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
Sunitinibum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor. See section 4.

Table of contents

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

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

Sunitinib Vipharm contains sunitinib as the active substance, which is a protein kinase inhibitor. Sunitinib Vipharm is used in the treatment of certain cancers. It inhibits the activity of a specific group of proteins known to be involved in the growth and spread of cancer cells.
Sunitinib Vipharm 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 drug) 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), hormone-producing tumours of the pancreas, which are progressing and cannot be surgically removed.

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

2. Important information before taking Sunitinib Vipharm

When not to take Sunitinib Vipharm

• 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 Sunitinib Vipharm, discuss the following with your doctor:

• If the patient has high blood pressure. Sunitinib Vipharm may increase blood pressure. The doctor may monitor blood pressure during treatment with Sunitinib Vipharm, and the patient may require antihypertensive medication if necessary.
• If the patient has or has previously had blood disorders, bleeding or bruising. Treatment with Sunitinib Vipharm may increase the risk of bleeding or alter the number of certain blood cells, which may cause anaemia or affect the blood's ability to clot. If the patient is taking warfarin or acenocoumarol, anticoagulant medicines used to prevent blood clots, there may be an increased risk of bleeding. Inform the doctor about any bleeding episodes during treatment with Sunitinib Vipharm.
• If the patient has heart conditions. Sunitinib Vipharm may cause heart problems. Inform the doctor if the patient experiences extreme fatigue, shortness of breath, or swelling of the feet or ankles.
• If the patient has or has previously had heart rhythm disorders. Sunitinib Vipharm may cause irregular heart rhythms. During treatment with Sunitinib Vipharm, the doctor may perform an electrocardiogram (ECG) to assess these disturbances. Inform the doctor if the patient experiences dizziness, fainting, or irregular heartbeat during treatment with Sunitinib Vipharm.
• If the patient has recently had blood clots in veins and/or arteries (types of blood vessels), including stroke, heart attack, pulmonary embolism or thrombosis. Contact the doctor immediately if, during treatment with Sunitinib Vipharm, the patient experiences symptoms such as chest pain or pressure, 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 the patient has or has previously had an aneurysm (a bulge and weakening of a blood vessel wall) or arterial dissection.
• If the patient has or has previously had damage to the smallest blood vessels known as thrombotic microangiopathy. Inform the doctor if the patient develops fever, fatigue, weakness, bruising, bleeding, swelling, confusion, vision loss or seizures.
• If the patient has or has previously had thyroid disorders. Sunitinib Vipharm may cause thyroid problems. Inform the doctor if the patient feels unusually tired, feels colder than others, or experiences voice changes during treatment with Sunitinib Vipharm. The doctor should check thyroid function before starting treatment with Sunitinib Vipharm and regularly during treatment. If the thyroid gland does not produce enough thyroid hormone, the patient may require thyroid hormone replacement therapy.
• If the patient has or has previously had pancreatic or gallbladder disorders. Inform the doctor if the patient experiences any of the following symptoms: stomach pain (upper abdomen), nausea, vomiting or fever. These may be symptoms of pancreatitis or gallbladder inflammation.
• If the patient has or has previously had liver disease. Inform the doctor if, during treatment with Sunitinib Vipharm, the patient develops 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. The doctor should order blood tests to monitor liver function before starting treatment with Sunitinib Vipharm, during treatment, and whenever clinically indicated.
• If the patient has or has previously had kidney disease. The doctor will monitor kidney function.
• If the patient is scheduled for or has recently undergone surgery. Sunitinib Vipharm may affect wound healing. The medicine is usually discontinued before surgery. The doctor will decide when to restart Sunitinib Vipharm.
• The patient is advised to have a dental examination before starting treatment with Sunitinib Vipharm:
• if the patient experiences oral pain, tooth or jaw pain, swelling or ulceration of the mouth, numbness or heaviness in the jaw, or loose teeth, inform the oncologist and dentist immediately.
• if the patient requires invasive dental treatment or oral surgery, inform the dentist about taking Sunitinib Vipharm, especially if the patient is also taking or has previously taken intravenous bisphosphonates. Bisphosphonates are medicines used to prevent bone problems and may be taken for another condition.
• If the patient has or has previously had skin and subcutaneous tissue disorders. While taking this medicine, pyoderma gangrenosum (painful skin ulceration) or necrotizing fasciitis (rapidly spreading infection of the skin and/or soft tissues, which may be life-threatening) may occur. Contact the doctor immediately if the patient develops signs of infection around skin lesions, including fever, pain, redness, swelling, or discharge of pus or blood. These conditions usually resolve after discontinuation of sunitinib. 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 skin lesions, often with central blisters. The rash may progress to extensive blistering or skin peeling and may be life-threatening. If the patient develops a rash or any of the above skin symptoms, seek medical attention immediately.
• If the patient has or has previously had seizures. Inform the doctor as soon as possible if the patient develops high blood pressure, headache or vision loss.
• If the patient has diabetes. Blood glucose levels should be monitored regularly in diabetic patients to assess whether antidiabetic medication dosage adjustments are needed to minimize the risk of hypoglycaemia. Inform the doctor promptly if the patient experiences symptoms of low blood sugar (fatigue, palpitations, excessive sweating, hunger, or loss of consciousness).

Children and adolescents
Sunitinib Vipharm is not recommended for patients under 18 years of age.
Sunitinib Vipharm with other medicines
Inform the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including those obtained without a prescription, as well as any medicines the patient plans to take.
Some medicines may affect the concentration of Sunitinib Vipharm in the body. Inform the doctor if the patient is taking medicines containing 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 diseases (such as allergic and/or respiratory disorders or skin conditions),
• 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.

