Suganet

Leaflet included in the packaging: information for the user

Suganet, 12.5 mg, hard capsules

Suganet, 25 mg, hard capsules

Suganet, 50 mg, hard capsules

Sunitinib

You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult your doctor or pharmacist.
• This medicine has been prescribed to you for a specific reason. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any undesirable effects, including any undesirable effects not mentioned in this leaflet, they should inform their doctor. See section 4.

Table of contents of the leaflet

• 1. What is Suganet and what is it used for
• 2. Important information before taking Suganet
• 3. How to take Suganet
• 4. Possible undesirable effects
• 5. How to store Suganet
• 6. Contents of the packaging and other information

1. What is Suganet and what is it used for

Suganet contains the active substance sunitinib, which is a protein kinase inhibitor. Suganet 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. Suganet is used to treat the following types of cancer in adults:

• gastrointestinal stromal tumors (GISTs), a type of stomach and intestine cancer, when imatinib (another anticancer medicine) has stopped working or the patient cannot take it;
• metastatic renal cell carcinoma (MRCC), a type of kidney cancer that has spread to other parts of the body;
• pancreatic neuroendocrine tumors (pNETs), tumors that arise from hormone-producing cells in the pancreas, which are progressing and cannot be surgically removed.

If you have any questions about how Suganet works or why it has been prescribed for you, you should consult your doctor.

2. Important information before taking Suganet

When not to take Suganet:

• 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 Suganet, you should discuss the following with your doctor:

• if the patient has high blood pressure. Suganet may increase blood pressure. Your doctor may check your blood pressure during treatment with Suganet, and you may need to be treated with blood pressure-lowering medicines if necessary.
• if the patient has or has had blood disorders, bleeding, or bruising. Treatment with Suganet 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 you are taking warfarin or acenocoumarol, blood-thinning medicines used to prevent blood clots, there may be a higher risk of bleeding. You should tell your doctor about any bleeding during treatment with Suganet.
• if the patient has heart problems. Suganet may cause heart problems. You should tell your doctor if you experience extreme fatigue, shortness of breath, or swelling of the feet or ankles.
• if the patient has irregular heart rhythms. Suganet may cause irregular heart rhythms. During treatment with Suganet, your doctor may perform an electrocardiogram to assess these irregularities. You should tell your doctor if you experience dizziness, fainting, or irregular heart rhythms while taking Suganet.
• if the patient has recently had blood clots in the veins and/or arteries (including stroke, heart attack, embolism, or thrombosis). You should contact your doctor immediately if you experience symptoms such as chest pain or tightness, arm, back, neck, or jaw pain, shortness of breath, choking, or weakness on one side of the body, difficulty speaking, headache, or dizziness while taking Suganet.
• 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 a condition called thrombotic microangiopathy (a condition characterized by the formation of blood clots in small blood vessels). You should tell your doctor if you experience fever, fatigue, tiredness, bruising, bleeding, swelling, confusion, loss of vision, or seizures.
• if the patient has thyroid problems. Suganet may cause thyroid problems. You should tell your doctor if you experience weight loss, feel cold, or have a hoarse voice while taking Suganet. Your doctor should check your thyroid function before starting treatment with Suganet and regularly during treatment. If your thyroid does not produce enough thyroid hormone, you may need to be treated with a thyroid hormone replacement.
• if the patient has or has had pancreas or gallbladder problems. You should tell your doctor if you experience any of the following symptoms: stomach pain, nausea, vomiting, or fever, which may be signs of pancreatitis or gallbladder inflammation.
• if the patient has or has had liver disease. You should inform your doctor if you experience any of the following symptoms of liver dysfunction: yellowing of the eyes or skin, dark urine, or pain and discomfort in the right upper abdomen. Your doctor should perform blood tests to check liver function before starting treatment with Suganet, during treatment, and if there are any clinical signs of liver problems.
• if the patient has or has had kidney disease. Your doctor will monitor your kidney function.
• if the patient is going to have surgery or has recently had surgery. Suganet may affect wound healing. The medicine is usually discontinued in patients before surgery. Your doctor will decide when to restart Suganet.
• Patient is advised to have a dental check-up before starting treatment with Suganet:
• if the patient experiences mouth pain, toothache, or jaw pain, swelling, or mouth ulcers, difficulty swallowing, or a feeling of heaviness in the jaw, they should inform their oncologist and dentist immediately.
• if the patient requires invasive dental treatment or oral surgery, they should inform their dentist about taking Suganet, especially if they are also taking or have taken bisphosphonates. Bisphosphonates are medicines used to prevent bone problems, which may be taken for another condition.
• if the patient has or has had skin and subcutaneous tissue disorders. While taking this medicine, the patient may experience a condition called pyoderma gangrenosum (painful skin ulcers) or necrotizing fasciitis (a rapidly spreading infection of the skin and/or soft tissues that can be life-threatening). You should contact your doctor immediately if you experience signs of infection around a skin injury, including fever, pain, redness, swelling, or discharge of pus or blood. These conditions usually resolve after discontinuation of Suganet. While taking this medicine, severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) have been observed, which initially appear as reddened targets or circular patches, often with centrally located blisters. The rash may progress to widespread blisters or peeling of the skin and can be life-threatening. If you experience a rash or the above-mentioned skin symptoms, you should contact your doctor immediately.
• if the patient has or has had seizures. You should inform your doctor as soon as possible if you experience high blood pressure, headache, or loss of vision.
• if the patient has diabetes. In patients with diabetes, blood sugar levels should be regularly checked to assess whether the dose of the antidiabetic medicine needs to be adjusted to minimize the risk of hypoglycemia. You should inform your doctor as soon as possible if you experience symptoms related to low blood sugar (fatigue, palpitations, excessive sweating, hunger, and loss of consciousness).

Children and adolescents

Suganet is not recommended for patients under 18 years of age.

Suganet and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, including those available without a prescription. Some medicines may affect the levels of Suganet in your body. You should inform your doctor if you are taking medicines containing the following active substances:

• ketokonazole, itraconazole - used to treat fungal infections,
• erythromycin, clarithromycin, rifampicin - used to treat infections,
• ritonavir - used to treat HIV infections,
• dexamethasone - a corticosteroid used to treat various conditions (such as allergic disorders and/or respiratory problems or skin diseases),
• phenytoin, carbamazepine, phenobarbital - used to treat epilepsy and other neurological conditions,
• herbal products containing St. John's Wort (Hypericum perforatum) - used to treat depression and anxiety disorders.

Taking Suganet with food and drink

While taking Suganet, you should not drink grapefruit juice.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine. Women who can become pregnant should use effective contraception during treatment with Suganet. Breastfeeding women should inform their doctor. You should not breastfeed while taking Suganet.

Driving and using machines

If you experience dizziness or extreme fatigue, you should be cautious when driving or operating machinery.

Suganet contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per capsule, which is considered to be "sodium-free".

3. How to take Suganet

This medicine should always be taken exactly as prescribed by your doctor. If you are unsure, you should consult your doctor. Your doctor will prescribe the dose that is right for you, depending on the type of cancer. For patients being treated for:

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

Your doctor will determine the correct dose for you and when to stop taking Suganet. Suganet can be taken with or without food. To open the blisters, you should tear off one single dose from the blister strip, along the perforated line. Then, peel off the foil from the blister and remove the capsule. You should not push the capsule through the foil, as this may damage it.

Taking a higher dose of Suganet than recommended

If you have taken too many capsules, you should contact your doctor immediately. Medical intervention may be necessary.

Missing a dose of Suganet

You should not take a double dose to make up for a missed dose.

4. Possible undesirable effects

Like all medicines, Suganet can cause undesirable effects, although not everybody gets them. You should contact your doctor immediately if you experience any of the following undesirable effects (see also section 2 "Important information before taking Suganet"):

• heart problems. You should tell your doctor if you feel extremely tired, have shortness of breath, or swelling of the feet and ankles. These may be symptoms of heart problems, which can include heart failure and problems with the heart muscle (cardiomyopathy).
• lung disease or breathing difficulties. You should tell your doctor if you 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 problems. You should tell your doctor if you experience changes in urination frequency or inability to urinate, which may be symptoms of kidney failure.
• bleeding. You should tell your doctor if you experience any of the following symptoms or severe bleeding while taking Suganet: stomach pain and swelling; 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.
• tumor lysis syndrome leading to intestinal perforation. You should tell your doctor if you experience severe stomach pain, fever, nausea, vomiting, blood in the stool, or changes in bowel movements.

Other undesirable effects of Suganet may include:

Very commonundesirable effects (may affect more than 1 in 10 people)

• decrease in the 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, angioedema
• mouth pain, toothache, or jaw pain, swelling, or mouth ulcers, difficulty swallowing, or a feeling of heaviness in the jaw, dry mouth, changes in taste, gastrointestinal disorders, nausea, vomiting, diarrhea, constipation, abdominal pain and/or swelling, loss of appetite
• decrease in thyroid function (hypothyroidism)
• dizziness
• headache
• nosebleeds
• back pain, joint pain
• arm and leg pain
• skin discoloration and/or pigmentation, excessive skin pigmentation, hair color changes, palmar-plantar erythrodysesthesia, rash, dry skin
• coughing
• fever
• difficulty sleeping

Commonundesirable effects (may affect up to 1 in 10 people)

• blood clots in blood vessels
• insufficient blood supply to the heart due to a blockage or narrowing of the coronary arteries
• chest pain
• decrease in the amount of blood pumped by the heart
• fluid accumulation, including in the lungs
• infections
• complications after severe infection (sepsis), which can lead to tissue damage, organ failure, and death
• decrease in blood sugar levels (see section 2)
• protein loss in the urine, sometimes causing swelling
• pseudo-flu syndrome
• abnormal blood test results, including pancreatic and liver enzymes
• high levels of uric acid in the blood
• hemorrhoids, anal pain, rectal bleeding, difficulty swallowing, or loss of swallowing ability
• burning or pain in the mouth, inflammation of the mucous membranes of the digestive tract, excessive gas in the stomach or intestines
• weight loss
• musculoskeletal pain (muscle and bone pain), muscle weakness, fatigue, muscle cramps
• dryness of the nasal mucosa, feeling of nasal congestion
• excessive tearing
• skin sensation disorders, flushing, skin peeling, and inflammation, blisters, itching, nail discoloration, hair loss
• skin sensation disorders
• disorders related to increased or decreased sensitivity, especially to touch
• heartburn
• dehydration
• hot flashes
• abnormal urine color
• depression
• chills

Uncommonundesirable effects (may affect up to 1 in 100 people)

• life-threatening infection of soft tissues (including the genital and anal area) (see section 2)
• stroke
• heart attack caused by interruption or reduction of blood supply to the heart
• changes in heart rhythm or arrhythmias
• fluid accumulation around the heart (pericardial effusion)
• liver failure
• stomach pain caused by pancreatitis
• tumor lysis syndrome leading to intestinal perforation
• inflammation of the gallbladder (with or without gallstones)
• formation of abnormal connections between one body cavity and another or with the skin
• mouth pain, toothache, or jaw pain, swelling, or mouth ulcers, difficulty swallowing, or a feeling of heaviness in the jaw. These may be symptoms of jawbone damage (osteonecrosis), see section 2 "Important information before taking Suganet"
• excessive production of thyroid hormones leading to increased resting metabolism
• impaired wound healing after surgery
• increase in the activity of the muscle enzyme (creatine phosphokinase) in the blood
• excessive allergic reaction, including fever, skin rash, itching, hives, swelling of any part of the body, and difficulty breathing
• inflammation of the large intestine (colitis, ischemic colitis)

Rareundesirable effects (may affect up to 1 in 1000 people)

• life-threatening skin and/or mucous membrane reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme)
• tumor lysis syndrome, 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, and changes in laboratory test results (high levels of potassium, uric acid, and phosphorus, and low levels of calcium in the blood), which can lead to kidney damage and acute kidney failure
• abnormal muscle breakdown, which can cause kidney disease (rhabdomyolysis)
• abnormal brain changes that can cause a syndrome of symptoms including headache, disorientation, seizures, and loss of vision (reversible posterior leukoencephalopathy syndrome)
• painful skin ulcers (pyoderma gangrenosum)
• liver inflammation
• thyroid inflammation
• damage to small blood vessels called thrombotic microangiopathy

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

• enlargement and weakening of the wall of a blood vessel or rupture of the wall of a blood vessel (aneurysm and arterial dissection)
• lack of energy, lethargy, drowsiness, loss of consciousness, or sleepiness - these symptoms may be signs of a toxic effect of high ammonia levels in the blood on the brain (hyperammonemic encephalopathy)

Reporting undesirable effects

If you experience any undesirable effects, including any undesirable effects not mentioned in this leaflet, you should inform your doctor or pharmacist. Undesirable effects can be reported directly to the Department of Drug Safety Monitoring 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. Undesirable effects can also be reported to the marketing authorization holder. By reporting undesirable effects, you can help provide more information on the safety of this medicine.

