Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about taking 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.
WARNING: Important safety information is provided in a boxed warning in the
full CMI. Read before taking this medicine.
1. Why am I taking SOHONOS?
SOHONOS contains the active ingredient palovarotene. SOHONOS is used for reducing
inappropriate bone formation in muscle and soft tissues in adults and children (aged
8 years and above for females and 10 years and above for males) with fibrodysplasia
ossificans progressiva (FOP). For more information, see Section
1. Why am I taking SOHONOS? in the full CMI.
2. What should I know before I take SOHONOS?
Do not use if you have ever had an allergic reaction to palovarotene 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. For more information, see Section
2. What should I know before I take SOHONOS? in the full CMI.
3. What if I am taking other medicines?
4. How do I take SOHONOS?
The recommended dosage regimen of SOHONOS consists of a combination of daily treatment
referred to as 'Chronic Treatment' and a higher-dose treatment taken at the time of
a flare-up known as 'Flare-up Treatment'.
Chronic Treatment: The recommended dose for adults and children over 14 years of age
is 5 mg once daily.
Flare-up Treatment: On starting Flare-up dosing you must stop Chronic daily dosing. The recommended dose is 20 mg once daily for the first 4 weeks, followed by 10 mg
once daily for 8 weeks for a total of 12 weeks even if symptoms resolve earlier.
For children under 14 years of age your doctor will adjust the dose based on the weight
of the child for both chronic and flare-up treatment. More instructions can be found
in Section
4. How do I take SOHONOS? in the full CMI.
5. What should I know while taking SOHONOS?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are taking SOHONOS.
Use effective contraception before, during and after taking SOHONOS (for women, unless
your doctor decides this is not necessary) because SOHONOS can seriously harm an unborn
baby.
Ensure women who are pregnant or who intend to become pregnant avoid contact with
SOHONOS.
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Things you should not do
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You should not donate blood during treatment with this medicine and for 1 month after
stopping SOHONOS because an unborn baby could be harmed if a pregnant patient receives
your blood.
You should never give this medicinal product to another person. Please take any unused
capsules to your pharmacist at the end of treatment. Grapefruit juice should be avoided
while taking SOHONOS.
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|
Driving or using machines
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SOHONOS may have a minor influence on the ability to drive and use machines and may
affect your ability to see in the dark. SOHONOS should be taken with caution.
|
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Looking after your medicine
|
Keep blister strip in the outer carton in order to protect from light.
Store it in a cool dry place away from moisture, heat or sunlight.
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6. Are there any side effects?
The most common side effects are infection of the nail, headache, dry eyes, nose bleeds,
dry lips and mouth, nausea, dry skin, hair loss and rashes. Serious side effects include
early closure of growth plates in growing children, skin infection (cellulitis), depression
linked with suicidal thoughts, seizures (fits), and fracture within the spine (vertebral
fracture). 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 .
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WARNING:
Can seriously harm an unborn baby. Women must use effective contraception.
Do not take SOHONOS if you are pregnant or you think you may be pregnant. See section
2 'What should I know before I take SOHONOS'.
Can cause bone growth to stop early in growing patients.
Close monitoring is recommended in growing patients. See section 2 'What should I
know before I take SOHONOS'.
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Active ingredient:
Palovarotene
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using SOHONOS. 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 SOHONOS.
Keep this leaflet with the medicine. You may need to read it again.
Where to find information in this leaflet:
1. Why am I taking SOHONOS?
SOHONOS contains the active ingredient palovarotene. SOHONOS interrupts the process where damaged soft tissues are replaced by bone. Palovarotene
is a member of the retinoid class of drugs.
SOHONOS is used
for preventing inappropriate bone formation in muscle and soft tissues in adults and
children (aged 8 years and above for females and 10 years and above for males) with
fibrodysplasia ossificans progressiva (FOP).
FOP is a disorder in which skeletal muscle and connective tissue, such a tendons and
ligaments, are gradually replaced by bone.
