Nintedanib Viatris 150 mg soft capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Nintedanib Viatris 100 mg soft capsules

Nintedanib Viatris 150 mg soft capsules

nintedanib

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Nintedanib Viatris is and what it is used for
2. What you need to know before taking Nintedanib Viatris
3. How to take Nintedanib Viatris
4. Possible side effects
5. How to store Nintedanib Viatris
6. Contents of the pack and other information

1. What Nintedanib Viatris is and what it is used for

Nintedanib Viatris contains the active substance nintedanib, a medicine belonging to the class of drugs known as tyrosine kinase inhibitors, and is used to treat the following conditions:

Idiopathic pulmonary fibrosis (IPF) in adults

IPF is a disease that causes thickening, hardening, and scarring of lung tissue over time. As a result, this scarring reduces the ability to transfer oxygen from the lungs into the bloodstream, making it difficult to breathe deeply. Nintedanib Viatris helps reduce the progression of further scarring and hardening of the lungs.

Other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype in adults

In addition to IPF, there are other diseases in which lung tissue gradually becomes thickened, hardened, and scarred (pulmonary fibrosis) and continues to worsen (progressive phenotype). Examples of these diseases include hypersensitivity pneumonitis, autoimmune ILDs (such as ILD associated with rheumatoid arthritis), idiopathic nonspecific interstitial pneumonia, unclassifiable idiopathic interstitial pneumonia, and other ILDs. Nintedanib Viatris helps reduce the progression of further scarring and hardening of the lungs.

Clinically significant progressive fibrosing interstitial lung diseases (ILDs) in children and adolescents aged 6 to 17 years

Pulmonary fibrosis may occur in patients with childhood interstitial lung disease. In this case, the lung tissue in children and adolescents becomes thickened, hardened, and scarred over time. Nintedanib helps reduce the progression of further scarring and hardening of the lungs.

Interstitial lung disease associated with systemic sclerosis (ILD-SSc) in adults, adolescents, and children aged 6 years and older

Systemic sclerosis (SSc), also known as scleroderma (and juvenile systemic sclerosis in children and adolescents), is a rare chronic autoimmune disease affecting connective tissue in many parts of the body. SSc causes fibrosis (scarring and hardening) of the skin and other internal organs, such as the lungs. When the lungs are affected by fibrosis, it is called interstitial lung disease (ILD), and thus the condition is referred to as ILD-SSc. Fibrosis in the lungs reduces the ability to transfer oxygen into the bloodstream and impairs breathing capacity. Nintedanib Viatris helps reduce the progression of further scarring and hardening of the lungs.

2. What you need to know before taking Nintedanib Viatris

Do not take Nintedanib Viatris

• if you are pregnant,
• if you are allergic to nintedanib, peanuts, soy, or any of the other components of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Nintedanib Viatris:

• if you have or have had liver problems,
• if you have or have had kidney problems, or if you have been found to have increased levels of protein in your urine,
• if you have or have had bleeding problems,
• if you are taking medicines to thin the blood (such as warfarin, phenprocoumon, or heparin) to prevent blood clots,
• if you are taking pirfenidone, as this may increase the risk of developing diarrhoea, nausea, vomiting, and liver problems,
• if you have or have had heart problems (such as a heart attack),
• if you have recently undergone surgery. Nintedanib may affect how wounds heal. Therefore, treatment with Nintedanib Viatris will generally be interrupted for a period of time if you undergo surgery. Your doctor will decide when to resume treatment with this medicine.
• if you have high blood pressure,
• if you have abnormally high blood pressure in the blood vessels of the lungs (pulmonary hypertension),
• if you have or have had an aneurysm (a bulge and weakening of the wall of a blood vessel) or a tear in the wall of a blood vessel.

Based on this information, your doctor may carry out certain blood tests, for example, to check your liver function. Your doctor will discuss the results of these tests with you to decide whether you can take Nintedanib Viatris.

