Package Insert: Information for the User

Sunitinib Viatris 12.5 mg Hard Capsules EFG

Read this package insert carefully before you start taking this medicine, because it contains important information for you.

-Keep this package insert, as you may need to read it again.

-If you have any questions, consult your doctor or pharmacist.

-This medicine has been prescribed only for you and should not be given to others, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

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

2.What you need to know before you start taking Sunitinib Viatris

3.How to take Sunitinib Viatris

4.Possible side effects

5.Storage of Sunitinib Viatris

6.Contents of the pack and additional information

This medication contains the active ingredient sunitinib, which is a protein kinase inhibitor. It is used for the treatment of cancer and acts by preventing the activity of a specific group of proteins involved in the growth and proliferation of cancer cells.

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

• Gastrointestinal stromal tumor (GIST), a type of stomach and intestinal cancer, when imatinib (another anticancer medication) has failed or cannot be taken.
• Metastatic renal cell carcinoma (mRCC), a type of kidney cancer that has spread to other parts of the body.
• Progressive or unresectable pancreatic neuroendocrine tumors (pNET) (tumors of hormone-secreting cells in the pancreas).

If you have any doubts about how this medication works or why this medication has been prescribed for you, consult your doctor.

Do not take Sunitinib Viatris:

• If you are allergic to sunitinib or any of the other ingredients of this medication (listed in section6).

Warnings and precautions

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

• If you have high blood pressure.This medication may increase blood pressure. Your doctor may monitor your blood pressure during treatment with Sunitinib Viatris and, if necessary, treat you with medications that reduce blood pressure.

• If you have or have had blood disorders, bleeding problems or bruises.Treatment with this medication may lead to a high risk of bleeding or produce changes in the number of certain blood cells, which may cause anemia or affect blood clotting. If you are taking warfarin or acenocoumarol, medications that thin the blood to prevent clots, there may be a greater risk of bleeding. If you experience any bleeding during treatment with this medication, consult your doctor.

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

• If you have abnormal heart rhythm changes.This medication may cause abnormal heart rhythm changes. Your doctor may obtain electrocardiograms to evaluate these problems during treatment with this medication. Consult your doctor if you experience dizziness, weakness or abnormal heartbeats during treatment with this medication.

• If you have had recent 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, pain in the arms, back, neck or jaw, difficulty breathing, numbness or weakness in one side of the body, speech problems, headache or dizziness while on treatment with this medication.

• If you have or have had an aneurysm (enlargement and weakening of the wall of a blood vessel) or a tear in the wall of a blood vessel.

• If you have or have had microangiopathic hemolytic anemia (MAT) – damage to the smallest blood vessels.Contact your doctor if you experience fever, fatigue, swelling, bruising, bleeding, swelling, confusion, vision loss and seizures.

• If you have thyroid problems.This medication may cause thyroid problems. Contact your doctor if you feel tired more easily, are always colder than others or your voice becomes deeper while taking this medication. Your thyroid function should be monitored before starting treatment with this medication and periodically while on treatment. If your thyroid gland does not produce enough thyroid hormone, you may be treated with thyroid hormone replacement.

• If you have or have had pancreatic disorders or gallbladder problems.Contact your doctor if you develop any of the following signs and symptoms: stomach pain (upper abdominal area), nausea, vomiting and 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 and symptoms of liver problems during treatment with this medication: itching, yellow eyes or skin, dark urine and pain or discomfort in the upper right abdominal area. Your doctor should perform blood tests to monitor liver function before and during treatment with this medication, as well as when clinically indicated.

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

• If you are about to undergo surgery or have had a recent operation.This medication may affect wound healing. If you are about to undergo surgery, you will usually stop taking this medication. Your doctor will decide when to start taking this medication again.

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

• If you have or have had mouth pain, tooth or gum problems, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw, or if a tooth has moved, tell your doctor and dentist immediately.
• If you need invasive dental treatment or dental surgery, tell your dentist that you are taking this medication, particularly if you are also taking bisphosphonates by intravenous administration. Bisphosphonates are medications used to prevent bone complications that may occur due to another medical condition.

• If you have or have had skin and subcutaneous tissue disorders.During treatment with this medication, you may develop “pyoderma gangrenosum” (painful skin ulceration) or “necrotizing fasciitis” (infection of the skin/soft tissues that spreads quickly and can be fatal). Contact your doctor immediately if you experience symptoms 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. Cases of severe skin rash (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) have been reported, associated with the use of sunitinib, which initially appeared as red spots resembling targets or circular spots, often accompanied by central blisters on the trunk. This rash may progress to form widespread blisters or cause skin peeling, and may be life-threatening. Consult your doctor immediately if you develop a skin rash or the indicated skin symptoms.

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

• If you have diabetes.Your blood glucose levels should be regularly checked to assess whether your diabetes medication dose needs to be adjusted 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 and loss of consciousness).

Children and adolescents

This medication is not recommended for patients under 18 years of age.

Other medications and Sunitinib Viatris

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

Some medications may affect the levels of this medication in your body. You should inform your doctor if you are taking medications containing any of the following active ingredients:

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

Taking Sunitinib Viatris with food and drinks

Avoid taking grapefruit juice while on treatment with this medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

If you can become pregnant, you should use a reliable contraceptive method during treatment with this medication.

If you are breastfeeding, inform your doctor. You should not breastfeed your child during treatment with this medication.

Driving and operating machinery

If you experience dizziness or unusual fatigue, exercise special caution when driving or operating machinery.

