Sunitinib Vipharm

Package Leaflet: Information for the User

Sunitinib Vipharm, 12.5 mg, hard capsules

Sunitinib Vipharm, 25 mg, hard capsules

Sunitinib Vipharm, 50 mg, hard capsules

Sunitinib

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

• Keep this package 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 others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor. See section 4.

Package Leaflet Contents

• 1. What is Sunitinib Vipharm and what is it used for
• 2. Important information before taking Sunitinib Vipharm
• 3. How to take Sunitinib Vipharm
• 4. Possible side effects
• 5. How to store Sunitinib Vipharm
• 6. Package contents and other information

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

Sunitinib Vipharm contains the active substance sunitinib, which is a protein kinase inhibitor. Sunitinib Vipharm is used to treat cancer. It works by blocking the activity of a specific group of proteins that are involved in the growth and spread of cancer cells.
Sunitinib Vipharm 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 cancer medicine) 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, which are in an advanced stage and cannot be removed by surgery.

If you have any questions about how Sunitinib Vipharm works or why it has been prescribed for you, ask your doctor.

2. Important information before taking Sunitinib Vipharm

When not to take Sunitinib Vipharm

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

Warnings and precautions

Before taking Sunitinib Vipharm, discuss with your doctor:

• If you have high blood pressure. Sunitinib Vipharm may increase your blood pressure. Your doctor may check your blood pressure during treatment with Sunitinib Vipharm, and you may need to take medicines to lower your blood pressure.
• If you have or have had blood disorders, bleeding, or blood clots. Treatment with Sunitinib Vipharm 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 medicines used to prevent blood clots, there may be a higher risk of bleeding. Tell your doctor about any bleeding during treatment with Sunitinib Vipharm.
• If you have heart problems. Sunitinib Vipharm may cause heart problems. Tell your doctor if you experience extreme tiredness, shortness of breath, or swelling of your feet or ankles.
• If you have irregular heart rhythms. Sunitinib Vipharm may cause irregular heart rhythms. During treatment with Sunitinib Vipharm, your doctor may perform an electrocardiogram to assess these irregularities. Tell your doctor if you experience dizziness, fainting, or irregular heart rhythms while taking Sunitinib Vipharm.
• If you have recently had blood clots in your 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 Sunitinib Vipharm.
• 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 (microangiopathic hemolytic anemia). Tell your doctor if you experience fever, fatigue, weakness, bruising, bleeding, swelling, confusion, loss of vision, or seizures.
• If you have thyroid problems. Sunitinib Vipharm may cause thyroid problems. Tell your doctor if you experience extreme tiredness, feel colder than others, or have a hoarse voice while taking Sunitinib Vipharm. Your doctor should check your thyroid function before starting Sunitinib Vipharm and regularly during treatment. If your thyroid does not produce enough thyroid hormone, you may need to take replacement thyroid hormone.
• If you have or have had pancreas problems 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 problems while taking Sunitinib Vipharm: 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 your liver function before starting Sunitinib Vipharm, during treatment, and if you experience any symptoms.
• 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. Sunitinib Vipharm may affect wound healing. The medicine is usually stopped in patients before surgery. Your doctor will decide when to restart Sunitinib Vipharm.
• Dental examination before starting treatment with Sunitinib Vipharm is recommended:
• if you experience pain in your mouth, tooth, or jaw, swelling or ulceration of the mouth, numbness or heaviness of the jaw, or tooth mobility, inform your oncologist and dentist immediately.
• if you need invasive dental treatment or oral surgery, inform your dentist about taking Sunitinib Vipharm, especially if you are also taking or have taken bisphosphonates intravenously. Bisphosphonates are medicines used to prevent bone problems, which may be taken for another condition.
• If you have or have had skin and subcutaneous tissue disorders. While taking this medicine, you may experience pyoderma gangrenosum (painful skin ulcers) or necrotizing fasciitis (a rapidly spreading infection of the skin and/or soft tissues that can be life-threatening). Contact your doctor immediately if you experience signs of infection around a skin lesion, including fever, pain, redness, swelling, or discharge of pus or blood. These disorders usually resolve after stopping sunitinib treatment. While taking this medicine, severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) have been observed, which initially appear as reddened patches with a target-like shape or round patches, often with centrally located blisters. The rash may progress to 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 loss of vision.
• If you have diabetes. In patients with diabetes, blood sugar levels should be regularly checked to assess whether the dose of the anti-diabetic medicine 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, sweating, hunger, and loss of consciousness).

