Sunitinib Cipla Capsules

SUNITINIB CIPLA contains the active substance sunitinib, which is a protein kinase inhibitor. It is used to treat cancer by preventing the activity of a special group of proteins which are known to be involved in the growth and spread of cancer cells.

SUNITINIB CIPLA is used to treat adults with the following types of cancer:

• Gastrointestinal stromal tumour (GIST), a type of cancer of the stomach and bowel, where imatinib (another anticancer medicine) no longer works or you cannot take imatinib.
• 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 in the pancreas) that have progressed or cannot be removed with surgery.

Do not take SUNITINIB CIPLA

• If you are allergic to sunitinib or any of the other ingredients of SUNITINIB CIPLA (listed in section 6).
• If you are pregnant or breastfeeding.

Warnings and precautions

Tell your doctor or health care provider before taking SUNITINIB CIPLA:

• If you have high blood pressure. SUNITINIB CIPLA can raise blood pressure. Your doctor may check your blood pressure during treatment with SUNITINIB CIPLA, and you may be treated with medicines to reduce the blood pressure, if needed.
• If you have or have had blood disease, bleeding problems, bruising or solid tumours. Treatment with SUNITINIB CIPLA may lead to a higher risk of bleeding or lead to changes in the number of certain cells in the blood which may lead to anaemia or affect the ability of your blood to clot. If you are taking warfarin or acenocoumarole, medicines which prevent blood clots, there may be a greater risk of bleeding. Tell your doctor if you have any bleeding while on treatment with SUNITINIB CIPLA.
• If you have heart problems. SUNITINIB CIPLA can cause heart problems. Tell your doctor if you feel very tired, are short of breath, or have swollen feet and ankles.
• If you have abnormal heart rhythm changes. SUNITINIB CIPLA can cause abnormality of your heart rhythm. Your doctor may obtain electrocardiograms to evaluate for these problems during your treatment with SUNITINIB CIPLA. Tell your doctor if you feel dizzy, faint, or have abnormal heartbeats while taking SUNITINIB CIPLA.
• If you have had a recent problem with blood clots in your veins and/or arteries (types of blood vessels), including stroke, heart attack, embolism, or thrombosis. Call your doctor immediately if you get symptoms such as chest pain or pressure, pain in your arms, back, neck or jaw, shortness of breath, numbness or weakness on one side of your body, trouble talking, headache, or dizziness while on treatment with SUNITINIB CIPLA.
• If you have or have had an aneurysm (enlargement and weakening of a blood vessel wall) or a tear in a blood vessel wall.
• If you have or have had damage to the smallest blood vessels known as thrombotic microangiopathy (TMA). Tell your doctor if you develop fever, fatigue, tiredness, bruising, bleeding, swelling, confusion, vision loss, and seizures.
• If you have thyroid gland problems. SUNITINIB CIPLA can cause thyroid gland problems. Tell your doctor if you get tired more easily, generally feel colder than other people, or your voice deepens whilst taking SUNITINIB CIPLA. Your thyroid function should be checked before you take SUNITINIB CIPLA and regularly while you are taking it. If your thyroid gland is not producing enough thyroid hormone, you may be treated with thyroid hormone replacement.
• If you have or have had pancreatic or gallbladder disorders. Tell your doctor if you develop any of the following signs and symptoms: pain in the area of the stomach (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. Tell your doctor if you develop any of the following signs and symptoms of liver problems during SUNITINIB CIPLA treatment: itching, yellow eyes or skin, dark urine, and pain or discomfort in the right upper stomach area. Your doctor should do blood tests to check your liver function before and during treatment with SUNITINIB CIPLA, and as clinically indicated.
• If you have or have had kidney problems. Your doctor will monitor your kidney function.
• If you are going to have surgery or if you had an operation recently. SUNITINIB CIPLA may affect the way your wounds heal. You will usually be taken off SUNITINIB CIPLA if you are having an operation. Your doctor will decide when to start SUNITINIB CIPLA again.
• You may be advised to have a dental check-up before you start treatment with SUNITINIB CIPLA. If you have or have had pain in the mouth, teeth and/or jaw, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw, or loosening of a tooth, tell your doctor and dentist immediately.
• If you need to undergo an invasive dental treatment or dental surgery, tell your dentist that you are being treated with SUNITINIB CIPLA in particular when you are also receiving or have received intravenous bisphosphonates. Bisphosphonates are medicines used to prevent bone complications that may have been given for another medical condition.
• If you have or have had skin and subcutaneous tissue disorders. While you are on this medicine "pyoderma gangrenosum" (painful skin ulceration) or “necrotising fasciitis” (rapidly spreading infection of the skin/soft tissue that may be life-threatening) may occur. Contact your doctor immediately if symptoms of infection occur around a skin injury, including fever, pain, redness, swelling, or drainage of pus or blood. This event is generally reversible after sunitinib discontinuation. Severe skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) have been reported with the use of sunitinib, appearing initially as reddish target-like spots or circular patches often with central blisters on the trunk. The rash may progress to widespread blistering or peeling of the skin and may be life-threatening. If you develop a rash or these skin symptoms, seek immediate advice from a doctor.
• If you have or have had seizures. Notify your doctor as soon as possible if you have high blood pressure, headache, or loss of sight.
• If you have diabetes. Blood sugar levels in diabetic patients should be checked regularly in order to assess if antidiabetic medicine’s dosage needs to be adjusted to minimise the risk of low blood sugar. Notify your doctor as soon as possible if you experience any signs and symptoms of low blood sugar (fatigue, palpitations, sweating, hunger and loss of consciousness).
• You will be carefully monitored for signs of a stroke (a loss of blood flow to a part of the brain) whilst on treatment.

