Nintedanib onkogen

Package leaflet: Information for the user

Nintedanib Onkogen, 150 mg, soft capsules
Nintedanibum
Please read this leaflet carefully before taking this medicine, as 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, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

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

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

Nintedanib Onkogen contains the active substance nintedanib, which belongs to a group of medicines called tyrosine kinase inhibitors. It is used to treat the following conditions:

Idiopathic pulmonary fibrosis (IPF) in adults
IPF is a disease in which lung tissue gradually becomes thicker, stiffer, and scarred. This scarring reduces the ability of the lungs to transfer oxygen into the bloodstream and makes deep breathing difficult. Nintedanib Onkogen helps reduce further scarring and stiffening of the lungs.

Other chronic fibrosing interstitial lung diseases (ILD) with a progressive phenotype in adults
Besides IPF, there are other conditions in which lung tissue over time becomes thicker, stiffer, and scarred (lung fibrosis) and continues to worsen (progressive phenotype). Examples of these conditions include hypersensitivity pneumonitis, autoimmune ILD (e.g. ILD associated with rheumatoid arthritis), idiopathic nonspecific interstitial pneumonia, unclassifiable idiopathic interstitial pneumonia, and other ILDs. Nintedanib Onkogen helps reduce further scarring and stiffening of the lungs.

Clinically significant, progressive fibrosing interstitial lung diseases (ILD) in children and adolescents aged 6 to 17 years
Patients with childhood interstitial lung disease (chILD) may develop lung fibrosis. In such cases, lung tissue in children and adolescents gradually becomes thickened, stiff, and scarred over time. Nintedanib Onkogen helps reduce 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 stiffening) of the skin and internal organs such as the lungs. When fibrosis affects the lungs, it is referred to as interstitial lung disease (ILD), and the condition is then known as SSc-ILD. Lung fibrosis reduces the ability to transfer oxygen into the bloodstream, making breathing difficult. Nintedanib Onkogen helps reduce further scarring and stiffening of the lungs.

2. Important information before taking Nintedanib Onkogen

When not to take Nintedanib Onkogen

• if the patient is pregnant,
• if the patient is allergic to nintedanib or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Nintedanib Onkogen, discuss with your doctor or
pharmacist:

• if the patient has or has had liver disease,
• if the patient has or has had kidney disease or if protein in the urine has been detected,
• if the patient has or has had bleeding problems,
• if the patient is taking medicines that reduce blood clotting (such as warfarin, phenprocoumon or heparin) to prevent blood clots,
• if the patient is taking pirfenidone, as this may increase the risk of diarrhoea, nausea, vomiting and liver disease,
• if the patient has or has had heart disease (e.g. heart attack),
• if the patient has recently undergone surgery. Nintedanib may affect wound healing. Therefore, treatment with Nintedanib Onkogen is usually temporarily discontinued if the patient undergoes surgery. The doctor will decide when treatment should be resumed.
• if the patient has high blood pressure,
• if the patient has pulmonary hypertension (abnormally high blood pressure in the blood vessels of the lungs),
• if the patient has or has previously had an aneurysm (a weakened and bulging blood vessel wall) or a tear in the wall of a blood vessel.

Based on this information, the doctor may perform blood tests, for example to
assess liver function. The doctor will discuss the results of these tests with the patient and decide whether
the patient can take Nintedanib Onkogen.
Contact the doctor immediately if, while taking this medicine,

• the patient develops diarrhoea. Early treatment of diarrhoea is important (see section 4);
• the patient experiences vomiting or nausea (feeling sick);
• the patient develops unexplained symptoms such as yellowing of the skin or whites of the eyes (jaundice), dark or brown (tea-coloured) urine, pain in the upper right part of the abdomen, more frequent than usual bleeding or bruising, or feeling tired. These may be signs of serious liver disease;
• the patient develops severe stomach pain, fever, chills, nausea, vomiting, or a hard abdomen or bloating, as these may be symptoms of a perforation in the wall of the intestine (gastrointestinal perforation). The doctor should also be informed if the patient has previously had peptic ulcers or diverticular disease of the intestine, or if the patient is taking anti-inflammatory medicines (non-steroidal anti-inflammatory drugs, NSAIDs) (used to treat pain and swelling) or steroids (used to treat inflammatory and allergic conditions) at the same time, as these factors increase this risk;
• the patient simultaneously develops severe abdominal pain or cramps, red blood in the stool or diarrhoea, as these may be symptoms of intestinal inflammation due to inadequate blood supply to the intestine (ischaemic colitis);
• the patient develops pain, swelling, redness and increased temperature in a limb, as these may be symptoms of a blood clot forming in one of the veins (a type of blood vessel);
• the patient experiences pressure or pain in the chest, usually on the left side of the body, pain in the neck, jaw, arm or hand, rapid heartbeat, shortness of breath, nausea, vomiting, as these may be symptoms of a heart attack;
• the patient experiences serious bleeding.
• the patient develops bruising, bleeding, fever, fatigue and confusion. This may be a sign of blood vessel damage called thrombotic microangiopathy (TMA).
• the patient develops symptoms such as headache, visual disturbances, disorientation, seizures or other neurological disturbances such as weakness in the arms or legs, with or without high blood pressure. These may be symptoms of a brain disorder called posterior reversible encephalopathy syndrome (PRES).

Children and adolescents
Nintedanib Onkogen should not be given to children under 6 years of age.
The doctor may perform regular dental examinations at least every 6 months until tooth development is complete and monitor the patient's growth annually (bone imaging) during treatment with this medicine.

Nintedanib Onkogen and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including herbal medicines and medicines available without a prescription.
Nintedanib Onkogen may interact with certain other medicines. The following medicines are examples of those that may increase the concentration of nintedanib in the blood and thereby increase the risk of adverse effects (see section 4):

• a medicine used to treat fungal infections (ketoconazole),
• a medicine used to treat bacterial infections (erythromycin),
• a medicine affecting the immune system (cyclosporine).

The following medicines are examples of those that may reduce the concentration of nintedanib in the blood and thereby reduce the effectiveness of Nintedanib Onkogen:

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

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant or plans to have a
child, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Do not take this medicine during pregnancy, as it may harm the unborn child and cause congenital malformations.
A pregnancy test should be performed before starting treatment with Nintedanib Onkogen to confirm that the patient is not pregnant. Consult your doctor about this.
Contraception

• Women of childbearing potential must use a highly effective method of contraception to prevent pregnancy at the time of starting treatment with Nintedanib Onkogen, during treatment, and for at least 3 months after stopping treatment.

• Discuss with the doctor the most appropriate contraceptive method for the patient.

• Vomiting and/or diarrhoea or other gastrointestinal disturbances may affect the absorption of oral hormonal contraceptives, such as contraceptive pills, and may reduce their effectiveness. Therefore, in the event of such disturbances, discuss with the doctor the use of an alternative, more appropriate method of contraception.

• If the patient becomes pregnant or suspects she may be pregnant while taking Nintedanib Onkogen, she should immediately inform her doctor or pharmacist.

Breastfeeding
Do not breastfeed during treatment with Nintedanib Onkogen, as it may harm the breastfed child.

Driving and using machines
Nintedanib Onkogen may have a minor influence on the ability to drive and use machines. If the patient experiences nausea, he or she should not drive or operate machinery.

3. How to take Nintedanib Onkogen

This medicine should always be taken as directed by the physician or pharmacist. If in doubt, consult the physician or pharmacist.

The recommended dose is one 150 mg capsule twice daily (total 300 mg per day). Capsules should be taken twice daily, approximately 12 hours apart, around the same time each day, for example one capsule in the morning and one in the evening. This ensures maintenance of a constant level of nintedanib in the patient's bloodstream. Capsules must be swallowed whole with water and must not be chewed. It is recommended to take the capsules with food, i.e. during, immediately before, or immediately after a meal. Capsules must not be opened or crushed (see section 5).

To facilitate swallowing, capsules may be taken with a small amount (one teaspoonful) of cold or soft food at room temperature, such as applesauce or chocolate pudding. The capsules should be swallowed immediately and must not be chewed, so that the capsule remains intact.

Adults
The recommended dose is one capsule containing 150 mg taken twice daily (total 300 mg per day).
Do not take a higher dose than recommended, i.e. two capsules of Nintedanib Onkogen 150 mg per day.

If the patient does not tolerate the recommended dose of two capsules of Nintedanib Onkogen 150 mg per day (see possible adverse reactions in section 4), the physician may reduce the daily dose of nintedanib. Do not reduce the dose or discontinue treatment independently without first consulting the physician.

The physician may reduce the recommended dose to 100 mg twice daily (total 200 mg per day). In such a case, the physician will prescribe Nintedanib Onkogen 100 mg capsules for continued treatment. Do not take more than the recommended dose of two capsules of Nintedanib Onkogen 100 mg per day if the patient's daily dose has been reduced to 200 mg per day.

Use in children and adolescents
The recommended dose depends on the patient's body weight.

Inform the physician if, at any time during treatment, the patient's body weight drops below 13.5 kg.

Inform the physician if the patient has liver problems.

The physician will determine the correct dose. The dose may be adjusted by the physician as treatment progresses.

If the patient does not tolerate the recommended dose of Nintedanib Onkogen capsules per day (see possible adverse reactions in section 4), the physician may reduce the daily dose of Nintedanib Onkogen.

Do not reduce the dose or discontinue treatment independently without prior consultation with the physician.

Dosing of Nintedanib Onkogen capsules in children and adolescents according to body weight:

Body weight range Nintedanib Onkogen dose
in kilograms (kg) in milligrams (mg)
13.5–22.9 kg 50 mg (two 25 mg capsules) twice daily
23.0–33.4 kg 75 mg (three 25 mg capsules) twice daily
33.5–57.4 kg 100 mg (one 100 mg capsule or four
25 mg capsules) twice daily
57.5 kg and above 150 mg (one 150 mg capsule or six
25 mg capsules) twice daily

Nintedanib Onkogen is available only as soft capsules in strengths of 100 mg and 150 mg. Therefore, it is not possible to administer Nintedanib Onkogen to pediatric patients requiring a dose lower than the full 100 mg dose. If an alternative dose is required, other products containing nintedanib, which allow such dosing, may be used.

The physician may reduce the recommended dose to 100 mg twice daily (total 200 mg per day). In such a case, the physician will prescribe Nintedanib Onkogen 100 mg. Do not take more than the recommended dose of two capsules of Nintedanib Onkogen 100 mg per day if the daily dose has been reduced to 200 mg per day.

Taking more Nintedanib Onkogen than prescribed
Contact a physician or pharmacist immediately.

Missing a dose of Nintedanib Onkogen
Do not take two capsules at the same time if a previous dose has been missed. Take the next dose of Nintedanib Onkogen 150 mg as scheduled at the usual time, in accordance with the physician's or pharmacist's instructions.

Stopping treatment with Nintedanib Onkogen
Do not stop taking Nintedanib Onkogen without first consulting the physician. It is important to take this medicine every day for as long as directed by the physician.

If there are any further questions about the use of this medicine, consult the physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Special attention should be paid if the following adverse reactions occur during treatment with Nintedanib Onkogen:
Diarrhoea (very common, may affect more than 1 in 10 people):
Diarrhoea may lead to dehydration: loss of fluids and important salts (electrolytes such as sodium or potassium) from the body. If the first symptoms of diarrhoea occur, drink plenty of fluids and contact your doctor immediately. Appropriate anti-diarrhoeal treatment, e.g. with loperamide, should be started as soon as possible.
The following other adverse reactions have been observed during treatment with this medicine.
If any adverse reactions occur in the patient, inform the doctor.

Idiopathic pulmonary fibrosis (IPF)
Very common adverse reactions (may affect more than 1 in 10 people)

• Nausea
• Abdominal pain (pain in the lower part of the trunk)
• Abnormal liver function test results

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

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

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

• Pancreatitis
• Colitis
• Severe liver disease
• Decreased platelet count (thrombocytopenia)
• High blood pressure (hypertension)
• Jaundice, i.e. yellowing of the skin and whites of the eyes due to increased bilirubin concentration
• Itching
• Heart attack
• Hair loss (alopecia)
• Increased protein in the urine (proteinuria)

Frequency not known (frequency cannot be estimated from the available data)

• Kidney failure
• Enlargement and weakening of a blood vessel wall or tear in the blood vessel wall (aneurysm and arterial dissection)
• Brain disorder characterized by symptoms such as headache, visual disturbances, confusion, seizures, or other neurological disturbances such as weakness in arms or legs, with or without high blood pressure (posterior reversible encephalopathy syndrome).

