Sunitinib Vipharm

Leaflet accompanying the packaging: information for the user

Sunitinib Vipharm, 12.5 mg, hard capsules

Sunitinib Vipharm, 25 mg, hard capsules

Sunitinib Vipharm, 50 mg, hard capsules

Sunitinib

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should 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 as yours.
• 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 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. Contents of the packaging 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 inhibits the activity of a special group of proteins known to be involved in the growth and spread of cancer cells.
Sunitinib Vipharm is used to treat the following types of cancer in adults:

• Gastrointestinal stromal tumors (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, which are progressing and cannot be surgically removed.

If you have any questions about how Sunitinib Vipharm works or why it has been prescribed for you, you should consult 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 starting treatment with Sunitinib Vipharm, you should discuss it with your doctor:

• If you have high blood pressure. Sunitinib Vipharm may increase blood pressure. Your doctor may check your blood pressure during treatment with Sunitinib Vipharm, and you may need to be treated with blood pressure-lowering medicines.
• 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. You should tell your doctor about any bleeding during treatment with Sunitinib Vipharm.
• If you have heart disease. Sunitinib Vipharm may cause heart disease. You should tell your doctor if you experience extreme fatigue, shortness of breath, or swelling of the feet or ankles.
• If you have heart rhythm disorders. Sunitinib Vipharm may cause abnormal heart rhythm. During treatment with Sunitinib Vipharm, your doctor may perform an electrocardiogram to assess these disorders. You should tell your doctor if you experience dizziness, fainting, or abnormal heart rhythm during treatment with Sunitinib Vipharm.
• If you have recently had blood clots in the veins and/or arteries (types of blood vessels), including stroke, heart attack, embolism, or thrombosis. You should 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.
• 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. You should tell your doctor if you experience fever, fatigue, weakness, bruising, bleeding, swelling, confusion, loss of vision, or seizures.
• If you have thyroid disease. Sunitinib Vipharm may cause thyroid disease. You should tell your doctor if you easily get tired, feel colder than others, or experience a deepening of your voice during treatment with Sunitinib Vipharm. Your doctor should check your thyroid function before starting treatment with Sunitinib Vipharm 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 disorders of the pancreas or gallbladder. You should 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 disease. You should inform your doctor if you experience any of the following symptoms of liver dysfunction: itching, yellowing of the eyes or skin, dark urine, and pain or discomfort in the right upper abdomen. Your doctor should order blood tests to check liver function before starting treatment with Sunitinib Vipharm, during treatment, and if there are clinical signs.
• If you have or have had kidney disease. 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 discontinued in patients before surgery. Your doctor will decide when to restart Sunitinib Vipharm.
• A dental examination is recommended before starting treatment with Sunitinib Vipharm:
• if you experience pain in the mouth, toothache, and/or jaw pain, swelling, or ulceration of the mouth, numbness or a feeling of heaviness in the jaw, or tooth mobility, you should immediately inform your oncologist and dentist.
• if you require invasive dental treatment or need to undergo dental surgery, you should inform your dentist about taking Sunitinib Vipharm, especially if you are also taking or have taken intravenous bisphosphonates. Bisphosphonates are medicines used to prevent bone problems, which may be taken due to another disease.
• 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. You should 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 discontinuation of sunitinib treatment. During treatment with 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 can transform into extensive blisters or peeling of the skin and can be life-threatening. If you experience a rash or the above-mentioned skin symptoms, you should immediately consult your doctor.
• If you have or have had seizures. You should 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 it is necessary to adjust the dose of the anti-diabetic medicine to minimize the risk of hypoglycemia. You should inform your doctor as soon as possible if you experience symptoms related to low blood sugar (fatigue, palpitations, excessive sweating, hunger, and loss of consciousness).

Children and adolescents

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

Sunitinib Vipharm and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those that are available without a prescription, as well as any medicines you plan to take.
Some medicines may affect the level of Sunitinib Vipharm in your body. You should 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

During treatment with Sunitinib Vipharm, you should not drink grapefruit juice.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist 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. You should not breastfeed while taking Sunitinib Vipharm.

Driving and using machines

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

Sunitinib Vipharm contains sodium

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

3. How to take Sunitinib Vipharm

This medicine should always be taken exactly as prescribed by your doctor. If you are unsure, you should consult your doctor.
Your doctor will prescribe the appropriate dose for you, depending on the type of cancer.
In the case of 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 treatment cycles.
• pNET, the usual dose is 37.5 mg taken once a day continuously.

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

Taking a higher dose of Sunitinib Vipharm than recommended

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

Missing a dose of Sunitinib Vipharm

You should not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should contact your doctor immediately if you experience any of the following serious side effects (see also Important information before taking Sunitinib Vipharm):
Heart disease. You should tell your doctor if you feel extremely tired, have shortness of breath, or swelling of the feet and ankles. These may be symptoms of heart problems, which can include heart failure and problems with the heart muscle (cardiomyopathy).
Lung disease or breathing difficulties. You should 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 dysfunction. You should tell your doctor if you experience disturbed or absent urination, which may be a sign of kidney failure.
Bleeding. You should 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 the urine; headache or changes in consciousness; coughing up blood or bloody sputum from the lungs or airways.
Tumor lysis syndrome leading to intestinal perforation. You should tell your doctor if you experience severe abdominal pain, fever, nausea, vomiting, blood in the 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 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 mucous membranes of the mouth, taste disorders, stomach disorders, nausea, vomiting, diarrhea, constipation, abdominal pain and/or swelling, loss of and/or decreased appetite.
• Decreased thyroid function (hypothyroidism).
• Dizziness.
• Headache.
• Nosebleeds.
• Back pain, joint pain.
• Pain in the 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 disorders.

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.
• Pseudo-flu 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 sensation or pain in the 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, fatigue, muscle cramps.
• Dryness of the nasal mucous membranes, 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 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 rhythm 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, toothache, and/or jaw pain, swelling, or ulceration of the mouth, numbness or a feeling of heaviness in 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 surgical procedures.
• Increased activity of the muscle enzyme (creatine phosphokinase) in the blood.
• Excessive allergic reaction, including hay 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, clouding of the 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, disorientation, seizures, and loss of vision (reversible posterior leukoencephalopathy syndrome).
• Painful skin ulcers (pyoderma gangrenosum).
• Hepatitis.
• Thyroiditis.
• Damage to the 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 rupture of 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 this leaflet, you should 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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Sunitinib Vipharm

• The medicine should be stored out of 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 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 there are signs of previous attempts to open it.

Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Sunitinib Vipharm contains

Sunitinib Vipharm 12.5 mg hard capsules

The active substance of the medicine 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 of the medicine 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 of the medicine 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 in the form of hard gelatin capsules with a brown cap and brown body, with a white ink inscription "12.5 mg" on the cap, containing granules of yellow to orange color.
Sunitinib Vipharm 25 mg is available in the form of hard gelatin capsules with a light brown cap and brown body, size 3, with a white ink inscription "25 mg" on the cap, containing granules of yellow to orange color.
Sunitinib Vipharm 50 mg is available in the form of hard gelatin capsules with a light brown cap and light brown body, size 2, with a white ink inscription "50 mg" on the cap, containing granules of yellow to orange color.
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: [email protected]

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

Hungary
Sunitinib Vipharm 12.5 mg hard capsule
Sunitinib Vipharm 25 mg hard capsule
Sunitinib Vipharm 50 mg hard capsule
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 leaflet:21.08.2024