2. What should I know before I take SOHONOS?
Warnings
Do not take SOHONOS if:
you are allergic to palovarotene, or any of the ingredients listed at the end of this
leaflet. Always check the ingredients to make sure you can take this medicine.
you are pregnant or breastfeeding.
you are a female who is able to get pregnant you must not take this medicine unless
you follow all of the conditions for pregnancy prevention. See additional information
in this section under Pregnancy and breastfeeding.
You must not become pregnant while taking this medicine. You must stop taking this
medicine immediately and contact your doctor if you do become pregnant or think you
might be pregnant
Check with your doctor if you:
have any other medical conditions
take any medicines for any other condition
have liver or kidney problems. This medicine is not recommended to be taken by people
with severe kidney or liver problems.
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?
Growing Children
SOHONOS causes early closing of growth plates in growing children
A growth plate is the area of growing tissue found at the ends of bones. This medicine
can cause growth plates to fuse stopping any further growth, therefore your doctor
will monitor your child’s growth whilst taking this medicine.
Pregnancy and breastfeeding
Pregnancy Prevention
Women who are pregnant must not take SOHONOS.
This medicine can seriously harm an unborn baby (the medicine is said to be 'teratogenic')
- it can cause serious abnormalities such as cleft palate (where the roof of the mouth
does not form properly), misshapen skull (head) bones and abnormal growth of other
bones (they may be too short or not symmetrical). This may happen even if this medicine
is taken only for a short time during pregnancy.
Check with your doctor if you are pregnant or intend to become pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
You must not take this medicine if:
you are pregnant or if you think you might be pregnant.
you are breastfeeding. The medicine is likely to pass into your milk and may harm
your baby.
you could get pregnant during treatment
You must not get pregnant for one month after stopping this treatment because some
medicine may still be left in your body.
Women who could get pregnant are prescribed SOHONOS under strict rules. This is because
of the risk of serious harm to the unborn baby.
These are the rules:
your doctor must explain the risk of harm to the unborn baby
you must understand why you must not get pregnant and what you need to do to prevent
pregnancy
you must have talked about contraception (birth control) with your doctor. Your doctor
will give you information on how not to get pregnant. Your doctor may send you to
a specialist for contraception advice.
before you start treatment, your doctor will ask you to take a pregnancy test. The
test must show that you are not pregnant when starting treatment with this medicine.
You will be required to show that you are not pregnant every month while taking this
medicine and one month after stopping treatment.
Women must use effective contraception before, during and after taking SOHONOS
you must agree to use at least one highly effective method of contraception (for example,
an intra uterine device) or two effective methods that work in different ways (for
example, a hormonal contraceptive pill and a condom). Discuss with your doctor which
methods would be suitable for you.
you must use contraception for a month before taking this medicine, during treatment
and for a month afterwards.
if you are taking this medicine only for the treatment of flare-ups (not chronic dosing), you must continue to use effective
contraception even during times when you are not taking this medicine, as the timing
of flare-ups may not be predictable.
you must use contraception even if you are not sexually active (unless your doctor
decides this is not necessary).
Women must agree to be in touch with their doctor monthly to ensure they are not pregnant
you must not get pregnant during treatment or for a month afterwards because some
medicine may still be left in your body.
you must agree to have monthly pregnancy tests before you start treatment, during
treatment and, because some medicine may still be left in your body, one month after
stopping this medicine (unless your doctor decides this is not necessary for you).
Your doctor will discuss and make sure you understand and agree to follow the rules
above
If you become pregnant while taking SOHONOS, stop taking the medicine straight away, and contact your doctor. Your doctor may send you to a specialist for advice.
Also, if you become pregnant within one month after you stop taking this medicine,
you must contact your doctor. Your doctor may send you to a specialist for advice.
Male Patients
The amount of medicine that passes into the semen of males is too low to cause any
ill effects to a female partner or her unborn child.
Fractures of the spine (vertebral fracture)
This medicine may cause fractures of the spine (vertebral fractures), as seen on radiology
images of some people treated with SOHONOS. Periodic radiology imaging for this risk
is recommended during treatment with this medicine.
