Sunitinib adamed

Package leaflet: Information for the user

Sunitynib Adamed, 12.5 mg, hard capsules
Sunitynib Adamed, 25 mg, hard capsules
Sunitynib Adamed, 37.5 mg, hard capsules
Sunitynib Adamed, 50 mg, hard capsules
Sunitynib
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them 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.

Contents of the leaflet

1. What Sunitynib Adamed is and what it is used for
2. What you need to know before taking Sunitynib Adamed
3. How to take Sunitynib Adamed
4. Possible side effects
5. How to store Sunitynib Adamed
6. Contents of the pack and other information

1. What Sunitynib Adamed is and what it is used for

Sunitynib Adamed contains sunitinib as the active substance, which is a protein kinase inhibitor.
Sunitynib Adamed is used in the treatment of cancers. It inhibits the activity of a specific group of
proteins known to be involved in the growth and spread of cancer cells.
Sunitynib Adamed is used in the treatment of the following types of cancer in adults:

• Gastrointestinal stromal tumours (GIST), a type of tumour of the stomach and intestines, 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;
• Pancreatic neuroendocrine tumours (pNET) (tumours arising from hormone-producing cells in the pancreas), which are progressing and cannot be surgically removed.

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

2. Important information before using Sunitynib Adamed

When not to use Sunitynib Adamed

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

Warnings and precautions
Before starting treatment with Sunitynib Adamed, discuss the following with your doctor:

• If the patient has high blood pressure. Sunitynib Adamed may increase blood pressure. Your doctor may monitor blood pressure during treatment with Sunitynib Adamed, and the patient may require medication to lower blood pressure if necessary.
• If the patient has or has had blood disorders, bleeding or bruising. Treatment with Sunitynib Adamed may increase the risk of bleeding or cause changes in the number of certain blood cells, which may 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, the risk of bleeding may be higher. Inform your doctor of any bleeding events during treatment with Sunitynib Adamed.
• If the patient has heart problems. Sunitynib Adamed may cause heart-related issues. Inform your doctor if the patient experiences extreme fatigue, shortness of breath, or swelling in the feet or ankles.
• If the patient has heart rhythm disorders. Sunitynib Adamed may cause irregular heart rhythms. During treatment with Sunitynib Adamed, your doctor may perform an electrocardiogram (ECG) to monitor for such disturbances. Inform your doctor if the patient experiences dizziness, fainting, or irregular heartbeat while taking Sunitynib Adamed.
• 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 Sunitynib Adamed, the patient experiences symptoms such as chest pain or tightness, pain in the 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, exhaustion, bruising, bleeding, swelling, confusion, vision loss or seizures.
• If the patient has thyroid gland problems. Sunitynib Adamed may cause thyroid problems. Inform your doctor if the patient becomes easily fatigued, feels colder than usual, or experiences voice changes during treatment with Sunitynib Adamed. Your doctor should check thyroid function before starting treatment with Sunitynib Adamed and regularly during treatment. If the thyroid gland does not produce enough thyroid hormone, the patient may require thyroid hormone replacement therapy.
• If the patient has or has had pancreas or gallbladder problems. 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 Sunitynib Adamed, the patient experiences any of the following signs of liver problems: itching, yellowing of the eyes or skin, dark urine, or pain or discomfort in the upper right part of the abdomen. Your doctor should order blood tests to monitor liver function before starting treatment with Sunitynib Adamed, during treatment, and whenever clinically indicated.
• If the patient has or has had kidney problems. Your doctor will monitor kidney function.
• If the patient is scheduled for surgery or has recently undergone surgery. Sunitynib Adamed may affect wound healing. The medicine is usually discontinued before surgery. Your doctor will decide when to restart Sunitynib Adamed.
• The patient is advised to have a dental examination before starting treatment with Sunitynib Adamed:
• if the patient experiences mouth pain, tooth or jaw pain, swelling or ulceration in the mouth, numbness or heaviness in the jaw, or loose teeth, inform the oncologist and dentist immediately.
• if the patient requires invasive dental treatment or oral surgery, inform the dentist about taking Sunitynib Adamed, especially if the patient is also taking or has taken intravenous bisphosphonates. Bisphosphonates are medicines used to prevent bone problems, which may be taken due to another condition.
• If the patient has or has had skin and subcutaneous tissue disorders. 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 the patient develops signs of infection around a skin injury, including fever, pain, redness, swelling, or pus or blood discharge. These conditions usually resolve after discontinuation of Sunitynib Adamed. Severe skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) have been observed during treatment, which 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 the patient develops a rash or any of the above-mentioned skin symptoms, seek medical attention immediately.
• If the patient has or has had seizures. Inform your doctor as soon as possible 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 assess whether adjustment of antidiabetic medication is needed to minimize the risk of hypoglycaemia. Inform your doctor immediately if the patient experiences symptoms of low blood sugar (fatigue, palpitations, excessive sweating, hunger, or loss of consciousness).

Children and adolescents
Sunitynib Adamed is not recommended for patients under 18 years of age.
Sunitynib Adamed and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including those obtained without a prescription, as well as any medicines the patient plans to take.
Some medicines may affect the concentration of Sunitynib Adamed in the 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 and/or respiratory disorders 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.

