Sunitinib msn

Package leaflet: Information for the user

Sunitinib MSN, 12.5 mg, hard capsules
Sunitinib MSN, 25 mg, hard capsules
Sunitinib MSN, 37.5 mg, hard capsules
Sunitinib MSN, 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. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm someone else even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor. See section 4.

Leaflet contents:

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

1. What Sunitinib MSN is and what it is used for

Sunitinib MSN contains the active substance sunitinib, which is a protein kinase inhibitor.
This medicine is used in the treatment of cancers by preventing the activity of a specific group of proteins known to be involved in the growth and spread of cancer cells.
Sunitinib MSN is used to treat the following types of cancer in adults:

• Gastrointestinal stromal tumours (GIST), a type of stomach and intestinal cancer, 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 or cannot be surgically removed.

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

2. Important information before using Sunitinib MSN

When not to use Sunitinib MSN

• 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 MSN, discuss the following with your doctor:

• If the patient has high blood pressure. Sunitinib MSN may increase blood pressure. Your doctor may monitor your blood pressure during treatment with Sunitinib MSN, and you may be treated with antihypertensive medicines if necessary.
• If the patient has or has had blood disorders, bleeding or bruising. Treatment with Sunitinib MSN may increase the risk of bleeding or may 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, there may be an increased risk of bleeding. Inform your doctor about any bleeding episodes during treatment with Sunitinib MSN.
• If the patient has heart diseases. Sunitinib MSN may cause heart problems. Inform your doctor if the patient experiences extreme fatigue, shortness of breath, or swelling of the feet or ankles.
• If the patient has heart rhythm disorders. Sunitinib MSN may cause heart rhythm disturbances. During treatment with Sunitinib MSN, your doctor may perform an electrocardiogram (ECG) to assess these disturbances. Inform your doctor if the patient experiences dizziness, fainting, or irregular heartbeat during treatment with Sunitinib MSN.
• If the patient has recently had blood clots in the veins and/or arteries (types of blood vessels), including stroke, heart attack, embolism, or thrombosis. Contact your doctor immediately if, during treatment with Sunitinib MSN, 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 disorders. Sunitinib MSN may cause thyroid problems. Inform your doctor if the patient becomes easily tired, feels colder than usual, or experiences voice changes during treatment with Sunitinib MSN. Your doctor should check thyroid function before starting treatment with Sunitinib MSN 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 pancreatic disorders or gallbladder diseases. Inform your doctor if the patient experiences any of the following symptoms: stomach pain (upper abdomen), nausea, vomiting, or fever. These may be symptoms of pancreatitis or gallbladder inflammation.
• If the patient has or has had liver diseases. Inform your doctor if, during treatment with Sunitinib MSN, the patient experiences any of the following symptoms related to liver disease: itching, yellowing of the eyes or skin, dark urine, or pain or discomfort in the upper right part of the abdomen. Your doctor should perform blood tests to check liver function before starting treatment with Sunitinib MSN, during treatment, and if any clinical signs occur.
• If the patient has or has had kidney diseases. Your doctor will monitor the patient's kidney function.
• If the patient is scheduled for surgery or has recently undergone surgery. Sunitinib MSN may affect wound healing. Sunitinib MSN is usually discontinued before surgery. Your doctor will decide when to restart treatment with Sunitinib MSN.
• The patient is advised to have a dental examination before starting treatment with Sunitinib MSN:
• if the patient experiences oral pain, tooth or jaw pain, swelling or ulceration of 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 Sunitinib MSN, especially if also receiving or having received 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 skin lesions, including fever, pain, redness, swelling, or discharge of pus or blood. These conditions usually resolve after discontinuation of sunitinib treatment. Severe skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) have been observed during sunitinib treatment. These rashes 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 immediate medical advice.
• 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 promptly if the patient experiences symptoms of low blood sugar (fatigue, palpitations, excessive sweating, hunger, or loss of consciousness).

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

Sunitinib MSN 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 Sunitinib MSN in the body. Inform your doctor if the patient is taking medicines containing 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 to treat various disorders (such as allergies/respiratory disorders or skin diseases)
• phenytoin, carbamazepine, phenobarbital – used to treat epilepsy and other neurological disorders
• herbal preparations containing St. John's wort (Hypericum perforatum) – used to treat depression and anxiety.

Sunitinib MSN with food and drink
Do not drink grapefruit juice during treatment with Sunitinib MSN.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Female patients who could become pregnant should use an effective method of contraception during treatment with Sunitinib MSN.
Breastfeeding patients should inform their doctor. Breastfeeding must not be continued during treatment with Sunitinib MSN.

