Sunitinib sanexcel

Patient Information Leaflet: Instructions for the User

Sunitinib SaneXcel, 12.5 mg, hard capsules
Sunitinib SaneXcel, 25 mg, hard capsules
Sunitinib SaneXcel, 50 mg, hard capsules
Sunitinib
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, 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.

Table of Contents

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

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

Sunitinib SaneXcel contains sunitinib malate as the active substance, which is a protein kinase inhibitor. This medicine is used in the treatment of cancers by inhibiting the activity of a specific group of proteins known to be involved in the growth and spread of cancer cells.
Sunitinib SaneXcel is used to treat the following types of cancer in adults:

• Gastrointestinal stromal tumour (GIST), a type of stomach and intestinal cancer, when imatinib (another anticancer medicine) 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.
• Advanced pancreatic neuroendocrine tumours (pNET) (tumours arising from hormone-producing cells in the pancreas) that are progressing or cannot be surgically removed.

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

2. Important information before taking Sunitinib SaneXcel

When not to take Sunitinib SaneXcel:

• if the patient is allergic to sunitinib or any of the other ingredients of Sunitinib SaneXcel (listed in section 6).

Warnings and precautions
Before starting treatment with Sunitinib SaneXcel, discuss the following with your doctor:

• If high blood pressure is present. Sunitinib SaneXcel may increase blood pressure. Your doctor may monitor your blood pressure during treatment with Sunitinib SaneXcel, and you may require treatment with medications to lower blood pressure if necessary.
• If you have or have had blood disorders, bleeding, or bruising. Treatment with Sunitinib SaneXcel 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 you are taking warfarin or acenocoumarol—anticoagulant medications used to prevent blood clots—the risk of bleeding may be higher. Inform your doctor of any bleeding episodes while taking Sunitinib SaneXcel.
• If you have heart conditions. Sunitinib SaneXcel may cause heart problems. Inform your doctor if you experience extreme fatigue, shortness of breath, or swelling in the feet or ankles.
• If you have or have had heart rhythm disorders. Sunitinib SaneXcel may cause abnormal heart rhythms. During treatment, your doctor may perform an electrocardiogram (ECG) to assess these disturbances. Inform your doctor if you experience dizziness, fainting, or irregular heartbeat while taking Sunitinib SaneXcel.
• If you have 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 SaneXcel, you experience 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 you have or have had an aneurysm (a bulging and weakening of a blood vessel wall) or a tear in the wall of a blood vessel.
• If you have or have had damage to the smallest blood vessels, known as thrombotic microangiopathy. Inform your doctor if you develop fever, fatigue, weakness, bruising, bleeding, swelling, confusion, vision loss, or seizures.
• If you have thyroid disorders. Sunitinib SaneXcel may cause thyroid problems. Inform your doctor if you feel unusually tired, feel colder than others, or experience voice changes while taking Sunitinib SaneXcel. Your doctor should check thyroid function before starting treatment and regularly during therapy. If your thyroid does not produce enough thyroid hormone, you may require thyroid hormone replacement therapy.
• If you have or have had pancreas or gallbladder disorders. Inform your doctor if you experience any of the following symptoms: stomach pain (upper abdomen), nausea, vomiting, or fever. These may be signs of pancreatitis or gallbladder disease.
• If you have or have had liver disorders. Inform your doctor if, during treatment with Sunitinib SaneXcel, you develop any of the following signs of liver dysfunction: itching, yellowing of the eyes or skin (jaundice), dark-colored urine, or pain or discomfort in the upper right abdomen. Your doctor should order blood tests to monitor liver function before starting treatment, during therapy, and whenever clinically indicated.
• If you have or have had kidney disorders. Your doctor will monitor kidney function.
• If you are scheduled for surgery or have recently undergone surgery. Sunitinib SaneXcel may affect wound healing. The drug is usually discontinued before surgery. Your doctor will decide when to restart Sunitinib SaneXcel.
• A dental examination is recommended before starting treatment with Sunitinib SaneXcel.
• If you develop mouth pain, tooth or jaw pain, swelling or ulceration in the mouth, numbness or heaviness in the jaw, or loose teeth, inform your oncologist and dentist immediately.
• If you require invasive dental treatment or oral surgery, inform your dentist that you are taking Sunitinib SaneXcel, especially if you are currently or have previously received intravenous bisphosphonates. Bisphosphonates are medications used to prevent bone problems and may be taken for other medical conditions.
• If you have or have had skin and subcutaneous tissue disorders. While taking this medication, you may develop pyoderma gangrenosum (painful skin ulceration) or necrotizing fasciitis (a rapidly spreading and potentially life-threatening infection of the skin and/or soft tissues). Contact your doctor immediately if you develop 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 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 you develop a rash or any of the above skin symptoms, seek immediate medical attention.
• If you have or have had seizures. Inform your doctor as soon as possible if you develop high blood pressure, headache, or vision loss.
• If you have diabetes. Patients with diabetes should regularly monitor blood glucose levels to determine whether adjustment of antidiabetic medication is needed to minimize the risk of hypoglycemia. Inform your doctor immediately if you experience symptoms of low blood sugar (fatigue, palpitations, excessive sweating, hunger, or loss of consciousness).

Children and adolescents
Sunitinib SaneXcel is not recommended for individuals under 18 years of age.

Sunitinib SaneXcel and other medicines
Inform your doctor or pharmacist about all medications you are currently taking or have recently taken, including over-the-counter drugs, as well as any medications you plan to use.
Some medications may affect the concentration of Sunitinib SaneXcel in the body. Inform your doctor if you are taking any of the following active substances:

• ketoconazole, itraconazole – used to treat fungal infections
• erythromycin, clarithromycin, rifampicin – used to treat infections
• ritonavir – used in the treatment of HIV infection
• dexamethasone – a corticosteroid used in various conditions (such as allergies and/or respiratory disorders or skin diseases)
• phenytoin, carbamazepine, phenobarbital – used to treat epilepsy and other neurological conditions
• herbal remedies containing St. John’s wort (Hypericum perforatum) – used to treat depression and anxiety disorders

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

Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a child, consult your doctor or pharmacist before using this medicine.
Women of childbearing potential should use an effective method of contraception during treatment with Sunitinib SaneXcel.
Breastfeeding women should inform their doctor. Breastfeeding is not recommended while taking Sunitinib SaneXcel.

Driving and operating machinery
Exercise caution when driving or operating machinery if you experience dizziness or significant fatigue.

Sunitinib SaneXcel contains mannitol
Mannitol may have a mild laxative effect.

3. How to take Sunitinib SaneXcel

This medicine should always be taken as prescribed by your doctor. If in doubt, consult your doctor.
Your doctor will prescribe the appropriate dose 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, in 6-week treatment cycles.
• pNET: the usual dose is 37.5 mg taken once daily continuously.

Your doctor will determine the appropriate dose for you, as well as whether and when treatment with Sunitinib SaneXcel should be interrupted.
Sunitinib SaneXcel may be taken with or without food.
Taking more Sunitinib SaneXcel than prescribed
If too many capsules are taken, contact your doctor immediately. Medical assistance may be required.
Missing a dose of Sunitinib SaneXcel
Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should contact your doctor immediately if the patient experiences any of the following
severe adverse reactions (see also "Important information before taking Sunitinib SaneXcel").

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 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. 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 SaneXcel: painful, swollen abdomen (stomach); 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 SaneXcel may include:

Very common: may occur in 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 due to fluid accumulation under the skin and around the eyes, severe allergic rash.
• Pain/irritation in the mouth, mouth ulcers/inflammation/dryness of the oral mucosa, taste disturbances, stomach discomfort, nausea, vomiting, diarrhoea, constipation, abdominal pain/swelling, loss of appetite.
• Decreased thyroid activity (hypothyroidism).
• Dizziness.
• Headache.
• Nosebleeds.
• Back pain, joint pain.
• Pain in arms and legs.
• Yellowing/discoloration of the skin, excessive skin pigmentation, hair color changes, rash on palms and soles, skin rash, dry skin.
• Cough.
• Fever.
• Difficulty falling asleep.