Tell your doctor immediately while you are taking this medicine

• if you have diarrhoea. It is important to treat diarrhoea early (see section 4, “Possible side effects”);
• if you have vomiting or feel sick (nausea);
• if you experience unexplained symptoms such as yellowing of the skin or the whites of the eyes (jaundice), dark or brown-coloured urine (like tea), pain in the upper right side of the stomach area (abdomen), bleeding, or you bruise more easily than normal, or feel tired. These could be symptoms of serious liver problems;
• if you have sudden, severe stomach pain, fever, chills, dizziness, vomiting, or abdominal stiffness or swelling, as these could be symptoms of a hole in the wall of the intestines (“gastrointestinal perforation”). Also inform your doctor if you have previously had peptic ulcers or diverticular disease, or if you are being treated at the same time with
• anti-inflammatory medicines (NSAIDs) (used to relieve pain and swelling) or steroids (used for inflammation and allergies), as all of these may increase this risk;
• if you have a combination of severe or cramp-like stomach pain, red blood in the stools, or diarrhoea, as these could be symptoms of intestinal inflammation due to insufficient blood supply;
• if you have pain, swelling, redness, or warmth in a limb, as these could be symptoms of a blood clot in one of your veins (a type of blood vessel);
• if you have pressure or pain in the chest, usually on the left side of the body, pain in the neck, jaw, shoulder, or arm, rapid heartbeat, difficulty breathing, nausea or vomiting, as these could be symptoms of a heart attack;
• if you have significant bleeding;
• if you experience bruising, bleeding, fever, fatigue, and confusion, as these may be signs of damage to blood vessels known as thrombotic microangiopathy (TMA);
• if you experience symptoms such as headache, changes in vision, confusion, seizures, or other neurological disturbances such as weakness in an arm or leg, with or without high blood pressure, which could be symptoms of a brain disorder called reversible posterior encephalopathy syndrome (RPES).

Children and adolescents

Children under 6 years of age must not take Nintedanib Viatris.

Your doctor may perform periodic dental examinations at least every 6 months until tooth development is complete and monitor your growth once a year (bone imaging study) while you are taking this medicine.

Other medicines and Nintedanib Viatris

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including herbal medicines and those obtained without a prescription.

Nintedanib Viatris may interact with other medicines. The following medicines may increase the blood levels of nintedanib and therefore increase the risk of side effects (see section 4, “Possible side effects”):

• a medicine used to treat fungal infections (ketoconazole)
• a medicine used to treat bacterial infections (erythromycin)
• a medicine that affects your immune system (cyclosporine)

The following medicines are examples that may decrease the blood levels of nintedanib and thus reduce the effectiveness of Nintedanib Viatris:

• an antibiotic used to treat tuberculosis (rifampicin)
• medicines used to treat seizures (carbamazepine, phenytoin)
• a herbal medicine used to treat depression (St. John’s wort)

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Do not take this medicine during pregnancy, as it may harm the unborn baby and cause birth defects.

A pregnancy test must be performed to ensure you are not pregnant before starting treatment with Nintedanib Viatris. Consult your doctor.

Contraception

• Women who can become pregnant must use a highly effective method of contraception to prevent pregnancy when starting treatment with Nintedanib Viatris,
• while taking Nintedanib Viatris, and for at least 3 months after stopping treatment.
• Consult your doctor about the most appropriate contraceptive methods for you.
• Vomiting and/or diarrhoea or other gastrointestinal disorders may affect the absorption of hormonal oral contraceptives, such as birth control pills, and may reduce their effectiveness. Therefore, if you experience any of these conditions, consult your doctor to consider a more appropriate alternative contraceptive method.
• Inform your doctor or pharmacist immediately if you become pregnant or think you may be pregnant during treatment with Nintedanib Viatris.

Breastfeeding

Do not breastfeed during treatment with Nintedanib Viatris, as it may cause harm to the breastfed infant.

Driving and using machines

Nintedanib Viatris has minor influence on the ability to drive and use machines. You should not drive or operate machinery if you feel dizzy.

Nintedanib Viatris contains soya lecithin

If you are allergic to soy or peanuts, do not take this medicine (see section 2, “Do not take Nintedanib Viatris”).

