Sunitinib Medical Vallei

Leaflet accompanying the packaging: patient information

Sunitinib Medical Valley, 12.5 mg, hard capsules

Sunitinib Medical Valley, 25 mg, hard capsules Sunitinib Medical Valley, 37.5 mg, hard capsules

Sunitinib Medical Valley, 50 mg, hard capsules

Sunitinib

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 specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms 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 Sunitinib Medical Valley and what is it used for
• 2. Important information before taking Sunitinib Medical Valley
• 3. How to take Sunitinib Medical Valley
• 4. Possible side effects
• 5. How to store Sunitinib Medical Valley
• 6. Contents of the packaging and other information

1. What is Sunitinib Medical Valley and what is it used for

Sunitinib Medical Valley contains the active substance sunitinib, which is a protein kinase inhibitor. Sunitinib Medical Valley is used to treat cancer. It inhibits the activity of a special group of proteins known to participate in the growth and spread of cancer cells.

Sunitinib Medical Valley is used to treat the following types of cancer in adults:

• Gastrointestinal stromal tumor (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 Sunitinib Medical Valley works or why it has been prescribed, you should consult your doctor.

2. Important information before taking Sunitinib Medical Valley

When not to take Sunitinib Medical Valley

Warnings and precautions

Before starting treatment with Sunitinib Medical Valley, you should discuss it with your doctor.

If you have high blood pressure. Sunitinib Medical Valley may increase blood pressure. Your doctor may take blood pressure measurements during treatment with Sunitinib Medical Valley, and you may need to be treated with blood pressure-lowering medications if necessary.

• If you have or have had blood diseases, bleeding, or bruising. Treatment with Sunitinib Medical Valley may increase the risk of bleeding or change 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 medications used to prevent blood clots, there may be a higher risk of bleeding. You should tell your doctor about all bleeding episodes while taking Sunitinib Medical Valley.
• If you have heart problems. Sunitinib Medical Valley 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 you have heart rhythm disorders. Sunitinib Medical Valley may cause abnormal heart rhythms. During treatment with Sunitinib Medical Valley, your doctor may perform an electrocardiogram to assess these disorders. You should tell your doctor if you experience dizziness, fainting, or abnormal heart rhythms while taking Sunitinib Medical Valley.
• If you have 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, numbness or weakness on one side of the body, difficulty speaking, headache, or dizziness while taking Sunitinib Medical Valley.
• If you have or have had an aneurysm (enlargement and weakening of the blood vessel wall) or a tear in the blood vessel wall.
• If you have or have had microangiopathic thrombocytopenic purpura (a condition characterized by the formation of blood clots in small blood vessels). You should tell your doctor if you experience fever, fatigue, weakness, bruising, bleeding, swelling, disorientation, loss of vision, or seizures.
• If you have thyroid problems. Sunitinib Medical Valley may cause thyroid problems. You should tell your doctor if you easily get tired, feel colder than others, or experience a deepened voice while taking Sunitinib Medical Valley. Your doctor should check your thyroid function before starting treatment with Sunitinib Medical Valley and regularly during treatment. If your thyroid does not produce enough thyroid hormone, you may need to be treated with replacement thyroid hormone.
• If you have or have had pancreatic or gallbladder problems. You should tell your doctor if you experience any of the following symptoms: stomach pain (upper abdomen), nausea, vomiting, and fever. These may be symptoms of pancreatitis or gallbladder inflammation.
• If you have or have had liver disease. You should inform your doctor if you experience any of the following symptoms of liver disorders while taking Sunitinib Medical Valley: itching, yellowing of the eyes or skin, dark urine, or pain and discomfort in the right upper abdomen. Your doctor should order blood tests to check liver function before starting treatment with Sunitinib Medical Valley, during treatment, and if there are clinical signs.

Your doctor will monitor your kidney function.

• If you are going to have surgery or have recently had surgery. Sunitinib Medical Valley may affect wound healing. The medicine is usually discontinued in patients before surgery. Your doctor will decide when to restart Sunitinib Medical Valley.
• It is recommended that you have a dental check-up before starting treatment with Sunitinib Medical Valley

Sunitinib Medical Valley:

• If you have or have had skin and subcutaneous tissue disorders. While taking this medicine, you may experience 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 symptoms of infection around a skin lesion, including fever, pain, redness, swelling, or discharge of pus or blood. These disorders usually resolve after discontinuation of sunitinib. While taking sunitinib, severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) have been observed, which initially appear as reddened patches with a target-like shape or round 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 you have or have had seizures. You should inform your doctor as soon as possible if you experience high blood pressure, headache, or loss of vision.
• If you have diabetes. In patients with diabetes, blood sugar levels should be regularly checked to assess whether it is necessary to adjust the dose of the anti-diabetic medication 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

Sunitinib Medical Valley is not recommended for patients under 18 years of age.

