Sunitinib mylan

Package leaflet: Information for the user

Sunitynib Mylan, 12.5 mg, hard capsules
Sunitynib Mylan, 25 mg, hard capsules
Sunitynib Mylan, 37.5 mg, hard capsules
Sunitynib Mylan, 50 mg, hard capsules
Sunitinib
Please read all of this leaflet carefully before 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. Do not pass it on to other people. 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. See section 4.

Contents of the leaflet

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

1. What Sunitynib Mylan is and what it is used for

Sunitynib Mylan contains sunitinib as the active substance, which is a protein kinase inhibitor.
Sunitynib Mylan is used in the treatment of cancers. It inhibits the activity of a specific group of proteins
known to be involved in the growth and spread of cancer cells.
Sunitynib Mylan is used in the treatment of the following types of cancer in adults:

• Gastrointestinal stromal tumours (GIST), a type of stomach and intestinal tumour, when imatinib (another anticancer medicine) is no longer effective 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 arising from hormone-producing cells in the pancreas), which are progressing and cannot be surgically removed.

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

2. Important information before taking Sunitynib Mylan

When not to take Sunitynib Mylan

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

Warnings and precautions
Before starting treatment with Sunitynib Mylan, discuss the following with your doctor:

• If high blood pressure is present. Sunitynib Mylan may increase blood pressure. Your doctor may monitor your blood pressure during treatment with Sunitynib Mylan, and you may require treatment with antihypertensive medications if necessary.
• If there are or have been in the past blood disorders, bleeding or bruising. Treatment with Sunitynib Mylan may increase the risk of bleeding or may alter the number of certain blood cells, potentially causing anemia or affecting the blood’s ability to clot. If you are taking warfarin or acenocoumarol—anticoagulant drugs used to prevent blood clots—the risk of bleeding may be higher. Inform your doctor about any bleeding episodes during treatment with Sunitynib Mylan.
• If there are heart problems. Sunitynib Mylan may cause heart-related issues. Inform your doctor if you experience unusual fatigue, shortness of breath, or swelling in your feet or ankles.
• If there are heart rhythm disorders. Sunitynib Mylan may cause irregular heart rhythms. Your doctor may perform an electrocardiogram (ECG) during treatment to monitor for such disturbances. Inform your doctor if you experience dizziness, fainting, or irregular heartbeat while taking Sunitynib Mylan.
• If there have recently been problems with blood clots in veins and/or arteries (types of blood vessels), including stroke, heart attack, embolism, or thrombosis. Contact your doctor immediately if, during treatment with Sunitynib Mylan, you experience symptoms such as chest pain or tightness, pain in arms, back, neck, or jaw, shortness of breath, numbness or weakness on one side of the body, difficulty speaking, headache, or dizziness.
• If you have or have previously 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 previously had damage to the smallest blood vessels known as thrombotic microangiopathy. Inform your doctor if you develop fever, fatigue, weakness, bruising, bleeding, swelling, confusion, vision loss, or seizures.
• If you have thyroid gland problems. Sunitynib Mylan may cause thyroid dysfunction. Inform your doctor if you feel unusually tired, feel colder than others, or experience voice changes during treatment with Sunitynib Mylan. Your doctor should check thyroid function before starting treatment with Sunitynib Mylan and regularly during treatment. If your thyroid does not produce enough thyroid hormone, you may require thyroid hormone replacement therapy.
• If you have or have previously had pancreas or gallbladder problems. Inform your doctor if you experience any of the following symptoms: stomach pain (upper abdomen), nausea, vomiting, or fever. These may be signs of pancreatitis or cholecystitis.
• If you have or have previously had liver problems. Inform your doctor if, during treatment with Sunitynib Mylan, you experience any of the following signs of liver dysfunction: itching, yellowing of the eyes or skin (jaundice), dark urine, or pain or discomfort in the right upper abdomen. Your doctor should order blood tests to monitor liver function before starting treatment with Sunitynib Mylan, during treatment, and if clinically indicated.
• If you have or have previously had kidney problems. Your doctor will monitor kidney function.
• If you are scheduled for surgery or have recently undergone surgery. Sunitynib Mylan may affect wound healing. The medicine is usually discontinued before surgery. Your doctor will decide when to restart Sunitynib Mylan.
• Patients are advised to have a dental examination before starting treatment with Sunitynib Mylan:
• if you experience oral pain, tooth or jaw pain, swelling or ulceration in the mouth, numbness or heaviness in the jaw, or loose teeth, inform your oncologist and dentist immediately.
• if you require invasive dental treatment or oral surgery, inform your dentist that you are taking Sunitynib Mylan, especially if you are also taking or have previously taken intravenous bisphosphonates. Bisphosphonates are medications used to prevent bone problems, which may be taken for other conditions.
• If you have or have previously had skin and subcutaneous tissue disorders. While taking this medicine, pyoderma gangrenosum (painful skin ulceration) or necrotizing fasciitis (a rapidly spreading and potentially life-threatening skin and/or soft tissue infection) may occur. Contact your doctor immediately if you develop signs of infection around a skin lesion, including fever, pain, redness, swelling, or discharge of pus or blood. These conditions usually resolve after discontinuation of Sunitynib Mylan. Severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) have been observed during treatment, which initially appear as red, target-shaped or circular spots, often with central blisters. The rash may progress to widespread blistering or skin peeling and may be life-threatening. If you develop a rash or any of the above-mentioned skin symptoms, contact your doctor immediately.
• If you have or have previously had seizures. Inform your doctor as soon as possible if you develop high blood pressure, headache, or vision loss.
• If you have diabetes. Blood glucose levels should be monitored regularly in diabetic patients to assess whether adjustment of antidiabetic medication is needed to minimize the risk of hypoglycemia. Inform your doctor promptly if you experience symptoms of low blood sugar (fatigue, palpitations, excessive sweating, hunger, or loss of consciousness).

