Elexacaftor / Ivacaftor / Tezacaftor: package leaflet

Kaftrio contains three active substances: ivacaftor, tezacaftor and elexacaftor. The medicine helps lung cells to work better in some patients with cystic fibrosis (CF). CF is an inherited condition in which the lungs and the digestive system can become clogged with thick, sticky mucus.

Kaftrio taken with ivacaftor is for patients aged 6 years and over who have CF, with at least one mutation in the CFTR (cystic fibrosis transmembrane conductance regulator) gene that is responsive to Kaftrio. It is intended as a long-term treatment.

Kaftrio works on a protein called CFTR. The protein is damaged in some people with CF, if they have a mutation in the CFTR gene.

Kaftrio is normally taken with another medicine, ivacaftor. Ivacaftor causes the protein to work better, while tezacaftor and elexacaftor increase the amount of protein at the cell surface.

Kaftrio (taken with ivacaftor) helps your breathing by improving your lung function. You may also notice that you do not get ill as often, or that it is easier to gain weight.

Do not take Kaftrio:
- If you are allergic to ivacaftor, tezacaftor, elexacaftor, or any other ingredients of this medicine (listed in section 6).
- Talk to your doctor and do not take the tablets, if this applies to you.

Warnings and precautions

Talk to your doctor if you have liver problems or have had them previously. Your doctor may need to adjust your dose (see section 4).

• Your doctor will do some blood tests to check your liver before and during treatment with Kaftrio, especially if your blood tests showed high liver enzymes in the past. Liver enzymes in the blood can increase in patients receiving Kaftrio.

Tell your doctor right away if you have any symptoms of liver problems. These are listed in section 4.

• Depression (including suicidal thoughts, changes in behaviours, anxiety, and sleep disorders) has been reported in patients while taking Kaftrio, usually starting within the first three months of treatment. Talk to your doctor straight away if you (or someone taking this medicine) experience any of the following symptoms which may be signs of depression: sad or altered mood, anxiety, feelings of emotional discomfort or thoughts of harming or killing yourself, and/or sleep difficulties (see section 4).

Talk to your doctor if you recognize behavioural changes in your child within the first 2 months of treatment initiation.

• Talk to your doctor if you have kidney problems, or you have previously had them.

• If you have two Class I mutations (mutations known not to make CFTR protein), you should not take Kaftrio, as you are not expected to respond to this medicine.

• Talk to your doctor before starting treatment with Kaftrio if you have received 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 Kaftrio.

• Your doctor may do eye examinations before and during treatment with Kaftrio. Cloudiness of the eye lens (cataract) without any effect on vision has occurred in some children and adolescents receiving this treatment.

Children under 6 years
Do not give this medicine to children under the age of 6 years because it is not known if Kaftrio tablets are safe and effective in this age group.

Other medicines and Kaftrio
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines can affect how Kaftrio works or may make side effects more likely. In particular, tell your doctor if you take any of the medicines listed below. Your doctor may change the dose of one of the medicines if you take any of these.
- 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, rifampicin, rifabutin 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, glipizide, glyburide, nateglinide and repaglinide.
• Medicines for lowering blood cholesterol. These include pitavastatin and rosuvastatin.
• Medicines for lowering blood pressure. These include verapamil.

Kaftrio with food and drink
Avoid food or drinks containing grapefruit during treatment as these may increase the side effects of Kaftrio by increasing the amount of Kaftrio in your body.

Pregnancy and breast-feeding
- Ask your doctor for advice before taking this medicine if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby.
- Pregnancy: It may be better to avoid using this medicine during pregnancy. Your doctor will help you decide what is best for you and your child.
- Breast-feeding: Ivacaftor, tezacaftor, and elexacaftor have been detected in breastfed babies.
Your doctor will consider the benefit of breast-feeding for your baby and the benefit of treatment for you to help you decide whether to stop breast-feeding or to stop treatment.

Driving and using machines
Kaftrio can make you dizzy. If you feel dizzy, do not drive, cycle, or use machines unless you are not affected.

Kaftrio contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium-free”.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor will determine the correct dose for you.

Kaftrio is usually taken with ivacaftor.

