Sunitinib stada

Package leaflet: Information for the user

Sunitinib Stada, 50 mg, hard capsules
sunitinib
Please read 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 personally. 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 any not listed in this leaflet, tell your doctor. See section 4.

Contents of the leaflet:

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

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

Sunitinib Stada contains the active substance sunitinib, which is a protein kinase inhibitor.
This medicine is used in the treatment of cancers, as it blocks the activity of a specific group of proteins known to be involved in the growth and spread of cancer cells.
Sunitinib Stada is used in adult patients for the treatment of the following cancers:

• gastrointestinal stromal tumours (GIST) – a type of tumour of the stomach and intestines, when imatinib is ineffective (another anticancer medicine) or the patient cannot take imatinib.
• metastatic renal cell carcinoma (MRCC) – a type of kidney cancer that has spread to other parts of the body.
• pancreatic neuroendocrine tumours (pNET) (tumours of hormone-producing cells of the pancreas) that are progressing or cannot be surgically removed.

If you have any questions about how Sunitinib Stada works or why your doctor has prescribed it, please consult your doctor.

2. Important information before taking Sunitinib Stada

When not to use Sunitinib Stada

• 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 Stada, discuss the following with your doctor:

• If the patient has high blood pressure. Sunitinib Stada may increase blood pressure. Your doctor may monitor your blood pressure during treatment with Sunitinib Stada and, if necessary, may prescribe antihypertensive medications.
• If the patient has or has had blood disorders, bleeding or bruising. Treatment with Sunitinib Stada may increase the risk of bleeding or alter the count of certain blood cells, potentially causing anemia or affecting 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 your doctor of any bleeding episodes during treatment with Sunitinib Stada.
• If the patient has heart conditions. Sunitinib Stada may cause heart problems. Inform your doctor if the patient experiences unusual fatigue, shortness of breath, or swelling in the feet or ankles.
• If the patient has or has had heart rhythm disorders. Sunitinib Stada may cause heart rhythm disturbances. During treatment, your doctor may perform an electrocardiogram (ECG) to monitor for such disturbances. Inform your doctor if the patient experiences dizziness, fainting, or irregular heartbeat while taking Sunitinib Stada.
• If the patient has recently had blood clots in veins and/or arteries (types of blood vessels), including stroke, heart attack, pulmonary embolism, or deep vein thrombosis. Contact your doctor immediately if, during treatment with Sunitinib Stada, 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 had an aneurysm (a bulge and weakening in the wall of a blood vessel) or a tear in a blood vessel wall.
• If the patient has or has had damage to the smallest blood vessels, known as thrombotic microangiopathy. Inform your doctor if the patient develops fever, fatigue, weakness, bruising, bleeding, swelling, confusion, vision loss, or seizures.
• If the patient has or has had thyroid disorders. Sunitinib Stada may affect thyroid function. Inform your doctor if the patient becomes easily fatigued, feels unusually cold compared to others, or experiences voice changes during treatment. Your doctor should check thyroid function before starting Sunitinib Stada and regularly during treatment. If the thyroid gland does not produce enough hormones, the patient may require thyroid hormone replacement therapy.
• If the patient has or has had pancreas or gallbladder disorders. Inform your doctor if the patient experiences any of the following symptoms: stomach pain (upper abdomen), nausea, vomiting, or fever. These may be signs of pancreatitis or gallbladder inflammation.
• If the patient has or has had liver disease. Inform your doctor if, during treatment with Sunitinib Stada, the patient develops any of the following signs of liver dysfunction: itching, yellowing of the eyes or skin (jaundice), dark-colored urine, or pain/discomfort in the upper right abdomen. Your doctor should order blood tests to monitor liver function before starting Sunitinib Stada, during treatment, and whenever clinically indicated.
• If the patient has or has had kidney disease. Your doctor will monitor kidney function.
• If the patient is scheduled for surgery or has recently undergone surgery. Sunitinib Stada may impair wound healing. Sunitinib Stada is usually discontinued before surgery. Your doctor will determine when to resume treatment.
• The patient is advised to have a dental examination before starting treatment with Sunitinib Stada.
• If the patient experiences mouth pain, tooth or jaw pain, swelling or ulceration in the mouth, numbness or heaviness in the jaw, or loose teeth, inform the treating doctor and dentist immediately.
• If the patient requires invasive dental treatment or oral surgery, the dentist must be informed about the use of Sunitinib Stada, especially if the patient is also taking or has previously received intravenous bisphosphonates. Bisphosphonates are medicines used to prevent bone complications that may be prescribed for other conditions.
• If the patient has or has had skin and subcutaneous tissue disorders. During treatment with this medicine, pyoderma gangrenosum (painful skin ulceration) or necrotizing fasciitis (a rapidly spreading and potentially life-threatening infection of the skin and/or soft tissues) may occur. Contact your doctor immediately if signs of infection appear 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 sunitinib treatment. These initially appear as red, target-shaped or circular spots, 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 had seizures. Inform your doctor promptly 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 adjustment of antidiabetic medication is needed to minimize the risk of hypoglycemia. Inform your doctor immediately if any symptoms of low blood sugar occur (such as fatigue, palpitations, sweating, hunger, or loss of consciousness).