Children and adolescents

SUNITINIB CIPLA is not recommended for people aged under 18.

Other medicines and SUNITINIB CIPLA

Always tell your health care provider if you are taking, any other medicines. (This includes all complementary or traditional medicines.)

Some medicines can affect the levels of SUNITINIB CIPLA in your body. You should inform your health care provider if you are taking medicines containing the following active substances:

• Ketoconazole, itraconazole – used to treat fungal infections. These medicines may increase the levels of SUNITINIB CIPLA in your body.
• Erythromycin, clarithromycin – used to treat infections. These medicines may decrease the levels of SUNITINIB CIPLA in your body.
• Ritonavir – used to treat HIV. This medicine may increase the level of SUNITINIB CIPLA in your body.
• Grapefruit juice – may increase the level of SUNITINIB CIPLA in your body.
• Rifampicin – used to treat infections. May decrease the level of SUNITINIB CIPLA in your body.
• Dexamethasone – a corticosteroid used for various conditions (such as allergic/breathing disorders or skin diseases). This medicine may decrease the level of SUNITINIB CIPLA in your body.
• Phenytoin, carbamazepine, phenobarbital – used to treat epilepsy and other neurological conditions. These medicines may decrease the level of SUNITINIB CIPLA in your body.
• Herbal preparations containing St. John’s Wort (Hypericum perforatum) used to treat depression and anxiety. This medicine may decrease the level of SUNITINIB CIPLA in your body.

SUNITINIB CIPLA with food and drink

You should avoid drinking grapefruit juice while on treatment with SUNITINIB CIPLA.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, please consult your doctor, pharmacist or other healthcare professional for advice before taking this medicine.

If you might get pregnant, you should use a reliable method of contraception during treatment with SUNITINIB CIPLA and four weeks after the last dose of SUNITINIB CIPLA.

If you are breastfeeding, tell your doctor, pharmacist or other healthcare professional. You should not breastfeed during treatment with SUNITINIB CIPLA.

Driving and using machines

If you experience dizziness or you feel unusually tired, take special care when driving or using machines. It is not always possible to predict to what extent SUNITINIB CIPLA may interfere with the daily activities of a patient. Patients should ensure that they do not engage in the above activities until they are aware of the measure to which SUNITINIB CIPLA affects them.