Children and adolescents
Sunitynib Mylan is not recommended for patients under 18 years of age.

Sunitynib Mylan and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those obtained without a prescription, as well as any medicines you plan to take.
Some medicines may affect the concentration of Sunitynib Mylan in the body. 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 infection,
• dexamethasone – a corticosteroid used in various conditions (such as allergic and/or respiratory disorders or skin diseases),
• phenytoin, carbamazepine, phenobarbital – used to treat epilepsy and other neurological conditions,
• herbal remedies containing St. John’s wort (Hypericum perforatum) – used to treat depression and anxiety.

Taking Sunitynib Mylan with food and drink
Do not drink grapefruit juice while taking Sunitynib Mylan.

Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Women of childbearing potential should use an effective method of contraception during treatment with Sunitynib Mylan.
Women who are breastfeeding should inform their doctor. Breastfeeding is not recommended during treatment with Sunitynib Mylan.

Driving and using machines
Exercise caution when driving or operating machinery if you experience dizziness or significant fatigue.

Sunitynib Mylan contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, meaning it is considered "sodium-free."

3. How to take Sunitynib Mylan

This medicine should always be taken exactly as prescribed by the doctor. If in doubt,
consult the doctor.
The doctor will prescribe the dose appropriate for the individual patient, depending on the type of tumour.
For patients being treated for:

• GIST or MRCC, the usual dose is 50 mg taken once daily for 28 days (4 weeks), followed by a 14-day (2-week) treatment-free period (without medication), in 6-week treatment cycles.
• pNET, the usual dose is 37.5 mg taken once daily continuously.

The doctor will determine the appropriate dose for the individual patient and the time to stop treatment
with Sunitynib Mylan.
Sunitynib Mylan may be taken with or without food.
Taking more Sunitynib Mylan than prescribed
If too many capsules have been taken, contact the doctor immediately.
Emergency medical attention may be required.
Missing a dose of Sunitynib Mylan
Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although they do not occur in everyone.
Contact your doctor immediately if the patient experiences any of the following adverse reactions (see also Important information before taking Sunitynib Mylan):
Heart problems. Tell the doctor if the patient feels very tired, has shortness of breath, or swelling in the feet and ankles. These may be symptoms of heart problems, which may include heart failure and problems with the heart muscle (cardiomyopathy).
Lung or breathing problems. Tell the doctor if the patient develops cough, chest pain, sudden shortness of breath, or coughs up blood. These may be symptoms of a condition called pulmonary embolism, which occurs when blood clots travel to the lungs.
Kidney function disorders. Tell the doctor if the patient experiences changes in frequency or absence of urination, which may be signs of kidney failure.
Bleeding. Tell the doctor if the patient experiences any of the following symptoms or severe bleeding while taking Sunitynib Mylan: stomach (abdominal) pain and swelling; vomiting blood; black, tarry stools; blood in the urine; headache or changes in consciousness; coughing up blood or bloody sputum from the lungs or airways.
Tumour rupture leading to intestinal perforation. Tell the doctor if the patient experiences severe abdominal pain, fever, nausea, vomiting, blood in the stool, or changes in bowel function.