Skin reactions
Tell your doctor or pharmacist if you experience a skin reaction that looks like severe
sunburn (burning, reddening, blistering). These symptoms may appear when exposed to
the sun, therefore you must avoid being out in the sun for long periods of time. You
may also notice:
dry skin
dry lips
dry eyes
loss of hair
itching, rash, redness, skin exfoliation (shedding), skin irritation, bedsores, or
infection around the skin of your finger or toenails
Tell your doctor or pharmacist if you notice any of these symptoms.
Your doctor may recommend the use of skin emollients, sunscreen, lip moisturisers,
artificial tears (drops to lubricate the eye), or other helpful treatments to reduce
these side effects. Protective clothing and sunglasses may also help to reduce exposure
to sunlight and minimise these side effects.
Mental health problems
Depression, worsening of depression, anxiety, changes in mood and suicidal thoughts
and behaviours (suicide attempts) have been reported in patients treated with medicines
like SOHONOS. Tell your doctor if you notice any mental health problems while taking
this medicine. If you have a history of mental health problems tell your doctor as
extra care must be taken while taking this medicine.
Night blindness
This medicine may cause night blindness (poor vision at night). Talk to your doctor
if you experience any visual difficulties.
Children and adolescents
This medicine must not be given to children under the age of 8 years (girls) and 10
years (boys). Clinical studies of this medicine in growing children have identified
a serious side effect in which bone growth can be stopped early (this is called early
closure of growth plates). This effect on bone growth is permanent and can cause short
stature (height) and differences in limb length (arms and legs). Your doctor will
explain the risks to you and your child. Your doctor will closely monitor you child’s
growth during treatment and may stop treatment if your child is affected.
3. What if I am taking other medicines?
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.
Some medicines may interfere with SOHONOS and affect how it works.
Medicines that may
increase
the effect of SOHONOS include:
vitamin supplements containing vitamin A or other medicines derived from vitamin A
used for skin conditions, known as 'retinoids', such as acitretin, isotretinoin, tretinoin,
adapalene and tazarotene. Because Vitamin A in high doses has many of the same side
effects as SOHONOS. Taking both together may increase your chance of getting side
effects.
medicines used to treat fungal infections, such as fluconazole, itraconazole and ketoconazole
medicines called "protease inhibitors" used to treat human immunodeficiency virus
(HIV) and acquired immunodeficiency syndrome (AIDS) or COVID 19 infection such as
ritonavir and nirmatrelvir.
medicines used to treat bacterial infections (antibiotics), such as clarithromycin,
erythromycin and tetracyclines
Diltiazem which is a medicine used to treat heart conditions including angina, high
blood pressure, arrythmias and heart failure.
A medicine called aprepitant used to prevent nausea (feeling sick in your stomach)
and vomiting.
Medicines that may
reduce
the effect of SOHONOS include:
medicines used to treat epilepsy, such as phenytoin and carbamazepine
A medicine called bosentan used to treat pulmonary arterial hypertension (high blood
pressure in the blood vessels in the lungs).
medicines used to treat bacterial infections (antibiotics), such as rifampicin and
rifabutin
herbal preparations containing St John's Wort extract (Hypericum perforatum)
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect SOHONOS.
4. How do I take SOHONOS?
How much to take
The recommended dosage regimen of SOHONOS consists of a combination of daily treatment
referred to as ‘Chronic Treatment’ and a higher-dose treatment taken at the time of
a flare-up known as ‘Flare-up Treatment’.
Follow the instructions provided and take SOHONOS until your doctor tells you to stop.
Chronic Treatment
The recommended dose for adults and children 14 years of age and older is 5 mg once
daily.
For children under 14 years of age your doctor will adjust the dose based on the weight
of the child.
You must stop taking the Chronic dose at the time a flare-up starts and you begin
taking the Flare-up dose. Do not take both doses at the same time.
Flare-Up Treatment
On starting Flare-up dosing you must stop Chronic daily dosing.
At the time of a flare-up or a trauma that could lead to a flare-up the dose is increased
to 20 mg once daily for the first 4 weeks, followed by 10 mg once daily for 8 weeks,
for a total of 12 weeks even if symptoms resolve earlier. If the flare-up symptoms
are persistent, your doctor may extend your Flare-up Treatment in 4-week intervals
with 10 mg once daily, which must be continued until the flare-up resolves. Once the
Flare-up has finished you will restart the 5 mg daily Chronic dose. For children under
14 years of age your doctor will adjust the dose based on the weight of the child.
