Sunitinib Milan

Leaflet attached to the packaging: 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

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor. See section 4.

Table of contents of the leaflet

• 1. What is Sunitynib Mylan and what is it used for
• 2. Important information before taking 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 is Sunitynib Mylan and what is it used for

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

• Gastrointestinal stromal tumor (GIST), a type of stomach and intestine cancer, when imatinib (another anticancer drug) has stopped working or the patient cannot take it;
• Metastatic renal cell carcinoma (MRCC), a type of kidney cancer that has spread to other parts of the body;
• Pancreatic neuroendocrine tumors (pNET) (tumors that arise from hormone-producing cells in the pancreas) that are progressing and cannot be surgically removed.

If you have any questions about how Sunitynib Mylan works or why it has been prescribed, ask 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 Sunitynib Mylan, discuss with your doctor:

• If you have high blood pressure. Sunitynib Mylan may increase blood pressure. Your doctor may check your blood pressure during treatment with Sunitynib Mylan, and you may need to be treated with blood pressure-lowering medications.
• If you have or have had blood disorders, bleeding, or bruising. Treatment with Sunitynib Mylan may increase the risk of bleeding or changes in the number of certain blood cells, which can cause anemia or affect the blood's ability to clot. If you are taking warfarin or acenocoumarol, blood-thinning medications used to prevent blood clots, you may be at increased risk of bleeding. Tell your doctor about any bleeding during treatment with Sunitynib Mylan.
• If you have heart problems. Sunitynib Mylan may cause heart problems. Tell your doctor if you experience extreme fatigue, shortness of breath, or swelling of your feet or ankles.
• If you have heart rhythm disorders. Sunitynib Mylan may cause abnormal heart rhythms. During treatment with Sunitynib Mylan, your doctor may perform an electrocardiogram to assess these disorders. Tell your doctor if you experience dizziness, fainting, or abnormal heart rhythms while taking Sunitynib Mylan.
• If you have recently had problems with blood clots in the 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 tightness, arm, back, neck, or jaw pain, shortness of breath, numbness or weakness on one side of the body, difficulty speaking, headache, or dizziness while taking Sunitynib Mylan.
• 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 damage to the smallest blood vessels called thrombotic microangiopathy. Tell your doctor if you experience fever, fatigue, weakness, bruising, bleeding, swelling, confusion, loss of vision, or seizures.
• If you have thyroid problems. Sunitynib Mylan may cause thyroid problems. Tell your doctor if you easily get tired, feel colder than others, or experience a deepened voice while taking Sunitynib Mylan. Your doctor should check your thyroid function before starting Sunitynib Mylan and regularly during treatment. If your thyroid does not produce enough thyroid hormone, you may need to be treated with replacement thyroid hormone.
• If you have or have had pancreas or gallbladder problems. Tell your doctor if you experience any of the following symptoms: stomach pain (upper abdomen), nausea, vomiting, and fever. These may be symptoms of pancreatitis or gallbladder inflammation.
• If you have or have had liver problems. Inform your doctor if you experience any of the following symptoms of liver disorders: itching, yellowing of the eyes or skin, dark urine, and pain or discomfort in the right upper abdomen. Your doctor should perform blood tests to check liver function before starting Sunitynib Mylan, during treatment, and if there are clinical signs.
• If you have or have had kidney problems. Your doctor will monitor your kidney function.
• If you are going to have surgery or have recently had surgery. Sunitynib Mylan may affect wound healing. The medicine is usually stopped in patients before surgery. Your doctor will decide when to restart Sunitynib Mylan.
• Dental examination is recommended before starting treatment with Sunitynib Mylan:
• -if you experience mouth pain, toothache, and/or jaw pain, swelling or ulceration of the mouth, numbness or heaviness of the jaw, or tooth mobility, inform your oncologist and dentist immediately.
• -if you require invasive dental treatment or oral surgery, inform your dentist about taking Sunitynib Mylan, especially if you are also taking or have taken intravenous bisphosphonates. Bisphosphonates are medications used to prevent bone problems, which may be taken for another condition.
• If you have or have had skin and subcutaneous tissue disorders. During treatment with this medicine, pyoderma gangrenosum (painful skin ulcers) or necrotizing fasciitis (a rapidly spreading infection of the skin and/or soft tissues that can be life-threatening) may occur. Contact your doctor immediately if you experience symptoms of infection around skin damage, including fever, pain, redness, swelling, or discharge of pus or blood. These disorders usually resolve after stopping treatment with Sunitynib Mylan. Severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) have been observed during treatment with this medicine, which initially appear as reddened patches with a target-like shape or round patches, often with centrally located blisters. The rash can transform into widespread blisters or peeling of the skin and can be life-threatening. If you experience a rash or the above-mentioned skin symptoms, contact your doctor immediately.
• If you have or have had seizures. Inform your doctor as soon as possible if you experience high blood pressure, headache, or vision loss.
• If you have diabetes. In patients with diabetes, blood sugar levels should be regularly checked to assess whether the dose of the antidiabetic medication needs to be adjusted to minimize the risk of low blood sugar. Inform your doctor as soon as possible if you experience symptoms of low blood sugar (fatigue, palpitations, excessive sweating, hunger, and loss of consciousness).

