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.
1. Why am I using KALYDECO?
KALYDECO contains the active ingredient ivacaftor. KALYDECO is used for the treatment
of cystic fibrosis (CF) in patients aged 4 months and older who have at least one
mutation in the CFTR gene that is responsive to ivacaftor potentiation based on clinical and/or in vitro
assay data.
2. What should I know before I use KALYDECO?
Do not use if you have ever had an allergic reaction to KALYDECO 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.
3. What if I am taking other medicines?
Some medicines may interfere with KALYDECO and affect how it works.
4. How do I use KALYDECO?
Your doctor will tell you how much KALYDECO you need to take each day. This may depend
on your condition and whether or not you are taking any other medicines. KALYDECO
is for oral use.
5. What should I know while using KALYDECO?
|
Things you should do
|
Remind any doctor, dentist or pharmacist you visit that you are using KALYDECO.
Use KALYDECO exactly as your doctor has prescribed.
Take KALYDECO with fat-containing food and avoid food containing grapefruit.
Tell your doctor if you become pregnant while using KALYDECO.
|
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Things you should not do
|
Do not stop using KALYDECO or change the dose without first checking with your doctor.
Do not take any other medicines whether they require a prescription or not without
first telling your doctor or consulting a pharmacist.
|
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Looking after your medicine
|
Store below 30°C, in a dry place away from moisture, heat or sunlight.
Keep this medicine where young children cannot reach it.
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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.
Ask your doctor or pharmacist if you have any further questions about side effects.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking KALYDECO.
Some common side effects experienced by patients taking KALYDECO include the common
cold, sore throat and nasal congestion, headache, abdominal pain, diarrhoea and rash.
If you experience significant pain or discomfort in the upper right abdominal area,
or yellowing of your skin or the white parts of your eyes these may be indicative
of serious side effects. 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.
Active ingredient(s):
Ivacaftor
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using KALYDECO. 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 KALYDECO
Where to find information in this leaflet:
1. Why am I using KALYDECO?
KALYDECO contains the active ingredient ivacaftor.
KALYDECO is used for the chronic treatment of cystic fibrosis (CF) in patients aged
4 months and older who have at least one mutation in the CFTR gene that is responsive
to ivacaftor potentiation based on clinical and/or in vitro assay data.
KALYDECO belongs to a group of medicines called "cystic fibrosis transmembrane conductance
regulator (CFTR) modulators."
In people with a G551D or other gating (class III) mutation and in people with an R117H mutation, the CFTR protein is present in normal amounts but its ability to allow chloride to pass through
is reduced. KALYDECO is a CFTR potentiator, which is a drug that increases the opening of the CFTR protein, allowing more chloride to pass through.
KALYDECO is not addictive.
What is cystic fibrosis?
Cystic fibrosis is caused by genetic defects that limit the flow of chloride and water
through cell membranes. As a result, the mucus in the lungs (and other organs) becomes
thick and sticky, clogs the lungs and makes it easier for germs to grow. KALYDECO
is a medicine that works by improving the flow of chloride and water in patients with
cystic fibrosis who have a certain genetic defect.
2. What should I know before I use KALYDECO?
Warnings
Do not use KALYDECO if:
you are allergic to ivacaftor, 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
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
Check with your doctor if you are pregnant or intend to become pregnant.
Your doctor will help you decide what is best for you or your child.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
It is unknown whether KALYDECO is excreted in human milk. If you plan to breast-feed,
ask your doctor for advice before taking KALYDECO.
Use in children
Do not give KALYDECO to children weighing less than 5 kg or under 4 months of age.
The safety and efficacy of this medicine in children aged less than 4 months have
not been established.
Abnormality of the eye lens (cataract) without any effect on vision has been noted
in some children receiving KALYDECO.
Your doctor may perform some eye examinations prior to and during the treatment with
KALYDECO.
Laboratory Testing
Your doctor will do some blood tests to check your liver prior to and while you are
taking KALYDECO, particularly during the first year and especially if you have had
high liver enzymes in the past.
Talk to your doctor if you have been told you have liver or kidney disease or if you
are taking any other medicine, as your doctor may need to adjust the dose of KALYDECO.
Increased liver enzymes in the blood have been seen in some people receiving KALYDECO.
Tell your doctor right away if you have any of these symptoms, which may be a sign
of liver problems:
pain or discomfort in the upper right abdominal area
yellowing of the skin or the white part of the eyes
loss of appetite
nausea or vomiting
dark urine
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 KALYDECO and affect how it works. You may need different
amounts of your medicines, or you may need to take different medicines. Your doctor
will advise you.