3. How to take Nintedanib Viatris

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Take the capsules twice daily, approximately 12 hours apart and at approximately the same time each day; for example, one capsule in the morning and one capsule in the evening. This ensures a constant level of nintedanib in your blood. Swallow the capsules whole with water, without chewing them. It is recommended to take the capsules with food, that is, during meals or immediately before or after meals. Do not open or break the capsule (see section 5, "Storage of Nintedanib Viatris"). To make swallowing easier, the capsules may be taken with a small amount (one teaspoonful) of cold or room temperature soft food, such as apple sauce or chocolate pudding. Swallow immediately and do not chew the capsule to ensure it remains intact.

Adults

The recommended dose is one 100 mg capsule or one 150 mg capsule, twice daily (a total of 200 mg or 300 mg per day).

Do not take more than the recommended dose of 200 mg or 300 mg per day.

If you do not tolerate the recommended dose (see possible adverse effects in section 4), your doctor may reduce the daily dose of Nintedanib Viatris or advise you to stop taking Nintedanib Viatris. Do not reduce the dose or interrupt treatment on your own without first consulting your doctor.

Use in children and adolescents

The recommended dose depends on the patient's body weight.

Inform your doctor if at any time during treatment the patient's weight falls below 13.5 kg.

Inform your doctor if you have liver problems.

Your doctor will determine the correct dose. Your doctor may adjust the dose during the course of treatment.

If you do not tolerate the recommended daily dose of Nintedanib Viatris capsules (see possible adverse effects in section 4), your doctor may reduce the daily dose of Nintedanib Viatris.

Do not reduce the dose or interrupt treatment on your own without first consulting your doctor.

Dosage based on weight for nintedanib capsules in children and adolescents:

#Nintedanib Viatris is only available in 100 mg and 150 mg soft capsules. Therefore, it is not possible to administer Nintedanib Viatris to pediatric patients who require a dose lower than the full 100 mg dose. If an alternative dose is required, other nintedanib products offering such an option may be used.

If you take more Nintedanib Viatris than you should

Contact your doctor or pharmacist immediately.

If you forget to take Nintedanib Viatris

Do not take two capsules together if you have missed your previous dose. You should take your next dose of Nintedanib Viatris at the next scheduled and recommended time according to your doctor or pharmacist.

If you stop taking Nintedanib Viatris

Do not stop taking Nintedanib Viatris without first consulting your doctor. It is important to take this medicine every day as long as your doctor prescribes it.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

You should pay special attention if you experience the following adverse effects during treatment with Nintedanib Viatris:

Diarrhoea (very common, may affect more than 1 in 10 people):

Diarrhoea may lead to dehydration: a loss of important body fluids and salts (electrolytes, such as sodium or potassium). At the first signs of diarrhoea, drink plenty of fluids and contact your doctor immediately. Start an appropriate anti-diarrhoeal treatment as soon as possible, for example, by taking loperamide.

The following adverse effects have also been observed during treatment with this medicine.

Consult your doctor if you experience any type of adverse effect.

Idiopathic pulmonary fibrosis (IPF)

Very common adverse effects (may affect more than 1 in 10 people)

• Nausea
• Pain in the lower part of the body (abdomen)
• Abnormal liver function test results

Common adverse effects (may affect up to 1 in 10 people)

• Vomiting
• Loss of appetite
• Weight loss
• Bleeding
• Rash
• Headache

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

• Pancreatitis
• Inflammation of the large intestine
• Serious liver problems
• Low platelet count (thrombocytopenia)
• High blood pressure (hypertension)
• Jaundice, i.e. yellowing of the skin and whites of the eyes due to high levels of bilirubin
• Itching
• Heart attack
• Hair loss (alopecia)
• Increased amount of protein in the urine (proteinuria)

Frequency not known (cannot be estimated from available data)

• Kidney failure
• Enlargement and weakening of a blood vessel wall or tear in the blood vessel wall (aneurysms and arterial dissections)
• Brain disorder with symptoms such as headache, changes in vision, confusion, seizures, or other neurological disturbances such as weakness in an arm or leg, with or without high blood pressure (posterior reversible encephalopathy syndrome)

Other chronic fibrosing interstitial lung diseases (ILD) with a progressive phenotype

Very common adverse effects (may affect more than 1 in 10 people)

• Nausea
• Vomiting
• Loss of appetite
• Abdominal pain
• Abnormal liver function test results