Children and adolescents
Sunitinib Stada is not recommended for patients under 18 years of age.

Sunitinib Stada and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Some medicines may affect the concentration of Sunitinib Stada in the patient’s body. Inform your doctor if the patient is 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 for various conditions (such as allergic reactions and/or breathing disorders or skin diseases)
• phenytoin, carbamazepine, phenobarbital – used to treat epilepsy and other neurological disorders
• herbal medicines containing St. John’s wort (Hypericum perforatum) – used to treat depression and anxiety

Taking Sunitinib Stada with food and drink
Do not drink grapefruit juice during treatment with Sunitinib Stada.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Women of childbearing potential should use an effective method of contraception during treatment with Sunitinib Stada.
Inform your doctor if you are breastfeeding. Breastfeeding is not recommended during treatment with Sunitinib Stada.

Driving and operating machinery
If dizziness or significant fatigue occurs, exercise particular caution when driving or operating machinery.

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

3. How to use Sunitinib Stada

This medicine should always be used exactly as prescribed by the doctor. In case of doubts, consult
your 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 once daily for 28 days (4 weeks), followed by a 14-day (2-week) treatment-free break, in 6-week treatment cycles.
• pNET, the usual dose is 37.5 mg once daily, taken continuously.

The doctor will determine the appropriate dose for the individual patient and the time when treatment
with Sunitinib Stada should end.
Sunitinib Stada may be taken with or without food.
Taking more Sunitinib Stada than prescribed
If the patient accidentally takes more capsules than recommended, the doctor should be contacted immediately,
as the patient may require urgent medical attention.
Missing a dose of Sunitinib Stada
Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Contact a doctor immediately if the patient experiences any of the following adverse reactions (see also Important information before taking Sunitinib Stada):
Heart disorders. Inform the doctor if the patient experiences extreme fatigue, shortness of breath, or swelling of the feet or ankles. These may be symptoms of heart problems, which may include heart failure and problems with the heart muscle (cardiomyopathy).
Lung disorders or breathing problems. Inform the doctor if the patient develops cough, chest pain, sudden onset of 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 function disorders. Inform the doctor if the patient experiences changes in frequency or absence of urination, which may be symptoms of kidney failure.
Bleeding. Inform the doctor if the patient experiences any of the following symptoms or severe bleeding during treatment with Sunitinib Stada: stomach (abdominal) pain and swelling, vomiting blood, black and sticky 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. Inform the doctor if the patient experiences severe abdominal pain, fever, nausea, vomiting, blood in the stool, or changes in bowel function.