Take KALYDECO with fat-containing food and avoid food containing grapefruit.
Tell your doctor or pharmacist if you are taking any of the following:
|
Antifungal medicines
used for the treatment of fungal infections
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ketoconazole, itraconazole, posaconazole, voriconazole, fluconazole
|
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Antibiotic medicines
used for treatment of bacterial infections
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telithromycin, clarithromycin, erythromycin, rifampicin, rifabutin
|
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Anticonvulsant medicines
used for the treatment of epileptic seizures
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phenobarbital, carbamazepine, phenytoin
|
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Anti-inflammatory medicines
used for the treatment of inflammation
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dexamethasone, high-dose prednisone
|
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Herbal medicine
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St. John's wort (Hypericum perforatum)
|
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Benzodiazepines
used for the treatment of anxiety, insomnia, agitation, etc.
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midazolam, alprazolam, diazepam, triazolam
|
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Immunosuppressants
used after organ transplantation
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ciclosporin, tacrolimus
|
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Cardiac glycosides
used for the treatment of mild to moderate congestive heart failure and an abnormal
heart rhythm
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digoxin
|
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Anticoagulants
used to prevent blood clots from forming or growing larger in blood and blood vessels
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warfarin
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Your doctor or pharmacist has more information on medicines to be careful with or
to avoid while taking KALYDECO.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect KALYDECO.
4. How do I use KALYDECO?
How much to take
Your doctor will tell you how much KALYDECO you need to take each day. This may depend
on your condition and whether or not you are taking any other medicines.
KALYDECO dosing recommendations for patients aged 4 months and older are as follows:
|
Age
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Weight
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Dose
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Total daily dose
|
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4 months to less than 6 months
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≥5 kg
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One sachet of 25 mg granules taken orally every 12 hours
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50 mg (two sachets)
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6 months and older
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≥5 kg to <7 kg
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One sachet of 25 mg granules taken orally every 12 hours
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50 mg (two sachets)
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≥7 kg to <14 kg
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One sachet of 50 mg granules taken orally every 12 hours
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100 mg (two sachets)
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≥14 kg to <25 kg
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One sachet of 75 mg granules taken orally every 12 hours
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150 mg (two sachets)
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≥25 kg
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One 150 mg tablet taken orally every 12 hours
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300 mg (two tablets)
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If you have liver problems, your doctor may need to reduce the dose as your liver
is not clearing ivacaftor as fast as in people who do not have problems with liver
function.
When to take KALYDECO
KALYDECO should be taken every 12 hours.
How to take KALYDECO
KALYDECO is for oral use.
Tablets
Take 1 tablet (150 mg) of KALYDECO every 12 hours by mouth with a fat-containing meal
or snack.
Granules
Take 1 sachet of KALYDECO every 12 hours by mouth with a fat-containing meal or snack.
Each sachet is for single use only.
Giving KALYDECO to your child
Hold sachet of granules with cut line on top.
Shake sachet gently to settle contents.
Tear or cut sachet open along cut line.
Mix the entire content of a sachet with one teaspoon (5 mL) of age-appropriate soft
food or liquid. Food or liquid should be at room temperature or below. Some examples
of age-appropriate soft foods or liquids include puréed fruits or vegetables, yogurt,
water, breast milk, infant formula, whole milk, or juice.
Once mixed, give the product to your child immediately. If this is not possible, give
it within one hour after mixing. Ensure that the mixture is completely and immediately
consumed.
A fat-containing meal or snack should be given to your child just before or just after
dosing.
Examples of meals or snacks that contain fat are those prepared with butter or oils
or those containing eggs. Other fat-containing foods are:
Cheese, breast milk, infant formula, whole milk, whole-milk dairy products, yogurt,
chocolate
Meats, oily fish
Avocados, hummus, soy-based products (tofu)
Nuts, fat-containing nutritional bars or drinks
If you forget to take KALYDECO
KALYDECO should be used regularly at the same time each day. If you miss your dose
at the usual time, take the missed dose if less than 6 hours have passed since the
time you missed the dose. Otherwise, wait until your next scheduled dose as you normally
would.
Do not take a double dose to make up for the dose you missed.
This may increase the chance of you getting an unwanted side effect.
If you are not sure what to do, talk to your doctor or pharmacist.
If you take too much KALYDECO
If you think that you have used too much KALYDECO, 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.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while using KALYDECO?
