Sunitinib Aurobindo

Patient Information Leaflet

Sunitinib Aurobindo 12.5 mg hard capsules, 25 mg hard capsules, 37.5 mg hard capsules, 50 mg hard capsules

Equivalent medicine
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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

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

• Gastrointestinal stromal tumour (GIST), a type of stomach and intestinal tumour, in cases where imatinib (another anticancer medicine) is no longer effective or can no longer be taken.
• Metastatic renal cell carcinoma (MRCC), a type of kidney cancer that has spread to other parts of the body.
• Pancreatic neuroendocrine tumours (pNET) (tumours of the hormone-producing cells of the pancreas) that are progressing or cannot be surgically removed.

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

2. What you need to know before taking Sunitinib Aurobindo

Do not take Sunitinib Aurobindo

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

Warnings and precautions
Talk to your doctor before taking Sunitinib Aurobindo:

• If you have high blood pressure. Sunitinib Aurobindo may cause an increase in blood pressure. Your doctor may monitor your blood pressure during treatment with Sunitinib Aurobindo and, if necessary, you may need to take medicines to lower your blood pressure.
• If you have or have had blood disorders, bleeding problems or bruising. Treatment with Sunitinib Aurobindo may increase the risk of bleeding, changes in the number of certain blood cells whose deficiency leads to anaemia, or affect the blood’s ability to clot. The risk of bleeding may be higher if you are taking warfarin or acenocoumarol, medicines that thin the blood to prevent blood clots. Inform your doctor if bleeding occurs while you are taking Sunitinib Aurobindo.
• If you have heart problems. Sunitinib Aurobindo may cause heart-related issues. Inform your doctor if you feel very tired, have shortness of breath, or experience swelling in your feet and ankles.
• If you experience abnormal changes in heart rhythm. Sunitinib Aurobindo may cause changes in heart rhythm. During treatment with Sunitinib Aurobindo, your doctor may perform an electrocardiogram (ECG) to assess these changes. Inform your doctor if you feel dizzy, faint, or have irregular heartbeats during treatment with Sunitinib Aurobindo.
• If you have recently had problems due to 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 Aurobindo, you experience symptoms such as chest tightness or pain, arm, back, neck or jaw pain, 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 bulging and weakening of the wall of a blood vessel) or a tear in the wall of a blood vessel.
• If you have or have had damage to small blood vessels known as thrombotic microangiopathy (TMA). Inform your doctor if you notice fever, fatigue, tiredness, bruising, bleeding, swelling, mental confusion, vision loss, or seizures.
• If you have thyroid problems. Sunitinib Aurobindo may cause thyroid-related issues. Inform your doctor if, while taking Sunitinib Aurobindo, you feel unusually tired, feel colder than others, or your voice becomes deeper. Thyroid function should be checked before starting Sunitinib Aurobindo and regularly during treatment. If your thyroid does not produce enough thyroid hormone, you may need to take a thyroid hormone replacement.
• If you have or have had pancreas or gallbladder problems. Inform your doctor if you experience any of the following signs and symptoms: stomach pain (upper abdomen), nausea, vomiting, and fever. These may be caused by inflammation of the pancreas or gallbladder.
• If you have or have had liver problems. Inform your doctor if, during treatment with Sunitinib Aurobindo, you experience any of the following signs and symptoms of liver problems: itching, yellowing of the skin or eyes, dark urine, or pain or discomfort in the upper right part of the stomach. Your doctor should perform blood tests to check liver function before and during treatment with Sunitinib Aurobindo, and as clinically appropriate.
• If you have or have had kidney problems. Your doctor will monitor kidney function.
• If you are about to undergo surgery or have recently had an operation. Sunitinib Aurobindo may affect how wounds heal. Generally, you will need to stop treatment with Sunitinib Aurobindo before undergoing surgery. Your doctor will decide when to restart treatment with Sunitinib Aurobindo.
• It is advisable to have a dental check-up before starting treatment with Sunitinib Aurobindo.
• If you have or have had mouth, tooth, and/or jaw pain, swelling or sores in the mouth, numbness or a feeling of heaviness in the jaw, or tooth loss, inform your doctor and dentist immediately.
• If you need to undergo invasive dental procedures or oral surgery, inform your dentist that you are being treated with Sunitinib Aurobindo, especially if you are currently taking or have previously taken intravenous bisphosphonates. Bisphosphonates are medicines used to prevent bone complications that may have been prescribed for another clinical condition.
• If you have or have had skin and subcutaneous tissue disorders. During treatment with this medicine, conditions such as "pyoderma gangrenosum" (painful skin ulceration) or "necrotizing fasciitis" (a rapidly spreading skin/soft tissue infection that can be fatal) may occur. Contact your doctor immediately if you experience signs of infection around a skin wound, including fever, pain, redness, swelling, or pus or blood drainage. This event is generally reversible after discontinuation of sunitinib treatment. Severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) have been reported with sunitinib use, initially appearing on the trunk as reddish target-shaped spots or circular patches, often with blisters in the center. The reaction may progress to widespread blistering or skin peeling and can be fatal. If you develop a skin rash or any of these skin symptoms, consult a doctor immediately.
• If you have or have had seizures. Inform your doctor as soon as possible if you have high blood pressure, headache, or vision loss.
• If you have diabetes. Blood sugar levels should be monitored regularly in diabetic patients to determine whether the dosage of diabetes medicines needs adjustment, in order to minimize the risk of low blood sugar levels. Inform your doctor as soon as possible if you notice signs and symptoms of low blood sugar (tiredness, palpitations, sweating, hunger, loss of consciousness).