Taking Sunitinib Vipharm with food and drink
Do not drink grapefruit juice during treatment with Sunitinib Vipharm.
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Women of childbearing potential should use an effective method of contraception during treatment with Sunitinib Vipharm.
Breastfeeding women should inform their doctor. Breastfeeding is not recommended during treatment with Sunitinib Vipharm.
Driving and operating machinery
Exercise particular caution when driving or operating machinery if the patient experiences dizziness or significant fatigue.
Sunitinib Vipharm contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning it is considered "sodium-free".

3. How to take Sunitinib Vipharm

This medicine should always be taken exactly as directed by the doctor. In case of doubt,
consult the doctor.
The doctor will prescribe the appropriate dose 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 break (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 whether and when treatment with Sunitinib Vipharm should be discontinued.
Sunitinib Vipharm may be taken with or without food.
Taking more than the recommended dose of Sunitinib Vipharm
If too many capsules have been taken, contact the doctor immediately.
Medical assistance may be required.
Missing a dose of Sunitinib Vipharm
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 not everyone will experience them.
You should contact a doctor immediately if the patient experiences any of the following severe adverse
reactions (see also Important information before taking Sunitinib Vipharm):
Heart problems. Tell the doctor if the patient feels very tired, has shortness of breath, or swelling
of the feet and ankles. These may be symptoms of heart problems, which may include heart failure
and problems with the heart muscle (cardiomyopathy).
Lung diseases or breathing difficulties. 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 symptoms of kidney failure.
Bleeding. Tell the doctor if the patient experiences any of the following symptoms or severe
bleeding during treatment with Sunitinib Vipharm: 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 lysis 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 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.
• Hypertension.
• Extreme 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 oral mucosa, taste disturbances, gastric disturbances, nausea, vomiting, diarrhoea, constipation, abdominal pain and/or swelling, loss of and/or reduced appetite.
• Reduced thyroid function (hypothyroidism).
• Dizziness.
• Headache.
• Nosebleeds.
• Back pain, joint pain.
• Pain in arms and legs.
• Yellowing of the skin and/or skin discoloration, excessive skin pigmentation, change in hair colour, rash on palms and soles, rash, dry skin.
• Cough.
• Fever.
• Difficulty sleeping.

Common: may affect up to 1 in 10 people

• Blood clots in blood vessels.
• Inadequate blood flow to the heart muscle 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 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, bleeding gums, difficulty swallowing or loss of swallowing ability.
• Burning sensation or pain in the tongue, inflammation of the gastrointestinal mucosa, 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 mucosa, sensation of nasal congestion.
• Excessive tearing.
• Skin sensory disturbances, itching, skin peeling and inflammation, blisters, acne, nail discoloration, hair loss.
• Sensory disturbances in limbs.
• Disorders related to increased or decreased sensitivity, especially to touch.
• Heartburn.
• Dehydration.
• Hot flashes.
• Abnormal urine colour.
• Depression.
• Chills.

Uncommon: may affect up to 1 in 100 people

• Life-threatening soft tissue infections, including around the anus and genital organs (see section 2).
• Stroke.
• Myocardial infarction caused by interruption or reduction of blood flow to the heart.
• Changes in electrical function or heart rhythm disorders.
• Presence of fluid around the heart (pericardial effusion).
• Liver failure.
• Abdominal pain due to inflammation of the pancreas.
• Tumour lysis leading to intestinal perforation.
• Inflammation (swelling and 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 wound healing after surgical procedures.
• Increased activity of muscle enzyme (creatine phosphokinase) in blood.
• Excessive reaction to allergens, including hay fever, skin rash, itching, hives, swelling of any body part, and breathing difficulties.
• Inflammation of the large intestine (colitis, ischemic colitis).

Rare: may affect up to 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 products released from dying tumour 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 phosphate, and low calcium levels in 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 including headache, confusion, seizures, and vision loss (reversible posterior leukoencephalopathy syndrome).
• Painful skin ulceration (pyoderma gangrenosum).
• Hepatitis.
• Thyroiditis.
• 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 rupture of the blood vessel wall (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 effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse.
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.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Sunitinib Vipharm

• Keep the 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 the stated month.
• No special storage instructions 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. 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 is sunitinib. Each capsule contains sunitinib malate equivalent to
12.5 mg of sunitinib. The other ingredients are:

• Capsule contents: mannitol (E421), sodium croscarmellose, povidone (K-25) and magnesium stearate.
• Capsule shell: gelatin, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), 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 contents: mannitol, sodium croscarmellose, povidone (K-25) and magnesium stearate.
• Capsule shell: gelatin, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), 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 contents: mannitol, sodium croscarmellose, povidone (K-25) and magnesium stearate.
• Capsule shell: gelatin, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), 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 a brown body, marked with "12.5 mg" in white ink on the cap, containing yellow to orange granules.
Sunitinib Vipharm 25 mg is available as hard gelatin capsules with a light brown cap and a brown body, size 3, marked with "25 mg" in white ink on the cap, containing yellow to orange granules.
Sunitinib Vipharm 50 mg is available as hard gelatin capsules with a light brown cap and a light brown body, size 2, marked with "50 mg" in white ink on the cap, containing yellow to orange granules.
HDPE bottle with HDPE cap in a cardboard box.
The pack contains 30 hard capsules.

Marketing Authorisation 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 medicinal product is authorised for sale in the European Economic Area under the following names:
Hungary: Sunitinib Vipharm 12.5 mg kemény kapszula
Sunitinib Vipharm 25 mg kemény kapszula
Sunitinib Vipharm 50 mg kemény kapszula
Czech Republic: Sunitinib Vipharm
Poland: Sunitinib Vipharm
Slovakia: Sunitinib Vipharm 12.5 mg
Sunitinib Vipharm 25 mg
Sunitinib Vipharm 50 mg