5. How to store Suganet

The medicine should be stored 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 month stated. Store in the original packaging to protect from moisture. There are no special storage temperature requirements. Do not use this medicine if you notice that the packaging is damaged or if there are signs of previous attempts to open it. Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Suganet contains

Suganet 12.5 mg hard capsules

The active substance is sunitinib. Each capsule contains sunitinib malate equivalent to 12.5 mg of sunitinib. The other ingredients are:

• Capsule content:povidone K30, microcrystalline cellulose, sodium croscarmellose (see section 2, "Suganet contains sodium"), magnesium stearate;
• Capsule shell:gelatin, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172).
• Printing ink:shellac, titanium dioxide (E171), propylene glycol.

Suganet 25 mg hard capsules

The active substance is sunitinib. Each capsule contains sunitinib malate equivalent to 25 mg of sunitinib. The other ingredients are:

• Capsule content:povidone, microcrystalline cellulose, sodium croscarmellose (see section 2, "Suganet contains sodium"), magnesium stearate;
• Capsule shell:gelatin, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172).
• Printing ink:shellac, titanium dioxide (E171), propylene glycol.

Suganet 50 mg hard capsules

The active substance is sunitinib. Each capsule contains sunitinib malate equivalent to 50 mg of sunitinib. The other ingredients are:

• Capsule content:povidone, microcrystalline cellulose, sodium croscarmellose (see section 2, "Suganet contains sodium"), magnesium stearate;
• Capsule shell:gelatin, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172).
• Printing ink:shellac, black iron oxide (E172), propylene glycol.

What Suganet looks like and contents of the pack

Suganet 12.5 mg: hard gelatin capsule (capsule) with an orange cap and orange body, with white ink prints "SNB" and "12.5 mg" on the body. The capsule is filled with an orange powder. Capsule size: 4 (length approximately 14 mm). Suganet 25 mg: hard gelatin capsule (capsule) with a caramel (light brown) cap and orange body, with white ink prints "SNB" and "25 mg" on the body. The capsule is filled with an orange powder. Capsule size: 3 (length approximately 16 mm). Suganet 50 mg: hard gelatin capsule (capsule) with a caramel cap and caramel (light brown) body, with white ink prints "SNB" and "50 mg" on the body. The capsule is filled with an orange powder. Capsule size: 1EL (elongated; length approximately 20 mm). The medicine is available in plastic bottles with a desiccant, containing 30 capsules, in blisters with a desiccant, containing 28 or 30 capsules, and in perforated unit dose blisters with a desiccant, containing 28 x 1 or 30 x 1 capsules. Not all pack sizes may be marketed.

Marketing authorization holder

GEDEON RICHTER POLSKA Sp. z o.o., ul. Ks. J. Poniatowskiego 5, 05-825 Grodzisk Mazowiecki, Poland

Manufacturer

Synthon Hispania, S.L., Calle Castello 1, 08830 Sant Boi de Llobregat Barcelona, Spain; Synthon BV, Microweg 22, 6545 CM Nijmegen, Netherlands; Synthon, s.r.o., Brnenska 32/č.p. 597, 678 01 Blansko, Czech Republic

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

NL: Suganet 12.5 mg hard capsules, Suganet 25 mg hard capsules, Suganet 50 mg hard capsules; BG: Suganet 12.5 mg, Suganet 25 mg, Suganet 50 mg; HU: Suganet 12.5 mg hard capsule, Suganet 25 mg hard capsule, Suganet 50 mg hard capsule; PL: Suganet 12.5 mg, Suganet 25 mg, Suganet 50 mg

Date of last revision of the leaflet: August 2024.