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Kalydeco (ivacaftor) – Package leaflet - R07AX02

Updated on site: 08-Oct-2017

Medication nameKalydeco
ATC CodeR07AX02
Substanceivacaftor
ManufacturerVertex Pharmaceuticals (Europe) Ltd

Package leaflet: Information for the patient

Kalydeco 150 mg film-coated tablets

Ivacaftor

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. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.What Kalydeco is and what it is used for

2.What you need to know before you take Kalydeco

3.How to take Kalydeco

4.Possible side effects

5.How to store Kalydeco

6.Contents of the pack and other information

1.What Kalydeco is and what it is used for

Kalydeco contains the active ingredient 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 for the treatment of patients with cystic fibrosis (CF) aged 6 years and older and weighing 25 kg or more who have one of the following gating mutations in the CFTR gene:

G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R.

Kalydeco tablets are also indicated for the treatment of patients with cystic fibrosis (CF) aged 18 years and older who have an R117H mutation in the CFTR gene.

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 before taking Kalydeco.

Ivacaftor should only be used in patients who have at least one of the mutations in their CFTR gene listed in section 1 (What Kalydeco is and what it is used for).

Increased liver enzymes in the blood have been seen in some people receiving ivacaftor. Tell your doctor right away if you have any of these symptoms, which may be a sign of liver problems:

o Pain or discomfort in the upper right stomach (abdominal) area

o Yellowing of the skin or the white part of the eyes o Loss of appetite

o Nausea or vomiting o Dark urine

Your doctor will do some blood tests to check your liver prior to and while you are taking ivacaftor, 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. Your doctor may need to adjust the dose of Kalydeco if you have any moderate or severe problems with your liver function (please refer to section 3 on How to take Kalydeco).

Kalydeco is not recommended for patients who have undergone an organ transplant.

Abnormality of the eye lens (cataract) without any effect on vision has been noted in some children and adolescents receiving ivacaftor.

Your doctor may perform some eye examinations prior to and during treatment with ivacaftor.

Children

Do not give this medicine to children under 2 years of age with gating mutations as it is not known if ivacaftor is safe and effective in these children, or to subjects under 18 years of age with an R117H mutation as ivacaftor may not work in them.

Kalydeco tablets are not adequate for children under 6 years of age.

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 it more likely that you will have side effects. Kalydeco can also affect how some other medicines work.

Tell your doctor if you take any of the following medicines:

Ketoconazole, itraconazole, posaconazole, voriconazole, fluconazole, antifungal medicines used for the treatment of fungal infections

Telithromycin, clarithromycin, erythromycin, rifampicin, rifabutin, antibiotic medicines used for the treatment of bacterial infections

Phenobarbital, carbamazepine, phenytoin, anticonvulsant medicines used for the treatment of epileptic seizures

Herbal medicines, i.e., St. John’s wort (Hypericum perforatum)

Midazolam, alprazolam, diazepam or triazolam, benzodiazepines used for the treatment of anxiety, insomnia, agitation, etc.

Ciclosporin, tacrolimus, immunosuppressants used after an organ transplantation

Digoxin, cardiac glycosides used for the treatment of mild to moderate congestive heart failure and an abnormal heart rhythm called atrial fibrillation

Warfarin, anticoagulants used to prevent blood clots from forming or growing larger in blood and blood vessels

Tell your doctor if you are taking any of these. Your doctor may decide to adjust your dose or that you need extra checkups.

Kalydeco with food and drink

Avoid food containing grapefruit or Seville oranges during treatment with Kalydeco as they may increase ivacaftor exposure 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. Do not drive or use machines unless you are sure you are not affected.

Kalydeco 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.

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.

The recommended dose is one 150 mg tablet every 12 hours (in total 2 tablets: 300 mg per day) with fat-containing food. You must keep using all other medicines you use, unless your doctor tells you to stop using any.

If you have moderate or severe problems with liver function, your doctor may need to reduce the dose of Kalydeco, as your liver is not clearing ivacaftor as fast as in people who have normal liver function.