Driving and operating machinery
Exercise particular caution when driving or operating machinery if dizziness or significant fatigue occurs.

Sunitinib MSN contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. the medicine is considered "sodium-free".

3. How to take Sunitinib MSN

This medicine should always be taken exactly as prescribed by the doctor. If in doubt, consult the
doctor.
The doctor will prescribe the appropriate dose for the patient, depending on the type of tumour. For
patients being treated for:

• GIST or MRCC: the usual dose is 50 mg taken once daily for 28 days (4 weeks), followed by a 14-day (2-week) break (without medicine), 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 patient, as well as whether and when treatment with
Sunitinib MSN should be interrupted.
Sunitinib MSN may be taken with or without food.
Taking more Sunitinib MSN than prescribed
If the patient accidentally takes too many capsules, contact the doctor immediately. Medical assistance may be
necessary.
Missing a dose of Sunitinib MSN
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
severe adverse reactions (see also "Important information before taking Sunitinib MSN").
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 diseases or breathing difficulties. Inform the doctor if the patient develops
cough, chest pain, sudden onset of 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
urination frequency or absence of urination, which may be symptoms of kidney failure.
Bleeding. Inform the doctor if, during treatment with Sunitinib MSN, the patient experiences
any of the following symptoms or a serious bleeding problem: painful, swollen abdomen (belly);
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 rupture leading to bowel 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 during treatment with Sunitinib MSN may include:

Very common: may affect more than 1 in 10 people

• Decreased number of platelets, red blood cells, and/or white blood cells (e.g. neutrophils).
• Shortness of breath.
• High blood pressure.
• Extreme fatigue, loss of strength.
• Swelling due to fluid accumulation under the skin and around the eyes, deep allergic rash.
• Pain/irritation in the mouth, ulceration/inflammation/dryness of the oral mucosa, taste disturbances, stomach discomfort, nausea, vomiting, diarrhoea, constipation, abdominal pain/swelling, loss of appetite or reduced appetite.
• Reduced thyroid activity (hypothyroidism).
• Dizziness.
• Headache.
• Nosebleeds.
• Back pain, joint pain.
• Pain in arms and legs.
• Yellowing/discoloration of the skin, excessive skin pigmentation, change in hair colour, rash on palms and soles, rash, dry skin.
• Cough.
• Fever.
• Difficulty falling asleep.

Common: may affect less than 1 in 10 people

• Blood clots in blood vessels.
• Inadequate blood supply to the heart muscle 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.
• Severe infection complication (blood infection), which may lead to tissue damage, organ failure, and death.
• Low 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.
• Haemorrhoids, rectal pain, bleeding gums, difficulty swallowing or loss of swallowing ability.
• Burning sensation or pain 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 the limbs.
• Sensory disturbances related to increased or decreased sensitivity, especially to touch.
• Heartburn.
• Dehydration.
• Hot flashes.
• Abnormal urine colour.
• Depression.
• Chills.

Uncommon: may affect less than 1 in 100 people

• Life-threatening soft tissue infections, including around the anus and genital organs (see section 2).
• Stroke.
• Heart attack caused by interruption or reduction of blood flow to the heart.
• Changes in electrical function or irregular heart rhythm.
• Fluid around the heart (pericardial effusion).
• Liver failure.
• Stomach (abdominal) pain caused by inflammation of the pancreas.
• Tumour rupture leading to bowel perforation.
• Inflammation (swelling and 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 oral mucosa, numbness or heaviness in the jaw, or loose teeth. These may be symptoms of jawbone damage (osteonecrosis), see section 2.
• Excessive production of thyroid hormones leading to increased energy consumption by the body at rest.
• Impaired healing of surgical wounds.
• Increased activity of a muscle enzyme (creatine phosphokinase) in the blood.
• Excessive allergic reaction, including hay fever, skin rash, skin itching, hives, swelling of body parts, and breathing difficulties.
• Inflammation of the large intestine (colitis, ischemic colitis).

Rare: may affect less than 1 in 1,000 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 products released from dying cancer cells and may include: nausea, shortness of breath, irregular heartbeat, muscle cramps, seizures, cloudy urine, and laboratory test abnormalities (high levels of potassium, uric acid, and phosphate, and low calcium levels in the blood), which may lead to kidney function changes and acute kidney failure.
• Abnormal muscle breakdown that may lead to kidney problems (rhabdomyolysis).
• Abnormal changes in the brain that may cause various 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 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 reactions
If any adverse symptoms occur, including any adverse symptoms not listed
in this leaflet, inform the doctor. Adverse reactions 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 181C,
02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website:
https://smz.ezdrowie.gov.pl
By reporting adverse reactions, additional information on the safety of the medicine can be collected.
Adverse reactions can also be reported to the marketing authorisation holder.