Other chronic fibrosing interstitial lung diseases (ILD) with progressive phenotype
Very common adverse reactions (may affect more than 1 in 10 people)

• Nausea
• Vomiting
• Loss of appetite
• Abdominal pain (pain in the lower part of the trunk)
• Abnormal liver function test results

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

• Weight loss
• High blood pressure (hypertension)
• Bleeding
• Severe liver disease
• Rash
• Headache

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

• Pancreatitis
• Colitis
• Decreased platelet count (thrombocytopenia)
• Jaundice, i.e. yellowing of the skin and whites of the eyes due to increased bilirubin concentration
• Itching
• Heart attack
• Hair loss (alopecia)
• Increased protein in the urine (proteinuria)

Frequency not known (frequency cannot be estimated from the available data)

• Kidney failure
• Enlargement and weakening of a blood vessel wall or tear in the blood vessel wall (aneurysm and arterial dissection)
• Brain disorder characterized by symptoms such as headache, visual disturbances, confusion, seizures, or other neurological disturbances such as weakness in arms or legs, with or without high blood pressure (posterior reversible encephalopathy syndrome).

Systemic sclerosis-associated interstitial lung disease (SSc-ILD)
Very common adverse reactions (may affect more than 1 in 10 people)

• Nausea
• Vomiting
• Abdominal pain (pain in the lower part of the trunk)
• Abnormal liver function test results

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

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

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

• Colitis
• Severe liver disease
• Kidney failure
• Decreased platelet count (thrombocytopenia)
• Rash
• Itching

Frequency not known (frequency cannot be estimated from the available data)

• Heart attack
• Pancreatitis
• Jaundice, i.e. yellowing of the skin and whites of the eyes due to increased bilirubin concentration
• Enlargement and weakening of a blood vessel wall or tear in the blood vessel wall (aneurysm and arterial dissection)
• Hair loss (alopecia)
• Increased protein in the urine (proteinuria)
• Brain disorder characterized by symptoms such as headache, visual disturbances, confusion, seizures, or other neurological disturbances such as weakness in arms or legs, with or without high blood pressure (posterior reversible encephalopathy syndrome).

Fibrosing interstitial lung diseases (ILD) in children and adolescents
Adverse reactions in children and adolescents were similar to those in adult patients.
Consult a doctor if any adverse reactions occur in the patient.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C,
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Nintedanib Onkogen

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. The expiry date refers to the last day of the stated month.
Do not store above 25°C. Store in the original packaging to protect from moisture.
Do not use this medicine if the blister containing the capsules is open or if a capsule appears damaged.
In case of contact with the capsule contents, immediately wash hands thoroughly 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 no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Nintedanib Onkogen contains

• The active substance is nintedanib. One capsule contains 150 mg of nintedanib (as nintedanib esilate).
• The other ingredients are:
  Capsule contents: macrogol 400.
  Capsule shell: gelatin 150, sorbitol liquid, partially dehydrated, glycerol (E 422), titanium dioxide (E 171), iron oxide red (E 172), and iron oxide yellow (E 172).

What Nintedanib Onkogen looks like and contents of the pack
Nintedanib Onkogen 150 mg is an opaque, brown, elongated soft gelatin capsule.
Two pack sizes of Nintedanib Onkogen 150 mg soft capsules are available:

• 30 x 1 soft capsule in single-dose blisters, perforated or non-perforated, made of PET/Aluminium - PA/Aluminium/PVC foil
• 60 x 1 soft capsule in single-dose blisters, perforated or non-perforated, made of PET/Aluminium - PA/Aluminium/PVC foil

Not all pack types may be marketed.
Marketing Authorisation Holder
Onkogen Kft.
Bécsi út 77-79
1037 Budapest
Hungary
Email: [email protected]
Manufacturer
Cyndea Pharma, S.L.
Polígono Industrial Emiliano Revilla Sanz.
Avenida de Ágreda 31, 42110, Ólvega (Soria)
Spain
This medicinal product is authorised in the European Economic Area countries under the following names:
Croatia Nintedanib Onkogen 150 mg meke kapsule
Spain Nintedanib Cinfa 150 mg cápsulas blandas EFG
Netherlands Nintedanib Onkogen 150 mg zachte capsules
Poland Nintedanib Onkogen
Hungary Nintedanib Onkogen 150 mg lágy kapszula