Sunitinib Viatris contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

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

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

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

This medication can 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, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Sunitinib Viatris

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

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

You should contact your doctor immediately if you experience any of these serious side effects (see alsoWhat you need to know before starting to take Sunitinib Viatris):

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

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

Kidney problems.Consult your doctor if you experience a change 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 a severe bleeding problem during treatment with this medicine: stomach (abdomen) pain or swelling; vomit blood; have black, sticky stools; urinate blood; have a headache or any change in your mental state; cough up blood or have bloody sputum from the lungs or airways.

Tumor destruction causing a perforation in the intestine.Consult your doctor if you have severe abdominal pain, fever, nausea, vomiting, blood in stools, or changes in bowel habits.

Other side effects of Sunitinib Viatris may include:

Very common: may affect more than 1 in 10 people

• Reduction 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.
• Fast swelling of tissues caused by fluid under the skin and around the eye, severe allergic rash.
• Mouth pain/irritation, mouth sores/inflammation/dryness, taste disturbances, stomach discomfort, nausea, vomiting, diarrhea, constipation, abdominal pain/swelling, loss/decrease of appetite.
• Decreased activity of the thyroid gland (hypothyroidism).
• Dizziness.
• Headache.
• Nosebleeds.
• Back pain, joint pain.
• Pain in arms and legs.
• Yellow skin/skin discoloration, skin hyperpigmentation, hair color change, skin rash on palms of hands and soles of feet, rash, dry skin.
• Cough.
• Fever.
• Difficulty falling asleep.

Common: may affect up to 1 in 10 people

• Blood clots in blood vessels.
• Lack of blood flow to the heart muscle due to blockage or constriction of coronary arteries.
• Chest pain.
• Decreased amount of blood pumped by the heart.
• Fluid retention including around the lungs.
• Infections.
• Complication of a severe infection (the infection is present in the bloodstream) that can cause tissue damage, organ failure, and death.
• Low blood sugar (see section2).
• Protein loss in urine that can cause swelling.
• Pharyngitis-like syndrome.
• Alteration of blood tests including pancreatic and liver enzymes.
• High levels of uric acid in blood.
• Haemorrhoids, abdominal pain, gingival bleeding, difficulty swallowing or inability to swallow.
• Burning sensation or pain in the tongue, inflammation of the digestive tract lining, excessive gas in the stomach or intestine.
• Weight loss.
• Musculoskeletal pain (pain in muscles and bones), weakness, muscle fatigue, muscle pain, muscle spasms.
• Runny nose, nasal congestion.
• Excessive tear production.
• Abnormal skin sensation, itching, scaly and inflamed skin, blisters, acne, nail color change, hair loss.
• Abnormal sensation in extremities.
• Abnormally decreased/increased sensitivity, especially to touch.
• Stomach burning.
• Dehydration.
• Hot flashes.
• Abnormal urine color.
• Depression.
• Chills.

Uncommon: may affect up to 1 in 100 people

• Potentially fatal soft tissue infection, including the anogenital region (see section2).
• Cerebrovascular accident.
• Myocardial infarction caused by interruption or reduction of blood flow to the heart.
• Abnormal heart rhythm or arrhythmia.
• Fluid around the heart (pericardial effusion).
• Liver insufficiency.
• Abdominal pain caused by pancreatitis inflammation.
• Tumor destruction causing a perforation in the intestine.
• Bile duct inflammation, associated or not with gallstones.
• Abnormal tube formation as if it were a conduit from a normal body cavity to another body cavity or to the skin.
• Mouth pain, tooth and/or jaw pain, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw, or feeling like a tooth is loose. All of these may be signs and symptoms of jaw bone damage (osteonecrosis), see section2.
• Overproduction of thyroid hormones that increase the amount of energy the body consumes at rest.
• Problems with wound healing after surgery.
• High levels of a muscle enzyme (creatine phosphokinase) in blood.
• Excessive reaction to an allergen, including pollen allergy, skin rash, itching, urticaria, swelling of body parts, and difficulty breathing.
• Colitis, ischemic colitis.

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

• Severe skin and/or mucous membrane reaction (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme).
• Tumor lysis syndrome (TLS) – TLS includes a series of metabolic complications that can occur during cancer treatment. These complications are caused by the products released by dying cancer cells and may include: nausea, shortness of breath, irregular heartbeat, muscle cramps, seizures, dark urine, and fatigue, associated with abnormal laboratory test results (high levels of potassium, uric acid, and phosphorus, and low levels of calcium in blood) that can lead to kidney function changes and acute kidney failure.
• Abnormal muscle breakdown that can lead to kidney problems (rhabdomyolysis).
• Abnormal changes in the brain that can cause a series of symptoms that include headache, confusion, seizures, and vision loss (posterior reversible encephalopathy syndrome).
• Painful skin ulceration (pyoderma gangrenosum).
• Liver inflammation (hepatitis).
• Thyroid gland inflammation.
• Damage to small blood vessels known as microangiopathic thrombosis (MAT).

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

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box, bottle, and blister pack after CAD or EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

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

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Sunitinib Viatris

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

The other components are:

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

Appearance of the product and packaging content

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

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

Only some packaging sizes may be marketed.

Marketing authorization holder::

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible for manufacturing:

Remedica Ltd.

Aharnon Street, Limassol Industrial Estate

3056 Limassol

Cyprus

or

Pharmacare Premium Ltd.

HHF003 Hal Far Industrial Estate

Birzebbugia, BBG3000

Malta

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Last revision date of this leaflet:September 2024

More detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)https://www.aemps.gob.es/