Children and adolescents

Sunitinib Vipharm is not recommended for use in children and adolescents under 18 years of age.

Sunitinib Vipharm 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.
Some medicines may affect the levels of Sunitinib Vipharm 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,
• products containing St. John's Wort ( Hypericum perforatum) - used to treat depression and anxiety disorders.

Taking Sunitinib Vipharm with food and drink

While taking Sunitinib Vipharm, do not drink grapefruit juice.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Women who may become pregnant should use effective contraception during treatment with Sunitinib Vipharm.
Women who are breastfeeding should inform their doctor. Do not breastfeed while taking Sunitinib Vipharm.

Driving and using machines

If you experience dizziness or extreme tiredness, be careful while driving or operating machinery.

Sunitinib Vipharm contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per capsule, which is essentially "sodium-free".

3. How to take Sunitinib Vipharm

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

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

Your doctor will determine the correct dose for you and whether and when to stop treatment with Sunitinib Vipharm.
Sunitinib Vipharm can be taken with or without food.

Taking more than the recommended dose of Sunitinib Vipharm

If you have taken more capsules than you should, contact your doctor immediately.
Medical attention may be necessary.

Missing a dose of Sunitinib Vipharm

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 serious side effects (see also Important information before taking Sunitinib Vipharm):
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 problems or breathing difficulties. 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 travel to the lungs.
Kidney problems. Tell your doctor if you experience changes in urination frequency or inability to urinate, which may be symptoms of kidney failure.
Bleeding. Tell your doctor if you experience any of the following symptoms or severe bleeding during treatment with Sunitinib Vipharm: 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 Sunitinib Vipharm may include:
Very common: may affect more than 1 in 10 people

• Decreased number of platelets, red blood cells, and/or white blood cells (e.g., neutrophils).
• Shortness of breath.
• High blood pressure.
• Extreme tiredness, 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 mucosa, taste disturbances, stomach upset, nausea, vomiting, diarrhea, constipation, abdominal pain and/or swelling, loss of appetite.
• Decreased thyroid function (hypothyroidism).
• Dizziness.
• Headache.
• Nosebleeds.
• Back pain, joint pain.
• Pain in arms and legs.
• Yellowing of the skin and/or discoloration, excessive skin pigmentation, 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 flow to the heart muscle 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.
• Decreased blood sugar levels (see section 2).
• Protein loss in the urine, sometimes causing swelling.
• Flu-like syndrome.
• Abnormal blood test results, including elevated liver and pancreas enzymes.
• High levels of uric acid in the blood.
• Hemorrhoids, anal pain, gum bleeding, difficulty swallowing, or loss of swallowing ability.
• Burning sensation or pain in the mouth, 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, nasal congestion, loss of smell.
• Excessive tearing.
• Skin sensitivity disorders, itching, peeling, and inflammation of the skin, blisters, acne, nail discoloration, hair loss.
• Sensitivity disorders in the 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 area around the anus and genital organs (see section 2).
• Stroke.
• Heart attack caused by interruption or reduction of blood flow to the heart.
• Changes in the electrical or rhythmic activity of the heart.
• Fluid accumulation around the heart (pericardial effusion).
• Liver failure.
• Abdominal pain caused by pancreatitis.
• Tumor lysis syndrome leading to intestinal perforation (perforation).
• Inflammation (swelling and redness) of the gallbladder with or without gallstones.
• Formation of abnormal connections between one body cavity and another or with the skin.
• Pain in the mouth, tooth, or jaw, 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, a group of metabolic complications that can occur during cancer treatment. These complications are caused by the breakdown products of dying cancer cells and may include: nausea, shortness of breath, irregular heartbeat, muscle cramps, seizures, cloudy urine, 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 damage and acute kidney failure.
• Abnormal muscle breakdown, which can cause kidney disease (rhabdomyolysis).
• Abnormal changes in the brain, which can cause a syndrome of symptoms including headache, confusion, seizures, and loss of vision (reversible posterior leukoencephalopathy syndrome).
• Painful skin ulcers (pyoderma gangrenosum).
• Hepatitis.
• Thyroiditis.
• Damaged smallest blood vessels (microangiopathic hemolytic anemia).

