Sunitinib Glenmark

Leaflet accompanying the packaging: information for the user

Sunitinib Glenmark, 12.5 mg, hard capsules

Sunitinib Glenmark, 25 mg, hard capsules

Sunitinib Glenmark, 50 mg, hard capsules

Sunitinib

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

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

Sunitinib Glenmark contains the active substance sunitinib, which is a protein kinase inhibitor.
This medicine is used to treat cancer, as it inhibits the activity of a special group of proteins,
known to be involved in the processes of growth and spread of cancer cells.
Sunitinib Glenmark is used in adult patients to treat the following cancers:

• gastrointestinal stromal tumors (GIST), a type of stomach and intestine cancer, when imatinib is ineffective (another anticancer drug) or the patient cannot take imatinib.
• metastatic renal cell carcinoma (MRCC), a type of kidney cancer that has spread to other parts of the body.
• pancreatic neuroendocrine tumors (pNET) (tumors of the pancreas cells that produce hormones), which develop or cannot be surgically removed.

If the patient has any questions about the action of Sunitinib Glenmark or the reasons why the doctor prescribed it, they should ask their doctor.

2. Important information before taking Sunitinib Glenmark

When not to take Sunitinib Glenmark

• 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 Glenmark, the patient should discuss it with their doctor or pharmacist:

• If the patient has high blood pressure.Sunitinib Glenmark may increase blood pressure. The doctor may monitor the patient's blood pressure during treatment with Sunitinib Glenmark and, if necessary, prescribe blood pressure-lowering medications.
• If the patient has or has had blood diseases, bleeding, or bruising in the past.Treatment with Sunitinib Glenmark 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 medications used to prevent blood clots, the risk of bleeding may be higher. The patient should tell their doctor about all bleeding episodes during treatment with Sunitinib Glenmark.
• If the patient has heart disease.Sunitinib Glenmark may cause heart disease. 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 Glenmark may cause heart rhythm disorders. During treatment with Sunitinib Glenmark, the doctor may perform an electrocardiogram to assess these disorders. The patient should tell their doctor if they experience dizziness, fainting, or irregular heartbeat during treatment with Sunitinib Glenmark.
• If the patient has recently had blood clots in the veins and/or arteries (a type of blood vessel), 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, speech problems, headache, or dizziness during treatment with Sunitinib Glenmark.
• If the patient has or has had an aneurysm (enlargement and weakening of the wall of a blood vessel) or a tear in the wall of a blood vessel.
• If the patient has or has had damage to the smallest blood vessels called thrombotic microangiopathy.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 disease.Sunitinib Glenmark may cause thyroid disease. The patient should tell their doctor if they experience extreme fatigue, feel colder than others, or have a hoarse voice. The doctor should check the patient's thyroid function before starting treatment with Sunitinib Glenmark and regularly during treatment. If the thyroid does not produce enough thyroid hormones, the patient may receive thyroid hormone replacement therapy.
• If the patient has or has had pancreatic disorders or gallbladder disease.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 tell their doctor if they experience any of the following symptoms of liver function disorders during treatment with Sunitinib Glenmark: itching, yellowing of the whites of the eyes or skin, dark urine, and pain or discomfort in the right upper abdomen. The doctor should order blood tests to check liver function before starting treatment with Sunitinib Glenmark, during treatment, and if there are clinical signs.
• If the patient has or has had kidney disease.The doctor will monitor the patient's kidney function.
• If the patient is to undergo surgery or has recently undergone surgery.Sunitinib Glenmark may affect wound healing. Before surgery, treatment with Sunitinib Glenmark is usually stopped. The doctor will decide when to restart treatment with Sunitinib Glenmark.

Before surgery, the doctor may recommend a dental check-up before starting treatment with Sunitinib Glenmark.

• If the patient experiences mouth pain, toothache, and/or jaw pain, swelling, or mouth ulcers, 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 oral surgery, they should inform their dentist about taking Sunitinib Glenmark, especially if they are also taking or have taken intravenous bisphosphonates. Bisphosphonates are medications used to prevent bone complications that may be taken for another disease.
• 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 signs of infection around the skin damage, including fever, pain, redness, swelling, or discharge of pus or blood. These disorders usually resolve after discontinuing sunitinib treatment. During sunitinib treatment, 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 transform into widespread blisters or peeling of the skin and can be life-threatening. If the patient experiences a rash or these skin symptoms, they should immediately see their doctor.
• If the patient has or has had seizures.The patient should immediately inform their doctor 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 monitored to assess whether it is necessary to adjust the dosage of the anti-diabetic medication to minimize the risk of hypoglycemia. The patient should immediately inform their doctor if they experience any symptoms of hypoglycemia (fatigue, palpitations, sweating, hunger, and loss of consciousness).