Recommended dose for patients aged 6 years and over
Age
Weight
Morning dose
Evening dose
6 to < 12 years
< 30 kg
Two ivacaftor 37.5 mg/tezacaftor
25 mg/elexacaftor 50 mg tablets
One ivacaftor 75 mg tablet
6 to < 12 years
≥ 30 kg
Two ivacaftor 75 mg/tezacaftor
50 mg/elexacaftor 100 mg tablets
One ivacaftor 150 mg tablet
12 years and older
- Two ivacaftor 75 mg/tezacaftor
50 mg/elexacaftor 100 mg tablets
One ivacaftor 150 mg tablet

Take the morning and evening tablets about 12 hours apart.

The tablets are for oral use.

Take both Kaftrio and ivacaftor 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

Avoid food and drink containing grapefruit while you are taking Kaftrio. See Kaftrio with food and drink in section 2 for more details.

Swallow the tablets whole. Do not chew, crush or break the tablets before swallowing.

You must keep using all your other medicines, unless your doctor tells you to stop.

If you have liver problems, either moderate or severe, your doctor may reduce the dose of your tablets or decide to stop treatment with Kaftrio. See also Warnings and precautions in section 2.

If you take more Kaftrio than you should
Contact your doctor or pharmacist for advice. If possible, take your medicine and this leaflet with you.
You may get side effects, including those mentioned in section 4 below.

If you forget to take Kaftrio
If you forget a dose, work out how long it is since the dose you missed.
- If less than 6 hours have passed since you missed a dose, either morning or evening, take the forgotten tablet(s) as soon as possible. Then go back to your usual schedule.
- If more than 6 hours have passed:
- If you missed a morning dose of Kaftrio, take it as soon as you remember. Do not take the evening dose of ivacaftor. Take the next morning dose at the usual time.
- If you missed an evening dose of ivacaftor, do not take the missed dose. Wait for the next day and take the morning dose of Kaftrio tablets as usual.
Do not take a double dose to make up for any missed tablets.

If you stop taking Kaftrio
Your doctor will tell you how long you need to keep taking Kaftrio. It is important to take this medicine regularly. Do not make changes unless your doctor tells you.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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

Serious side effects:

Possible signs of liver problems
Liver damage and worsening of liver function in people with or without liver disease. The worsening of liver function can be serious and may require transplantation (see section 2).

Increased liver enzymes in the blood are very common in patients treated with Kaftrio. These may be signs of liver problems:
- Pain or discomfort in the upper right area of the stomach (abdominal) area
- Yellowing of the skin or the white part of the eyes
- Loss of appetite
- Nausea or vomiting
- Dark urine

Depression. Signs of this include sad or altered mood, anxiety, feelings of emotional discomfort (see section 2).

Tell your doctor straight away if you have any of these symptoms.

Very common side effects (may affect more than 1 in 10 people)
- Rash (more common in children, and in women compared to men)

Tell your doctor straight away if you notice a rash.

Other side effects:
Very common (may affect more than 1 in 10 people)
- Headache
- Dizziness
- Upper respiratory tract infection (common cold)
- Oropharyngeal pain (sore throat)
- Nasal congestion
- Stomach or abdominal pain
- Diarrhoea
- Increased liver enzymes (signs of stress on the liver)
- Changes in the type of bacteria in mucus
- Increased creatine phosphokinase (sign of muscle breakdown) seen in blood tests

Common (may affect up to 1 in 10 people)
- Flu
- Abnormal breathing (shortness of breath or difficulty breathing)
- Low blood sugar (hypoglycaemia)
- Runny nose
- Sinus problems (sinus congestion)
- Redness or soreness in the throat
- Ear problems: ear pain or discomfort, ringing in the ears, inflamed eardrum
- Spinning sensation (inner ear disorder)
- Wind (flatulence)
- Spots (acne)
- Itchy skin
- Breast mass
- Feeling nauseous

Uncommon (may affect up to 1 in 100 people)
- Breast and nipple problems: inflammation, pain
- Enlargement of the breast in men
- Increases in blood pressure
- Wheezing
- Blocked ears (ear congestion)

Not known (frequency cannot be estimated from the available data)
- Allergic reactions (hypersensitivity)
- Damage to the liver (liver injury)
- Raised bilirubin measurement (liver blood test)
- Behavioural changes

Additional side effects in adolescents
Side effects in adolescents are similar to those observed in adults.

