for no more than a total combined time of 5 days.
Keep the oral solution in the original amber bottle to protect from light.
Keep the oral solution bottle in an upright position with the cap closed tightly.
Keep it where young children cannot reach it.
Once transferred from the bottle to the oral syringe, use Evrysdi right away. Do not
store the Evrysdi solution in the syringe.
Wash the syringes as described in the “Instructions for use” leaflet. Do not throw them away.
When to discard your medicine (as relevant)
Evrysdi oral solution can be used for up to 64 days after reconstitution by your pharmacist
when stored in the refrigerator at 2°C to 8°C. Your pharmacist will write the "Discard
contents after" date on the bottle label.
Discard the medicine:
after the expiry date printed on the bottle label or after the “Discard contents after”
date written on the bottle label,
or if the medicine has been stored at room temperature (below 40°C) for more than
a total combined time of 5 days,
or if the medicine has been stored at above 40°C.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to a pharmacy
for safe disposal.
Do not use this medicine after the expiry date.
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 or pharmacist if you
have any further questions about side effects.
Less serious side effects include
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Less serious side effects
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What to do
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Stomach related:
constipation or
diarrhea
nausea
vomiting
pain in the upper region of the stomach
heartburn, difficulty swallowing, a chronic cough
Skin related
rash
ulcers in the mouth and the inside of the lip and cheek
eczema
General
fever
teething
headache
Muscle and joint related
swelling and pain in the joints
Infections
urinary tract infection, symptoms include strong and frequent urge to urinate, cloudy,
bloody or strong-smelling urine, pain or a burning sensation when urinating
infection of the airways, symptoms include runny nose, stuffy nose, cough, sore throat
ear infection, symptoms include pain in the ear, fever, loss of balance, difficulty
hearing
infection and inflammation of the digestive system (gastroenteritis), symptoms include
watery and possibly bloody diarrhea, stomach cramps, nausea, vomiting, fever
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Speak to your doctor if you have any of these side effects and they worry you.
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Serious side effects include
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Serious side effects
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What to do
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Lung related
difficulty breathing, rapid breathing or shortness of breath, shallow breaths or flaring
of the nostrils
your skin, fingernails or lips look blue or pale
wheezing
increased heart rate
tiredness or loss of consciousness
pneumonia or bronchitis, symptoms include fever, chills, shortness of breath, cough,
phlegm and occasionally blood in the phlegm
Skin related
cutaneous vasculitis, inflammation of the blood vessels of the skin, causing them
to be narrowed or blocked. Symptoms include areas if flat and red skin, raised skin,
bleeding into the skin causing small red or reddish-blue to purple spots or net-like
patterns on the skin, skin hives ((raised red patches of skin that are often very
itchy) or skin ulcers (round open sores in the skin)
Muscle and joint related
dislocation of a joint
Related to the reproductive system
undescended testicle or testis
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Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
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Tell your doctor or pharmacist if you notice anything else that may be making you
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.
This medicine is only available with a doctor's prescription.
What Evrysdi contains
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Active ingredient
(main ingredient) |
Risdiplam
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Other ingredients
(inactive ingredients) |
Mannitol
Isomalt Strawberry flavour Tartaric acid Sodium benzoate Macrogol 6000 Sucralose Ascorbic acid Disodium edetate |
Do not take this medicine if you are allergic to any of these ingredients.
When prepared by your healthcare provider, the volume of the solution is 80 mL. Each
mL of the reconstituted oral solution contains 750 micrograms of risdiplam.
Each Evrysdi pack contains 1 bottle of the medicine and press-in bottle adapter, 2
plastic 1mL re-usable oral syringes, 2 plastic 6 mL re-usable oral syringes and 1
plastic 12 mL re-usable oral syringe.
What Evrysdi looks like
You should receive Evrysdi from your healthcare provider as a greenish yellow to yellow,
strawberry flavoured oral solution. The liquid solution must be prepared by your healthcare
provider. If the medicine in the bottle is a powder, do not use it. Contact your healthcare provider for a replacement.
Evrysdi is a powder for oral solution (AUST R 340350).
