Sunitinib g.l. pharma

Package leaflet: Information for the patient

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

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What Sunitinib G.L. Pharma is and what it is used for

Sunitinib G.L. Pharma contains sunitinib as the active substance, which is a protein kinase inhibitor. Sunitinib G.L. Pharma is used in the treatment of certain cancers. It inhibits the activity of a specific group of proteins known to be involved in the growth and spread of cancer cells.

Sunitinib G.L. Pharma is used to treat the following types of cancer in adults:

• Gastrointestinal stromal tumours (GIST), a type of stomach and intestinal cancer, when imatinib (another anticancer drug) 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;
• Progressive, unresectable pancreatic neuroendocrine tumours (pNET) (tumours arising from hormone-producing cells in the pancreas).

If you have any questions about how Sunitinib G.L. Pharma works or why this medicine was prescribed for you, please consult your doctor.

2. Important information before using Sunitinib G.L. Pharma

When not to use Sunitinib G.L. Pharma:

• 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 G.L. Pharma, discuss the following with your doctor:

• If high blood pressure occurs. Sunitinib G.L. Pharma may increase blood pressure. Your doctor may monitor your blood pressure during treatment with Sunitinib G.L. Pharma, and you may require treatment with antihypertensive medicines if necessary.

• If bleeding disorders, bleeding or bruising have occurred or have occurred in the past. Treatment with Sunitinib G.L. Pharma may increase the risk of bleeding or may alter the number of certain blood cells, which may cause anaemia or affect the blood’s ability to clot. If you are taking warfarin or acenocoumarol, anticoagulant medicines used to prevent blood clots, there may be an increased risk of bleeding. Inform your doctor of any bleeding events during treatment with Sunitinib G.L. Pharma.

• If heart diseases are present. Sunitinib G.L. Pharma may cause heart problems. Inform your doctor if you experience unusual fatigue, shortness of breath, or swelling of the feet or ankles.

• If heart rhythm disorders are present. Sunitinib G.L. Pharma may cause irregular heart rhythms. During treatment with Sunitinib G.L. Pharma, your doctor may perform an electrocardiogram (ECG) to assess these disturbances. Inform your doctor if you experience dizziness, fainting, or irregular heartbeat during treatment with Sunitinib G.L. Pharma.

• If there have recently been blood clots in the veins and/or arteries (types of blood vessels), including stroke, heart attack, embolism, or thrombosis. Contact your doctor immediately if, during treatment with Sunitinib G.L. Pharma, 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 the blood vessel wall) or a tear in the blood vessel wall.

• If thrombotic microangiopathy (damage to the smallest blood vessels) is present or has occurred in the past. Inform your doctor if you experience fever, fatigue, weakness, bruising, bleeding, swelling, confusion, vision loss, or seizures.

• If thyroid disorders are present. Sunitinib G.L. Pharma may cause thyroid problems. Inform your doctor if you feel unusually tired, feel colder than others, or experience voice changes during treatment with Sunitinib G.L. Pharma. Your doctor should check thyroid function before starting treatment with Sunitinib G.L. Pharma and regularly during treatment. If the thyroid gland does not produce enough thyroid hormone, you may require thyroid hormone replacement therapy.

• If pancreatic dysfunction or gallbladder disorders are present or have occurred in the past. Inform your doctor if you experience any of the following symptoms: stomach pain (upper abdomen), nausea, vomiting, or fever. These may be symptoms of pancreatitis or gallbladder inflammation.

• If liver disorders are present or have occurred in the past. Inform your doctor if, during treatment with Sunitinib G.L. Pharma, you experience any of the following symptoms of liver dysfunction: itching, yellowing of the eyes or skin (jaundice), dark urine, or pain or discomfort in the right upper abdomen. Your doctor should order blood tests to monitor liver function before starting treatment with Sunitinib G.L. Pharma, during treatment, and whenever clinically indicated.

• If kidney disorders are present or have occurred in the past. Your doctor will monitor kidney function.

• If the patient is scheduled for surgery or has recently undergone surgery. Sunitinib G.L. Pharma may affect wound healing. The medicine is usually discontinued before surgery. Your doctor will decide when to restart Sunitinib G.L. Pharma.

• A dental examination is recommended before starting treatment with Sunitinib G.L. Pharma:

  • if you experience or have experienced pain in the mouth, tooth or jaw pain, swelling or ulceration of 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 G.L. Pharma, especially if you are also taking or have taken intravenous bisphosphonates. Bisphosphonates are medicines used to prevent bone problems that may be taken due to another condition.

• If skin and subcutaneous tissue disorders are present or have occurred in the past. 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 you develop signs of infection around skin injury, including fever, pain, redness, swelling, or discharge of pus or blood. These conditions usually resolve after discontinuation of Sunitinib G.L. Pharma. Severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) have been observed during treatment, which initially appear as red, target-shaped or round 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 medical attention immediately.

