Sunitinib Stada

Leaflet accompanying the packaging: information for the user

Sunitinib Stada, 25 mg, hard capsules

Sunitinib

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor. See section 4.

Table of contents of the leaflet:

• 1. What is Sunitinib Stada and what is it used for
• 2. Important information 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 is Sunitinib Stada and what is it used for

Sunitinib Stada contains the active substance sunitinib, which is a protein kinase inhibitor. This medicine is used to treat cancer, 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 to treat the following cancers:

• Gastrointestinal stromal tumor (GIST) - a type of stomach and intestine cancer, when imatinib (another anticancer medicine) is not effective 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 tumors (pNET) - tumors of the pancreas that produce hormones, which continue to grow or cannot be surgically removed.

If the patient has any questions about how Sunitinib Stada works or why their doctor has prescribed it, they should ask their doctor.

2. Important information before taking Sunitinib Stada

When not to take 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, the patient should discuss it with their doctor.

• If the patient has high blood pressure.Sunitinib Stada may increase blood pressure. The doctor may monitor the patient's blood pressure during treatment with Sunitinib Stada and may prescribe blood pressure-lowering medicines if necessary.
• If the patient has or has had blood disorders, bleeding, or bruising.Treatment with Sunitinib Stada 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 the patient is taking warfarin or acenocoumarol, blood-thinning medicines used to prevent blood clots, there may be a higher risk of bleeding. The patient should tell their doctor about any bleeding during treatment with Sunitinib Stada.
• If the patient has heart disease.Sunitinib Stada may cause heart disease. The patient should tell their doctor if they experience extreme fatigue, shortness of breath, or swelling of the feet or ankles.
• If the patient has heart rhythm disorders.Sunitinib Stada may cause heart rhythm disorders. During treatment with Sunitinib Stada, the doctor may perform an electrocardiogram to assess these disorders. The patient should tell their doctor if they experience dizziness, fainting, or irregular heartbeat during treatment with Sunitinib Stada.
• If the patient has recently had blood clots in the veins and/or arteries (types of blood vessels), including stroke, heart attack, embolism, or thrombosis.The patient should contact their doctor immediately if they 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 during treatment with Sunitinib Stada.
• If the patient has or has had an aneurysm (enlargement and weakening of the wall of a blood vessel) or a tear in the wall of a blood vessel.
• If the patient has or has had damage to the smallest blood vessels called microangiopathic hemolytic anemia.The patient should tell their doctor if they experience fever, fatigue, weakness, bruising, bleeding, swelling, confusion, loss of vision, or seizures.
• If the patient has thyroid disease.Sunitinib Stada may cause thyroid disease. The patient should tell their doctor if they experience extreme fatigue, feel colder than others, or have a deepened voice during treatment with Sunitinib Stada. The doctor should check the patient's thyroid function before starting treatment with Sunitinib Stada and regularly during treatment. If the thyroid does not produce enough thyroid hormones, the patient may receive thyroid hormone replacement therapy.
• If the patient has or has had pancreatic or gallbladder disorders.The patient should tell their doctor if they experience any of the following symptoms: stomach pain (upper abdomen), nausea, vomiting, and fever. These may be symptoms of pancreatitis or gallbladder inflammation.
• If the patient has or has had liver disease.The patient should inform their doctor if they experience any of the following symptoms of liver dysfunction during treatment with Sunitinib Stada: itching, yellowing of the eyes or skin, dark urine, and pain or discomfort in the right upper abdomen. The doctor should perform blood tests to check liver function before starting treatment with Sunitinib Stada, during treatment, and if there are clinical signs.
• If the patient has or has had kidney disease.The doctor will monitor the patient's kidney function.
• If the patient is going to have surgery or has recently had surgery.Sunitinib Stada may affect wound healing. Sunitinib Stada is usually discontinued in patients before surgery. The doctor will decide when to resume treatment with Sunitinib Stada.
• The patient is advised to have a dental check-up before starting treatment with Sunitinib.

Sunitinib Stada.