Taking Sunitynib Adamed with food and drink
Do not drink grapefruit juice during treatment with Sunitynib Adamed.
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before using this medicine.
Women of childbearing potential should use an effective method of contraception during treatment with Sunitynib Adamed.
Women who are breastfeeding should inform their doctor. Breastfeeding must not be continued during treatment with Sunitynib Adamed.
Driving and operating machinery
Exercise particular caution when driving or operating machinery if dizziness or significant fatigue occurs.
Sunitynib Adamed contains mannitol
It may have a mild laxative effect.

3. How to use Sunitynib Adamed

This medicine should always be taken as prescribed by your doctor. If in doubt, consult your doctor.
Your doctor will prescribe the appropriate dose for the individual 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) treatment-free interval (without medication), 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 the individual patient and the date when treatment with Sunitynib Adamed should end.
Sunitynib Adamed may be taken with food or without food.
Taking more Sunitynib Adamed than prescribed
If an excessive number of capsules has been taken, contact your doctor immediately.
Medical intervention may be necessary.
Missing a dose of Sunitynib Adamed
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.
Contact a doctor immediately if the patient experiences any of the following adverse reactions (see also Important information before taking Sunitynib Adamed):

Heart problems. Inform 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 disease or breathing difficulties. 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 Sunitynib Adamed: stomach (abdominal) pain and swelling; vomiting blood; black, tarry stools; blood in the urine; headache or changes in consciousness; coughing up blood or bloody phlegm 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 Sunitynib Adamed may include:

Very common: may affect more than 1 in 10 people

• Decreased platelet count, red blood cells, and/or white blood cells (e.g. neutrophils).
• Shortness of breath.
• Hypertension.
• 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 ulceration and/or inflammation, and/or dryness of the mouth, taste disturbances, gastrointestinal disturbances, nausea, vomiting, diarrhoea, constipation, abdominal pain and/or swelling, loss of and/or reduced appetite.
• Decreased 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, rash on palms and soles, rash, dry skin.
• Cough.
• Fever.
• Difficulty sleeping.

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 volume 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.
• 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 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 related to 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 in 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 rhythm disturbances of the heart.
• 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 to the skin.
• Oral 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 resting metabolism.
• Impaired healing after surgical procedures.
• Increased activity of muscle enzyme (creatine phosphokinase) in 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 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 spasms, 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 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 known as 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).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can also be reported directly to:
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 this medicine.

5. How to store Sunitynib Adamed

• Keep this medicine out of 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 requirements for this medicine.
• Do not use this medicine if you notice that the packaging is damaged or shows 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. These measures help protect the environment.

6. Contents of the pack and other information

What Sunitynib Adamed contains

• The active substance is sunitinib (as sunitinib malate).

Sunitynib Adamed 12.5 mg hard capsules
Each capsule contains sunitinib malate equivalent to 12.5 mg of sunitinib.
Other ingredients are:

• Capsule contents: Mannitol, Sodium croscarmellose, Povidone K-25, Magnesium stearate
• Capsule shell: Gelatin, Iron oxide red (E172), Titanium dioxide (E171), Purified water

Sunitynib Adamed 25 mg hard capsules
Each capsule contains sunitinib malate equivalent to 25 mg of sunitinib.
Other ingredients are:

• Capsule contents: Mannitol, Sodium croscarmellose, Povidone K-25, Magnesium stearate
• Capsule shell: Gelatin, Iron oxide yellow (E172), Iron oxide red (E172), Titanium dioxide (E171), Purified water

Sunitynib Adamed 37.5 mg hard capsules
Each capsule contains sunitinib malate equivalent to 37.5 mg of sunitinib.
Other ingredients are:

• Capsule contents: Mannitol, Sodium croscarmellose, Povidone K-25, Magnesium stearate
• Capsule shell: Gelatin, Iron oxide yellow (E172), Titanium dioxide (E171), Purified water

Sunitynib Adamed 50 mg hard capsules
Each capsule contains sunitinib malate equivalent to 50 mg of sunitinib.
Other ingredients are:

• Capsule contents: Mannitol, Sodium croscarmellose, Povidone K-25, Magnesium stearate
• Capsule shell: Gelatin, Iron oxide yellow (E172), Iron oxide red (E172), Titanium dioxide (E171), Purified water

What Sunitynib Adamed looks like and contents of the pack
Sunitynib Adamed 12.5 mg hard capsules are gelatin capsules with an opaque red body and an opaque red cap.
Sunitynib Adamed 25 mg hard capsules are gelatin capsules with an opaque red body and an opaque orange cap.
Sunitynib Adamed 37.5 mg hard capsules are gelatin capsules with a yellow body and a yellow cap.
Sunitynib Adamed 50 mg hard capsules are gelatin capsules with an opaque orange body and an opaque orange cap.
The medicine is available in blisters containing 28 capsules, packed in a cardboard carton.

Marketing Authorisation Holder
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
tel. 22 732 77 00

Importer
Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice
Tecnimede – Sociedade Técnico Medicinal, S.A.
Quinta da Cerca, Caixaria,
2565-187 Dois Portos
Portugal

This medicinal product has been authorised for marketing in EEA Member States under the following names:
Greece: Sunitinib / Ariti
Poland: Sunitynib Adamed