Do not share medicines prescribed for you with any other person.

Always take SUNITINIB CIPLA exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor will prescribe a dose that is right for you, depending on the type of cancer to be 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 14 days (2 weeks) of rest (no medicine), in 6-week cycles. The daily dose should not exceed 75 mg nor be decreased below 25 mg.
• pNET: the usual dose is 37.5 mg once daily without a rest period. The maximum dose administered in the pNET study was 50 mg daily. Your doctor will determine the appropriate dose you need to take, as well as if and when you need to stop treatment with SUNITINIB CIPLA.

SUNITINIB CIPLA can be taken with or without food.

If you take more SUNITINIB CIPLA than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

If you forget to take SUNITINIB CIPLA

Do not take a double dose to make up for a forgotten individual doses.

SUNITINIB CIPLA can have side effects. Not all side effects reported for SUNITINIB CIPLA are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking SUNITINIB CIPLA, please consult your health care provider for advice.

If any of the following happens, stop taking SUNITINIB CIPLA and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing.
• Rash or itching.
• A life-threatening skin disorder characterised by blistering and peeling of the skin (toxic epidermal necrolysis).

These are all very serious side effects. If you have them, you may have had a serious reaction to SUNITINIB CIPLA. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Heart problems. Tell your doctor if you feel very tired, have chest pain, are short of breath, have a fast heartbeat or swollen feet and ankles. These may be symptoms of heart problems that may include heart failure and heart muscle problems (cardiomyopathy).
• Heart attack – symptoms include tightness or pain in the chest, neck, back or arms, feeling tired, light-headedness, anxiety and an abnormal heartbeat.
• Torsade de pointes – an abnormal heart rhythm that can lead to sudden cardiac death.
• An enlargement and weakening of a blood vessel wall or a tear in a blood vessel wall (aneurysms and artery dissections).
• Abnormal build-up of excess fluid around the heart.
• Deficiency of blood supply to the heart muscle, due to obstruction or constriction of the coronary arteries.
• Thrombotic microangiopathy, a condition which results in the formation of small blood clots which damages small blood vessels.
• A stroke or bleeding in the brain that may be life-threatening.
• Bleeding tumour that can be fatal.
• Lung or breathing problems. Tell your doctor if you develop cough, chest pain, sudden onset of shortness of breath, or coughing up blood. These may be symptoms of a condition called pulmonary embolism that occurs when blood clots travel to your lungs.
• Pleural effusion (water in the lungs) which can be fatal. Symptoms include coughing, chest pain or shortness of breath.
• Respiratory failure, a serious condition that makes it difficult to breathe on your own.
• A life-threatening complication of an infection. Symptoms include fever, difficulty breathing, low blood pressure, fast heart rate and mental confusion.
• Bacterial infection that destroys tissue under the skin. Symptoms include fever, chills, blisters, feeling tired and pain that worsens.
• Tumour lysis syndrome (TLS) – TLS consists of a group of metabolic complications that can occur during treatment of cancer. These complications are caused by the break-down products of dying cancer cells and may include the following: nausea, shortness of breath, irregular heartbeat, muscular cramps, seizure, clouding of urine and tiredness associated with abnormal laboratory test results (high potassium, uric acid and phosphorous levels and low calcium levels in the blood) that can lead to changes in kidney function and acute renal failure.
• Abnormal changes in the brain that can cause a collection of symptoms including headache, confusion, seizures, and vision loss (reversible posterior leukoencephalopathy syndrome).
• Leg pain or swelling with redness which can be due to a blood clot.
• Liver failure. Symptoms include yellowed skin and eyes (jaundice) along with stomach pain and swelling.
• Inflammation (swelling and redness) of the gallbladder with or without associated gallstones, which may be fatal.
• Kidney disorders. Tell your doctor if you experience altered frequency or absence of urination which may be symptoms of kidney failure.
• Bleeding - lung or gastrointestinal bleeding which can be fatal. Tell your doctor if you have any of these symptoms or a serious bleeding problem during treatment with SUNITINIB CIPLA: painful, swollen stomach (abdomen); vomiting blood; black, sticky stools; bloody urine; headache or change in your mental status; coughing up of blood or bloody sputum from the lungs or airway.
• Inflammation of the throat (oesophagus), that can be life-threatening.
• Tumour destruction leading to hole in the intestine. Tell your doctor if you have severe abdominal pain, fever, nausea, vomiting, blood in your stool, or changes in bowel habits.
• Severe reaction of the skin and/or mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme).
• Abnormal tube-like passage from one normal body cavity to another body cavity or the skin, that may be life-threatening.
• Abnormal muscle breakdown which can lead to kidney problems (rhabdomyolysis).

