Patient leaflet - Kalydeco 75 mg film-coated tablets
• 1 What Kalydeco is and what it is used for
Kalydeco contains the active substance ivacaftor. Ivacaftor acts at the level of the cystic fibrosis transmembrane conductance regulator (CFTR), a protein that forms a channel at the cell surface that allows the movement of particles such as chloride in and out of the cell. Due to mutations in the CFTR gene (see below), chloride movement is reduced in those with cystic fibrosis (CF). Ivacaftor helps certain abnormal CFTR proteins open more often to improve chloride movement in and out of the cell.
Kalydeco tablets are indicated:
As monotherapy for patients aged 6 years and older and weighing 25 kg or more with cystic fibrosis (CF) who have an R117H CFTR mutation or one of the following gating mutations in the CFTR gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R.
- In combination with tezacaftor/ivacaftor tablets for patients aged 6 years and older with CF who have two F508del mutations in the CFTR gene (homozygous for the F508del mutation) or who have an F508del mutation and certain other second mutations that result in reduced amount and/or function of the CFTR protein (heterozygous for the F508del mutation with a residual function (RF) mutation). If you have been prescribed Kalydeco to be taken with tezacaftor/ ivacaftor, read the package leaflet of the latter. It contains important information about how to take these two medicines.
- In combination with ivacaftor/tezacaftor/elexacaftor tablets for patients aged 6 years and over who have CF, with at least one F508del mutation in the CFTR gene. If you have been prescribed Kalydeco to be taken with ivacaftor/ tezacaftor/elexacaftor, read the package leaflet of the latter. It contains important information about how to take these two medicines.
• 2 What you need to know before you take Kalydeco
Do not take Kalydeco
- if you are allergic to ivacaftor or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Kalydeco.
- Talk to your doctor if you have liver problems or have previously had them. Your doctor may need to adjust your dose.
Increased liver enzymes in the blood have been seen in some people receiving Kalydeco (alone or in combination with tezacaftor/ivacaftor or ivacaftor/ tezacaftor/elexacaftor). 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
Your doctor will do some blood tests to check your liver before and during treatment, particularly during the first year and especially if your blood tests showed high liver enzymes in the past.
- Talk to your doctor if you have kidney problems or have previously had them.
- Kalydeco (alone or in combination with tezacaftor/ivacaftor or ivacaftor/ tezacaftor/elexacaftor) is not recommended if you have undergone an organ transplant.
- Talk to your doctor if you are using hormonal contraception – for example, women using the contraceptive pill. This may mean you are more likely to get a rash while taking Kalydeco in combination with ivacaftor/tezacaftor/ elexacaftor.
- Abnormality of the eye lens (cataract) without any effect on vision has been noted in some children and adolescents treated with Kalydeco (alone or in combination with tezacaftor/ivacaftor or ivacaftor/tezacaftor/elexacaftor). Your doctor may perform some eye examinations prior to and during treatment.
Kalydeco (alone or in combination with tezacaftor/ivacaftor or ivacaftor/ tezacaftor/elexacaftor) should only be used if you have one of the mutations in the CFTR gene indicated in section 1 (What Kalydeco is and what it is used for).
Children and adolescents
Do not give this medicine to children under 1 month of age as it is not known if ivacaftor is safe and effective in these children.
Do not give this medicine in combination with tezacaftor/ivacaftor to children under 6 years of age or in combination with ivacaftor/tezacaftor/elexacaftor to children under 2 years of age as it is not known if they are safe and effective for them.
Other medicines and Kalydeco
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. Some medicines can affect how Kalydeco works or make side effects more likely. In particular, tell your doctor if you are taking any of the medicines listed below. Your doctor may decide to adjust your dose or that you need extra check-ups.
- Antifungal medicines (used for the treatment of fungal infections). These include fluconazole, itraconazole, ketoconazole, posaconazole, and voriconazole.
- Antibiotic medicines (used for the treatment of bacterial infections). These include clarithromycin, erythromycin, rifabutin, rifampicin, and telithromycin.
- Epilepsy medicines (used for the treatment of epileptic seizures or fits). These include carbamazepine, phenobarbital, and phenytoin.
- Herbal medicines. These include St. John’s wort (Hypericum perforatum).
- Immunosuppressants (used after an organ transplantation). These include ciclosporin, everolimus, sirolimus, and tacrolimus.
- Cardiac glycosides (used for the treatment of some heart conditions). These include digoxin.
- Anticoagulant medicines (used to prevent blood clots). These include warfarin.
- Medicines for diabetes. These include glimepiride and glipizide.
- Medicines for lowering blood pressure. These include verapamil.
Kalydeco with food and drink
Avoid food or drink containing grapefruit during treatment with Kalydeco as they may increase the side effects of Kalydeco by increasing the amount of ivacaftor in your body.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. It may be better to avoid using Kalydeco during pregnancy, if possible, and your doctor will help you decide what is best for you and your child.