Sunitinib Medical Valley and other medicines

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take, including those obtained without a prescription and those that have not been prescribed before.

Some medicines may affect the levels of Sunitinib Medical Valley 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 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.

Sunitinib Medical Valley with food and drink

While taking Sunitinib Medical Valley, you should not drink grapefruit juice.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before taking this medicine.

Women who may become pregnant should use effective contraception during treatment with Sunitinib Medical Valley.

Breastfeeding women should inform their doctor. You should not breastfeed while taking Sunitinib Medical Valley.

Driving and using machines

If you experience dizziness or extreme fatigue, you should be careful while driving or operating machinery.

Sunitinib Medical Valley contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means it is considered "sodium-free".

Sunitinib Medical Valley 37.5 mg contains orange yellow FCF and tartrazine

Sunitinib Medical Valley 37.5 mg contains orange yellow FCF (E 110) and tartrazine (E 102), which may cause allergic reactions.

3. How to take Sunitinib Medical Valley

This medicine should always be taken as directed 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 appropriate dose for you and when to stop treatment with Sunitinib Medical Valley.

Sunitinib Medical Valley can be taken with or without food.

Taking a higher dose of Sunitinib Medical Valley than recommended

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

Missing a dose of Sunitinib Medical Valley

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

4. Possible side effects

Like all medicines, Sunitinib Medical Valley can cause side effects, although not everybody gets them.

You should contact your doctor immediately if you experience any of the following serious side effects (see also section "Important information before taking Sunitinib Medical Valley"): 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 or breathing problems. 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 move to the lungs.

Kidney problems. You should tell your doctor if you experience disturbed or absent urination, which may be a sign of kidney failure.

Bleeding. You should tell your doctor if you experience any of the following symptoms or severe bleeding while taking Sunitinib Medical Valley: stomach pain and swelling; 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. You should tell your doctor if you experience severe stomach pain, fever, nausea, vomiting, blood in the stool, or changes in bowel movements.

Other side effects of Sunitinib Medical Valley 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.
• Pain and/or irritation in the mouth, painful ulcers and/or inflammation and/or dryness of the mouth mucosa, taste disorders, stomach disorders, nausea, vomiting, diarrhea, constipation, abdominal pain and/or swelling, loss and/or decreased appetite.
• Decreased thyroid activity (hypothyroidism).
• Dizziness.
• Headache.
• Nosebleeds.
• Back pain, joint pain.
• Pain in the arms and legs.
• Yellowing and/or discoloration of the skin, excessive pigmentation of the skin, hair color changes, rash on the palms and soles, rash, dry skin.
• Coughing.
• Fever.
• Sleep disorders.

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 severe infection (sepsis), which can lead to tissue damage, organ failure, and death.
• Decreased blood sugar levels (see section 2).
• Protein loss in the urine, sometimes causing swelling.
• Flu-like 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 tongue, inflammation of the mucous membrane of the digestive tract, excessive gas in the stomach or intestines.
• Weight loss.
• Musculoskeletal pain (muscle and bone pain), muscle weakness, muscle fatigue, muscle cramps.
• Dryness of the nasal mucosa, feeling of nasal congestion.
• Excessive tearing.
• Skin sensation disorders, itching, peeling and inflammation of the skin, blisters, acne, nail discoloration, hair loss.
• Sensation 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 anal and genital area (see section 2).
• Stroke.
• Heart attack caused by interruption or narrowing of the coronary arteries.
• Changes in heart electrical activity or rhythm disorders.
• Fluid accumulation around the heart (pericardial effusion).
• Liver failure.
• Stomach pain (abdominal pain) caused by pancreatitis.
• Tumor lysis syndrome 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 with the skin.
• Mouth pain, toothache, and/or jaw pain, swelling or ulceration of the mouth, 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.
• Impaired wound healing after surgery.
• Increased 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).

Rare: may affect up to 1 in 1000 people

• Severe skin and mucous membrane reaction (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 damage and acute kidney failure.
• Abnormal muscle breakdown, which can cause kidney disease (rhabdomyolysis).
• Abnormal brain changes, which 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 gland inflammation.
• Damage to the smallest blood vessels, known as microangiopathic thrombocytopenic purpura.

Unknown (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 be signs of the toxic effect of high ammonia levels in the blood on the brain (hyperammonemic encephalopathy).