Children and adolescents
Sunitinib Aurobindo is not indicated for patients under 18 years of age.
Other medicines and Sunitinib Aurobindo
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those purchased without a prescription and over-the-counter products.
Some medicines can alter the levels of Sunitinib Aurobindo in the body. You must inform your doctor if you are 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 AIDS;
• dexamethasone – a corticosteroid used for various conditions (such as allergic/respiratory disorders or skin diseases);
• phenytoin, carbamazepine, phenobarbital – used to treat epilepsy and other neurological conditions;
• herbal preparations containing St. John’s wort (Hypericum perforatum) – used to treat depression and anxiety.

Sunitinib Aurobindo with food and drinks
Grapefruit juice should be avoided during treatment with Sunitinib Aurobindo.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
If you could become pregnant, you must use a reliable method of contraception during treatment with Sunitinib Aurobindo.
If you are breastfeeding, inform your doctor. You must not breastfeed during treatment with Sunitinib Aurobindo.
Driving and using machines
If you experience dizziness or unusual tiredness, exercise particular caution when driving or operating machinery.
Sunitinib Aurobindo contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e., essentially 'sodium-free'.

3. How to take Sunitinib Aurobindo

Take this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor.
Your doctor will prescribe the dose suitable for you, depending on the type of cancer being treated. If you are being treated for:

• GIST or MRCC: the usual dose is 50 mg once daily, taken for 28 days (4 weeks), followed by a 14-day (2-week) rest period (without medication), in 6-week cycles.
• pNET: the usual dose is 37.5 mg once daily, without a rest period.

Your doctor will determine the appropriate dose for you and when to stop treatment with Sunitinib Aurobindo.
Sunitinib Aurobindo may be taken with or without food.
If you take more Sunitinib Aurobindo than you should
If you accidentally take too many capsules, speak to your doctor immediately. You may require medical attention.
If you forget to take Sunitinib Aurobindo
Do not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Contact your doctor immediately if you experience any of the following serious side effects (see also What you must know before taking Sunitinib Aurobindo):
Heart problems. Inform your doctor if you feel very tired, have shortness of breath, or have swollen feet and ankles. These could be symptoms of heart problems such as heart failure or problems with the heart muscle (cardiomyopathy).
Lung or breathing problems. Inform your doctor if you develop cough, chest pain, sudden onset of shortness of breath, or coughing up blood. These could be symptoms of pulmonary embolism, which occurs when blood clots reach the lungs.
Kidney problems. Inform your doctor if you notice changes in how often you urinate or if you stop passing urine, which could be symptoms of kidney failure.
Bleeding. Inform your doctor if you experience any of the following symptoms or a serious bleeding problem while being treated with Sunitinib Aurobindo: swollen, painful stomach (abdomen); vomiting blood; dark, sticky stools; blood in the urine; headache or altered mental state; coughing up blood or blood-stained sputum from the lungs or airways.
Tumour breakdown causing intestinal perforation. Inform your doctor if you have severe abdominal pain, fever, nausea, vomiting, blood in the stools, or changes in bowel habits.

Other side effects that may occur with Sunitinib Aurobindo include:

Very common: may affect more than 1 in 10 people

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

Common: may affect up to 1 in 10 people

• Blood clot formation 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 around the lungs.
• Infections.
• Complications from severe infections (infection present in the bloodstream) that may cause tissue damage, organ failure, and death.
• Low blood sugar levels (see section 2).
• Loss of protein in the urine, which sometimes leads to swelling.
• Flu-like syndrome.
• Abnormal blood tests, including levels of liver and pancreatic enzymes.
• High levels of uric acid in the blood.
• Haemorrhoids, rectal pain, bleeding gums, difficulty swallowing or inability to swallow.
• Burning or painful sensation on the tongue, inflammation of the lining of the digestive tract, excess gas in the stomach or intestines.
• Weight loss.
• Musculoskeletal pain (pain in muscles and bones), muscle weakness, muscle fatigue, muscle pain, muscle spasms.
• Dry nose, nasal congestion.
• Excessive tearing.
• Skin sensitivity changes, itching, skin peeling and inflammation, blister formation, acne, nail discolouration, hair loss.
• Abnormal sensations in the extremities.
• Excessive reduction/increase in sensitivity, particularly to touch.
• Stomach burning.
• Dehydration.
• Hot flushes.
• Change in urine colour.
• Depression.
• Chills.

Uncommon: may affect up to 1 in 100 people

• Soft tissue infections, including in the anogenital region, potentially life-threatening (see section 2).
• Stroke.
• Heart attack caused by interrupted or reduced blood supply to the heart.
• Changes in the heart's electrical activity or altered heart rhythm.
• Fluid around the heart (pericardial effusion).
• Liver failure.
• Stomach (abdominal) pain caused by inflammation of the pancreas.
• Tumour breakdown causing intestinal perforation.
• Inflammation (swelling and redness) of the gallbladder, with or without associated gallstones.
• Abnormal passage connecting two body cavities or connecting a cavity to the skin.
• Pain in the mouth, teeth and/or jaw, swelling or ulcers in the mouth, numbness or heaviness in the jaw, or tooth loss. These could be signs and symptoms of jaw bone damage (osteonecrosis), see section 2.
• Excessive production of thyroid hormones leading to increased metabolism.
• Problems with wound healing after surgery.
• Increased levels of a muscle enzyme in the blood (creatine phosphokinase).
• Inappropriate and excessive reaction to allergens, including hay fever, skin rash, skin itching, hives, localized swelling, and breathing difficulties.
• Inflammation of the colon (colitis, ischemic colitis).