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

• Enlargement and weakening of the wall of a blood vessel or rupture 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 those not listed in this package leaflet, tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sunitinib Vipharm

• 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 bottle after EXP. The expiry date refers to the last day of that month.
• 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. These measures will help protect the environment.

6. Package contents and other information

What Sunitinib Vipharm contains

Sunitinib Vipharm 12.5 mg hard capsules

The active substance is sunitinib. Each capsule contains sunitinib malate equivalent to 12.5 mg of sunitinib. The other ingredients are:

• Capsule content:mannitol (E421), croscarmellose sodium, povidone (K-25), and magnesium stearate.
• Capsule shell:gelatin, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), and black iron oxide (E172).
• Printing ink:shellac, propylene glycol, sodium hydroxide, povidone, and titanium dioxide (E171).

Sunitinib Vipharm 25 mg hard capsules

The active substance is sunitinib. Each capsule contains sunitinib malate equivalent to 25 mg of sunitinib. The other ingredients are:

• Capsule content:mannitol, croscarmellose sodium, povidone (K-25), and magnesium stearate.
• Capsule shell:gelatin, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), and black iron oxide (E172).
• Printing ink:shellac, propylene glycol, sodium hydroxide, povidone, and titanium dioxide (E171).

Sunitinib Vipharm 50 mg hard capsules

The active substance is sunitinib. Each capsule contains sunitinib malate equivalent to 50 mg of sunitinib. The other ingredients are:

• Capsule content:mannitol, croscarmellose sodium, povidone (K-25), and magnesium stearate.
• Capsule shell:gelatin, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), and black iron oxide (E172).
• Printing ink:shellac, propylene glycol, sodium hydroxide, povidone, and titanium dioxide (E171).

What Sunitinib Vipharm looks like and contents of the pack

Sunitinib Vipharm 12.5 mg is available as hard gelatin capsules with a brown cap and brown body, with white ink printing "12.5 mg" on the cap, containing yellow to orange granules.
Sunitinib Vipharm 25 mg is available as hard gelatin capsules with a light brown cap and brown body, size 3, with white ink printing "25 mg" on the cap, containing yellow to orange granules.
Sunitinib Vipharm 50 mg is available as hard gelatin capsules with a light brown cap and light brown body, size 2, with white ink printing "50 mg" on the cap, containing yellow to orange granules.
HDPE bottle with HDPE cap in a cardboard box.
The pack contains 30 hard capsules.

Marketing authorization holder and manufacturer

Vipharm S.A.
ul. A. i F. Radziwiłłów 9
05-850 Ożarów Mazowiecki
tel.: +48 22 679 51 35
fax: +48 22 678 92 87
e-mail: vipharm@vipharm.com.pl

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

Hungary
Sunitinib Vipharm 12.5 mg hard capsules
Sunitinib Vipharm 25 mg hard capsules
Sunitinib Vipharm 50 mg hard capsules
Czech Republic
Sunitinib Vipharm
Poland
Sunitinib Vipharm
Slovakia
Sunitinib Vipharm 12.5 mg
Sunitinib Vipharm 25 mg
Sunitinib Vipharm 50 mg
Date of last revision of the package leaflet:21.08.2024