Sunitinib Viatris 12,5 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Sunitinib Viatris 12.5 mg hard capsules EFG

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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people. It may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Leaflet contents

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

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

This medicine contains the active substance sunitinib, which is a protein kinase inhibitor. It is used to treat cancer and works by blocking the activity of a specific group of proteins involved in the growth and spread of cancer cells.

This medicine is used to treat adults with the following types of cancer:

• Gastrointestinal stromal tumour (GIST), a type of cancer of the stomach and intestine, when imatinib (another anticancer medicine) has already failed or cannot be used.
• Metastatic renal cell carcinoma (mRCC), a type of kidney cancer that has spread to other parts of the body.
• Pancreatic neuroendocrine tumours (pNET) (tumours of hormone-secreting cells in the pancreas) that have progressed or cannot be surgically removed.

If you have any questions about how this medicine works or why it has been prescribed for you, please consult your doctor.

2. What you need to know before starting to take Sunitinib Viatris

Do not take Sunitinib Viatris:

• If you are allergic to sunitinib or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

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

• If you have high blood pressure. This medicine may increase blood pressure. Your doctor may monitor your blood pressure during treatment with Sunitinib Viatris and, if necessary, may prescribe medicines to lower your blood pressure.

• If you have or have had blood disorders, bleeding problems or bruising. Treatment with this medicine may lead to a high risk of bleeding or cause changes in the number of certain blood cells, which may result in anaemia or affect the blood's ability to clot. If you are taking warfarin or acenocoumarol, medicines used to thin the blood to prevent clots, there may be an increased risk of bleeding. If you experience any bleeding during treatment with this medicine, consult your doctor.

• If you have heart problems. This medicine may cause heart problems. Consult your doctor if you feel very tired, become short of breath, or have swollen feet or ankles.

• If you have abnormal heart rhythms. This medicine may cause irregularities in heart rhythm. Your doctor may perform electrocardiograms (ECGs) to assess these issues during treatment. Consult your doctor if, during treatment with this medicine, you feel dizzy, weak, or experience abnormal heartbeats.

• If you have recently had blood clots in veins and/or arteries (types of blood vessels), including stroke, heart attack, embolism, or thrombosis. Contact your doctor immediately if you experience symptoms such as chest pain or pressure, arm, back, neck, or jaw pain, difficulty breathing, numbness or weakness on one side of the body, speech difficulties, headache, or dizziness while on treatment with this medicine.

• 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.

• If you have or have had damage to the smallest blood vessels, known as thrombotic microangiopathy (TMA). Contact your doctor if you experience fever, fatigue, tiredness, bruising, bleeding, swelling, confusion, vision loss, or seizures.

• If you have thyroid gland problems. This medicine may cause thyroid gland disorders. Contact your doctor if you feel unusually tired, are more sensitive to cold than usual, or your voice becomes deeper while taking this medicine. Thyroid function should be monitored before starting treatment and periodically during treatment. If your thyroid gland does not produce enough thyroid hormone, you may be treated with replacement thyroid hormone.

• If you have or have had pancreatic or gallbladder disorders. Contact your doctor if you develop any of the following signs and symptoms: stomach pain (upper abdomen), nausea, vomiting, or fever. These may be caused by inflammation of the pancreas or gallbladder.

• If you have or have had liver problems. Contact your doctor if you develop any of the following signs or symptoms of liver problems during treatment: itching, yellowing of the eyes or skin, dark urine, or pain or discomfort in the upper right part of the stomach. Your doctor should perform blood tests to monitor liver function before and during treatment, and whenever clinically indicated.

• If you have or have had kidney problems. Your doctor will monitor your kidney function.

• If you are scheduled for surgery or have recently undergone surgery. This medicine may affect wound healing. If you are due to have surgery, you will usually stop taking this medicine. Your doctor will decide when to restart treatment.

• Before starting treatment with Sunitinib Viatris, you may be advised to have a dental check-up.

• If you have or have had mouth, teeth, and/or jaw pain, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw, or loose teeth, inform your doctor and dentist immediately.

• If you need invasive dental treatment or dental surgery, inform your dentist that you are being treated with this medicine, especially if you are also being treated or have been treated with intravenous bisphosphonates. Bisphosphonates are medicines used to prevent bone complications that may occur due to other medical conditions.

• If you have or have had skin and subcutaneous tissue disorders. During treatment with this medicine, you may develop "pyoderma gangrenosum" (painful skin ulceration) or "necrotizing fasciitis" (a rapidly spreading skin/soft tissue infection that can be fatal). Contact your doctor immediately if you notice signs of infection around a skin lesion, such as fever, pain, redness, swelling, or pus or blood discharge. This reaction is usually reversible after stopping sunitinib. Severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) have been reported with sunitinib use. These initially appear as red, target-like spots or circular lesions, often with central blisters on the trunk. The rash may progress to widespread blistering or skin peeling and can be life-threatening. Contact your doctor immediately if you develop a skin rash or the skin symptoms described.

• If you have had seizures. If you have high blood pressure, headache, or vision loss, inform your doctor as soon as possible.

• If you have diabetes. Blood glucose levels in diabetic patients should be checked regularly to determine whether the dose of antidiabetic medication needs adjustment, to minimize the risk of low blood sugar. Inform your doctor as soon as possible if you experience signs and symptoms of low blood sugar (fatigue, palpitations, sweating, hunger, or loss of consciousness).

Children and adolescents

The use of this medicine is not recommended in patients under 18 years of age.

Other medicines and Sunitinib Viatris

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Some medicines may affect the levels of this medicine in your body. You must inform your doctor if you are taking medicines containing any of the following active substances:

• ketoconazole, itraconazole – used to treat fungal infections
• erythromycin, clarithromycin, rifampicin – used to treat infections
• ritonavir – used to treat HIV
• dexamethasone – a corticosteroid used for various conditions (such as allergic/respiratory disorders or skin diseases)
• phenytoin, carbamazepine, phenobarbital – used to treat epilepsy and other neurological conditions
• herbal remedies containing St. John’s wort or hypericum (Hypericum perforatum) used to treat depression and anxiety.

Taking Sunitinib Viatris with food and drink

You should avoid drinking grapefruit juice while being treated with this medicine.

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.

If you could become pregnant, you should use a reliable method of contraception during treatment with this medicine.

If you are breastfeeding, inform your doctor. You must not breastfeed while being treated with this medicine.

Driving and using machines

If you experience dizziness or unusual tiredness, take special care when driving or operating machinery.

Sunitinib Viatris contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; that is, essentially “sodium-free”.

3. How to take Sunitinib Viatris

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

Your doctor will determine the correct dose for you depending on the type of cancer being treated. If you are receiving treatment for:

• GIST or MRCC: the usual dose is 50 mg once daily for 28 days (4 weeks), followed by a 14-day (2-week) break (no medication), in 6-week cycles.
• pNET: the usual dose is 37.5 mg once daily without a break period.

Your doctor will inform you of the appropriate dose you need to take, as well as whether you need to interrupt treatment with this medicine and when.

This medicine may be taken with or without food.

If you take more Sunitinib Viatris than you should

If you have accidentally taken too many capsules, consult your doctor immediately. You may require medical attention.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Sunitinib Viatris

Do not take a double dose to make up for missed doses.

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 will experience them.

You should contact your doctor immediately if you experience any of the following serious adverse effects (see also What you need to know before you start taking Sunitinib Viatris):

Heart problems. Consult your doctor if you feel very tired, short of breath, or have swollen feet or ankles. These may be symptoms of heart problems, which may include heart failure and heart muscle problems (cardiomyopathy).

Lung or breathing problems. Consult your doctor if you develop cough, chest pain, sudden breathing difficulties, or cough up blood. These may be symptoms of a condition called pulmonary embolism, which occurs when blood clots travel to the lungs.

Kidney problems. Consult your doctor if you experience changes in the frequency or absence of urination, as these may be symptoms of kidney failure.

Bleeding. Consult your doctor if you have any of these symptoms or experience a serious bleeding problem during treatment with this medicine: painful or swollen stomach (abdomen); vomiting blood; black, tarry stools; blood in urine; headache or any change in mental status; coughing up blood or bloody sputum from the lungs or airways.

Tumour destruction leading to intestinal perforation. Consult your doctor if you have severe abdominal pain, fever, nausea, vomiting, blood in stools, or changes in bowel habits.

Other adverse effects of Sunitinib Viatris may include:

Very common: may affect more than 1 in 10 people

• Decrease in the number of platelets, red blood cells, and/or white blood cells (e.g., neutrophils).
• Difficulty breathing.
• High blood pressure.
• Extreme tiredness, loss of strength.
• Rapid swelling of tissues due to fluid accumulation under the skin and around the eye, severe allergic skin rash.
• Mouth pain/irritation, mouth sores/inflammation/dryness in the mouth, taste disturbances, stomach discomfort, nausea, vomiting, diarrhoea, constipation, abdominal pain/swelling, loss/reduced appetite.
• Decreased activity of the thyroid gland (hypothyroidism).
• Dizziness.
• Headache.
• Nosebleeds.
• Back pain, joint pain.
• Pain in arms and legs.
• Yellow skin/skin discoloration, excessive skin pigmentation, change in hair colour, skin rash on the palms of the hands and soles of the feet, rash, dry skin.
• Cough.
• Fever.
• Difficulty falling asleep.

Common: may affect up to 1 in 10 people

• Blood clots in blood vessels.
• Reduced blood flow to the heart muscle due to blockage or narrowing of the coronary arteries.
• Chest pain.
• Decreased amount of blood pumped by the heart.
• Fluid retention, including around the lungs.
• Infections.
• Complication of a severe infection (infection present in the bloodstream) that may cause tissue damage, organ failure, and death.
• Low blood sugar level (see section 2).
• Loss of protein in urine, which may cause swelling.
• Pseudoflu-like syndrome.
• Abnormal blood test results, including pancreatic and liver enzymes.
• Elevated blood uric acid levels.
• Haemorrhoids, rectal pain, bleeding gums, difficulty swallowing or inability to swallow.
• Burning sensation or pain in the tongue, inflammation of the lining of the digestive tract, excess gas in the stomach or intestines.
• Weight loss.
• Musculoskeletal pain (pain in muscles and bones), weakness, muscle fatigue, muscle pain, muscle spasms.
• Dry nose, nasal congestion.
• Excessive tearing.
• Abnormal skin sensation, itching, scaly and inflamed skin, blisters, acne, nail colour changes, hair loss.
• Abnormal sensation in the limbs.
• Abnormally decreased/increased sensitivity, especially to touch.
• Indigestion.
• Dehydration.
• Hot flushes.
• Abnormal urine colour.
• Depression.
• Chills.

Uncommon: may affect up to 1 in 100 people

• Potentially life-threatening soft tissue infection, including in the anogenital region (see section 2).
• Stroke.
• Myocardial infarction caused by interruption or reduction of blood flow to the heart.
• Changes in the heart's electrical activity or abnormal heart rhythm.
• Fluid around the heart (pericardial effusion).
• Liver failure.
• Stomach (abdominal) pain caused by inflammation of the pancreas.
• Tumour destruction leading to a hole in the intestine (perforation).
• Inflammation (swelling and redness) of the gallbladder, with or without gallstones.
• Abnormal tube-like connection from one body cavity to another body cavity or to the skin.
• Pain in the mouth, teeth, and/or jaw, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw, or loose teeth. These may be signs and symptoms of bone damage in the jaw (osteonecrosis), see section 2.
• Overproduction of thyroid hormones, increasing the body's resting energy consumption.
• Problems with wound healing after surgery.
• Elevated blood levels of a muscle enzyme (creatine phosphokinase).
• Severe allergic reaction, including pollen allergy, skin rash, skin itching, hives, swelling of body parts, and difficulty breathing.
• Inflammation of the colon (colitis, ischaemic colitis).

Rare: may affect up to 1 in 1,000 people

• Severe skin and/or mucous membrane reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme).
• Tumour lysis syndrome (TLS) – TLS includes a series of metabolic complications that may occur during cancer treatment. These complications are caused by substances released from dying cancer cells and may include: nausea, shortness of breath, irregular heartbeat, muscle cramps, seizures, dark urine, and fatigue, associated with abnormal laboratory results (high levels of potassium, uric acid, and phosphate, and low calcium levels in blood), which may lead to changes in kidney function and acute kidney failure.
• Abnormal breakdown of muscles, which may lead to kidney problems (rhabdomyolysis).
• Abnormal changes in the brain that may cause a range of symptoms including headache, confusion, seizures, and vision loss (reversible posterior leukoencephalopathy syndrome).
• Painful skin ulceration (pyoderma gangrenosum).
• Inflammation of the liver (hepatitis).
• Inflammation of the thyroid gland.
• Damage to the smallest blood vessels known as thrombotic microangiopathy (TMA).

Frequency not known (cannot be estimated from available data):

• Enlargement and weakening of a blood vessel wall or tearing of a blood vessel wall (arterial aneurysms and dissections).
• Lack of energy, confusion, drowsiness, loss of consciousness/coma: these symptoms may be signs of brain toxicity caused by high levels of ammonia in the blood (hyperammonaemic encephalopathy).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Sunitinib 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, bottle, and blister after CAD or EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Do not use this medicine if you notice that the packaging is damaged or shows signs of having been opened.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point at your pharmacy. If you are unsure, 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 other information

Composition of Sunitinib Viatris

The active substance is sunitinib. Each capsule contains 12.5 mg of sunitinib.

The other components are:

• Capsule contents: microcrystalline cellulose (E-460), mannitol (E-421), sodium croscarmellose (see section 2 Sunitinib Viatris contains sodium), povidone (E-1201), magnesium stearate (E-470b).
• Capsule shell: red iron oxide (E-172), titanium dioxide (E-171), gelatin.
• White printing ink: shellac glaze, titanium dioxide (E-171), propylene glycol (E-1520).

Appearance of the product and contents of the container

Size 4 gelatin capsules with orange cap and orange body, printed with "12.5 mg" in white ink on the body, containing yellow to orange granules.

Sunitinib Viatris hard capsules are available in blisters containing 28 hard capsules, in unit-dose perforated blisters of 28 × 1 hard capsules, in unit-dose perforated blisters of 30 × 1 hard capsules, and in plastic bottles containing 30 hard capsules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder:

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturer:

Remedica Ltd.
Aharnon Street, Limassol Industrial Estate
3056 Limassol
Cyprus

or

Pharmacare Premium Ltd.
HHF003 Hal Far Industrial Estate
Birzebbugia, BBG3000
Malta

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

Viatris Pharmaceuticals, S.L.
C/ General Aranaz, 86
28027 - Madrid
Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this leaflet: September 2024

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) https://www.aemps.gob.es/