Common: may occur in not more than 1 in 10 people

• Blood clots in blood vessels.
• Inadequate blood supply 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 a 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.
• Influenza-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 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, sensation of nasal congestion.
• Excessive tearing.
• Skin sensation disorders, 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 occur in not more than 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 supply to the heart.
• Changes in electrical function or rhythm disturbances of the heart.
• Presence of fluid around the heart (pericardial effusion).
• Liver failure.
• Stomach (abdominal) pain caused by 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 oral mucosa, 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 by the body at rest.
• Impaired wound healing after surgical procedures.
• Increased activity of muscle enzyme (creatine phosphokinase) in the blood.
• Excessive allergic reaction, including hay fever, skin rash, itching, urticaria, swelling of any body part, and breathing difficulties.
• Inflammation of the large intestine (colitis, ischemic colitis).

Rare: may occur in not more than 1 in 1,000 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 levels of calcium in the blood), which may lead to kidney changes and acute kidney failure.
• Abnormal muscle breakdown that may cause 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.
• Inflammation of the thyroid gland.
• Damage to the smallest blood vessels called thrombotic microangiopathy.

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

• Enlargement and weakening of the blood vessel wall or rupture of the blood vessel wall (aneurysm and arterial dissection).
• Lack of energy, disorientation, drowsiness, loss of consciousness/coma – these symptoms may indicate harmful effects on the brain caused by high levels of ammonia in the blood (hyperammonaemic encephalopathy).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, tell 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, phone: +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 authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Sunitinib SaneXcel

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the cardboard box and blister pack after: EXP. The expiry date refers to the last day of the stated month.
• There are no special storage instructions for this medicine.
• Do not use this medicine if the packaging is damaged or if there are any 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 SaneXcel contains
The active substance is sunitinib malate.
Each capsule contains sunitinib malate equivalent to 12.5 mg of sunitinib.
Each capsule contains sunitinib malate equivalent to 25 mg of sunitinib.
Each capsule contains sunitinib malate equivalent to 50 mg of sunitinib.
The other ingredients are:

• Capsule contents: mannitol (E 421), sodium croscarmellose, povidone (K-25), magnesium stearate.
• Capsule shell, 12.5 mg: gelatin, iron oxide red (E 172), titanium dioxide (E 171).
• Capsule shell, 25 mg: gelatin, iron oxide yellow (E 172), iron oxide red (E 172), titanium dioxide (E 171).
• Capsule shell, 50 mg: gelatin, iron oxide yellow (E 172), iron oxide red (E 172), titanium dioxide (E 171).

What Sunitinib SaneXcel looks like and contents of the pack
Sunitinib SaneXcel 12.5 mg hard capsules are gelatin capsules with an opaque red body and an opaque red cap, 14.5 mm in length and 5.34 mm in diameter.
Sunitinib SaneXcel 25 mg hard capsules are gelatin capsules with an opaque red body and an opaque orange cap, 17.8 mm in length and 6.38 mm in diameter.
Sunitinib SaneXcel 50 mg hard capsules are gelatin capsules with an opaque orange body and an opaque orange cap, 21.8 mm in length and 7.66 mm in diameter.
Sunitinib SaneXcel 12.5 mg hard capsules are available in blister packs containing 30 capsules, in a cardboard carton.
Sunitinib SaneXcel 25 mg hard capsules are available in blister packs containing 30 capsules, in a cardboard carton.
Sunitinib SaneXcel 50 mg hard capsules are available in blister packs containing 30 capsules, in a cardboard carton.

Marketing Authorisation Holder:
J.J. Bishop Health a.s.
Rybná 682/14, Staré Město
110 00 Prague 1
Czech Republic
e-mail: [email protected]

Manufacturer/Importer:
Tecnimede – Sociedade Técnico Medicinal, S.A.
Quinta da Cerca, Caixaria
2565-187 Dois Portos
Portugal

This medicinal product is authorised in the European Economic Area under the following names:
Poland: Sunitinib SaneXcel
Czech Republic: Sunitinib SaneXcel
Slovakia: Sunitinib SaneXcel 12.5 mg
Sunitinib SaneXcel 25 mg
Sunitinib SaneXcel 50 mg
Bulgaria: Сунитиниб SaneXcel 12.5 mg, 25 mg, 50 mg твърди капсули
Hungary: Sunitinib SaneXcel 12.5 mg kapszula
Sunitinib SaneXcel 25 mg kapszula
Sunitinib SaneXcel 50 mg kapszula
Romania: Sunitinib SaneXcel 12.5 mg capsule
Sunitinib SaneXcel 25 mg capsule
Sunitinib SaneXcel 50 mg capsule
Portugal: Sunitinib JJ Bishop