Kalydeco

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.

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.

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 an R117H CFTR mutation or one of the following gating (class III) mutations in the CFTR gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R. For more information, see Section1. Why am I using KALYDECO? in the full CMI.

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.
For more information, see Section 2. What should I know before I use KALYDECO? in the full CMI.

What if I am taking other medicines?

Some medicines may interfere with KALYDECO and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

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. More instructions can be found in Section 4. How do I use KALYDECO? in the full CMI.

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.
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.
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.
For more information, see Section 5. What should I know while using KALYDECO? in the full CMI.

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 stomach (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
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:

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 an R117H CFTR mutation or one of the following gating (class III) mutations in the CFTR gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R.

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.

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
take any medicines for any other condition (See Section 3. What if I am taking other medicines?)
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 stomach (abdominal) area
yellowing of the skin or the white part of the eyes
loss of appetite
nausea or vomiting
dark urine

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
ketoconazole, itraconazole, posaconazole, voriconazole, fluconazole
Antibiotic medicines used for treatment of bacterial infections
telithromycin, clarithromycin, erythromycin, rifampicin, rifabutin
Anticonvulsant medicines used for the treatment of epileptic seizures
phenobarbital, carbamazepine, phenytoin
Anti-inflammatory medicines used for the treatment of inflammation
dexamethasone, high-dose prednisone
Herbal medicine
St. John's wort (Hypericum perforatum)
Benzodiazepines used for the treatment of anxiety, insomnia, agitation, etc.
midazolam, alprazolam, diazepam, triazolam
Immunosuppressants used after organ transplantation
ciclosporin, tacrolimus
Cardiac glycosides used for the treatment of mild to moderate congestive heart failure and an abnormal heart rhythm
digoxin
Anticoagulants used to prevent blood clots from forming or growing larger in blood and blood vessels
warfarin
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.

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
Weight
Dose
Total daily dose
4 months to less than 6 months
≥5 kg
One sachet of 25 mg granules taken orally every 12 hours
50 mg (two sachets)
6 months and older
≥5 kg to <7 kg
One sachet of 25 mg granules taken orally every 12 hours
50 mg (two sachets)
≥7 kg to <14 kg
One sachet of 50 mg granules taken orally every 12 hours
100 mg (two sachets)
≥14 kg to <25 kg
One sachet of 75 mg granules taken orally every 12 hours
150 mg (two sachets)
≥25 kg
One 150 mg tablet taken orally every 12 hours
300 mg (two tablets)
 
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.

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.

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

Less serious side effects
What to do
Very common side effects (may affect more than 1 in 10 people)
upper respiratory tract infection (the common cold), including sore throat and nasal congestion
headache
abdominal pain
diarrhoea
rash
Common side effects (may affect up to 1 in 10 people)
sinus congestion
red throat
runny nose
dizziness
changes in the type of bacteria in mucus
ear pain, ear discomfort
ringing in the ears
redness inside the ear
Uncommon side effects (may affect up to 1 in 100 people)
ear congestion
breast inflammation
breast mass
enlargement of the breast
nipple changes or pain
Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effects
What to do
Significant pain or discomfort in the upper right stomach (abdominal) area.
Yellowing of your skin or the white parts of your eyes.
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.
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.

Product details

This medicine is only available with a doctor's prescription.

What KALYDECO tablets contain

Active ingredient
(main ingredient)
ivacaftor
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).
Potential allergens
Lactose monohydrate

What KALYDECO granules contain

Active ingredient
(main ingredient)
ivacaftor
Other ingredients
(inactive ingredients)
silicon dioxide, croscarmellose sodium, hypromellose acetate succinate, lactose monohydrate, magnesium stearate, mannitol, sucralose, sodium lauryl sulfate.
Potential allergens
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 April 2022.
©2022 Vertex Pharmaceuticals Incorporated
KALYDECO, VERTEX and the VERTEX triangle logo are registered trademarks of Vertex Pharmaceuticals Incorporated.