It is unknown whether ivacaftor is excreted in human milk. If you plan to breast-feed, ask your doctor for advice before taking Kalydeco. Your doctor will decide whether to recommend that you stop breast-feeding or for you to stop ivacaftor therapy. Your doctor will take into account the benefit of breast-feeding for the child and the benefit of therapy for you.
Driving and using machines
Kalydeco can make you dizzy. If you feel dizzy, do not drive, cycle or use machines.
Kalydeco contains lactose and sodium.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Kalydeco contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.
• 3 How to take Kalydeco
Always take this medicine exactly as your doctor has told you to. Check with your doctor if you are not sure.
Your doctor will determine which medicine and dose is right for you.
Kalydeco dosing recommendations are provided in Table 1.
Table 1: Dosing recommendations
Morning Evening Kalydeco as monotherapy
6 years and older,
≥ 25 kg One Kalydeco 150 mg tablet One Kalydeco
150 mg tablet Kalydeco in combination with tezacaftor/ivacaftor
6 years to less than
12 years, < 30 kg
One tezacaftor 50 mg/
ivacaftor 75 mg tablet
One Kalydeco 75 mg tablet 6 years to less than
12 years, ≥ 30 kg
One tezacaftor 100 mg/
ivacaftor 150 mg tablet
One Kalydeco 150 mg tablet
12 years and older One tezacaftor 100 mg/
ivacaftor 150 mg tablet
One Kalydeco 150 mg tablet Kalydeco in combination with ivacaftor/tezacaftor/elexacaftor
6 years to less than
12 years, < 30 kg
Two ivacaftor 37.5 mg/tezacaftor 25 mg/ elexacaftor 50 mg tablets
One Kalydeco 75 mg tablet 6 years to less than
12 years, ≥ 30 kg
Two ivacaftor 75 mg/tezacaftor 50 mg/ elexacaftor 100 mg tablets
One Kalydeco 150 mg tablet
12 years and older Two ivacaftor 75 mg/tezacaftor 50 mg/ elexacaftor 100 mg tablets
One Kalydeco 150 mg tablet
Take the morning and evening doses approximately 12 hours apart with food that contains fat.
You must keep using all other medicines you use, unless your doctor tells you to stop using any.
If you have liver problems, either moderate or severe, your doctor may need to reduce the dose of your tablets, because your liver will not clear the medicine as fast as in people who have normal liver function.
This medicine is for oral use.
Swallow the tablet whole. Do not break, chew or dissolve the tablets. Take Kalydeco tablets with food that contains fat.
Meals or snacks that contain fat include those prepared with butter or oils or those containing eggs. Other fat-containing foods are:
- Cheese, whole milk, whole-milk dairy products, yogurt, chocolate
- Meats, oily fish
- Avocados, hummus, soy-based products (tofu)
Nuts, fat-containing nutritional bars or drinks
➤ PX3436/3
PX3436/3
Packaging Site: Almac
LFT-0007-02
Overall dimensions
560 x 280 mm
Folded dimensions (if needed)
70 x 35 mm
CMO Drawing
CDS-PX000078
CMO Code
10345000
Revision Date
01 Sep 2023
05 Mar 2024
Leaflet 01
PX3436/3 11 pt
34363 791446
N/A
If you take more Kalydeco than you should
You may experience side effects, including those mentioned in se If so, contact your doctor or pharmacist to ask for advice. If possib medicine and this leaflet with you.
If you forget to take Kalydeco
ction 4 below. le, have your
- Stomach or abdominal pain
- Changes in the type of bacteria in muc
- Increased liver enzymes (signs of stres
- Rash
Common side effects
Take the missed dose if less than 6 hours have passed since the ti the dose. Otherwise, wait until your next scheduled dose as you n Do not take a double dose to make up for a forgotten dose.
If you stop taking Kalydeco
Take Kalydeco for as long as your doctor recommends. Do not sto doctor advises you to.
me you missed ormally would.
p unless your
(may affect up to 1 in 10 people)
- Runny nose
- Ear pain, ear discomfort
- Ringing in the ears
- Redness inside the ear
- Inner ear disorder (feeling dizzy or spi
If you have any further questions on the use of this medicine, ask pharmacist.
• 4 Possible side effects
Like all medicines, this medicine can cause side effects, although gets them.
your doctor or
not everybody
- Sinus problems (sinus congestion)
- Redness in the throat
- Breast mass
- Feeling sick (nausea)
- Flu• Low blood sugar (hypoglycaemia)
Serious side effects
Stomach (abdominal) ache and increased liver enzymes in the bl
Possible signs of liver problems
Increased liver enzymes in the blood are common in patients wit also been reported in patients taking Kalydeco alone or in combi
ood.
h CF and have nation with
- Abnormal breathing (shortness of bre
- Wind (flatulence)
- Spots (acne)
- Itchy skin
- Increased creatine phosphokinase (sig blood tests
tezacaftor/ivacaftor or ivacaftor/tezacaftor/elexacaftor.