Common adverse effects (may affect up to 1 in 10 people)

• Weight loss
• High blood pressure (hypertension)
• Bleeding
• Serious liver problems
• Rash
• Headache

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

• Pancreatitis
• Inflammation of the large intestine
• Low platelet count (thrombocytopenia)
• Jaundice, i.e. yellowing of the skin and whites of the eyes due to high levels of bilirubin
• Itching
• Heart attack
• Hair loss (alopecia)
• Increased amount of protein in the urine (proteinuria)

Frequency not known (cannot be estimated from available data)

• Kidney failure
• Enlargement and weakening of a blood vessel wall or tear in the blood vessel wall (aneurysms and arterial dissections)
• Brain disorder with symptoms such as headache, changes in vision, confusion, seizures, or other neurological disturbances such as weakness in an arm or leg, with or without high blood pressure (posterior reversible encephalopathy syndrome)

Systemic sclerosis-associated interstitial lung disease (SSc-ILD)

Very common adverse effects (may affect more than 1 in 10 people)

• Nausea
• Vomiting
• Abdominal pain
• Abnormal liver function test results

Common adverse effects (may affect up to 1 in 10 people)

• Bleeding
• High blood pressure (hypertension)
• Loss of appetite
• Weight loss
• Headache

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

• Inflammation of the large intestine
• Serious liver problems
• Kidney failure
• Low platelet count (thrombocytopenia)
• Rash
• Itching

Frequency not known (cannot be estimated from available data)

• Heart attack
• Pancreatitis
• Jaundice, i.e. yellowing of the skin and whites of the eyes due to high levels of bilirubin
• Enlargement and weakening of a blood vessel wall or tear in the blood vessel wall (aneurysms and arterial dissections)
• Hair loss (alopecia)
• Increased amount of protein in the urine (proteinuria)
• Brain disorder with symptoms such as headache, changes in vision, confusion, seizures, or other neurological disturbances such as weakness in an arm or leg, with or without high blood pressure (posterior reversible encephalopathy syndrome)

Fibrosing interstitial lung diseases (ILD) in children and adolescents

Adverse effects in children and adolescents were similar to those in adult patients.

Inform your doctor if you experience any type of adverse effect.

Reporting of adverse effects

If you experience any adverse effect, please consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Nintedanib Viatris

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

Do not use this medicine after the expiry date stated on the carton and on the blister. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Do not use this medicine if the blister pack containing the capsules is open or if a capsule is broken. If you come into contact with the capsule contents, wash your hands immediately with plenty of water (see section 3).

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Nintedanib Viatris

• The active substance is nintedanib.

Each Nintedanib Viatris 100 mg soft capsule contains nintedanib esilate equivalent to 100 mg of nintedanib.

Each Nintedanib Viatris 150 mg soft capsule contains nintedanib esilate equivalent to 150 mg of nintedanib.

• The other components are:

Capsule contents: medium-chain triglycerides, lauroyl macrogol glycerides and soybean lecithin (E322).

Capsule shell: gelatin, glycerol (E422), titanium dioxide (E171), iron oxide red (E172) and iron oxide yellow (E172).

Black printing ink: shellac, iron oxide black (E172), ammonium hydroxide and propylene glycol (E1520).

Appearance of the product and contents of the container

Nintedanib Viatris 100 mg soft capsules are oblong, opaque, peach-coloured soft gelatin capsules, printed with “JF1” and approximately 16 mm x 6 mm in size.

Nintedanib Viatris 150 mg soft capsules are oblong, opaque, brown soft gelatin capsules, printed with “JF2” and approximately 18 mm x 7 mm in size.

Nintedanib Viatris is available in unit dose blisters containing 30 x 1 or 60 x 1 capsules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Viatris Limited
Damastown Industrial Park
Mulhuddart
Dublin 15
DUBLIN
Ireland

Manufacturer

Mylan Germany GmbH
Benzstrasse 1
61352 Bad Homburg v. d. Hohe
Germany

Mylan Hungary Kft. / Mylan Hungary Ltd.
Mylan utca 1
Komarom
2900, Hungary

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

Detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.euopa.eu.