Sunitinib stada

Package leaflet: Information for the user

Sunitinib Stada, 37.5 mg, hard capsules
sunitinib
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• Talk to your doctor or pharmacist if you have any further questions.
• 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 get 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 you take 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 to treat cancers because 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 stomach and intestinal tumour 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 talk to 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 medications to lower blood pressure.
• If the patient has or has had blood disorders, bleeding or bruising. Treatment with Sunitinib Stada may increase the risk of bleeding or may alter the count of certain blood cells, which could lead to 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 while taking Sunitinib Stada.
• If the patient has heart conditions. Sunitinib Stada may cause heart problems. Inform your doctor if the patient experiences extreme fatigue, shortness of breath, or swelling of the feet or ankles.
• If the patient has or has had 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 tightness, 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 of the blood vessel wall) or a tear in the 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 the thyroid gland. Inform your doctor if the patient feels unusually tired, feels colder than usual, or experiences voice changes while taking Sunitinib Stada. Your doctor should check thyroid function before starting treatment with 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 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 experiences any of the following signs of liver dysfunction: itching, yellowing of the eyes or skin, dark urine, or pain or discomfort in the upper right abdomen. Your doctor should order blood tests to monitor liver function before starting treatment with 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 affect wound healing. Sunitinib Stada is usually discontinued before surgery. Your doctor will decide when to restart 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 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 taken intravenous bisphosphonates. Bisphosphonates are medicines used to prevent bone complications and may be used for other conditions.
• If the patient has or has had skin and subcutaneous tissue disorders. While taking this medicine, pyoderma gangrenosum (painful skin ulceration) or necrotizing fasciitis (a rapidly spreading, potentially life-threatening infection of the skin and/or soft tissues) may occur. Contact your doctor immediately if signs of infection develop 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 spots resembling targets or circular patches, 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 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, palpitations, sweating, hunger, or loss of consciousness).

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

Sunitinib Stada with other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.
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 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 or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Women who could become pregnant 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 using machines
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 taken exactly as prescribed by the doctor. If in doubt, consult
your doctor.
Your doctor will prescribe the dose appropriate for you, 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) break (without medication), in 6-week treatment cycles.
• pNET, the usual dose is 37.5 mg once daily, taken continuously.

Your doctor will determine the appropriate dose for you and when treatment with Sunitinib Stada should end.
Sunitinib Stada may be taken with or without food.
Taking more Sunitinib Stada than prescribed
If you accidentally take more capsules than recommended, contact your doctor immediately, as you 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 issues with the heart muscle (cardiomyopathy).

Lung disorders or breathing problems. Inform the doctor if the patient develops cough, 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 function disorders. Inform the doctor if the patient experiences changes in frequency or absence of urination, which may be signs of kidney failure.

Bleeding. Inform the doctor if the patient experiences any of the following symptoms or severe bleeding during treatment with Sunitinib Stada: abdominal (stomach) pain and swelling, 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.

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 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.
• Reduced 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, skin rash, dry skin.
• Cough.
• Fever.
• Difficulty sleeping.

Common: may affect up to 1 in 10 patients

• Blood clots in blood vessels.
• Inadequate blood supply 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 swelling.
• Flu-like syndrome.
• Abnormal blood test results, including abnormal pancreatic and liver enzyme activity.
• High levels of uric acid in the blood.
• Haemorrhoids, anal pain, bleeding gums, difficulty swallowing or inability to swallow.
• 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 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 flushes.
• Abnormal urine color.
• 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 reduced 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 due to 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.
• 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 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, ischemic colitis).

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

• Severe skin and (or) mucous membrane 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 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 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 that may lead to kidney disease (rhabdomyolysis).
• Abnormal changes in the brain that 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: (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 ammonia levels in the blood 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 of 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 the 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:
Expiry date (EXP). The expiry date refers to the last day of the stated month.
No special storage instructions apply for this medicine.
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 packaging and other information

What Sunitinib Stada contains

• The active substance is sunitinib.

Sunitinib Stada 37.5 mg hard capsules
Each capsule contains 37.5 mg of sunitinib.

• Other ingredients are:
  Capsule contents: microcrystalline cellulose (E460), mannitol (E421), sodium croscarmellose, povidone K30 (E1201), magnesium stearate (E470b).
  Capsule shell: iron oxide yellow (E172), titanium dioxide (E171), gelatin.
  Black ink: shellac, iron oxide black (E172), propylene glycol (E1520), ammonium hydroxide (E527).

What Sunitinib Stada looks like and contents of the pack
Sunitinib Stada 37.5 mg hard capsules (capsules)
Hard gelatin capsules, size 2, with yellow cap and yellow body, printed in black ink with "37.5 mg" on the body, containing granules of yellow to orange colour.
Sunitinib Stada hard capsules are available in blister packs 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 37.5 mg harde capsules
Poland: Sunitinib Stada