Things you should do
Keep all of your doctor's appointments so that your progress can be checked.
Use KALYDECO exactly as your doctor has prescribed.
Take KALYDECO with fat-containing food and avoid food containing grapefruit.
Tell all doctors, dentists and pharmacists who are treating you that you are using
KALYDECO.
Tell your doctor if you become pregnant while using KALYDECO.
Tell your doctor if, for any reason, you have not used KALYDECO exactly prescribed.
Remind any doctor, dentist or pharmacist you visit that you are using KALYDECO.
Things you should not do
Do not stop using KALYDECO or change the dose without first checking with your doctor.
Do not let yourself run out of medicine over the weekend or on holidays.
Do not give KALYDECO to anyone else even if they have the same condition as you.
Do not use KALYDECO to treat other complaints unless your doctor tells you to.
Do not take any other medicines whether they require a prescription or not without
first telling your doctor or consulting a pharmacist.
Things to be careful of
Avoid food containing grapefruit during treatment with KALYDECO as they may increase
the amount of KALYDECO in your body.
KALYDECO tablets contains lactose. KALYDECO granules contains lactose, mannitol and
sucralose. 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 KALYDECO
affects you.
KALYDECO may cause dizziness in some people. Do not drive or use machines unless you
are sure that you are not affected.
If your child is taking KALYDECO, it is advised that he/she does not ride his/her
bike or do anything else that’s needs his/her full attention unless you are sure that
your child is not affected.
Looking after your medicine
Store below 30°C, in a dry place away from moisture, heat or sunlight.
Keep this medicine where young children cannot reach it.
Do not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Follow the instructions in the carton on how to take care of your medicine properly.
Granules
Once mixed with food, KALYDECO granules are stable for one hour.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
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 or pharmacist if you
have any further questions about side effects.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking KALYDECO.
Less serious side effects
Serious side effects
These may be indicative of serious side effects. You may need urgent medical attention.
Serious side effects are uncommon.
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell, even if it is not on the list.
This is not a complete list of all possible side effects. Your doctor or pharmacist
has a more complete list. Others may occur in some people and there may be some side
effects not yet known.
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 KALYDECO tablets contain
|
Active ingredient
(main ingredient)
|
ivacaftor
|
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Other ingredients
(inactive ingredients)
|
microcrystalline cellulose, lactose monohydrate, hypromellose acetate succinate, croscarmellose
sodium, sodium lauryl sulfate, silicon dioxide, magnesium stearate, carnauba wax,
Opadry II complete film coating system 85F90614 Blue (PI# 108371), OPACODE monogramming
ink S-1-17823 BLACK (PI# 12108).
|
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Potential allergens
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Lactose monohydrate
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What KALYDECO granules contain
|
Active ingredient
(main ingredient)
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ivacaftor
|
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Other ingredients
(inactive ingredients)
|
silicon dioxide, croscarmellose sodium, hypromellose acetate succinate, lactose monohydrate,
magnesium stearate, mannitol, sucralose, sodium lauryl sulfate.
|
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Potential allergens
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Lactose monohydrate, mannitol and sucralose
|
Do not take this medicine if you are allergic to any of these ingredients.
What KALYDECO looks like
KALYDECO 150 mg film-coated tablets are light blue, capsule-shaped tablets, 16.5 mm
x 8.4 mm, printed with "V 150" in black ink on one side and plain on the other. (150
mg blister pack: Aust R 198655).
KALYDECO 25 mg, 50 mg and 75 mg granules are white to off-white sweetened, unflavoured
granules approximately 2 mm in diameter.
(25 mg sachet: Aust R 342815; 50 mg sachet: Aust R 267390; 75 mg sachet: Aust R 269661)
Availability
Tablets
KALYDECO 150 mg tablets are available in in a blister pack containing 56 film-coated
tablets.
Granules
KALYDECO 25 mg, 50 mg and 75 mg granules are available in the following pack size:
56 sachets (containing 4 individual wallets with 14 sachets per wallet)
Who distributes KALYDECO
Vertex Pharmaceuticals (Australia) Pty Ltd
Suite 3, Level 3
601 Pacific Highway
St Leonards
NSW 2065
Australia
Telephone: 1800 179 987
This leaflet was prepared in February 2023.
©2023 Vertex Pharmaceuticals Incorporated
KALYDECO, VERTEX and the VERTEX triangle logo are registered trademarks of Vertex
Pharmaceuticals Incorporated.