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your 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 181 C, 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, you can help provide more information on the safety of this medicine.

5. How to store Sunitinib Medical Valley

• 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 or blister after "EXP". The expiry date refers to the last day of the month stated.
• There are no special storage instructions for this medicine.
• 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 Sunitinib Medical Valley contains

Sunitinib Medical Valley, 12.5 mg, hard capsules

The active substance is sunitinib. Each capsule contains sunitinib malate, equivalent to 12.5 mg of sunitinib.

Other ingredients are:

• Capsule content: povidone (K-25), mannitol, sodium croscarmellose, magnesium stearate.
• Capsule shell: gelatin, iron oxide red (E 172), titanium dioxide (E 171), iron oxide black (E 172).
• Printing ink: shellac, propylene glycol, sodium hydroxide, povidone, titanium dioxide (E 171).

Sunitinib Medical Valley, 25 mg, hard capsules

The active substance is sunitinib. Each capsule contains sunitinib malate, equivalent to 25 mg of sunitinib.

Other ingredients are:

• Capsule content: povidone (K-25), mannitol, sodium croscarmellose, magnesium stearate.
• Capsule shell: gelatin, titanium dioxide (E 171), iron oxide red (E 172), iron oxide black (E 172), iron oxide yellow (E 172).
• Printing ink: shellac, propylene glycol, sodium hydroxide, povidone, titanium dioxide (E 171).

Sunitinib Medical Valley, 37.5 mg, hard capsules

The active substance is sunitinib. Each capsule contains sunitinib malate, equivalent to 37.5 mg of sunitinib.

Other ingredients are:

• Capsule content: povidone (K-25), mannitol, sodium croscarmellose, magnesium stearate.
• Capsule shell: gelatin, titanium dioxide (E 171), orange yellow FCF (E 110), tartrazine (E 102).
• Printing ink: shellac, propylene glycol, ammonium hydroxide, iron oxide black (E 172), potassium hydroxide.

Sunitinib Medical Valley, 50 mg, hard capsules

The active substance is sunitinib. Each capsule contains sunitinib malate, equivalent to 50 mg of sunitinib.

Other ingredients are:

• Capsule content: povidone (K-25), mannitol, sodium croscarmellose, magnesium stearate.
• Capsule shell: gelatin, titanium dioxide (E 171), iron oxide yellow (E 172), iron oxide red (E 172), iron oxide black (E 172).
• Printing ink: shellac, propylene glycol, sodium hydroxide, povidone, titanium dioxide (E 171).

What Sunitinib Medical Valley looks like and contents of the pack

Sunitinib Medical Valley 12.5 mg is provided in the form of hard capsules with a dark brown, opaque cap and a dark brown, opaque body, 13.8-14.8 mm in size, with a white print "LP" on the cap and "650" on the body, containing granules of yellow to orange color.

Sunitinib Medical Valley 25 mg is provided in the form of hard capsules with a light brown, opaque cap and a dark brown, opaque body, 15.4-16.4 mm in size, with a white print "LP" on the cap and "651" on the body, containing granules of yellow to orange color.

Sunitinib Medical Valley 37.5 mg is provided in the form of hard capsules with a yellow, opaque cap and a yellow, opaque body, 17.5-18.5 mm in size, with a black print "LP" on the cap and "652" on the body, containing granules of yellow to orange color.

Sunitinib Medical Valley 50 mg is provided in the form of hard capsules with a light brown, opaque cap and a light brown, opaque body, 17.5-18.5 mm in size, with a white print "LP" on the cap and "653" on the body, containing granules of yellow to orange color.

The medicine is available in cardboard boxes containing blisters of PVC/PCTFE/Aluminum foil with 28 hard capsules in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder

Medical Valley Invest AB

Brädgårdsvägen 28

236 32 Höllviken

Sweden

Manufacturer/Importer

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park

Paola PLA 3000

Malta

Adalvo Limited

Malta Life Sciences Park, Building 1, Level 4

Sir Temi Zammit Buildings

SGN 3000 San Gwann

Malta

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

Iceland:

Sunitinib Medical Valley 12.5/25/37.5/50 mg hard capsules

Sweden:

Sunitinib Medical Valley 12.5/25/37.5/50 mg hard capsules

Denmark:

Sunitinib Medical Valley 12.5/25/37.5/50 mg hard capsules

Norway:

Sunitinib Medical Valley 12.5/25/37.5/50 mg hard capsules

Poland:

Sunitinib Medical Valley

Date of last revision of the leaflet:08/2024

Other sources of information

Detailed information on this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products.