Children and adolescents

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

Sunitynib Mylan and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those obtained without a prescription, as well as any medicines you plan to take.
Some medicines may affect the levels of Sunitynib Mylan in your body. Inform your doctor if you are taking medicines containing the following active substances:

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

Taking Sunitynib Mylan with food and drink

Do not drink grapefruit juice while taking Sunitynib Mylan.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Women who may become pregnant should use effective contraception during treatment with Sunitynib Mylan.
Women who are breastfeeding should inform their doctor. Do not breastfeed while taking Sunitynib Mylan.

Driving and using machines

If you experience dizziness or extreme fatigue, be careful when driving or operating machinery.

Sunitynib Mylan contains sodium

This medicine contains less than 1mmol sodium (23mg) per dose, which means it is essentially 'sodium-free'.

3. How to take Sunitynib Mylan

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor.
Your doctor will prescribe the dose that is right for you, depending on the type of cancer.
For patients being treated for:

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

Your doctor will determine the appropriate dose for you and when to stop taking Sunitynib Mylan.
Sunitynib Mylan can be taken with or without food.

Taking more Sunitynib Mylan than prescribed

If you have taken too many capsules, contact your doctor immediately. You may need urgent medical attention.

Missing a dose of Sunitynib Mylan

Do not take a double dose to make up for a forgotten dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately if you experience any of the following side effects (see also Important information before taking Sunitynib Mylan):
Heart problems. Tell your doctor if you feel extremely tired, have shortness of breath, or swelling of your feet and ankles. These may be symptoms of heart problems, including heart failure and problems with the heart muscle (cardiomyopathy).
Lung or breathing problems. Tell your doctor if you experience coughing, chest pain, sudden shortness of breath, or coughing up blood. These may be symptoms of a condition called pulmonary embolism, which occurs when blood clots move to the lungs.
Kidney problems. Tell your doctor if you experience changes in urination or lack of urination, which may be a sign of kidney failure.
Bleeding. Tell your doctor if you experience any of the following symptoms or severe bleeding during treatment with Sunitynib Mylan: stomach pain and swelling (abdomen); vomiting blood; black and tarry stools; blood in urine; headache or changes in consciousness; coughing up blood or bloody sputum from the lungs or airways.
Tumor lysis syndrome leading to intestinal perforation. Tell your doctor if you experience severe stomach pain, fever, nausea, vomiting, blood in stool, or changes in bowel movements.
Other side effects of Sunitynib Mylan may include:
Very common: may affect more than 1 in 10 people

• Decreased platelet count, red blood cells, and/or white blood cells (e.g., neutrophils).
• Shortness of breath.
• High blood pressure.
• Extreme fatigue, loss of strength.
• Swelling caused by fluid accumulation under the skin and around the eyes, allergic rash, deep.
• Pain and/or irritation in the mouth, painful ulcers and/or inflammation, and/or dryness of the mouth, taste disturbances, stomach upset, nausea, vomiting, diarrhea, constipation, abdominal pain and/or swelling, loss of appetite.
• Decreased thyroid activity (hypothyroidism).
• Dizziness.
• Headache.
• Nosebleeds.
• Back pain, joint pain.
• Pain in arms and legs.
• Yellowing of the skin and/or discoloration, excessive pigmentation of the skin, hair color changes, palmar-plantar erythrodysesthesia, rash, dry skin.
• Cough.
• Fever.
• Sleep disturbances.

Common: may affect up to 1 in 10 people

• Blood clots in blood vessels.
• Insufficient blood supply to the heart due to a blockage or narrowing of the coronary arteries.
• Chest pain.
• Decreased amount of blood pumped by the heart.
• Fluid accumulation, including in the lungs.
• Infections.
• A complication after a severe infection (sepsis), which can 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.
• Hemorrhoids, anal pain, gum bleeding, difficulty swallowing or loss of swallowing ability.
• Burning or painful tongue, inflammation of the mucous membrane of the digestive tract, excessive gas in the stomach or intestines.
• Weight loss.
• Musculoskeletal pain (muscle and bone pain), muscle weakness, muscle fatigue, muscle cramps.
• Dryness of the nasal mucosa, feeling of nasal congestion, excessive tearing.
• Disorders of skin sensation, itching, peeling and inflammation of the skin, blisters, acne, nail discoloration, hair loss.
• Disorders of sensation in limbs.
• Disorders related to increased or decreased sensitivity, especially to touch.
• Heartburn.
• Dehydration.
• Hot flashes.
• Abnormal urine color.
• Depression.
• Chills.

Uncommon: may affect up to 1 in 100 people

• Life-threatening infection of soft tissues, including the perineal area (see section 2).
• Stroke.
• Heart attack caused by interruption or reduction of blood supply to the heart.
• Changes in heart electrical activity or rhythm disorders.
• Fluid accumulation around the heart (pericardial effusion).
• Liver failure.
• Stomach pain (abdomen) caused by pancreatitis.
• Tumor lysis syndrome leading to intestinal perforation (perforation).
• Inflammation (swelling or redness) of the gallbladder with or without gallstones.
• Formation of abnormal connections between one body cavity and another or with the skin.
• Mouth pain, toothache, and/or jaw pain, swelling or ulceration of the mouth, numbness or heaviness of the jaw, or tooth mobility. These may be symptoms of jawbone damage (osteonecrosis), see section 2.
• Excessive production of thyroid hormones leading to increased resting metabolism.
• Impaired wound healing after surgery.
• Increased activity of the muscle enzyme (creatine phosphokinase) in the blood.
• Excessive allergic reaction, including fever, skin rash, itching, hives, swelling of any part of the body, and difficulty breathing.
• Inflammation of the large intestine (colitis, ischemic colitis).

Rare: may affect up to 1 in 1000 people

• Severe skin and mucous membrane reaction (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme).
• Tumor lysis syndrome, which is a group of metabolic complications that can occur during cancer treatment. These complications are caused by the breakdown products of dying cancer cells and can include nausea, shortness of breath, irregular heartbeat, muscle cramps, seizures, lack of urine clarity, and fatigue associated with abnormal laboratory test results (high levels of potassium, uric acid, and phosphorus, and low levels of calcium in the blood), which can lead to kidney changes and acute kidney failure.
• Abnormal muscle breakdown, which can cause kidney disease (rhabdomyolysis).
• Abnormal brain changes, which can cause a syndrome of symptoms including headache, disorientation, seizures, and vision loss (reversible posterior leukoencephalopathy syndrome).
• Painful skin ulcers (pyoderma gangrenosum).
• Hepatitis.
• Thyroid inflammation.
• Damaged smallest blood vessels called thrombotic microangiopathy.

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

• Enlargement and weakening of the wall of a blood vessel or tear in the wall of a blood vessel (aneurysm and arterial dissection).
• Lack of energy, confusion, drowsiness, loss of consciousness, or coma - these symptoms may be a sign of the toxic effect of high ammonia levels in the blood on the brain (hyperammonemic encephalopathy).

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, tell your doctor. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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. Side effects can also be reported to the marketing authorization holder or its representative. By reporting side effects, you can help provide more information on the safety of this medicine.

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 EXP. The expiry date refers to the last day of the month stated.
• There are no special storage instructions for this medicine.
• Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This 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 content:microcrystalline cellulose, mannitol, sodium carmellose (see section 2 Sunitynib Mylan contains sodium), povidone K30, magnesium stearate

Sunitynib Mylan, 12.5 mg, hard capsules

• capsule shell:red iron oxide (E172), titanium dioxide (E171), gelatin.
• white printing ink:shellac, titanium dioxide (E171), propylene glycol.

Sunitynib Mylan, 25 mg, hard capsules

• capsule shell:black iron oxide (E172), red iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171), gelatin.
• white printing ink:shellac, titanium dioxide (E171), propylene glycol.

Sunitynib Mylan, 37.5 mg, hard capsules

• capsule shell:yellow iron oxide (E172), titanium dioxide (E171), gelatin.
• black printing ink:shellac, black iron oxide (E172), propylene glycol, ammonium hydroxide.

Sunitynib Mylan, 50 mg, hard capsules

• capsule shell:black iron oxide (E172), red iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171), gelatin.
• white printing ink:shellac, titanium dioxide (E171), propylene glycol.

What Sunitynib Mylan looks like and contents of the pack

Sunitynib Mylan, 12.5 mg, hard capsules
Orange capsules (size 4) with a white printing "12.5 mg" on the body, containing yellow to orange granules.
Sunitynib Mylan, 25 mg, hard capsules
Caramel capsules (size 3) with a white printing "25 mg" on the body, containing yellow to orange granules.
Sunitynib Mylan, 37.5 mg, hard capsules
Yellow capsules (size 2) with a black printing "37.5 mg" on the body, containing yellow to orange granules.
Sunitynib Mylan, 50 mg, hard capsules
Caramel capsules (size 1) with a white printing "50 mg" on the body, containing yellow to orange granules.
Sunitynib Mylan, hard capsules, are available in blisters 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 authorization 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
To obtain more detailed information, contact the representative of the marketing authorization holder:

Viatris Healthcare Sp. z o.o.

Tel.: +48 22 546 64 00
Date of last revision of the leaflet:September 2024