Moderate liver problems: the dose may be reduced to one 150 mg tablet once daily.

Severe liver problems: the use is not recommended but your doctor may decide if it is appropriate for you to use this medical product in which case the dose must be reduced to one 150 mg tablet every other day.

Kalydeco is for oral use.

Swallow the tablet whole. Do not break, chew or dissolve the tablets.

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, 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 take more Kalydeco than you should

You may experience side effects, including those mentioned in section 4 below. If so, contact your doctor or pharmacist to ask for advice. If possible, have your medicine and this leaflet with you.

If you forget to take Kalydeco

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 a forgotten dose.

If you stop taking Kalydeco

Take Kalydeco for as long as your doctor recommends. Do not stop unless your doctor advises you to. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects include stomach (abdominal) ache and increased liver enzymes in the blood. Contact your doctor straight away if you get any of these.

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

Dizziness

Diarrhoea

Rash

Changes in the type of bacteria in mucus

Common side effects (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 spinning)

Sinus congestion

Redness in the throat

Breast mass

Uncommon side effects (may affect up to 1 in 100 people)

Ear congestion

Breast inflammation

Enlargement of the breast

Nipple changes or pain

Additional side effects in children

Side effects seen in children are similar to those observed in adults and adolescents. However, increased liver enzymes in the blood are more frequently seen in young children.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5.How to store Kalydeco

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the package after EXP. The expiry date refers to the last day of that month.

Store below 30°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Kalydeco contains

The active substance is ivacaftor. Each film-coated tablet contains 150 mg of ivacaftor.

The other ingredients are:

Tablet core: cellulose microcrystalline, lactose monohydrate (see section 2 – Kalydeco contains lactose), hypromellose acetate succinate, croscarmellose sodium, sodium laurilsulfate, colloidal silicon dioxide, and magnesium stearate.

Coating: polyvinyl alcohol, titanium dioxide (E171), macrogol (PEG 3350), talc, indigo carmine aluminium lake (E132) and carnauba wax.

Printing ink: shellac, iron oxide black (E172), propylene glycol and ammonium hydroxide.

What Kalydeco looks like and contents of the pack

Kalydeco 150 mg film-coated tablets are light blue, capsule-shaped, 16.5 mm x 8.4 mm, and printed with “V 150” in black ink on one side and plain on the other.

Kalydeco is available in the following pack sizes:

Blister pack containing 56 film-coated tablets

Bottle containing 56 film-coated tablets

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Vertex Pharmaceuticals (Europe) Limited

2 Kingdom Street

London W2 6BD

United Kingdom

Tel: +44 (0) 1923 437672

Manufacturer:

Almac Pharma Services Limited

Seagoe Industrial Estate

Craigavon

County Armagh

BT63 5UA

United Kingdom

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu. There are also links to other websites about rare diseases and treatments.

Package leaflet: Information for the patient

Kalydeco 50 mg granules in sachet

Kalydeco 75 mg granules in sachet

Ivacaftor

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. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before your child starts taking this medicine because it contains important information for your child.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your child’s doctor or pharmacist.

This medicine has been prescribed for your child only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as your child’s.

If your child gets any side effects, talk to your child’s doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.What Kalydeco is and what it is used for

2.What you need to know before your child takes Kalydeco

3.How to take Kalydeco

4.Possible side effects

5.How to store Kalydeco

6.Contents of the pack and other information

1. What Kalydeco is and what it is used for

Kalydeco contains the active ingredient 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 granules are indicated for the treatment of children with cystic fibrosis (CF) aged 2 years and older and weighing less than 25 kg who have one of the following gating mutations in the CFTR gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R.

2. What you need to know before your child takes Kalydeco

Do not take Kalydeco

if your child is allergic to ivacaftor or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your child’s doctor before your child takes Kalydeco.

Ivacaftor should only be used in patients who have at least one of the mutations in their CFTR gene listed in section 1 (What Kalydeco is and what it is used for).