• If seizures have occurred or have occurred in the past. Inform your doctor as soon as possible if you experience high blood pressure, headache, or vision loss.

• If the patient has diabetes. Patients with diabetes should regularly monitor blood glucose levels to determine whether adjustment of antidiabetic medication is needed to minimize the risk of hypoglycaemia. Inform your doctor immediately if symptoms of low blood sugar occur (fatigue, palpitations, excessive sweating, hunger, or loss of consciousness).

Children and adolescents
Sunitinib G.L. Pharma is not recommended for patients under 18 years of age.

Sunitinib G.L. Pharma and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Some medicines may affect the concentration of Sunitinib G.L. Pharma in the body. Inform your doctor if you are 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 and/or respiratory disorders or skin diseases),
• phenytoin, carbamazepine, phenobarbital – used to treat epilepsy and other neurological conditions,
• products containing St. John’s wort (Hypericum perforatum) – used to treat depression and anxiety.

Taking Sunitinib G.L. Pharma with food and drink
Do not drink grapefruit juice during treatment with Sunitinib G.L. Pharma.

Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Women who could become pregnant should use an effective method of contraception during treatment with Sunitinib G.L. Pharma.
Women who are breastfeeding should inform their doctor. Breastfeeding is not recommended during treatment with Sunitinib G.L. Pharma.

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

Sunitinib G.L. Pharma contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per capsule, i.e. it is considered "sodium-free".

3. How to take Sunitinib G.L. Pharma

This medicine should always be taken as prescribed by the doctor. In case of doubts, consult your doctor.

The doctor will prescribe the appropriate dose for each patient depending on the type of tumour.

For patients treated due to:

• GIST or MRCC: the usual dose is 50 mg taken 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 taken once daily continuously.

The doctor will determine the appropriate dose for each patient and the date when treatment with Sunitinib G.L. Pharma should end.

Sunitinib G.L. Pharma may be taken with food or on an empty stomach.

Taking more than the recommended dose of Sunitinib G.L. Pharma
If too many capsules have been taken, contact a doctor immediately. Medical intervention may be necessary.

Missing a dose of Sunitinib G.L. Pharma
Do not take a double dose to make up for a missed dose.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine may cause adverse reactions, although they do not occur in everyone.
You should contact your doctor immediately if any of the following adverse reactions occur in the patient (see also Important information before taking Sunitinib G.L. Pharma):
Heart diseases. Inform your 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 heart muscle disease (cardiomyopathy).
Lung diseases or breathing difficulties. Inform your 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 your doctor if the patient develops changes in frequency or absence of urination, which may be symptoms of kidney failure.
Bleeding. Inform your doctor if any of the following symptoms or severe bleeding occur during treatment with Sunitinib G.L. Pharma: stomach (abdominal) 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.
Tumour lysis leading to intestinal perforation. Inform your doctor if the patient develops severe abdominal pain, fever, nausea, vomiting, blood in the stool, or changes in bowel function.

Other adverse reactions of Sunitinib G.L. Pharma may include:
Very common: may affect more than 1 in 10 people

• Decreased platelet, red blood cell, and/or white blood cell counts (e.g. neutrophils).
• Shortness of breath.
• Hypertension.
• Severe 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 ulceration and/or inflammation, and/or dryness of the mouth, taste disturbances, gastric disturbances, nausea, vomiting, diarrhoea, constipation, abdominal pain and/or swelling, loss of and/or reduced appetite.
• Reduced thyroid activity (hypothyroidism).
• Dizziness.
• Headache.
• Nosebleeds.
• Back pain, joint pain.
• Pain in arms and legs.
• Yellowing of the skin and/or skin discoloration, excessive skin pigmentation, hair color changes, hand-foot skin reaction, rash, dry skin.
• Cough.
• Fever.
• Difficulty falling asleep.

Common: may affect less than 1 in 10 people

• Blood clots in blood vessels.
• Inadequate blood supply 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 in the lung area.
• Infections.
• Complication following severe infection (blood infection), which may lead to tissue damage, organ failure, and death.
• Decreased blood sugar concentration (see section 2).
• Protein loss in urine, sometimes causing oedema.
• Flu-like syndrome.
• Abnormal blood test results, including pancreatic and liver enzymes.
• High concentration of uric acid in blood.
• Haemorrhoids, rectal pain, bleeding gums, difficulty swallowing or loss of swallowing ability.
• Burning or painful sensation of the tongue, inflammation of the mucous membrane of the gastrointestinal tract, 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 mucous membrane, sensation of nasal congestion.
• Excessive tearing.
• Skin sensation 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 color.
• Depression.
• Chills.