Flare-up treatment must be started at the first symptom indicative of a FOP flare-up.
Contact your doctor immediately to start treatment if you notice any one symptom of
a flare-up. Typically symptoms are, for example, localised pain, soft tissue swelling/inflammation,
redness, warmth, decreased joint range of motion (movement), and stiffness. Your doctor
will explain to you the signs and symptoms that you must look for.
Flare-ups can occur in the absence of any apparent cause, but there is a high risk
that major physical traumatic events can induce flare-ups and inappropriate bone formation.
Examples of a traumatic event include surgery, vaccinations, injections for dental
work, muscle tiredness, blunt muscle trauma from bumps, bruises, falls or influenza-like
viral illnesses.
Contact your doctor if you experience any major physical traumatic events. Your doctor may start you on treatment to prevent a flare-up in these cases.
Contact your doctor if you experience another flare-up (new flare-up location or worsening of the original flare-up) at any time during
treatment, your doctor may consider restarting the 12-week Flare-up Treatment.
Once the flare-up has resolved, you should return to once daily Chronic Treatment.
You should not take both Chronic Treatment and Flare-up Treatment at the same time.
Children aged from 8 years (girls) and 10 years (boys) to less than 14 years
The dose of this medicine is adjusted based on the weight of children under 14 years
of age. Your doctor will prescribe the most appropriate dose based on your child’s
weight. (the dose will be increased as your child’s weight increases).
Recommended dose reduction if you experience side effects (Chronic and Flare-up treatment)
If you experience side effects during treatment, inform your doctor, who may decide
to reduce your dose. The daily dose can be reduced to the next lower dose. If you
are already receiving the lowest possible dose, then your doctor may stop your treatment
with SOHONOS. Subsequent Flare-up Treatments must be started at the same reduced dose
that was tolerated previously.
Flare-up only Treatment
If you experience side effects whilst taking Chronic daily treatment your doctor may
reduce your daily dose as shown above. If after this reduction in dose you still experience
side effects, then your doctor may change your treatment, so you only receive Flare-up
Treatment and stop receiving Chronic Treatment completely. The dose at Flare-up should
follow the same normal recommended dose.
Children under 8 years of age (girls) and under 10 years of age (boys)
This medicine must not be given to girls under 8 years of age and boys under 10 years of age due to the
risk of reduced bone growth.
Elderly
If you are over 65 years old your doctor may prescribe a lower dose of SOHONOS.
Precautions to be taken before handling or administering the medicine
To avoid unintended contact when handling this medicine, you must wear disposable
gloves when emptying the capsule contents onto soft food. Use disposable paper towels
and a container to collect waste (e.g. a resealable bag). Caregivers who are pregnant
or who intend to become pregnant must avoid contact with this medicine.
When to take SOHONOS
SOHONOS capsules should be swallowed whole and taken with food preferably at the same
time each day.
If you are unable to swallow capsules, you may open the capsules and sprinkle the
content onto a teaspoon of soft food and take it immediately. If you cannot take it
immediately, it can be taken after a maximum of 1 hour after the sprinkling, provided
it was maintained at room temperature and not exposed to direct sunlight.
If you forget to take SOHONOS
SOHONOS should be taken regularly at the same time each day. If you miss your dose
at the usual time, take the dose as soon as you remember.
If the dose has been missed by more than 6 hours, skip the dose you missed and take
your next dose when you are meant to.
Do not take a double dose to make up for the dose you missed.
If you take too much SOHONOS
If you think that you have taken too much SOHONOS, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital, taking this leaflet with
you.
You should do this even if there are no signs of discomfort or poisoning.
You may experience some of the following symptoms: severe headache, feeling sick or
vomiting, feeling drowsy, irritability, and itchy skin.
5. What should I know while taking SOHONOS?
Things you should do
Use effective contraception before, during and after taking SOHONOS (for women, unless
your doctor decides this is not necessary).
Ensure women who are pregnant or who intend to become pregnant avoid contact with
SOHONOS.
