Sunitinib Adamed

Leaflet attached to the packaging: 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

You should carefully read the contents of the 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 a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor. See section 4.

Table of contents of the leaflet

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

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

Sunitynib Adamed contains the active substance sunitinib, which is a protein kinase inhibitor.
Sunitynib Adamed is used to treat cancer. It inhibits the activity of a special group of proteins that are known to participate in the growth and spread of cancer cells.
Sunitynib Adamed is used to treat the following types of cancer in adults:

• Gastrointestinal stromal tumors (GIST), a type of stomach and intestine cancer, when imatinib (another anticancer drug) 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 (pNET), tumors that arise from hormone-producing cells in the pancreas, which are in a progressive phase and cannot be surgically removed.

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

2. Important information before taking Sunitynib Adamed

When not to take Sunitynib Adamed

Warnings and precautions

Before starting treatment with Sunitynib Adamed, you should discuss it with your doctor:

• If the patient has high blood pressure.Sunitynib Adamed may increase blood pressure. The doctor may take blood pressure measurements during treatment with Sunitynib Adamed, and the patient may be treated with blood pressure-lowering medications 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 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 medications used to prevent blood clots, there may be a higher risk of bleeding. The patient should tell their doctor about all bleeding episodes during treatment with Sunitynib Adamed.
• If the patient has heart problems.Sunitynib Adamed may cause heart problems. The patient should tell their doctor if they experience fatigue, shortness of breath, or swelling of the feet or ankles.
• If the patient has heart rhythm disorders.Sunitynib Adamed may cause abnormal heart rhythms. During treatment with Sunitynib Adamed, the doctor may perform an electrocardiogram to assess these disorders. The patient should tell their doctor if they experience dizziness, fainting, or abnormal heart rhythms during treatment with Sunitynib Adamed.
• If the patient has recently had blood clots in the veins and/or arteries (a type of blood vessel), 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.
• 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 (thrombotic microangiopathy).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 problems.Sunitynib Adamed may cause thyroid problems. The patient should tell their doctor if they feel tired, feel colder than others, or experience a deepening of their voice during treatment with Sunitynib Adamed. The doctor should check thyroid function before starting treatment with Sunitynib Adamed and regularly during treatment. If the thyroid does not produce enough thyroid hormone, the patient may be treated with replacement thyroid hormone.
• If the patient has or has had pancreatic disorders or problems with the gallbladder.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 Sunitynib Adamed: itching, yellowing of the eyes or skin, dark urine, and pain or discomfort in the right upper abdomen. The doctor should order blood tests to check liver function before starting treatment with Sunitynib Adamed, during treatment, and if there are clinical signs.

The doctor will monitor kidney function if the patient has or has had kidney disease.
If the patient is going to have surgery or has recently had surgery, Sunitynib Adamed may affect wound healing. The medicine is usually discontinued in patients before surgery. The doctor will decide when to restart Sunitynib Adamed.

• The patient is advised to have a dental check-up before starting treatment with Sunitynib Adamed:
• 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 immediately contact their doctor if they experience symptoms of infection around skin damage, including fever, pain, redness, swelling, or discharge of pus or blood. These disorders usually resolve after discontinuation of Sunitynib Adamed. During treatment with this medicine, severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) have been observed, which initially appear as reddened spots with a target-like shape or round spots, often with centrally located blisters. The rash can transform into extensive blisters or skin peeling and can be life-threatening. If the patient experiences a rash or the above-mentioned skin symptoms, they should immediately consult their doctor.
• 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 vision loss.
• If the patient has diabetes.In patients with diabetes, blood sugar levels should be regularly checked to assess whether it is necessary to adjust the dose of the antidiabetic medication to minimize the risk of hypoglycemia. The patient should inform their doctor as soon as possible if they experience symptoms related to low blood sugar (fatigue, palpitations, excessive sweating, hunger, and loss of consciousness).

Children and adolescents

Sunitynib Adamed is not recommended for patients under 18 years of age.

Sunitynib Adamed and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, including those that are available without a prescription, as well as any medicines they plan to take.
Some medicines may affect the levels of Sunitynib Adamed in the body. The patient should inform their doctor if they 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 in various diseases (such as allergic disorders 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 disorders.

Taking Sunitynib Adamed with food and drink

During treatment with Sunitynib Adamed, the patient should not drink grapefruit juice.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Women who may become pregnant should use effective contraception during treatment with Sunitynib Adamed.
Women who are breastfeeding should inform their doctor. They should not breastfeed while taking Sunitynib Adamed.

Driving and using machines

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

Sunitynib Adamed contains mannitol

It may have a mild laxative effect.

3. How to take Sunitynib Adamed

This medicine should always be taken exactly as prescribed by the doctor. If the patient has any doubts, they should consult their doctor.
The doctor will prescribe a dose suitable for the individual patient, 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.

