Sunitinib stada

Package leaflet: Information for the user

Sunitinib Stada, 12.5 mg, hard capsules
sunitinib
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform 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 inhibits 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 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 medicines to lower blood pressure.
• If the patient has or has had blood disorders, bleeding or bruising. Treatment with Sunitinib Stada may lead to an increased risk of bleeding or changes in 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 your doctor about 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 of the feet or ankles.
• If the patient has heart rhythm disorders. Sunitinib Stada may cause heart rhythm disturbances. During treatment with Sunitinib Stada, your doctor may perform an electrocardiogram (ECG) to assess these 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, embolism, or thrombosis. Contact your doctor immediately if, during treatment with Sunitinib Stada, the patient experiences symptoms such as chest pain or pressure, pain in the 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 bulging and weakening of a blood vessel wall) or a tear in the wall of a blood vessel.
• 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 thyroid disorders. Sunitinib Stada may cause thyroid problems. Inform your doctor if the patient feels unusually tired, feels colder than others, or experiences voice changes during treatment with Sunitinib Stada. Your doctor should check the patient's thyroid function before starting Sunitinib Stada and regularly during treatment. If the thyroid gland does not produce enough thyroid 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 symptoms of pancreatitis or gallbladder inflammation.
• If the patient has or has had liver disorders. Inform your doctor if, during treatment with Sunitinib Stada, the patient experiences any of the following signs of liver dysfunction: itching, yellowing of the eyes or skin, dark urine, or pain or discomfort in the right upper 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 disorders. Your doctor will monitor the patient's kidney function.
• If the patient is scheduled for surgery or has recently undergone surgery. Sunitinib Stada may affect wound healing. Sunitinib Stada is usually discontinued before surgery. Your doctor will decide when to resume treatment with Sunitinib Stada.
• 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 of the mouth, numbness or heaviness in the jaw, or loose teeth, inform the doctor and dentist immediately.
• If the patient requires invasive dental treatment or oral surgery, the patient should inform the dentist about taking Sunitinib Stada, especially if also taking or having taken intravenous bisphosphonates. Bisphosphonates are medicines used to prevent bone complications, which may be taken due to another condition.
• 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 (rapidly spreading infection of the skin and/or soft tissues, which may be life-threatening) 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 centrally located 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-mentioned skin symptoms, seek medical advice immediately.
• If the patient has or has had seizures. Inform your doctor immediately 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 determine whether adjustment of antidiabetic medication is needed to minimize the risk of hypoglycaemia. Inform your doctor immediately if any symptoms of low blood sugar occur (feeling tired, rapid heartbeat, 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
Tell 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 in various diseases (such as allergic reactions and/or breathing disorders or skin conditions)
• 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 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, i.e. this medicine is considered "sodium-free".

3. How to use Sunitinib Stada

This medicine should always be used as directed by the doctor. If in doubt, consult
your 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 once daily for 28 days (4 weeks), followed by a 14-day (2-week) treatment-free interval, in 6-week treatment cycles.
• pNET, the usual dose is 37.5 mg once daily, administered 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 recommended
If the patient accidentally takes more capsules than recommended, contact the doctor 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 there are any further doubts regarding the use of this medicine, consult the
doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Contact a doctor immediately if the patient experiences any of the following adverse reactions (see also Important information before taking Sunitinib Stada):

Heart diseases. 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 diseases or breathing disorders. 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 tarry stools, blood in the urine, headache, changes in consciousness, coughing up blood or bloody sputum from the lungs or airways.

Tumour rupture 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 of Sunitinib Stada may include:

Very common: may affect 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 mouth ulcers 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 legs.

• Yellowing of the skin and/or skin discoloration, excessive skin pigmentation, hair color changes, rash on palms and soles, skin rash, dry skin.

• Cough.

• Fever.

• Difficulty sleeping.

Common: may affect up to 1 in 10 patients

• Blood clots in blood vessels.
• Reduced blood flow to the heart due to embolism or narrowing of the coronary arteries.
• Chest pain.
• Reduced amount 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 swelling.
• 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 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 nasal mucosa, nasal congestion.
• Excessive tearing.
• Skin sensory disturbances, itching, skin peeling and inflammation, blisters, acne, nail discoloration, hair loss.
• Sensory disturbances in limbs.
• Disorders involving increased or decreased sensitivity, especially to touch.
• Heartburn.
• Dehydration.
• Hot flushes.
• Abnormal urine colour.
• Depression.
• Chills.

Uncommon: may affect up to 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 abnormal heart rhythm.
• Presence of fluid around the heart (pericardial effusion).
• Liver failure.
• Abdominal pain caused by inflammation of the pancreas.
• Tumour rupture 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 with 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 energy consumption at rest.
• Impaired wound healing after surgery.
• 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, ischemic colitis).

Rare: may affect up to 1 in 1,000 patients

• Severe reaction affecting the skin and/or mucous membranes (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 the breakdown products of 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 which may lead to kidney disease (rhabdomyolysis).
• Abnormal changes in the brain which may cause a syndrome of symptoms including headache, confusion, seizures, and vision loss (reversible posterior leukoencephalopathy syndrome).
• Painful skin ulcers (pyoderma gangrenosum).
• Hepatitis.
• Thyroiditis.
• Damage to the smallest blood vessels called 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 reactions occur, including any not listed in this leaflet, inform a doctor. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 this medicine out of 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 stated month.
No special storage conditions are required for this medicine.
Do not use this medicine if the packaging is damaged or shows signs of tampering.
Medicines must 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 12.5 mg hard capsules
Each capsule contains 12.5 mg of sunitinib.

• Other ingredients are:
  Capsule contents: microcrystalline cellulose (E460), mannitol (E421), sodium croscarmellose, povidone K30 (E1201), magnesium stearate (E470b).
  Sunitinib Stada 12.5 mg hard capsules
  Capsule shell: iron oxide red (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 12.5 mg hard capsules (capsules)
Hard gelatin capsules of size 4 with an orange cap and an orange body, printed in white ink with "12.5 mg" on the body, containing granules ranging in colour from yellow to orange.
Sunitinib Stada hard capsules are 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

Manufacturers:
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 European Economic Area under the following names:
Netherlands: Sunitinib Stada 12.5 mg harde capsules
Hungary: Sunitinib Stada 12.5 mg kemény kapszula
Poland: Sunitinib Stada