Additional side effects in children
Most cases of behavioural changes have been reported in younger children aged 2-5 years.

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.

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 outer carton and on the blister after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

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.

What Kaftrio contains
- The active substances are ivacaftor, tezacaftor and elexacaftor.

Kaftrio 37.5 mg/25 mg/50 mg film-coated tablets
Each film-coated tablet contains 37.5 mg of ivacaftor, 25 mg of tezacaftor and 50 mg of elexacaftor.

Kaftrio 75 mg/50 mg/100 mg film-coated tablets
Each film-coated tablet contains 75 mg of ivacaftor, 50 mg of tezacaftor and 100 mg of elexacaftor.

- The other ingredients are:
−
Tablet core: Hypromellose (E464), hypromellose acetate succinate, sodium laurilsulfate (E487), croscarmellose sodium (E468), microcrystalline cellulose (E460(i)), and magnesium stearate (E470b).
−
Tablet film coating: Hypromellose (E464), hydroxypropyl cellulose (E463), titanium dioxide (E171), talc (E553b), iron oxide yellow (E172), and iron oxide red (E172).

See the end of section 2 for important information about the contents of Kaftrio.

What Kaftrio looks like and contents of the pack
Kaftrio 37.5 mg/25 mg/50 mg film-coated tablets are light orange, capsule-shaped tablets stamped with “T50” on one side and plain on the other.

Kaftrio 75 mg/50 mg/100 mg film-coated tablets are orange, capsule-shaped tablets stamped with “T100” on one side and plain on the other.

Kaftrio is available in pack size of 56 tablets (4 blister cards, each with 14 tablets).

Marketing Authorisation Holder
Vertex Pharmaceuticals (Ireland) Limited
Unit 49, Block 5, Northwood Court, Northwood Crescent,
Dublin 9, D09 T665,
Ireland
Tel: +353 (0)1 761 7299

Manufacturer
Almac Pharma Services (Ireland) Limited
Finnabair Industrial Estate
Dundalk
Co. Louth
A91 P9KD
Ireland

Almac Pharma Services Limited
Seagoe Industrial Estate
Craigavon
Northern Ireland
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:
https://www.ema.europa.eu. There are also links to other websites about rare diseases and treatments.

Kaftrio contains three active substances: ivacaftor, tezacaftor and elexacaftor. The medicine helps lung cells to work better in some patients with cystic fibrosis (CF). CF is an inherited condition in which the lungs and the digestive system can become clogged with thick, sticky mucus.

Kaftrio taken with ivacaftor is for patients aged 2 to less than 6 years who have CF, with at least one mutation in the CFTR (cystic fibrosis transmembrane conductance regulator) gene that is responsive to Kaftrio. It is intended as a long-term treatment.

Kaftrio works on a protein called CFTR. The protein is damaged in some people with CF, if they have a mutation in the CFTR gene.

Kaftrio is normally taken with another medicine, ivacaftor. Ivacaftor causes the protein to work better, while tezacaftor and elexacaftor increase the amount of protein at the cell surface.

Kaftrio (taken with ivacaftor) helps your child’s breathing by improving his/her lung function. You may also notice that your child does not get ill as often, or that it is easier for your child to gain weight.

Do not give your child Kaftrio:
- If your child is allergic to ivacaftor, tezacaftor, elexacaftor, or any other ingredients of this medicine (listed in section 6).
- Talk to your child’s doctor and do not give your child this medicine, if this applies to your child.

Warnings and precautions

Talk to your child’s doctor if your child has liver problems or have had them previously. Your doctor may need to adjust your child’s dose (see section 4).

• Your doctor will do some blood tests to check your child’s liver before and during treatment with Kaftrio, especially if your child’s blood tests showed high liver enzymes in the past. Liver enzymes in the blood can increase in patients receiving Kaftrio.

Tell your doctor right away if your child has any symptoms of liver problems. These are listed in section 4.

• Depression (including suicidal thoughts, changes in behaviours, anxiety, and sleep disorders) has been reported in patients while taking Kaftrio, usually starting within the first three months of treatment. Talk to your doctor straight away if you (or someone taking this medicine) experience any of the following symptoms which may be signs of depression: sad or altered mood, anxiety, feelings of emotional discomfort or thoughts of harming or killing yourself, and/or sleep difficulties (see section 4).