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects:

• Reduction in the number of platelets, red blood cells and/or white blood cells (e.g. neutrophils).
• Infections, including viral, lung, fungal, urinary tract and skin infections.
• Abscess.
• Insomnia, a sleep disorder that can make it hard to fall asleep or stay asleep.
• High blood pressure.
• Extreme tiredness, loss of strength.
• Swelling caused by fluid under the skin and around the eye, deep allergic rash or swelling of eyelid.
• Mouth pain/irritation.
• Mouth sores/inflammation.
• Bleeding of the gums.
• Difficulty in swallowing or inability to swallow.
• Dry mouth.
• Chapped lips.
• Taste disturbances.
• Upset stomach.
• Diarrhoea.
• Nausea.
• Vomiting.
• Constipation.
• Abdominal pain/swelling.
• Abdominal discomfort.
• Acid reflux.
• Indigestion.
• Decreased appetite.
• Haemorrhoids, pain in the rectum.
• Burning or painful sensation in the tongue.
• Excessive gas in the stomach or intestine.
• Rectal pain.
• Shortness of breath during exercise.
• Decreased activity of thyroid gland (hypothyroidism).
• Dizziness.
• Headache.
• Nose bleeding.
• Back pain, joint pain.
• Pain in arms and legs.
• Yellow skin/skin discoloration.
• Abnormal sensation of the skin.
• Excess pigmentation of the skin.
• Hair colour change.
• Rash on the palms of the hands and soles of the feet.
• Rash, dryness of the skin.
• Skin redness.
• Blisters.
• Hair loss.
• Acne.
• Skin inflammation.
• Eczema – dry, itchy skin that can be red, scaly or with bumps and swelling.
• Nail discolouration.
• Thickening of the skin.
• Fever.
• Decreased blood sugar level (see section 2).
• Loss of protein in the urine sometime resulting in swelling.
• Flu-like symptoms.
• Abnormal blood tests including pancreatic and liver enzymes.
• High level of uric acid in the blood.
• Weight loss.
• Musculoskeletal pain (pain in muscles and bones), muscular weakness, muscular fatigue, muscle pain, muscle spasms.
• Nasal dryness, congested nose.
• Excessive tear flow.
• Abnormal sensations in extremities.
• Abnormally decreased/increased sensitivity, particularly to touch.
• Dehydration.
• Hot flushes.
• Abnormally coloured urine.
• Depression, a mood disorder that causes a persistent feeling of sadness or loss of interest.
• Chills.
• Increase in certain waste products made by the body.
• Increase in certain enzymes in the body.

Less frequent side effects:

• Bacterial infections.
• Low level of blood cells (pancytopenia). Symptoms include fatigue, weakness, dizziness, trouble breathing, fast heartbeat, fever, pale skin, purple or red spots on the skin, rash, easy bruising and abnormal bleeding.
• Loss of taste.
• Pain in the stomach (abdomen) caused by inflammation of the pancreas.
• Pain in the mouth, teeth and/or jaw, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw, or loosening of a tooth. These could be signs and symptoms of bone damage in the jaw (osteonecrosis), see section 2.
• Overproduction of thyroid hormones which increases the amount of energy the body uses at rest.
• Problems with wound healing after surgery.
• