Sunitinib Mylan

Patient Information Leaflet: Information for the User

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

Sunitinib
Generic medicine
Please read this leaflet carefully before you start taking this medicine, as 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 you, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Sunitinib Mylan 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 Mylan is used to treat adults with the following types of cancer:

• Gastrointestinal stromal tumour (GIST), a type of tumour of the stomach and intestine, in cases where imatinib (another anticancer medicine) is no longer effective or can no longer be used.
• Metastatic renal cell carcinoma (MRCC), a type of kidney cancer that has spread to other parts of the body.
• Advanced pancreatic neuroendocrine tumours (pNET) (tumours of hormone-producing cells of the pancreas) that are progressive or not amenable to surgery.

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

2. What you need to know before taking Sunitinib Mylan

Do not take Sunitinib Mylan:

• 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 or pharmacist before taking Sunitinib Mylan:

• If you have high blood pressure. Sunitinib Mylan may cause an increase in blood pressure. Your doctor may monitor your blood pressure during treatment with Sunitinib Mylan 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 Mylan may increase the risk of bleeding, changes in the number of certain blood cells whose deficiency can lead 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 you experience any bleeding while taking Sunitinib Mylan.
• If you have heart problems. Sunitinib Mylan 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 Mylan may cause changes in heart rhythm. During treatment with Sunitinib Mylan, your doctor may perform an electrocardiogram (ECG) to assess these changes. Inform your doctor if you feel dizzy, faint, or experience irregular heartbeats during treatment.
• If you have recently had problems due to 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 Mylan, you develop symptoms such as chest tightness or pain, pain in the arms, back, neck, or jaw, shortness of breath, numbness or weakness on one side of the body, unsteady gait, headache, or dizziness.
• If you have been diagnosed with an enlargement or “bulging” of the large blood vessel, the aorta, known as an aortic aneurysm.
• If you have previously experienced a tear in the aortic wall known as aortic dissection.
• If you have or have had damage to small blood vessels called thrombotic microangiopathy (TMA). Inform your doctor if you develop fever, fatigue, tiredness, bruising, bleeding, swelling, mental confusion, vision loss, or seizures.
• If you have problems with your thyroid gland. Sunitinib Mylan may cause thyroid problems. Inform your doctor if, while taking Sunitinib Mylan, you become more easily fatigued, generally feel colder than others, or your voice becomes deeper. Thyroid function should be checked before starting Sunitinib Mylan 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 or symptoms: stomach pain (upper abdomen), nausea, vomiting, or 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 Mylan, you develop any of the following signs or 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 Mylan, and as clinically appropriate.
• If you have or have had kidney problems. Your doctor will monitor your kidney function.
• If you are about to undergo surgery or have recently had surgery. Sunitinib Mylan may affect how wounds heal. Generally, you should stop treatment with Sunitinib Mylan before undergoing surgery. Your doctor will decide when to restart treatment.
• It is advisable to have a dental check-up before starting treatment with Sunitinib Mylan.
• 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 Mylan, especially if you are taking or have taken intravenous bisphosphonates. Bisphosphonates are medicines used to prevent bone complications that may have been prescribed for another medical 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 infection of the skin/soft tissue that can be fatal) may occur. Contact your doctor immediately if you develop signs of infection around a skin wound, including fever, pain, redness, swelling, or pus or blood discharge. This event is generally reversible after stopping sunitinib treatment. Severe skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) have been reported with sunitinib use. These rashes typically start on the trunk as red, target-shaped spots or circular patches, often with blisters in the center. The rash may progress to widespread blistering or skin peeling and can be life-threatening. If you develop a skin rash or any of these skin symptoms, consult a doctor immediately.
• If you 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 dose of diabetes medication needs adjustment, in order to minimize the risk of low blood sugar. Inform your doctor as soon as possible if you notice signs or symptoms of low blood sugar (fatigue, palpitations, sweating, hunger, or loss of consciousness).

Children and adolescents
Sunitinib Mylan is not indicated for patients under 18 years of age.
Other medicines and Sunitinib Mylan
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines can alter the levels of Sunitinib Mylan in your 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 Mylan with food and drink
Grapefruit juice should be avoided during treatment with Sunitinib Mylan.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are 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 Mylan.
If you are breastfeeding, inform your doctor. You must not breastfeed during treatment with Sunitinib Mylan.
Driving and using machines
If you experience dizziness or unusual tiredness, exercise particular caution when driving or operating machinery.
Sunitinib Mylan contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. it is essentially “sodium-free”.

3. How to take Sunitinib Mylan

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
Your doctor will determine the appropriate dose for you, depending on the type of cancer being treated. If you are being treated for:

• Gastrointestinal stromal tumour (GIST) or metastatic renal cell carcinoma (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.
• Pancreatic neuroendocrine tumours (pNET): the usual dose is 37.5 mg once daily, without a rest period. Your doctor will determine the dose needed for you, as well as if and when to stop treatment with Sunitinib Mylan.