Other adverse reactions with Sunitynib Mylan may include:

Very common: may occur in more than 1 in 10 people

• Decreased number of platelets, red blood cells, and (or) white blood cells (e.g. neutrophils).
• Shortness of breath.
• Hypertension.
• Severe fatigue, loss of strength.
• Swelling due to fluid accumulation under the skin and around the eyes, deep allergic rash.
• Pain and (or) irritation in the mouth, painful ulceration and (or) inflammation, and (or) dryness of the mouth, taste disturbances, gastric disturbances, nausea, vomiting, diarrhoea, constipation, abdominal pain and (or) swelling, loss of and (or) reduced appetite.
• Decreased thyroid activity (hypothyroidism).
• Dizziness.
• Headache.
• Nosebleeds.
• Back pain, joint pain.
• Pain in arms and legs.
• Yellowing of the skin and (or) skin discoloration, excessive skin pigmentation, hair color changes, rash on palms and soles, rash, dry skin.
• Cough.
• Fever.
• Difficulty sleeping.

Common: may occur in no more than 1 in 10 people

• Blood clots in blood vessels.
• Inadequate blood supply to the heart due to blockage or narrowing of the coronary arteries.
• Chest pain.
• Reduced amount of blood pumped by the heart.
• Fluid retention, including in the lung area.
• Infections.
• Complication following a severe infection (blood infection), which may lead to tissue damage, organ failure, and death.
• Low blood sugar levels (see section 2).
• Protein loss in urine, sometimes causing swelling.
• Flu-like syndrome.
• Abnormal blood test results, including pancreatic and liver enzymes.
• High levels of uric acid in the blood.
• Haemorrhoids, rectal pain, gum bleeding, difficulty swallowing or loss of swallowing ability.
• Burning or painful sensation of the tongue, inflammation of the mucous membrane of the gastrointestinal tract, excessive gas in the stomach or intestines.
• Weight loss.
• Musculoskeletal pain (muscle and bone pain), muscle weakness, muscle fatigue, muscle pain, muscle cramps.
• Dryness of the nasal mucous membrane, sensation of nasal congestion.
• Excessive tearing.
• Skin sensory disturbances, itching, skin peeling and inflammation, blisters, acne, nail discoloration, hair loss.
• Sensory disturbances in the limbs.
• Disorders related to increased or decreased sensitivity, especially to touch.
• Heartburn.
• Dehydration.
• Hot flushes.
• Abnormal urine color.
• Depression.
• Chills.

Uncommon: may occur in no more than 1 in 100 people

• Life-threatening soft tissue infections, including the anogenital area (see section 2).
• Stroke.
• Myocardial infarction caused by interruption or reduction of blood supply to the heart.
• Changes in electrical function or heart rhythm disturbances.
• Presence of fluid around the heart (pericardial effusion).
• Liver failure.
• Abdominal (stomach) pain due to inflammation of the pancreas.
• Tumour rupture leading to intestinal perforation.
• Inflammation (swelling or redness) of the gallbladder with or without gallstones.
• Formation of abnormal connections between one body cavity and another or to the skin.
• Mouth pain, tooth and (or) jaw pain, swelling or ulceration of the mouth, numbness or heaviness in the jaw, or loose teeth. These may be symptoms of jaw bone damage (osteonecrosis), see section 2.
• Excessive production of thyroid hormones leading to increased resting metabolism.
• Impaired healing of surgical wounds.
• Increased activity of muscle enzyme (creatine phosphokinase) in the blood.
• Excessive reaction to allergens, including hay fever, skin rash, itching, urticaria, swelling of any body part, and breathing difficulties.
• Inflammatory condition of the large intestine (colitis, ischemic colitis).

Rare: may occur in no more than 1 in 1000 people

• Severe reaction affecting the skin and (or) mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme).
• Tumour lysis syndrome, a group of metabolic complications that may occur during cancer treatment. These complications are caused by the breakdown products of dying tumour cells and may include: nausea, shortness of breath, irregular heartbeat, muscle spasms, seizures, cloudy urine, and fatigue associated with abnormal laboratory test results (high levels of potassium, uric acid, and phosphate, and low levels of calcium in the blood), which may lead to kidney changes and acute kidney failure.
• Abnormal muscle breakdown which may cause kidney disease (rhabdomyolysis).
• Abnormal changes in the brain which may cause a syndrome of symptoms including headache, confusion, seizures, and vision loss (reversible posterior leukoencephalopathy syndrome).
• Painful skin ulceration (pyoderma gangrenosum).
• Hepatitis.
• Inflammation of the thyroid gland.
• Damage to the smallest blood vessels called thrombotic microangiopathy.