In patients taking Kalydeco in combination with ivacaftor/tez elexacaftor, liver damage and worsening of liver function in p severe liver disease has been reported. The worsening of liver fun serious and may require transplantation.
These may be signs of liver problems:
acaftor/
eople with ction can be
Uncommon side effects
(may affect up to 1 in 100 people)
- Ear congestion
- Breast inflammation
- Enlargement of the breast in males
- Nipple changes or pain
- Wheezing
- Pain or discomfort in the upper right area of the stomach (abd
- Yellowing of the skin or white part of the eyes
- Loss of appetite
- Nausea or vomiting
Dark urine
ominal) area • Increased blood pressure
Additional side effects in children
Side effects seen in children and adolesc adults. However, increased liver enzymes in young children.
Tell your doctor straight away if you have any of these symptom
Very common side effects
(may affect more than 1 in 10 people)
- Upper respiratory tract infection (the common cold), including nasal congestion
Headache
s.
sore throat and
Reporting of side effects
If you get any side effects, talk to your do possible side effects not listed in this leaf directly via:
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard o
- Dizziness
Diarrhoea
us s on the liver)
nning)
ath or difficulty breathing)
n of muscle breakdown) seen in and adolescents ents are similar to those observed in in the blood are more frequently seen ctor or pharmacist. This includes any let. You can also report side effects r search for MHRA Yellow Card in the
Google Play or Apple App Store.
By reporting side effects you can help pr this medicine.
ovide more information on the safety of
• 5 How to store Kalydeco
Keep this medicine out of the sight and r
Do not use this medicine after the expiry blister and bottle label after EXP. The exp
each of children.
date which is stated on the carton, iry date refers to the last day of that month.
This medicine does not require any speci
Do not throw away any medicines via wa pharmacist how to throw away medicine help protect the environment.
al storage conditions.
stewater or household waste. Ask your s you no longer use. These measures will
• 6 Contents of the pack and othe
What Kalydeco contains
The active substance is ivacaftor.
Kalydeco 75 mg film-coated tablets Each 75 mg film-coated tablet contains 7
r information
5 mg of ivacaftor.
Kalydeco 150 mg film-coated tablets Each 150 mg film-coated tablet contains
The other ingredients are:
Tablet core: cellulose microcrystalline, acetate succinate, croscarmellose sodi colloidal anhydrous, and magnesium s
150 mg of ivacaftor.
lactose monohydrate, hypromellose um, sodium laurilsulfate (E487), silica, tearate.
- Coating: polyvinyl alcohol, titanium di indigo carmine aluminium lake (E132)
- Printing ink: shellac, iron oxide black (E ammonia solution, concentrated.
See the end of section 2 - Kalydeco conta
oxide (E171), macrogol (PEG 3350), talc, and carnauba wax.
172), propylene glycol (E1520) and ins lactose and sodium.
What Kalydeco looks like and con
Kalydeco 75 mg film-coated tablets are li 12.7 mm x 6.8 mm, and printed with “V 7 the other side.
The following pack sizes are available:
Blister card pack containing 28 film-co
tents of the pack ght blue, capsule-shaped,
5” in black ink on one side and plain on ated tablets
Kalydeco 150 mg film-coated tablets are 16.5 mm x 8.4 mm, and printed with “V 1 the other.
The following pack sizes are available:
Blister card pack containing 28 film-co
light blue, capsule-shaped,
50” in black ink on one side and plain on ated tablets
- Blister pack containing 56 film-coated
Bottle containing 56 film-coated table
tablets ts
Marketing Authorisation Holder
Vertex Pharmaceuticals (Europe) Limited 2 Kingdom Street
London, W2 6BD
United Kingdom
Tel: +44 (0)203 204 5100
Manufacturer
Almac Pharma Services Limited Seagoe Industrial Estate Craigavon
Northern Ireland
BT63 5UA
United Kingdom
This leaflet was last revised in Novemb
Other sources of information
Detailed information on this medicine is a Medicines and Healthcare products Regu
er 2023 vailable on the website of the latory Agency: http://www.mhra.gov.uk.
Packaging Site: Almac
LFT-0007-02
Overall dimensions
560 x 280 mm
Folded dimensions (if needed) 70 x 35 mm
CMO Drawing
CDS-PX000078
CMO Code
10345000
Revision Date
01 Sep 2023
2 of 2 05 Mar 2024
Leaflet 01
PX3436/3 11 pt
34363 791446
N/A