Rare: may affect up to 1 in 1,000 people

• Severe skin and/or mucous membrane reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme).
• Tumour lysis syndrome (TLS) – TLS includes a group of metabolic complications that may occur during tumour treatment. These are caused by the breakdown products of damaged tumour cells and may include: nausea, shortness of breath, irregular heartbeat, muscle cramps, seizures, cloudy urine, and fatigue, associated with abnormal laboratory test results (elevated levels of potassium, uric acid, and phosphate, and low calcium levels in the blood), which may lead to impaired kidney function and acute kidney failure.
• Abnormal breakdown of muscles that may cause kidney problems (rhabdomyolysis).
• Changes in brain function that may lead to various symptoms such as headache, confusion, seizures, and loss of vision (reversible posterior leukoencephalopathy syndrome).
• Painful skin ulceration (pyoderma gangrenosum).
• Inflammation of the liver (hepatitis).
• Inflammation of the thyroid gland.
• Damage to small blood vessels known as thrombotic microangiopathy (TMA).

Not known (frequency cannot be estimated from the available data):

• Abnormal dilation and weakening of a blood vessel wall, or a tear in the blood vessel wall (aneurysms and arterial dissections).
• Lack of energy, confusion, drowsiness, loss of consciousness/coma: these symptoms may indicate brain toxicity caused by high levels of ammonia in the blood (hyperammonaemic encephalopathy).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sunitinib Aurobindo

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton and blister after "EXP.". The expiry date refers to the last day of that month.
• This medicine does not require any special storage conditions.
• Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.

Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Sunitinib Aurobindo contains

• The active substance is sunitinib malate. Each capsule contains sunitinib malate, equivalent to 12.5 mg of sunitinib. Each capsule contains sunitinib malate, equivalent to 25 mg of sunitinib. Each capsule contains sunitinib malate, equivalent to 37.5 mg of sunitinib. Each capsule contains sunitinib malate, equivalent to 50 mg of sunitinib.
• The other components are: Capsule contents: Mannitol, sodium croscarmellose, povidone (K-25), magnesium stearate.

Capsule shell: Titanium dioxide (E171), yellow iron oxide (E172) (for 25 mg and 50 mg), red iron oxide (E172), indigo carmine (E132) (for 25 mg, 37.5 mg and 50 mg), gelatin.
Printing ink: Shellac (E904), titanium dioxide (E171) (for 12.5 mg and 25 mg), black iron oxide (E172) (for 37.5 mg and 50 mg), potassium hydroxide (E525).

Description of the appearance of Sunitinib Aurobindo and package contents
Hard capsules.
Sunitinib Aurobindo 12.5 mg hard capsules
Opaque red hard gelatin capsules with a size '4', marked with 'S12.5' in white ink on the body, filled with yellow/orange granules. The approximate capsule length is about 14 mm.
Sunitinib Aurobindo 25 mg hard capsules
Opaque olive green cap and opaque red body, hard gelatin capsules with a size '3', marked with 'S25' in white ink on the body, filled with yellow/orange granules. The approximate capsule length is about 16 mm.
Sunitinib Aurobindo 37.5 mg hard capsules
Opaque light green cap and opaque light green body, hard gelatin capsules with a size '3', marked with 'S37.5' in white ink on the body, filled with yellow/orange granules. The approximate capsule length is about 16 mm.
Sunitinib Aurobindo 50 mg hard capsules
Opaque olive green cap and opaque olive green body, hard gelatin capsules with a size '2', marked with 'S50' in white ink on the body, filled with yellow/orange granules. The approximate capsule length is about 18 mm.
Sunitinib Aurobindo 12.5 mg, 25 mg, 37.5 mg and 50 mg hard capsules are available in blister packs.
Pack sizes:
Blister packs: 30 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Eugia Pharma (Malta) Ltd
Vault 14, Level 2, Valletta Waterfront,
Floriana FRN 1914
Malta
Manufacturer
APL Swift Services (Malta) Ltd
HF26, Hal Far Industrial Estate,
Hal Far, Birzebbugia, BBG 3000
Malta
Generis Farmacêutica SA
Rua João de Deus, 19,
2700-487 Amadora
Portugal
This medicinal product is authorised in the European Economic Area countries under the
following names:
Italy: Sunitinib Aurobindo
Sweden: Sunitinib Eugia Pharma 12.5 mg/25 mg /37.5 mg/ 50 mg hårda kapslar