Sunitinib medical valley: detailed information

Package leaflet: Information for the patient

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
Sunitinibum
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, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If you experience any side effects, including any not listed in this leaflet, tell your doctor. See section 4.

Contents of the leaflet

What Sunitinib Medical Valley is and what it is used for
Important information before taking Sunitinib Medical Valley
How to take Sunitinib Medical Valley
Possible side effects
How to store Sunitinib Medical Valley
Contents of the pack and other information

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

Sunitinib Medical Valley contains sunitinib as the active substance, which is a protein kinase inhibitor. Sunitinib Medical Valley 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.
Sunitinib Medical Valley is used in the treatment of the following types of cancer in adults:

Gastrointestinal stromal tumours (GIST), a type of stomach and intestinal tumour, 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 Sunitinib Medical Valley works or why this medicine has been prescribed, please consult your doctor.

2. Important information before taking Sunitinib Medical Valley

When not to take Sunitinib Medical Valley

If you are allergic to sunitinib or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting Sunitinib Medical Valley, discuss the following with your doctor.

If you have or have had high blood pressure. Sunitinib Medical Valley may increase blood pressure. Your doctor may monitor your blood pressure during treatment with Sunitinib Medical Valley, and you may need to be treated with medicines to lower blood pressure if necessary.
If you have or have had blood disorders, bleeding or bruising. Treatment with Sunitinib Medical Valley may increase the risk of bleeding or alter the number of certain blood cells, which may lead to 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 about any bleeding episodes while taking Sunitinib Medical Valley.
If you have heart problems. Sunitinib Medical Valley may cause heart-related issues. Inform your doctor if you experience extreme fatigue, shortness of breath, or swelling in your feet or ankles.
If you have heart rhythm disorders. Sunitinib Medical Valley may cause irregular heart rhythms. Your doctor may perform an electrocardiogram (ECG) during treatment to monitor for such disturbances. Inform your doctor if you experience dizziness, fainting, or irregular heartbeat while taking Sunitinib Medical Valley.
If you have 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 Sunitinib Medical Valley, 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 weakened and enlarged blood vessel wall) or arterial dissection.
If you have or have had damage to the smallest blood vessels, known as thrombotic microangiopathy. Inform your doctor if you develop fever, fatigue, weakness, bruising, bleeding, swelling, confusion, vision loss, or seizures.
If you have or have had thyroid problems. Sunitinib Medical Valley may affect thyroid function. Inform your doctor if you feel unusually tired, feel colder than others, or experience voice changes while taking Sunitinib Medical Valley. Your doctor should check your thyroid function before starting treatment and regularly during therapy. If your thyroid does not produce enough thyroid hormone, you may require thyroid hormone replacement therapy.
If you have or have had pancreatic or gallbladder problems. Inform your doctor if you experience any of the following symptoms: stomach pain (upper abdomen), nausea, vomiting, or fever. These may be signs of pancreatitis or cholecystitis.
If you have or have had liver disease. Inform your doctor if, during treatment with Sunitinib Medical Valley, you develop any of the following signs of liver problems: itching, yellowing of the eyes or skin (jaundice), dark urine, or pain or discomfort in the upper right abdomen. Your doctor should order blood tests to monitor liver function before starting Sunitinib Medical Valley, during treatment, and whenever clinically indicated.
If you have or have had kidney disease. Your doctor will monitor kidney function.
If you are scheduled for surgery or have recently undergone surgery. Sunitinib Medical Valley may affect wound healing. The medicine is usually discontinued before surgery. Your doctor will decide when to restart Sunitinib Medical Valley.
You are advised to have a dental examination before starting treatment with Sunitinib Medical Valley:
- If you experience mouth pain, tooth or jaw pain, swelling or ulceration in 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 Medical Valley, especially if you are also taking or have previously taken intravenous bisphosphonates. Bisphosphonates are medicines used to prevent bone problems, which may be taken for other conditions.
If you have or have had skin and subcutaneous tissue disorders. While taking this medicine, pyoderma gangrenosum (painful skin ulceration) or necrotizing fasciitis (a rapidly spreading and potentially life-threatening skin and/or soft tissue infection) may occur. Contact your doctor immediately if you develop signs of infection around a skin lesion, including fever, pain, redness, swelling, or pus or blood discharge. These conditions usually resolve after discontinuation of sunitinib. Severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) have been observed during sunitinib treatment. These initially appear as red, target-like or circular 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 immediate medical attention.
If you have or have had seizures. Inform your doctor as soon as possible if you develop high blood pressure, headache, or vision loss.
If you have 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 you experience symptoms of low blood sugar (fatigue, palpitations, excessive sweating, hunger, or loss of consciousness).

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

Sunitinib Medical Valley with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take, including over-the-counter medicines and those not previously prescribed.
Some medicines may affect the concentration of Sunitinib Medical Valley in your 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 diseases (such as allergic and/or respiratory disorders or skin conditions),
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.

Sunitinib Medical Valley with food and drink
Do not drink grapefruit juice while taking Sunitinib Medical Valley.

Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.
Women of childbearing potential should use an effective method of contraception during treatment with Sunitinib Medical Valley.
Women who are breastfeeding should inform their doctor. Breastfeeding must not be undertaken while taking Sunitinib Medical Valley.

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

Sunitinib Medical Valley contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., it is considered "sodium-free".