• If the patient experiences mouth pain, toothache, and/or jaw pain, swelling, or mouth ulcers, numbness, or a feeling of heaviness in the jaw, or tooth mobility, they should inform their doctor and dentist immediately.
• If the patient requires invasive dental treatment or surgery, they should inform their dentist about taking Sunitinib Stada, especially if they are also taking or have taken bisphosphonates intravenously. Bisphosphonates are medicines used to prevent bone complications that may be taken for another disease.
• If the patient has or has 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. The patient should contact their doctor immediately if they experience signs of infection around the skin lesion, including fever, pain, redness, swelling, or the appearance of pus or blood. These disorders usually resolve after discontinuing sunitinib. During treatment with sunitinib, 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 widespread blisters or skin peeling and can be life-threatening. If the patient experiences a rash or the above-mentioned skin symptoms, they should contact their doctor immediately.
• If the patient has or has had seizures.The patient should inform their doctor as soon as possible if they experience high blood pressure, headache, or loss of vision.
• If the patient has diabetes.In patients with diabetes, blood sugar levels should be regularly monitored to assess whether the dosage of the anti-diabetic medicine needs to be adjusted to minimize the risk of low blood sugar. The patient should inform their doctor as soon as possible if they experience any symptoms of low blood sugar (fatigue, palpitations, sweating, hunger, and loss of consciousness).

Children and adolescents

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

Sunitinib Stada and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take. Some medicines may affect the levels of Sunitinib Stada in the patient's body. The patient should inform their doctor if they are 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 reactions and/or respiratory disorders or skin diseases)
• Phenytoin, carbamazepine, phenobarbital - used to treat epilepsy and other neurological diseases
• Herbal medicines containing St. John's Wort (Hypericum perforatum) - used to treat depression and anxiety

Taking Sunitinib Stada with food and drink

The patient should not drink grapefruit juice while taking Sunitinib Stada.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine. Women who can become pregnant should use effective contraception during treatment with Sunitinib Stada. The patient should inform their doctor about breastfeeding. During treatment with Sunitinib Stada, the patient should not breastfeed.

Driving and using machines

If the patient experiences dizziness or extreme fatigue, they should be cautious when driving or operating machinery.

Sunitinib Stada contains sodium

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

3. How to take Sunitinib Stada

The patient should always take this medicine exactly as their doctor has told them. If they are unsure, they should ask their doctor. The doctor will prescribe the dose that is right for the patient, depending on the type of cancer.

• For patients being treated for GIST or MRCC, the usual dose is 50 mg once a day for 28 days (4 weeks), followed by a 14-day (2-week) break (without the medicine), in 6-week treatment cycles.
• For patients being treated for pNET, the usual dose is 37.5 mg once a day, taken continuously.

The doctor will determine the correct dose for the patient and when to stop treatment with Sunitinib Stada. Sunitinib Stada can be taken with or without food.

Taking a higher dose of Sunitinib Stada than recommended

If the patient accidentally takes more capsules than prescribed, they should contact their doctor immediately, as they may need urgent medical attention.

Missing a dose of Sunitinib Stada

The patient should not take a double dose to make up for a missed dose. If they have any further questions about taking this medicine, they should ask their doctor or pharmacist.

4. Possible side effects

Like all medicines, Sunitinib Stada can cause side effects, although not everybody gets them. The patient should contact their doctor immediately if they experience any of the following side effects (see also "Important information before taking Sunitinib Stada"): Heart disease.The patient should tell their doctor if they experience extreme fatigue, shortness of breath, or swelling of the feet or ankles. These may be symptoms of heart problems, which can include heart failure and problems with the heart muscle (cardiomyopathy). Lung disease or respiratory disorders.The patient should tell their doctor if they 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 travel to the lungs. Kidney disorders.The patient should tell their doctor if they experience changes in urination frequency or absence of urination, which can be a sign of kidney failure. Bleeding.The patient should tell their doctor if they experience any of the following symptoms or severe bleeding during treatment with Sunitinib Stada: stomach pain and swelling (abdomen), vomiting blood, black and tarry stools, blood in urine, headache, or changes in consciousness, coughing up blood or bloody sputum from the lungs or airways. Tumor lysis syndrome leading to intestinal perforation.The patient should tell their doctor if they experience severe stomach pain, fever, nausea, vomiting, blood in stool, or changes in bowel movements.

