Ofev 100 mg soft capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Ofev 100mg soft capsules

nintedanib

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Ofev is and what it is used for

Ofev contains the active substance nintedanib, a medicine that belongs to a 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, stiffening, and scarring of the 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. Ofev helps reduce the progression of further scarring and stiffening 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 becomes thickened, stiffened, and scarred over time (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. Ofev helps reduce the progression of further scarring and stiffening 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 of children and adolescents becomes thickened, stiffened, and scarred over time. Ofev helps reduce the progression of further scarring and stiffening of the lungs.

Interstitial lung disease associated with systemic sclerosis (SSc-ILD) 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); thus, the condition is referred to as SSc-ILD. Fibrosis in the lungs reduces the ability to transfer oxygen into the bloodstream and impairs breathing capacity. Ofev helps reduce the progression of further scarring and stiffening of the lungs.

2. What you need to know before taking Ofev

Do not take Ofev

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Ofev

• if you have or have had liver problems,
• if you have or have had kidney problems, or if you have been found to have an increased amount of protein in your urine,
• if you have or have had bleeding problems,
• if you are taking blood-thinning medicines (such as warfarin, phenprocoumon, or heparin) to prevent blood clots,
• if you are taking pirfenidone, as this may increase the risk of developing diarrhea, 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 Ofev is generally paused for a period of time if you undergo surgery. Your doctor will decide when to restart 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 a blood vessel wall) or a tear in the wall of a blood vessel.

Based on this information, your doctor may carry out some 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 Ofev.

Tell your doctor immediately while you are taking this medicine

• if you have diarrhea. It is important to treat diarrhea 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-colored 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 signs 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 these may increase this risk;
• if you have a combination of severe or cramp-like stomach pain, red blood in the stools, or diarrhea, 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, shortness of breath, 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 a blood vessel disorder known as thrombotic microangiopathy (TMA);
• if you experience symptoms such as headache, changes in vision, confusion, seizures, or other neurological changes such as weakness in one arm or leg, with or without high blood pressure, which could be symptoms of a brain disorder called reversible posterior encephalopathy syndrome (RPLS).

Children and adolescents

Children under 6 years of age must not take Ofev.

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 Ofev

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.

Ofev may interact with other medicines. The following medicines may

increase 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 blood levels of nintedanib and thus reduce the effectiveness of Ofev:

• 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 are planning 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 should be performed to ensure you are not pregnant before starting treatment with Ofev. Consult your doctor.

Contraception

• Women who can become pregnant must use a highly effective method of contraception to prevent pregnancy when starting Ofev, while taking Ofev, and for at least 3 months after stopping treatment.
• Discuss with your doctor the most appropriate contraceptive methods for you.
• Vomiting and/or diarrhea 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 an alternative, more appropriate contraceptive method.
• Inform your doctor or pharmacist immediately if you become pregnant or think you may be pregnant during treatment with Ofev.

Breastfeeding

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

Driving and using machines

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

Ofev contains soy lecithin

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

3. How to take Ofev

Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. 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 will ensure that a constant level of nintedanib is maintained 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 split the capsule (see section 5, "Storage of Ofev").

To make swallowing the capsules easier, you may take them with a small amount (one teaspoonful) of cold or room temperature soft food, such as apple sauce or chocolate pudding. Swallow the capsules immediately and do not chew them to ensure they remain intact.

Adults

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

Do not take more than the recommended dose of two Ofev 100 mg capsules per day.

If you do not tolerate the recommended dose of two Ofev 100 mg capsules per day (see possible adverse effects in section 4), your doctor may recommend that you stop taking this medicine. Do not reduce the dose or stop 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 Ofev capsules (see possible adverse effects in section 4), your doctor may reduce the daily dose of Ofev.

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

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

If you take more Ofev than you should

Contact your doctor or pharmacist immediately.

If you forget to take Ofev

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

If you stop taking Ofev

Do not stop taking Ofev 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 may cause adverse effects, although not everyone experiences them.

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

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 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.

Contact your doctor if you experience any adverse effects.

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 results in liver function tests

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)

Chronic fibrosing interstitial lung diseases (ILD) with progressive phenotype

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

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

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)

Interstitial lung disease associated with systemic sclerosis (ILD-SSc)

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

• Nausea
• Vomiting
• Abdominal pain
• Abnormal results in liver function tests

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 adverse effects.

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly through the national reporting system listed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ofev

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 blister pack. The expiry date refers to the last day of the month indicated.

Do not store above 25 °C.

Store in the original packaging to protect from moisture.

Do not use this medicine if you notice that the blister containing the capsules is open or if a capsule is damaged.

If you come into contact with the capsule contents, wash your hands immediately with plenty of water (see section 3, "How to take Ofev").

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

6. Contents of the container and additional information

Composition of Ofev

• The active substance is nintedanib. Each capsule contains 100 mg of nintedanib (as esilate).
• The other components are:

Product Presentation and Contents of the Package

Ofev 100 mg capsules are soft gelatin capsules, oblong, opaque, and peach-colored (approximately 16 × 6 mm), marked on one side with the Boehringer Ingelheim company logo and the number "100".

Two package sizes are available for Ofev 100 mg capsules:

• 30 × 1 soft capsules in single-dose aluminum/aluminum blister packs, pre-perforated
• 60 × 1 soft capsules in single-dose aluminum/aluminum blister packs, pre-perforated

Only certain package sizes may be marketed.

Marketing Authorization Holder

Boehringer Ingelheim International GmbH
Binger Strasse 173
55216 Ingelheim am Rhein
Germany

Manufacturer

Boehringer Ingelheim Pharma GmbH & Co. KG
Binger Strasse 173
55216 Ingelheim am Rhein
Germany

Boehringer Ingelheim France
100-104 Avenue de France
75013 Paris
France

For further information regarding 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 website of the European Medicines Agency: https://www.ema.europa.eu.