Increased liver enzymes in the blood have been seen in some people receiving ivacaftor. Tell your child’s doctor right away if your child has any of these symptoms, which may be a sign of liver problems:

o Pain or discomfort in the upper right stomach (abdominal) area

o Yellowing of the skin or the white part of the eyes o Loss of appetite

o Nausea or vomiting o Dark urine

Your child’s doctor will do some blood tests to check your child’s liver prior to and while your child is taking ivacaftor, particularly during the first year and especially if he/she has had high liver enzymes in the past.

Talk to your child’s doctor if you have been told your child has liver or kidney disease. Your child’s doctor may need to adjust the dose of Kalydeco if your child has moderate or severe problems with their liver function (please refer to section 3 on How to take Kalydeco).

Kalydeco is not recommended for patients who have undergone an organ transplant.

Abnormality of the eye lens (cataract) without any effect on vision has been noted in some children and adolescents receiving ivacaftor.

Your child’s doctor may perform some eye examinations prior to and during treatment with ivacaftor.

Children

Do not give this medicine to children under 2 years of age with gating mutations as it is not known if ivacaftor is safe and effective in these children.

Other medicines and Kalydeco

Tell your child’s doctor or pharmacist if your child is using, has recently used or might use any other medicines.

Some medicines can affect how Kalydeco works, or make it more likely that your child will have side effects. Kalydeco can also affect how some other medicines work.

Tell your child’s doctor if your child takes any of the following medicines:

Ketoconazole, itraconazole, posaconazole, voriconazole, fluconazole, antifungal medicines used for the treatment of fungal infections

Telithromycin, clarithromycin, erythromycin, rifampicin, rifabutin, antibiotic medicines used for the treatment of bacterial infections

Phenobarbital, carbamazepine, phenytoin, anticonvulsant medicines used for the treatment of epileptic seizures

Herbal medicines, i.e., St. John’s wort (Hypericum perforatum)

Midazolam, alprazolam, diazepam or triazolam, benzodiazepines used for the treatment of anxiety, insomnia, agitation, etc.

Ciclosporin, tacrolimus, immunosuppressants used after an organ transplantation

Digoxin, cardiac glycosides used for the treatment of mild to moderate congestive heart failure and an abnormal heart rhythm called atrial fibrillation

Warfarin, anticoagulants used to prevent blood clots from forming or growing larger in blood and blood vessels

Tell your child’s doctor if he/she is taking any of these. Your child’s doctor may decide to adjust your child’s dose or that your child needs extra checkups.

Kalydeco with food and drink

Avoid giving your child food containing grapefruit or Seville oranges during treatment with Kalydeco as they may increase ivacaftor exposure in your child’s body.

Driving and using machines

Kalydeco can make your child dizzy. It is advised that your child does not ride his/her bike or do anything else that needs his/her full attention unless you are sure that your child is not affected.

Kalydeco contains lactose

If you have been told by your child’s doctor that your child has an intolerance to some sugars, contact your child’s doctor before your child takes this medicine.

3. How to take Kalydeco

Always give your child this medicine exactly as your child’s doctor has told you to. Check with your child’s doctor if you are not sure.

Your child’s doctor will determine the correct dose for your child. Your child must keep using all other medicines, unless your child’s doctor tells him/her to stop using any.

Ivacaftor dosing recommendations are provided in Table 1.

Table 1. Dosing recommendations for patients aged 2 years and older

Weight

Dose

Total daily dose

Less than 14 kg

One sachet of 50 mg granules taken orally

100 mg

 

every 12 hours with fat-containing food

 

14 kg to less than

One sachet of 75 mg granules taken orally

150 mg

25 kg

every 12 hours with fat-containing food

 

25 kg or more

Please refer to Kalydeco tablets Package Leaflet

 

 

 

If your child has moderate or severe problems with liver function, your child’s doctor may need to reduce the dose of Kalydeco, as your child’s liver is not clearing ivacaftor as fast as in children who have normal liver function.