Other adverse reactions associated with Sunitinib Stada may include:
Very common: may occur in more than 1 in 10 patients

• 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 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, indigestion, nausea, vomiting, diarrhoea, constipation, abdominal pain and/or swelling, loss of appetite or reduced appetite.
• Decreased thyroid function (hypothyroidism).
• Dizziness.
• Headache.
• Nosebleeds.
• Back pain, joint pain.
• Pain in hands and feet.
• 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 patients

• Blood clots in blood vessels.
• Inadequate blood flow to the heart due to embolism or narrowing of the coronary arteries.
• Chest pain.
• Reduced volume of blood pumped by the heart.
• Fluid retention, including around the lungs.
• Infections.
• Complications of severe infections (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 oedema.
• Flu-like syndrome.
• Abnormal blood test results, including abnormal pancreatic and liver enzyme activity.
• High levels of uric acid in the blood.
• Haemorrhoids, rectal pain, bleeding gums, difficulty swallowing or loss of swallowing ability.
• Burning or painful sensation of 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, nasal congestion.
• Excessive tearing.
• Skin sensation disorders, itching, skin peeling and inflammation, blisters, acne, nail discoloration, hair loss.
• Sensory disturbances in the limbs.
• Sensory disorders related to increased or decreased sensitivity, especially to touch.
• Heartburn.
• Dehydration.
• Hot flushes.
• Abnormal urine colour.
• Depression.
• Chills.

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

• 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 supply to the heart.
• Changes in electrical function or irregular heart rhythm.
• Presence of fluid around the heart (pericardial effusion).
• Liver failure.
• Abdominal pain caused by inflammation of the pancreas.
• Tumour lysis 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.
• Oral 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 energy consumption at rest.
• Impaired healing of surgical wounds.
• Increased activity of muscle enzyme (creatine phosphokinase) in blood.
• Excessive reaction to allergens including hay fever, skin rash, skin itching, urticaria, swelling of various body parts, and breathing difficulties.
• Inflammation of the large intestine (colitis, ischaemic colitis).

Rare: may occur in no more than 1 in 1,000 patients

• Severe skin and/or mucosal reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme).
• Tumour lysis syndrome (TLS), 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 potassium, uric acid, and phosphate levels, and low calcium levels in blood), which may lead to kidney changes and acute kidney failure.
• Abnormal muscle breakdown that may lead to kidney disease (rhabdomyolysis).
• Abnormal changes in the brain that may cause a syndrome of symptoms including headache, confusion, seizures, and vision loss (reversible posterior leukoencephalopathy syndrome).
• Painful skin ulceration (pyoderma gangrenosum).
• Hepatitis.
• Thyroiditis.
• Damage to the smallest blood vessels known as thrombotic microangiopathy.

Frequency not known: (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 symptoms occur, including any adverse symptoms not listed in this leaflet, inform the 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.: +48 22 49 21 301
Fax: +48 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 provide more information on the safety of this medicine.

5. How to store Sunitinib Stada

Keep the 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 pack
after: Expiry (EXP). The expiry date refers to the last day of the stated month.
No special storage instructions apply.
Do not use this medicine if 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. Contents of the pack and other information

What Sunitinib Stada contains

• The active substance is sunitinib.

Sunitinib Stada 50 mg, hard capsules
Each capsule contains 50 mg of sunitinib.

• Other ingredients are:
  Capsule contents: microcrystalline cellulose (E460), mannitol (E421), sodium croscarmellose, povidone K30 (E1201), magnesium stearate (E470b).
  Sunitinib Stada 50 mg, hard capsules
  Capsule shell: black iron oxide (E172), red iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171), gelatin.
  White ink: shellac, titanium dioxide (E171), propylene glycol (E1520).

What Sunitinib Stada looks like and contents of the pack
Sunitinib Stada 50 mg, hard capsules (capsules)
Hard gelatin capsules of size 1 with a light brown cap and a light brown body, printed in white ink with the marking "50 mg" on the body, containing granules of yellow to orange colour.
Sunitinib Stada, hard capsules, is available in blisters containing 28 hard capsules.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany

Manufacturer:
Remedica Ltd.
Aharnon Street, Limassol Industrial Estate,
3056 Limassol,
Cyprus
Pharmacare Premium Ltd.
HHF003 Hal Far Industrial Estate,
Birzebbugia, BBG3000
Malta
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Netherlands: Sunitinib Stada 50 mg hard capsules
Hungary: Sunitinib Stada 50 mg kemény kapszula
Poland: Sunitinib Stada