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

It is essential to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, the patient 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 inform 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. Package contents 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 specific group of proteins known to be involved in the growth and spread of cancer cells.

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

• Gastrointestinal stromal tumors (GISTs), a type of stomach and intestinal 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 the patient has any questions about how Sunitinib Medical Valley works or why it has been prescribed, they should consult their doctor.

2. Important information before taking Sunitinib Medical Valley

When not to take Sunitinib Medical Valley

• 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 Medical Valley, the patient should discuss it with their doctor.

If the patient has high blood pressure. Sunitinib Medical Valley may increase blood pressure. The doctor may check the patient's blood pressure during treatment with Sunitinib Medical Valley, and the patient 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 Sunitinib Medical Valley 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 medicines used to prevent blood clots, there may be a higher risk of bleeding. The patient should tell their doctor about any bleeding during treatment with Sunitinib Medical Valley.
• If the patient has heart problems. Sunitinib Medical Valley may cause heart problems. The patient should tell their doctor if they experience extreme fatigue, shortness of breath, or swelling of the feet or ankles.
• If the patient has heart rhythm disorders. Sunitinib Medical Valley may cause abnormal heart rhythms. During treatment with Sunitinib Medical Valley, 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 while taking Sunitinib Medical Valley.
• If the patient has recently had blood clots in the veins and/or arteries, 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 a blood vessel wall) or a tear in the blood vessel wall.
• If the patient has or has had thrombotic microangiopathy (a condition characterized by the formation of blood clots in small blood vessels). 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. Sunitinib Medical Valley may cause thyroid problems. The patient should tell their doctor if they become easily tired, feel colder than others, or experience a deepened voice while taking Sunitinib Medical Valley. The doctor should check the patient's thyroid function before starting treatment with Sunitinib Medical Valley and regularly during treatment. If the thyroid does not produce enough thyroid hormone, the patient may need to be treated with replacement thyroid hormone.
• If the patient has or has had pancreatic or gallbladder disorders. 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 disorders: itching, yellowing of the eyes or skin, dark urine, or pain or discomfort in the right upper abdomen. The doctor should perform blood tests to check liver function before starting treatment with Sunitinib Medical Valley, during treatment, and if there are clinical signs.

The doctor will monitor the patient's kidney function.

• If the patient is going to have surgery or has recently had surgery. Sunitinib Medical Valley may affect wound healing. The medicine is usually stopped in patients before surgery. The doctor will decide when to restart Sunitinib Medical Valley.
• The patient is advised to have a dental check-up before starting treatment with Sunitinib Medical Valley

Sunitinib Medical Valley:

• If the patient experiences 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, they should immediately inform their doctor and dentist.
• If the patient requires invasive dental treatment or surgery, they should inform their dentist about taking Sunitinib Medical Valley, especially if they are also taking or have taken intravenous 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. 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 sunitinib. During treatment with 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 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 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 anti-diabetic medicine needs to be adjusted to minimize the risk of low blood sugar. The patient should inform their doctor as soon as possible if they experience symptoms of 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

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or might take, including those obtained without a prescription.

• Ketoconazole, 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

The patient should not drink grapefruit juice while taking Sunitinib Medical Valley.

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 Sunitinib Medical Valley.

Women who are breastfeeding should inform their doctor. They should not breastfeed while taking Sunitinib Medical Valley.

Driving and using machines

If the patient experiences dizziness or extreme fatigue, they should be cautious 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 essentially "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 the doctor. If the patient is unsure, they should consult their doctor.

The doctor will prescribe the 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.
• For patients being treated for 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 date of 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 the patient takes too many capsules, they should contact their doctor immediately. Medical intervention may be necessary.

Missing a dose of Sunitinib Medical Valley

The patient 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.

The patient should contact their doctor immediately if they experience any of the following serious side effects (see also section "Important information before taking Sunitinib Medical Valley"): Heart problems. The patient should tell their doctor if they 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. 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 inability to urinate, 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 Sunitinib Medical Valley: stomach pain or 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. The patient should tell their doctor if they 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 cell count, and/or white blood cell count (e.g., neutrophils).
• Shortness of breath.
• High blood pressure.
• Extreme fatigue, weakness.
• 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 of appetite.
• Decreased thyroid activity (hypothyroidism).
• Dizziness.
• Headache.
• Nosebleeds.
• Back pain, joint pain.
• Arm and leg pain.
• Yellowing and/or discoloration of the skin, excessive pigmentation of the skin, hair color changes, palmar-plantar erythrodysesthesia, 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 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, 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 perianal area (see section 2).
• Stroke.
• Heart attack caused by a blockage or narrowing of the coronary arteries.
• Changes in heart rhythm or electrical activity.
• 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, 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, 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 changes in the brain, which can cause a syndrome of symptoms including headache, disorientation, seizures, and loss of vision (reversible posterior leukoencephalopathy syndrome).
• Painful skin ulcers (pyoderma gangrenosum).
• Hepatitis.
• Thyroid inflammation.
• Damage to the smallest blood vessels, known as thrombotic microangiopathy.

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

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

Reporting side effects

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

5. How to store Sunitinib Medical Valley

• 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 or 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 shows signs of tampering.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents 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 supplied 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 yellow to orange granules.

Sunitinib Medical Valley 25 mg is supplied 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 yellow to orange granules.

Sunitinib Medical Valley 37.5 mg is supplied 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 yellow to orange granules.

Sunitinib Medical Valley 50 mg is supplied 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 yellow to orange granules.

The medicine is available in cardboard boxes containing blisters of PVC/PCTFE/Aluminum 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.