Children and adolescents

Sunitinib Glenmark should not be used in patients under 18 years of age.

Sunitinib Glenmark and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take, including those available without a prescription.
Some medicines may affect the levels of Sunitinib Glenmark in the patient's body. The patient should inform their doctor if they are taking medicines containing the following active substances:

• ketokonazole, 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 reactions and/or respiratory disorders or skin diseases)
• phenytoin, carbamazepine, phenobarbital - used to treat epilepsy and other neurological diseases
• herbal medicines containing St. John's Wort (Hypericum perforatum) - used to treat depression and anxiety

Sunitinib Glenmark with food and drink

During treatment with Sunitinib Glenmark, the patient should not drink grapefruit juice.

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 of childbearing age should use effective contraception during treatment with Sunitinib Glenmark.
The patient should inform their doctor if they are breastfeeding. During treatment with Sunitinib Glenmark, the patient should not breastfeed.

Driving and using machines

If the patient experiences dizziness or extreme fatigue, they should be cautious when driving or operating machinery.

Sunitinib Glenmark contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per dose, which means the medicine is essentially 'sodium-free'.

3. How to take Sunitinib Glenmark

This medicine should always be taken exactly as prescribed by the doctor. If the patient is unsure, they should ask their doctor.
The doctor will prescribe a dose suitable for the patient, depending on the type of cancer. If the patient is being treated for

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

The doctor will determine the appropriate dose for the patient and the end of treatment with Sunitinib Glenmark.
Sunitinib Glenmark can be taken with or without food.

Taking a higher dose of Sunitinib Glenmark than recommended

If the patient accidentally takes more capsules than prescribed, they should immediately inform their doctor, as they may need urgent medical attention.

Missing a dose of Sunitinib Glenmark

The patient should not take a double dose to make up for a missed dose.
If the patient has any further questions about taking this medicine, they should ask their doctor or pharmacist.

4. Possible side effects

Like all medicines, Sunitinib Glenmark can cause side effects, although not everybody gets them.
The patient should immediately contact their doctor if they experience any of these side effects (see also Important information before taking Sunitinib Glenmark):
Heart disease.The patient should tell their doctor if they experience extreme fatigue, shortness of breath, or swelling of the feet or ankles. These may be symptoms of heart problems, including heart failure and problems with the heart muscle (cardiomyopathy).
Lung disease or respiratory disorders.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 disease called pulmonary embolism, which occurs when blood clots move to the lungs.
Kidney function disorders.The patient should tell their doctor if they experience changes in urination frequency or absence of urination, which may be a sign of kidney failure.
Bleeding.The patient should tell their doctor if they experience any of these symptoms or severe bleeding during treatment with Sunitinib Glenmark: abdominal 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 abdominal pain, fever, nausea, vomiting, blood in the stool, or changes in bowel movements.
Other side effects of Sunitinib Glenmark 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, weakness
• swelling caused by fluid accumulation under the skin and around the eyes, allergic rash, deep
• mouth pain, toothache, and/or jaw pain, mouth ulcers, painful swelling, and/or inflammation, dryness of the mouth mucosa, taste disorders, nausea, vomiting, diarrhea, constipation, abdominal pain or swelling, loss or decreased appetite
• decreased thyroid function (hypothyroidism)
• dizziness
• headache
• nosebleeds
• back pain, joint pain
• hand and foot pain
• skin yellowing and/or discoloration, excessive skin pigmentation, hair color changes, palmoplantar erythrodysesthesia, skin rash, dry skin
• cough
• fever
• sleep disorders

Common (may affect up to 1 in 10 people):