Sunitinib Medical Valley 37.5 mg contains sunset yellow FCF and tartrazine.
Sunitinib Medical Valley 37.5 mg contains sunset 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. In case of doubt, consult
your doctor.
The doctor will prescribe the dose appropriate for the individual patient, depending on the type of tumour.
For patients being 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 break, 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 the individual patient and the time when treatment with
Sunitinib Medical Valley should end.
Sunitinib Medical Valley may be taken with food or on an empty stomach.
Taking more Sunitinib Medical Valley than prescribed
If too many capsules are taken, contact your doctor immediately.
Medical intervention may be necessary.
Missing a dose of Sunitinib Medical Valley
Do not take a double dose to make up for a missed dose.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Contact a doctor immediately if the patient experiences any of the following serious adverse effects (see also section "Important information before taking Sunitinib Medical Valley"):

Heart problems. Tell 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 could include heart failure or problems with the heart muscle (cardiomyopathy).

Lung or breathing problems. Tell the doctor if the patient develops cough, chest pain, sudden shortness of breath, or coughs up blood. These may be symptoms of a condition called pulmonary embolism, which occurs when blood clots travel to the lungs.

Kidney function disorders. Tell the doctor if the patient experiences changes in frequency or absence of urination, which may be signs of kidney failure.

Bleeding. Tell the doctor if the patient experiences any of the following symptoms or severe bleeding while being treated with Sunitinib Medical Valley: 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 bowel perforation. Tell the doctor if the patient experiences severe abdominal pain, fever, nausea, vomiting, blood in the stool, or changes in bowel function.

Other adverse effects of Sunitinib Medical Valley may include:

Very common: may affect more than 1 in 10 people

Decreased platelet, red blood cell, and/or white blood cell (e.g. neutrophil) counts.
Shortness of breath.
Hypertension.
Extreme fatigue, loss of strength.
Swelling due to fluid accumulation under the skin and around the eyes, allergic rash.
Pain and/or irritation in the mouth, painful mouth ulcers and/or inflammation and/or dryness of the oral mucosa, taste disturbances, stomach discomfort, 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 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 up to 1 in 10 people

Blood clots in blood vessels.
Inadequate blood supply to the heart due to blockage 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.
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 the blood.
Haemorrhoids, rectal pain, bleeding gums, difficulty swallowing or loss of swallowing ability.
Burning or painful sensation in the tongue, inflammation of the gastrointestinal mucosa, 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, 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 up to 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 (pancreatitis).
Tumour lysis leading to bowel 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.
Mouth 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 wound healing after surgical procedures.
Increased activity of muscle enzyme (creatine phosphokinase) in blood.
Severe allergic reactions, including hay fever, skin rash, itching, hives, swelling of any body part, and breathing difficulties.
Inflammation of the large intestine (colitis, ischemic colitis).

Rare: may affect up to 1 in 1000 people

Severe skin and/or mucosal reaction (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 the breakdown products of dying tumour cells and may include: nausea, shortness of breath, irregular heartbeat, muscle twitching, seizures, cloudy urine, and fatigue associated with abnormal laboratory test results (high levels of potassium, uric acid, and phosphate, and low calcium levels in the blood), which may lead to kidney changes and acute kidney failure.
Abnormal muscle breakdown that may lead to kidney disease (rhabdomyolysis).
Abnormal changes in the brain that may cause a syndrome 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.

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 indicate toxic effects of high blood ammonia levels on the brain (hyperammonaemic encephalopathy).

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Adverse effects 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 181 C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Sunitinib Medical Valley

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or blister pack following "Expiry date (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 signs of prior tampering.

Medicines should 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 pack 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 contents: 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 contents: 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).
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 contents: 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, concentrated 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 contents: 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 as hard capsules with a dark brown, opaque cap and a dark brown, opaque body, 13.8–14.8 mm in size, printed in white with “LP” on the cap and “650” on the body, containing granules of yellow to orange colour.
Sunitinib Medical Valley 25 mg is supplied as hard capsules with a light brown, opaque cap and a dark brown, opaque body, 15.4–16.4 mm in size, printed in white with “LP” on the cap and “651” on the body, containing granules of yellow to orange colour.
Sunitinib Medical Valley 37.5 mg is supplied as hard capsules with a yellow, opaque cap and a yellow, opaque body, 17.5–18.5 mm in size, printed in black ink with “LP” on the cap and “652” on the body, containing granules of yellow to orange colour.
Sunitinib Medical Valley 50 mg is supplied as hard capsules with a light brown, opaque cap and a light brown, opaque body, 17.5–18.5 mm in size, printed in white with “LP” on the cap and “653” on the body, containing granules of yellow to orange colour.
The medicine is available in cardboard boxes containing PVC/PCTFE/Aluminium foil blisters with 28 hard capsules in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 authorised in the European Economic Area countries under the following names:
Iceland: Sunitinib Medical Valley 12.5/25/37.5/50 mg hörð hylki
Sweden: Sunitinib Medical Valley 12.5/25/37.5/50 mg hårda kapslar
Denmark: Sunitinib Medical Valley 12.5/25/37.5/50 mg hårde kapsler
Norway: Sunitinib Medical Valley 12.5/25/37.5/50 mg harde kapsler
Poland: Sunitinib Medical Valley

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.