5. How to store Sunitinib MSN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, bottle, and blister pack
after: EXP. The expiry date refers to the last day of the stated month.
Blister
Store below 30°C.
Bottle
Store below 25°C.
Do not use the medicine if the packaging is damaged or if there are signs of tampering.
Medicines must 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 MSN contains
The active substance is sunitinib. Each capsule contains sunitinib malate equivalent to
12.5 mg, 25 mg, 37.5 mg or 50 mg of sunitinib. The other ingredients are:

• Capsule contents: mannitol (E 421), sodium croscarmellose, pregelatinized starch (maize), magnesium stearate.
• Capsule shell: gelatin, purified water, titanium dioxide (E 171), iron oxide red (E 172) (for strengths 12.5 mg, 25 mg and 50 mg), iron oxide black (E 172) (for strengths 25 mg and 50 mg), iron oxide yellow (E 172) (for strengths 25 mg, 37.5 mg and 50 mg).
• Printing ink: shellac (E 904), propylene glycol (E 1520), potassium hydroxide (E 525), titanium dioxide (E 171) (for strengths 12.5 mg, 25 mg and 50 mg), iron oxide black (E 172) (for strength 37.5 mg).

What Sunitinib MSN looks like and contents of the pack
Sunitinib MSN 12.5 mg is available as hard gelatin capsules of size "4"
(approximately 15 mm in length) with an opaque orange body and an opaque orange cap,
printed in white ink with the characters "6" on the body and "MS" on the cap, filled with yellow granular powder.
Sunitinib MSN 25 mg is available as hard gelatin capsules of size "3"
(approximately 16 mm in length) with an opaque orange body and an opaque caramel cap,
printed in white ink with the characters "7" on the body and "MS" on the cap, filled with yellow granular powder.
Sunitinib MSN 37.5 mg is available as hard gelatin capsules of size "3"
(approximately 16 mm in length) with an opaque yellow body and an opaque yellow cap,
printed in black ink with the characters "8" on the body and "MS" on the cap, filled with yellow granular powder.
Sunitinib MSN 50 mg is available as hard gelatin capsules of size "2"
(approximately 18 mm in length) with an opaque caramel (light brown) body and an opaque caramel (light brown) cap,
printed in white ink with the characters "9" on the body and "MS" on the cap, filled with yellow granular powder.
The medicine is available in bottles containing 28 or 30 capsules, and in unit dose blisters containing 14 x 1, 28 x 1 or 30 x 1 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer/Importer
Marketing Authorisation Holder:
MSN Labs Europe Limited
KW20A, Corradino Park
Paola, PLA 3000
Malta
tel.: (+48) 699 711 147

Manufacturer/Importer:
Pharmadox Healthcare Limited
KW20A, Kordin Industrial Park
Paola, PLA3000
Malta
MSN Labs Europe Limited
KW20A, Corradino Park
Paola, PLA 3000
Malta

This medicinal product is authorised in the following European Economic Area countries under the following names:
Portugal: Sunitinib MSN
Czech Republic: Sunitinib MSN
Slovakia: Sunitinib MSN 12.5 mg
Sunitinib MSN 25 mg
Sunitinib MSN 37.5 mg
Sunitinib MSN 50 mg
Poland: Sunitinib MSN
Romania: Sunitinib MSN 12.5 mg capsule
Sunitinib MSN 25 mg capsule
Sunitinib MSN 37.5 mg capsule
Sunitinib MSN 50 mg capsule
Hungary: Sunitinib MSN 12.5 mg kemény kapszula
Sunitinib MSN 25 mg kemény kapszula
Sunitinib MSN 37.5 mg kemény kapszula
Sunitinib MSN 50 mg kemény kapszula
Bulgaria: Sunitinib MSN 12.5 mg твърди капсули
Sunitinib MSN 25 mg твърди капсули
Sunitinib MSN 37.5 mg твърди капсули
Sunitinib MSN 50 mg твърди капсули
Cyprus: Sunitinib MSN 12.5 mg καψάκια σκληρά
Sunitinib MSN 25 mg καψάκια σκληρά
Sunitinib MSN 50 mg καψάκια σκληρά
Croatia: Sunitinib MSN 12.5 mg tvrde kapsule
Sunitinib MSN 25 mg tvrde kapsule
Sunitinib MSN 50 mg tvrde kapsule
Slovenia: Sunitinib MSN 12.5 mg trde kapsule
Sunitinib MSN 25 mg trde kapsule
Sunitinib MSN 50 mg trde kapsule