Sunitinib Mylan may be taken with or without food.
If you take more Sunitinib Mylan than you should
If you accidentally take too many capsules, speak to your doctor immediately. Medical intervention may be necessary.
If you forget to take Sunitinib Mylan
Do not take a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You must contact your doctor immediately if you experience any of the following serious side effects (see also What you must know before taking Sunitinib Mylan):
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 a condition called 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 have a serious bleeding problem while being treated with Sunitinib Mylan: swollen, painful stomach (abdomen); vomiting blood; dark, sticky stools; blood in the urine; headache or changes in mental state; coughing up blood or bloody sputum from the lungs or airways.
Tumour destruction 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 Mylan:
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 erythema.

• Mouth pain/irritation, soreness/inflammation/dryness of the mouth, taste alterations, stomach discomfort, nausea, vomiting, diarrhoea, constipation, abdominal pain/gastric discomfort, 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) which 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 liver and pancreatic enzyme levels.
• 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, peeling and inflammation of the skin, blisters, acne, nail discolouration, hair loss.
• Abnormal sensations in the extremities.
• Excessive reduction/increase in sensitivity, particularly to touch.
• Heartburn.
• 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 destruction causes a hole in the intestine (perforation).
• Inflammation (swelling and redness) of the gallbladder with or without associated stones.
• Abnormal connection between two body cavities or between a cavity and the skin.
• Pain in the mouth, teeth and/or jaw, swelling or irritation in the mouth, numbness or a feeling of heaviness in the jaw, or tooth loss. These may be signs and symptoms of jaw bone damage (osteonecrosis), see section 2.
• Overproduction of thyroid hormones leading to increased metabolism.
• Problems with wound healing after surgery.
• Increased levels of a muscle enzyme in the blood (creatine phosphokinase).
• Severe allergic reactions, 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 set of metabolic complications that may occur during tumour treatment. These are caused by the breakdown products of affected tumour cells and may include the following symptoms: 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 changes in kidney function and acute kidney failure.
• Abnormal breakdown of muscles which may cause kidney problems (rhabdomyolysis).
• Changes in brain function that may lead to various symptoms such as headache, confusion, seizures, and vision loss (reversible posterior leukoencephalopathy syndrome).
• Painful skin ulceration (pyoderma gangrenosum).
• Inflammation of the liver (hepatitis).
• Inflammation of the thyroid gland.
• Damage to the small blood vessels known as thrombotic microangiopathy (TMA).

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

• Abnormal enlargement or "bulging" of the aortic vessel or a tear in the aortic wall (aortic aneurysms and dissections).

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor. You can also report side effects directly via the national reporting system at https://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 Mylan

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 after "EXP". The expiry date refers to the last day of the 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 any signs of tampering.
Do not dispose of medicines 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 Mylan contains

• The active substance is sunitinib.

Sunitinib Mylan 12.5 mg hard capsules
Each capsule contains 12.5 mg of sunitinib.
Sunitinib Mylan 25 mg hard capsules
Each capsule contains 25 mg of sunitinib.
Sunitinib Mylan 37.5 mg hard capsules
Each capsule contains 37.5 mg of sunitinib.
Sunitinib Mylan 50 mg hard capsules
Each capsule contains 50 mg of sunitinib.

• The other components are: Capsule contents: microcrystalline cellulose (E460), mannitol (E421), sodium croscarmellose, povidone (E1201), magnesium stearate (E470b).
  Sunitinib Mylan 12.5 mg hard capsules
• Capsule shell: red iron oxide (E172), titanium dioxide (E171), gelatin.
• Printing ink, white: shellac, titanium dioxide (E171), propylene glycol (E1520).
  Sunitinib Mylan 25 mg hard capsules
• Capsule shell: black iron oxide (E172), red iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171), gelatin.
• Printing ink, white: shellac, titanium dioxide (E171), propylene glycol (E1520).
  Sunitinib Mylan 37.5 mg hard capsules
• Capsule shell: yellow iron oxide (E172), titanium dioxide (E171), gelatin.
• Printing ink, black: shellac, black iron oxide (E172), propylene glycol (E1520), ammonium hydroxide (E527).
  Sunitinib Mylan 50 mg hard capsules
• Capsule shell: black iron oxide (E172), red iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171), gelatin.
• Printing ink, white: shellac, titanium dioxide (E171), propylene glycol (E1520).

Description of the appearance of Sunitinib Mylan and contents of the pack
Sunitinib Mylan 12.5 mg hard capsules (capsules)
Size 4 gelatin capsules with orange cap and body, printed in white ink with "12.5 mg" on the body and containing yellow/orange granules.
Sunitinib Mylan 25 mg hard capsules (capsules)
Size 3 gelatin capsules with caramel-coloured cap and orange body, printed in white ink with "25 mg" on the body and containing yellow/orange granules.
Sunitinib Mylan 37.5 mg hard capsules (capsules)
Size 2 gelatin capsules with yellow cap and body, printed in black ink with "37.5 mg" on the body and containing yellow/orange granules.
Sunitinib Mylan 50 mg hard capsules (capsules)
Size 1 gelatin capsules with caramel-coloured cap and body, printed in white ink with "50 mg" on the body and containing yellow/orange granules.
NL/H/4253/001-004/DC:
Sunitinib Mylan hard capsules are available in blisters containing 28 hard capsules, in divisible unit-dose blisters of 28 x 1 hard capsules, and in plastic bottles containing 30 hard capsules.

Marketing Authorization Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano, Italy

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