Talk to your doctor if you recognize behavioural changes in your child within the first 2 months of treatment initiation.

• Talk to your child’s doctor if your child has kidney problems, or your child has previously had them.

• If your child has two Class I mutations (mutations known not to make CFTR protein) you should not give Kaftrio to your child, as they are not expected to respond to this medicine.

• Talk to your child’s doctor before starting treatment with Kaftrio if your child has received an organ transplant.

- Your child’s doctor may do eye examinations before and during treatment with Kaftrio.
Cloudiness of the eye lens (cataract) without any effect on vision has occurred in some children and adolescents receiving this treatment.

Children under 2 years
Do not give Kaftrio granules to children under the age of 2 years because it is not known if Kaftrio granules are safe and effective in this age group.

Other medicines and Kaftrio
Tell your child’s doctor or pharmacist if your child is taking, has recently taken, or might take any other medicines. Some medicines can affect how Kaftrio works or may make side effects more likely. In particular, tell your child’s doctor if you take any of the medicines listed below. Your child’s doctor may change the dose of one of the medicines if your child takes any of these.
- 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, rifampicin, rifabutin 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, glipizide, glyburide, nateglinide and repaglinide.
• Medicines for lowering blood cholesterol. These include pitavastatin and rosuvastatin.
• Medicines for lowering blood pressure. These include verapamil.

Kaftrio with food and drink
Avoid giving your child food or drinks containing grapefruit during treatment as these may increase the side effects of Kaftrio by increasing the amount of Kaftrio in your child’s body.

Driving and using machines
Kaftrio can make your child dizzy. If your child feels dizzy, it is advised that your child does not ride his/her bike or do anything else that needs his/her full attention.

Kaftrio granules contains lactose and sodium
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.

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium-free”.

Always give your child this medicine exactly as your child’s doctor or pharmacist has told you. Check with your child’s doctor or pharmacist 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.

Kaftrio is usually taken with ivacaftor.

Recommended dose for patients aged 2 to less than 6 years
Age
Weight
Morning dose
Evening dose
2 to less than
6 years
10 kg to
< 14 kg
One sachet of ivacaftor 60 mg/tezacaftor
40 mg/elexacaftor 80 mg granules
One sachet of ivacaftor 59.5 mg granules
≥ 14 kg
One sachet of ivacaftor 75 mg/tezacaftor
50 mg/elexacaftor 100 mg granules
One sachet of ivacaftor 75 mg granules

Give your child the morning and evening doses about 12 hours apart.

The granules are for oral use.

To prepare Kaftrio granules:
- Hold the sachet with the cut line on top.
- Shake the sachet gently to settle the Kaftrio granules.
- Tear or cut sachet open along cut line.

- Carefully pour all the Kaftrio granules in the sachet into 1 teaspoon (5 mL) of soft food or liquid in a small container (like an empty bowl). Look inside the sachet to make sure there are no granules left inside.
o The food or liquid should be at or below room temperature.
o Examples of soft foods or liquids include pureed fruits, flavoured yogurt or pudding, and milk or juice.
- Mix the Kaftrio granules with food or liquid.
After mixing, give Kaftrio within 1 hour. Make sure all the medicine is taken.

Give both Kaftrio and ivacaftor doses 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

Avoid giving your child food and drink containing grapefruit while your child is taking Kaftrio. See Kaftrio with food and drink in section 2 for more details.

If your child has liver problems, either moderate or severe, your child’s doctor may reduce the dose of your child’s medicine or decide to stop treatment with Kaftrio. See also Warnings and precautions in section 2.

If your child takes more Kaftrio than he/she should
Contact your child’s doctor or pharmacist for advice. If possible, take your child’s medicine and this leaflet with you. Your child may get side effects, including those mentioned in section 4 below.

If you forget to give your child Kaftrio
If you forget to give your child a dose, work out how long it is since the missed dose.
- If less than 6 hours have passed since your child missed a dose, either morning or evening, give the forgotten dose as soon as possible. Then go back to your usual schedule.
- If more than 6 hours have passed:
- If your child missed a morning dose of Kaftrio, give it as soon as you remember. Do not give the evening dose of ivacaftor. Give the next morning dose at the usual time.
- If your child missed an evening dose of ivacaftor, do not give the missed dose. Wait for the next day and take the morning dose of Kaftrio as usual.
Do not give a double dose to make up for any missed doses.