Uncommon: may affect less than 1 in 100 people

• Life-threatening soft tissue infections, including the anogenital area (see section 2).
• Stroke.
• Myocardial infarction caused by interruption or reduction of blood supply to the heart.
• Changes in electrical function or heart rhythm disturbances.
• Presence of fluid around the heart (pericardial effusion).
• Liver failure.
• Abdominal pain caused by 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 the skin.
• Oral pain, tooth and/or jaw pain, swelling or ulceration of the mouth, numbness or heaviness in the jaw, or tooth mobility. These may be symptoms of jaw bone damage (osteonecrosis), see section 2.
• Excessive production of thyroid hormones leading to increased resting metabolism.
• Impaired wound healing after surgical procedures.
• Increased activity of muscle enzyme (creatine phosphokinase) in blood.
• Excessive reaction to allergens, 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 affect less than 1 in 1000 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 calcium levels in blood), which may lead to kidney changes and acute kidney failure.
• Abnormal muscle breakdown which may cause kidney disease (rhabdomyolysis).
• Abnormal changes in the brain which may cause a syndrome including headache, confusion, seizures, and vision loss (reversible posterior leukoencephalopathy syndrome).
• Painful skin ulceration (pyoderma gangrenosum).
• Liver inflammation.
• Inflammation of the thyroid gland.
• Damage to the smallest blood vessels called thrombotic microangiopathy.

Frequency not known (frequency 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 symptoms occur, including any adverse reactions not listed in this leaflet, inform 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
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 responsible entity.
By reporting adverse reactions, more information on the safety of this medicine can be collected.

5. How to store Sunitinib G.L. Pharma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister 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 visible signs of prior opening.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Sunitinib G.L. Pharma contains

• The active substance is sunitinib.

Sunitinib G.L. Pharma, 12.5 mg, hard capsules
Each capsule contains 12.5 mg of sunitinib.
Sunitinib G.L. Pharma, 25 mg, hard capsules
Each capsule contains 25 mg of sunitinib.
Sunitinib G.L. Pharma, 50 mg, hard capsules
Each capsule contains 50 mg of sunitinib.

• The other ingredients are:
  Capsule contents: microcrystalline cellulose, mannitol, sodium croscarmellose (see section 2 "Sunitinib G.L. Pharma contains sodium"), povidone K30, magnesium stearate.
  Sunitinib G.L. Pharma, 12.5 mg, hard capsules
  Capsule shell: iron oxide red (E172), titanium dioxide (E171), gelatin.
  Printing ink, white: shellac, titanium dioxide (E171), propylene glycol (E1520).
  Sunitinib G.L. Pharma, 25 mg, hard capsules
  Capsule shell: iron oxide black (E172), iron oxide red (E172), iron oxide yellow (E172), titanium dioxide (E171), gelatin.
  Printing ink, white: shellac, titanium dioxide (E171), propylene glycol (E1520).
  Sunitinib G.L. Pharma, 50 mg, hard capsules
  Capsule shell: iron oxide black (E172), iron oxide red (E172), iron oxide yellow (E172), titanium dioxide (E171), gelatin.
  Printing ink, white: shellac, titanium dioxide (E171), propylene glycol (E1520).

What Sunitinib G.L. Pharma looks like and contents of the pack
Sunitinib G.L. Pharma, 12.5 mg, hard capsules
Gelatin hard capsules of size 4 (approximate length 14.3 mm) with an orange cap and an orange body, with a white print "12.5 mg" on the body, containing granules of yellow to orange colour.
Sunitinib G.L. Pharma, 25 mg, hard capsules
Gelatin hard capsules of size 3 (approximate length 15.9 mm) with a caramel-coloured cap and an orange body, with a white print "25 mg" on the body, containing granules of yellow to orange colour.
Sunitinib G.L. Pharma, 50 mg, hard capsules
Gelatin hard capsules of size 1 (approximate length 19.4 mm) with a caramel-coloured cap and a caramel-coloured body, with a white print "50 mg" on the body, containing granules of yellow to orange colour.
Aluminium/OPA/Aluminium/PVC blisters containing 28 or 30 hard capsules in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria

Manufacturer
G.L. Pharma GmbH
Schlossplatz 1, Lannach
8502, Austria
Remedica Ltd.
Aharnon Street, Limassol Industrial Estate,
3056 Limassol,
Cyprus
Pharmacare Premium Ltd.
HHF003 Hal Far Industrial Estate,
Birzebbugia, BBG3000
Malta

For further information on this medicine, contact the representative of the Marketing Authorisation Holder:
G.L. PHARMA POLAND Sp. z o.o.
Al. Jana Pawła II 61/313
01-031 Warsaw, Poland
Tel: 022/ 636 52 23; 636 53 02
[email protected]