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

• Enlargement and weakening of the blood vessel wall or blood vessel wall tear (aneurysm and arterial dissection).
• Lack of energy, confusion, drowsiness, loss of consciousness, or coma – these symptoms may indicate toxic effects of high blood ammonia levels on the brain (hyperammonaemic encephalopathy).

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: 22 49-21-301
Fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder or its representative. By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Sunitynib Mylan

• 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: Expiry (EXP). The expiry date refers to the last day of the stated month.
• No special storage conditions are required for this medicine.
• Do not use this medicine if you notice that the packaging is damaged or shows signs of prior opening.

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 Sunitynib Mylan contains

• The active substance is sunitinib.

Sunitynib Mylan 12.5 mg, hard capsules
Each capsule contains 12.5 mg of sunitinib.
Sunitynib Mylan 25 mg, hard capsules
Each capsule contains 25 mg of sunitinib.
Sunitynib Mylan 37.5 mg, hard capsules
Each capsule contains 37.5 mg of sunitinib.
Sunitynib Mylan 50 mg, hard capsules
Each capsule contains 50 mg of sunitinib.

• Other ingredients are:
  Capsule contents: Microcrystalline cellulose, mannitol, sodium croscarmellose (see section 2 Sunitynib Mylan contains sodium), povidone K30, magnesium stearate.

Sunitynib Mylan 12.5 mg, hard capsules

• Capsule shell: Iron oxide red (E172), titanium dioxide (E171), gelatin.
• Printing ink (white): Shellac, titanium dioxide (E171), propylene glycol.

Sunitynib Mylan 25 mg, hard capsules

• Capsule shell: Iron oxide black (E172), iron oxide red (E172), iron oxide yellow (E172), titanium dioxide (E171), gelatin.
• Printing ink (white): Shellac, titanium dioxide (E171), propylene glycol.

Sunitynib Mylan 37.5 mg, hard capsules

• Capsule shell: Iron oxide yellow (E172), titanium dioxide (E171), gelatin.
• Printing ink (black): Shellac, iron oxide black (E172), propylene glycol, ammonium hydroxide.

Sunitynib Mylan 50 mg, hard capsules

• Capsule shell: Iron oxide black (E172), iron oxide red (E172), iron oxide yellow (E172), titanium dioxide (E171), gelatin.
• Printing ink (white): Shellac, titanium dioxide (E171), propylene glycol.

What Sunitynib Mylan looks like and contents of the pack
Sunitynib Mylan 12.5 mg, hard capsules
Orange cap and orange body, size 4 gelatin capsules, printed in white ink with "12.5 mg" on the body, containing granules of yellow to orange colour.
Sunitynib Mylan 25 mg, hard capsules
Caramel cap and orange body, size 3 gelatin capsules, printed in white ink with "25 mg" on the body, containing granules of yellow to orange colour.
Sunitynib Mylan 37.5 mg, hard capsules
Yellow cap and yellow body, size 2 gelatin capsules, printed in black ink with "37.5 mg" on the body, containing granules of yellow to orange colour.
Sunitynib Mylan 50 mg, hard capsules
Caramel cap and caramel body, size 1 gelatin capsules, printed in white ink with "50 mg" on the body, containing granules of yellow to orange colour.
Sunitynib Mylan hard capsules are available in blister packs containing 28 hard capsules, in perforated unit dose blisters containing 28 x 1 hard capsules, in perforated unit dose blisters containing 30 x 1 hard capsules, and in plastic bottles containing 30 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Mylan Ireland Limited
Unit 35/36 Grange Parade
Baldoyle Industrial Estate, Dublin 13
Ireland

Manufacturer
Remedica Ltd
Aharnon Street, Limassol Industrial Estate
3056 Limassol
Cyprus
Pharmacare Premium Ltd
HHF003 Hal Far Industrial Estate
BBG3000 Birzebbugia
Malta

For further information, please contact the Marketing Authorisation Holder:
Viatris Healthcare Sp. z o.o.
Tel.: +48 22 546 64 00