• blood clots in blood vessels
• insufficient blood flow 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 around the lungs
• infections
• complications of severe infections (blood infection), which can 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 abnormal activity of pancreatic and liver enzymes
• high levels of uric acid in the blood
• hemorrhoids, anal pain, gum bleeding, difficulty swallowing, or loss of swallowing ability
• tongue pain or burning sensation, 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, muscle fatigue, muscle cramps
• dryness of the nasal mucosa, nasal congestion
• excessive tearing
• skin sensation disorders, itching, skin peeling, and/or inflammation, blisters, acne, nail discoloration, hair loss
• skin sensation disorders
• sensitivity disorders, including 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 area 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 the electrical or abnormal heart rhythm
• fluid accumulation around the heart (pericardial effusion)
• liver failure
• abdominal pain caused by pancreatitis
• tumor lysis syndrome leading to intestinal perforation
• inflammation (swelling or redness) 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, mouth ulcers, painful swelling, and/or inflammation, 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 energy expenditure at rest
• abnormal wound healing after surgery
• increased activity of the muscle enzyme (creatine phosphokinase) in the blood
• allergic reactions, including hay fever, skin rash, itching, hives, swelling of various body parts, and breathing difficulties
• inflammation of the large intestine (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)
• 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 may include: nausea, shortness of breath, irregular heartbeat, muscle cramps, seizures, cloudy urine, and fatigue associated with abnormal 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 lead to kidney disease (rhabdomyolysis)
• abnormal brain changes, 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
• thyroiditis
• damage to the smallest blood vessels called thrombotic microangiopathy

Unknown frequency (cannot be estimated from the available data):

• enlargement and weakening of the wall of a blood vessel or rupture of a blood vessel (aneurysm and arterial dissection)
• lack of energy, confusion, drowsiness, loss of consciousness, or coma - these symptoms may be signs of the toxic effect of high blood ammonia levels 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 tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Sunitinib Glenmark

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or blister after EXP. The expiry date refers to the last day of the month.
There are no special storage instructions for this medicine.
Do not use this medicine if the packaging is damaged or the protective system has been compromised.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Sunitinib Glenmark contains

• The active substance of Sunitinib Glenmark is sunitinib. Sunitinib Glenmark, 12.5 mg, hard capsules Each capsule contains 12.5 mg of sunitinib. Sunitinib Glenmark, 25 mg, hard capsules Each capsule contains 25 mg of sunitinib.

Sunitinib Glenmark, 50 mg, hard capsules
Each capsule contains 50 mg of sunitinib.

• Other ingredients are: Capsule content:microcrystalline cellulose, mannitol, sodium croscarmellose, povidone K30, magnesium stearate. Sunitinib Glenmark, 12.5 mg, hard capsules
• Capsule shell: red iron oxide (E 172), titanium dioxide (E 171), gelatin.
• White ink:shellac, titanium dioxide (E 171), propylene glycol.

Sunitinib Glenmark, 25 mg, hard capsules

• Capsule shell:black iron oxide (E 172), red iron oxide (E 172), yellow iron oxide (E 172), titanium dioxide (E 171), gelatin.
• White ink:shellac, titanium dioxide (E 171), propylene glycol.

Sunitinib Glenmark, 50 mg, hard capsules

• Capsule shell:black iron oxide (E 172), red iron oxide (E 172), yellow iron oxide (E 172), titanium dioxide (E 171), gelatin.
• White ink:shellac, titanium dioxide (E 171), propylene glycol.

What Sunitinib Glenmark looks like and contents of the pack

Sunitinib Glenmark, 12.5 mg, hard capsules (capsules)
Orange gelatin capsules, size 4 (approximately 14.3 mm in length), with a white ink inscription "12.5 mg" on the body, containing yellow to orange granules.
Sunitinib Glenmark, 25 mg, hard capsules (capsules)
Carmine gelatin capsules, size 3 (approximately 15.9 mm in length), with a white ink inscription "25 mg" on the body, containing yellow to orange granules.
Sunitinib Glenmark, 50 mg, hard capsules (capsules)
Carmine gelatin capsules, size 1 (approximately 19.4 mm in length), with a white ink inscription "50 mg" on the body, containing yellow to orange granules.
Sunitinib Glenmark, hard capsules, are available in perforated single-dose blisters containing 28 hard capsules.

Marketing authorization holder

Glenmark Pharmaceuticals s.r.o.
Hvězdova 1716/2B
140 78 Prague 4
Czech Republic

Manufacturer

Remedica Ltd
Aharnon Street, Limassol Industrial Estate
3056 Limassol
Cyprus
Pharmacare Premium Ltd.
HHF003 Hal Far Industrial Estate
Birzebbugia, BBG3000
Malta
Glenmark Pharmaceuticals s.r.o.
Fibichova 143
566 17 Vysoké Mýto
Czech Republic

For more information, contact the local representative of the marketing authorization holder:

Glenmark Pharmaceuticals Sp. z o.o.
ul. Dziekońskiego 3
00-728 Warsaw
Email: poland.receptionist@glenmarkpharma.com
Date of last revision of the leaflet:December 2024