If you stop giving your child Kaftrio
Give Kaftrio 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.

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

Serious side effects:

Possible signs of liver problems
Liver damage and worsening of liver function in people with or without liver disease. The worsening of liver function can be serious and may require transplantation (see section 2).
Increased liver enzymes in the blood are very common in patients treated with Kaftrio. These may be signs of liver problems:
- Pain or discomfort in the upper right area of the stomach (abdominal) area
- Yellowing of the skin or the white part of the eyes
- Loss of appetite
- Nausea or vomiting
- Dark urine

Depression. Signs of this include sad or altered mood, anxiety, feelings of emotional discomfort (see section 2).

Tell your child’s doctor straight away if he/she have any of these symptoms.

Very common side effects (may affect more than 1 in 10 people)
- Rash (more common in children, and in women compared to men)

Tell your child’s doctor straight away if you notice a rash.

Other side effects:
Very common (may affect more than 1 in 10 people)
- Headache
- Dizziness
- Upper respiratory tract infection (common cold)
- Oropharyngeal pain (sore throat)
- Nasal congestion
- Stomach or abdominal pain
- Diarrhoea
- Increased liver enzymes (signs of stress on the liver)
- Changes in the type of bacteria in mucus
- Increased creatine phosphokinase (sign of muscle breakdown) seen in blood tests

Common (may affect up to 1 in 10 people)
- Flu
- Abnormal breathing (shortness of breath or difficulty breathing)
- Low blood sugar (hypoglycaemia)
- Runny nose
- Sinus problems (sinus congestion)
- Redness or soreness in the throat
- Ear problems: ear pain or discomfort, ringing in the ears, inflamed eardrum
- Spinning sensation (inner ear disorder)
- Wind (flatulence)
- Spots (acne)
- Itchy skin
- Breast mass
- Feeling nauseous

Uncommon (may affect up to 1 in 100 people)
- Breast and nipple problems: inflammation, pain
- Enlargement of the breast in men
- Increases in blood pressure
- Wheezing
- Blocked ears (ear congestion)

Not known (frequency cannot be estimated from the available data)
- Allergic reactions (hypersensitivity)
- Damage to the liver (liver injury)
- Raised bilirubin measurement (liver blood test)
- Behavioural changes

Additional side effects in adolescents
Side effects in adolescents are similar to those observed in adults.

Additional side effects in children
Most cases of behavioural changes have been reported in younger children aged 2-5 years.

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.

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 outer carton and on the sachet after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

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

What Kaftrio contains
- The active substances are ivacaftor, tezacaftor and elexacaftor.

Kaftrio 60 mg/40 mg/80 mg granules
Each sachet contains 60 mg of ivacaftor, 40 mg of tezacaftor and 80 mg of elexacaftor.

Kaftrio 75 mg/50 mg/100 mg granules
Each sachet contains 75 mg of ivacaftor, 50 mg of tezacaftor and 100 mg of elexacaftor.

• The other ingredients are: silica colloidal anhydrous (E551), croscarmellose sodium (E468), hypromellose (E464), hypromellose acetate succinate, lactose monohydrate, magnesium stearate (E470b), mannitol (E421), sodium laurilsulfate (E487), and sucralose (E955).

See the end of section 2 for important information about the contents of Kaftrio.

What Kaftrio looks like and contents of the pack
Kaftrio 60 mg/40 mg/80 mg granules are white to off-white granules in a sealed sachet.

Kaftrio 75 mg/50 mg/100 mg granules are white to off-white granules in a sealed sachet.

Kaftrio is available in pack size of 28 sachets (4 weekly wallets, each with 7 sachets).

Marketing Authorisation Holder
Vertex Pharmaceuticals (Ireland) Limited
Unit 49, Block 5, Northwood Court, Northwood Crescent,
Dublin 9, D09 T665,
Ireland
Tel: +353 (0)1 761 7299

Manufacturer
Almac Pharma Services (Ireland) Limited
Finnabair Industrial Estate
Dundalk
Co. Louth
A91 P9KD
Ireland

Almac Pharma Services Limited
Seagoe Industrial Estate
Craigavon
Northern Ireland
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:
https://www.ema.europa.eu. There are also links to other websites about rare diseases and treatments.