The doctor will determine the appropriate dose for the individual patient and the end of treatment with Sunitynib Adamed.
Sunitynib Adamed can be taken with or without food.

Taking more than the recommended dose of Sunitynib Adamed

If the patient has taken too many capsules, they should contact their doctor immediately.
Medical intervention may be necessary.

Missing a dose of Sunitynib Adamed

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

4. Possible side effects

Like all medicines, Sunitynib Adamed 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 Sunitynib Adamed):
Heart problems.The patient should tell their doctor if they feel very tired, experience 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.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 move to the lungs.
Kidney problems.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 Sunitynib Adamed: stomach pain (abdomen); vomiting blood; black and 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.The patient should tell their doctor if they experience severe abdominal pain, fever, nausea, vomiting, blood in the stool, or changes in bowel movements.
Other side effects of 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.
• 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, taste disturbances, stomach upset, nausea, vomiting, diarrhea, constipation, abdominal pain, and/or swelling, loss of and/or decreased appetite.
• Decreased thyroid activity (hypothyroidism).
• Dizziness.
• Headache.
• Nosebleeds.
• Back pain, joint pain.
• Pain in the arms and legs.
• Yellowing of the skin and/or discoloration, excessive skin pigmentation, hair color changes, rash on the palms and soles, rash, dry skin.
• Cough.
• Fever.
• Sleep disturbances.

Common: 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.
• Decreased amount of blood pumped by the heart.
• Fluid accumulation, including in the lungs.
• Infections.
• A complication of a severe infection (sepsis) that can lead to tissue damage, organ failure, and death.
• Decreased 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, gum bleeding, difficulty swallowing, or loss of swallowing ability.
• Burning sensation or pain in the mouth, inflammation of the mucous membrane of the digestive system, 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, feeling of nasal congestion.
• Excessive tearing.
• Skin sensitivity disorders, itching, peeling, and inflammation of the skin, blisters, acne, nail discoloration, hair loss.
• Sensitivity disorders in the limbs.
• Disorders related to increased or decreased sensitivity, especially to touch.
• Heartburn.
• Dehydration.
• Hot flashes.
• Abnormal urine color.
• Depression.
• Chills.

Uncommon: may affect up to 1 in 100 people

• Life-threatening infection of soft tissues, including the perianal and genital area (see section 2).
• Stroke.
• Heart attack caused by interruption or reduction of blood supply to the heart.
• Changes in the electrical activity or rhythm of the heart.
• Fluid accumulation around the heart (pericardial effusion).
• Liver failure.
• Abdominal 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.
• Pain in the mouth, 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 resting metabolism.
• Abnormal wound healing after surgery.
• Increased activity of the muscle enzyme (creatine phosphokinase) in the blood.
• Excessive reaction to allergens, including fever, skin rash, itching, hives, swelling of any part of the body, and difficulty breathing.
• Inflammation of the large intestine (colitis, ischemic colitis).

Rare: may affect up to 1 in 1000 people

• Severe skin and/or mucous membrane reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme).
• Tumor lysis syndrome, 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, lack of urine clarity, 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 cause kidney disease (rhabdomyolysis).
• Abnormal changes in the brain, which can cause a syndrome of symptoms including headache, disorientation, seizures, and vision loss (reversible posterior leukoencephalopathy syndrome).
• Painful skin ulcers (pyoderma gangrenosum).
• Hepatitis.
• Thyroid inflammation.
• Damaged smallest blood vessels (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).

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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, it is possible to gather more information on the safety of the medicine.

5. How to store Sunitynib Adamed

• The medicine should be stored out of sight and reach of children.
• The medicine should not be used after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month stated.
• There are no special storage instructions for the medicine.
• The medicine should not be used if 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. 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 packaging and other information

What Sunitynib Adamed contains

• The active substance of the medicine is sunitinib (in the form of sunitinib malate).

Sunitynib Adamed 12.5 mg hard capsules

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

• Capsule content:Mannitol Croscarmellose sodium 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.
The other ingredients are:

• Capsule content:Mannitol Croscarmellose sodium 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.
The other ingredients are:

• Capsule content:Mannitol Croscarmellose sodium 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.
The other ingredients are:

• Capsule content:Mannitol Croscarmellose sodium 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 capsulesare red, opaque, hard gelatin capsules with a red body and red cap.
Sunitynib Adamed 25 mg hard capsulesare red, opaque, hard gelatin capsules with a red body and orange cap.
Sunitynib Adamed 37.5 mg hard capsulesare yellow, opaque, hard gelatin capsules with a yellow body and yellow cap.
Sunitynib Adamed 50 mg hard capsulesare orange, opaque, hard gelatin capsules with an orange body and orange cap.
The medicine is available in blisters containing 28 capsules in a cardboard box.

Marketing authorization 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 authorized in the Member States of the EEA under the following names:

Greece
Sunitinib/ Ariti
Poland
Sunitynib Adamed

Date of last revision of the leaflet: 06.2022