Moderate liver problems: the dose may be reduced to one sachet once daily (50 mg for children weighing less than 14 kg and 75 mg for children weighing 14 kg to less than 25 kg).

Severe liver problems: the use is not recommended but your child’s doctor will decide if it is appropriate for your child to use this medical product in which case the dose must be reduced to one sachet every other day (50 mg for children weighing less than 14 kg and 75 mg for children weighing 14 kg to less than 25 kg).

Kalydeco is for oral use.

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 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, applesauce, water, milk, or juice.

Once mixed, give the product to your child immediately. If this is not possible, give it within the following 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 (some examples are provided below).

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, 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 your child takes more Kalydeco than he/she should

Your child may experience side effects, including those mentioned in section 4 below. If so, contact your child’s doctor or pharmacist to ask for advice. If possible, have your child’s medicine and this leaflet with you.

If you forget to give your child Kalydeco

Give the missed dose if less than 6 hours have passed since the time your child missed the dose. Otherwise, wait until your child’s next scheduled dose as you normally would. Do not give your child a double dose to make up for a forgotten dose.

If you stop giving your child Kalydeco

Give Kalydeco to your child for as long as your child’s doctor recommends. Do not stop unless your child’s doctor advises you to. If you have any further questions on the use of this medicine, ask your child’s doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects include stomach (abdominal) ache and increased liver enzymes in the blood. Contact your child’s doctor straight away if he/she gets any of these.

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

Dizziness

Diarrhoea

Rash

Changes in the type of bacteria in mucus

Common side effects (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 spinning)

Sinus congestion

Redness in the throat

Breast mass

Uncommon side effects (may affect up to 1 in 100 people)

Ear congestion

Breast inflammation

Enlargement of the breast

Nipple changes or pain

Additional side effects in children

Side effects seen in children are similar to those observed in adults and adolescents. However, increased liver enzymes in the blood are more frequently seen in young children.

Reporting of side effects

If your child gets any side effects, talk to your child’s doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Kalydeco

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the package after EXP. The expiry date refers to the last day of that month.

Store below 30°C.

Once mixed, the mixture has been shown to be stable for one hour.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Kalydeco contains

Kalydeco 50 mg granules in sachet: The active substance is ivacaftor. Each sachet contains 50 mg of ivacaftor.

Kalydeco 75 mg granules in sachet: The active substance is ivacaftor. Each sachet contains 75 mg of ivacaftor.

The other ingredients are: colloidal silicon dioxide, croscarmellose sodium, hypromellose acetate succinate, lactose monohydrate (see section 2 – Kalydeco contains lactose), magnesium stearate, mannitol, sucralose and sodium laurilsulfate.

What Kalydeco looks like and contents of the pack

Kalydeco 50 mg granules in sachet are white to off-white granules

Kalydeco 75 mg granules in sachet are white to off-white granules

The granules are supplied in sachets.

Pack size of 56 sachets (contains 4 individual wallets with 14 sachets per wallet)

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Vertex Pharmaceuticals (Europe) Limited

2 Kingdom Street

London W2 6BD

United Kingdom

Tel: +44 (0) 1923 437672

Manufacturer:

Almac Pharma Services Limited

Seagoe Industrial Estate

Craigavon

County Armagh

BT63 5UA

United Kingdom

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu. There are also links to other websites about rare diseases and treatments.

ANNEX IV

GROUNDS FOR ONE ADDITIONAL RENEWAL

Grounds for one additional renewal

Based upon the data that have become available since the granting of the initial Marketing authorisation, the CHMP considers that the benefit-risk balance of Kalydeco remains positive, but considers that its safety profile is to be closely monitored for the following reasons:

There is a PASS category 1 ongoing. The fourth annual analysis will be completed by December 2016, with the final report submitted by December 2017. Long term safety is considered a key element to evaluate the benefit-risk balance of the product and therefore a second renewal is required.

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