Ensure caregivers administering SOHONOS by emptying the capsule contents onto soft
food avoid unintended exposure by wearing disposable gloves when handling and use
disposable paper towels and a container to collect waste (e.g. a resealable bag).
Pregnancy, breast-feeding and fertility
Avoid consuming grapefruit juice or grapefruit-containing products for as long as
you are taking this medicine, as they may increase the levels of SOHONOS in your blood.
This medicine should not be used if you are pregnant or trying to get pregnant as
it may harm your baby. You should not breastfeed if you are taking SOHONOS, as the
medicine may be passed on to your baby.
If you are pregnant or breastfeeding, think you may be pregnant or are planning to
have a baby, ask your doctor for advice before taking this medicine.
Before starting treatment with SOHONOS your doctor will discuss contraceptive measures
with you.
For more information on pregnancy and contraception, see section 2 Pregnancy Prevention.
No studies have been conducted to evaluate the effects of palovarotene on fertility
in females or males.
Call your doctor straight away if you:
think you may be pregnant
experience another flare-up (new flare-up location or worsening of the original flare-up)
at any time during treatment. Your doctor may consider restarting the 12-week treatment.
have concerns about your child's growth
Remind any doctor, dentist or pharmacist you visit that you are taking SOHONOS.
Things you should not do
Avoid taking grapefruit-containing products for as long as you are taking this medicine
as they may increase the levels of SOHONOS in your blood.
Do not stop taking this medicine without first speaking to your doctor.
You should never give this medicine to another person. Please take any unused capsules
to your pharmacist at the end of treatment.
You should not donate blood during treatment with this medicine and for 1 month after
stopping SOHONOS because an unborn baby could be harmed if a pregnant patient receives
your blood.
Lactose intolerance
SOHONOS contains lactose. If you have been told by your doctor that you have an intolerance
to some sugars, contact your doctor before taking this medicine.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how SOHONOS
affects you.
SOHONOS may have a minor influence on the ability to drive and use machines. SOHONOS
may affect your ability to see in the dark. This condition usually clears up after
you stop taking SOHONOS, but it may persist. Therefore, SOHONOS should be used with
caution.
Looking after your medicine
Keep blister strips in the outer carton in order to protect from light.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
If you no longer need to take this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not take 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 or pharmacist if you
have any further questions about side effects.
Less serious side effects
Serious side effects
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.
7. Product details
This medicine is only available with a doctor's prescription.
What SOHONOS contains
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Active ingredient
(main ingredient)
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Each capsule contains 1 mg, 1.5 mg, 2.5 mg, 5 mg or 10 mg of palovarotene
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Other ingredients
(inactive ingredients)
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Capsule contents: lactose monohydrate, povidone, croscarmellose sodium, sodium lauryl
sulfate, microcrystalline cellulose, magnesium stearate
Capsule shell: gelatin, titanium dioxide (E 171)
Printing ink: shellac (E904), propylene glycol (E1520), potassium hydroxide (E525),
black iron oxide (E 172)
|
Do not take this medicine if you are allergic to any of these ingredients.
What SOHONOS looks like
SOHONOS are white, opaque, elongated, hard-gelatin capsules filled with white to off-white
powder.
SOHONOS 1 mg capsules have "PVO 1" printed with black ink on the body (AUST R 394003).
SOHONOS 1.5 mg capsules have "PVO 1.5" printed with black ink on the body (AUST R
394001).
SOHONOS 2.5 mg capsules have "PVO 2.5" printed with black ink on the body (AUST R
394002).
SOHONOS 5 mg capsules have "PVO 5" printed with black ink on the body (AUST R 394000).
SOHONOS 10 mg capsules have "PVO 10" printed with black ink on the body (AUST R 393999).
SOHONOS capsules are packaged into a blister strip composed of PVC/PCTFE (polyvinylchloride/poly-chloro-tri-fluoro-ethylene)
backed with push-through aluminium foil. The blister strips are then packaged into
a carton.
Each pack contains 28 capsules (2 x 14 blister strips).
Australian sponsor of SOHONOS
Ipsen Pty Ltd
Level 5, 627 Chapel Street
South Yarra, VIC 3141
This leaflet was prepared in November 2023.