Other side effects of Sunitinib Stada may include:

Very common: may affect more than 1 in 10 people

• Decreased number of platelets, 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 mouth mucosa, taste disorders, nausea, vomiting, diarrhea, constipation, abdominal pain and/or swelling, loss or decreased appetite.
• Decreased thyroid function (hypothyroidism).
• Dizziness.
• Headache.
• Nosebleeds.
• Back pain, joint pain.
• Pain in hands and feet.
• Yellowing of the skin and/or discoloration, excessive skin pigmentation, 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 due to a blockage or narrowing of the coronary arteries.
• Chest pain.
• Decreased amount of blood pumped by the heart.
• Fluid accumulation, including around the lungs.
• Infections.
• Complications of severe infections (sepsis), which can 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 liver and pancreatic enzyme activity.
• High levels of uric acid in the blood.
• Hemorrhoids, anal pain, gum bleeding, difficulty swallowing, or loss of swallowing ability.
• Mouth pain, toothache, and/or jaw pain, swelling, or mouth ulcers, numbness, or a feeling of heaviness in the jaw, or tooth mobility.
• Excessive production of thyroid hormones leading to increased energy expenditure at rest.
• Abnormal wound healing after surgery.
• Increased activity of the muscle enzyme (creatine phosphokinase) in the blood.
• Excessive allergic reaction, including hay fever, skin rash, itching, hives, swelling of various body parts, and breathing difficulties.
• Inflammation of the large intestine (colitis, ischemic colitis).

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 electrical activity or irregular heartbeat.
• Fluid accumulation around the heart (pericardial effusion).
• Liver failure.
• Abdominal pain caused by pancreatitis.
• Tumor lysis syndrome 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, toothache, and/or jaw pain, swelling, or mouth ulcers, 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 energy expenditure at rest.
• Abnormal wound healing after surgery.
• Increased activity of the muscle enzyme (creatine phosphokinase) in the blood.
• Excessive allergic reaction, including hay fever, skin rash, itching, hives, 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 people

• Severe skin and mucous membrane reaction (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme).
• Tumor lysis syndrome (TLS), 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, cloudy 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 changes and acute kidney failure.
• Abnormal muscle breakdown, which can lead to kidney disease (rhabdomyolysis).
• Abnormal brain changes, 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.
• Damaged smallest blood vessels called microangiopathic hemolytic anemia.

Frequency not known: (cannot be estimated from the available data):

• Enlargement and weakening of the wall of a blood vessel or rupture of a blood vessel (aneurysm and arterial dissection).
• Lack of energy, confusion, drowsiness, loss of consciousness, or coma - these symptoms may be signs of toxic effects of high blood ammonia levels on the brain (hyperammonemic encephalopathy).

Reporting side effects

If the patient experiences any side effects, including those not listed in the leaflet, they should tell their doctor. Side effects can be reported directly to the Department of Drug Safety, 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of this medicine.

5. How to store Sunitinib Stada

The medicine should be stored out of sight and reach of children. The patient should 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 month stated. There are no special storage instructions for this medicine. The patient should not use this medicine if the packaging is damaged or shows signs of opening. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Sunitinib Stada contains

• The active substance of Sunitinib Stada is sunitinib.

Sunitinib Stada, 25 mg, hard capsules. Each capsule contains 25 mg of sunitinib.

• Other ingredients are: capsule content:microcrystalline cellulose (E460), mannitol (E421), sodium croscarmellose, povidone K30 (E1201), magnesium stearate (E470b). Sunitinib Stada 25 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 25 mg, hard capsules (capsules). The capsules are size 3, with a light brown cap and an orange body, with "25 mg" printed in white ink on the body, containing yellow to orange granules. Sunitinib Stada, hard capsules, are available in blisters containing 28 hard capsules.

Marketing authorization holder and manufacturer

Marketing authorization 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 authorized in the Member States of the European Economic Area under the following names:

Netherlands: Sunitinib Stada 25 mg hard capsules, Hungary: Sunitinib Stada 25 mg hard capsules, Poland: Sunitinib Stada

Date of last revision of the leaflet: 07/2024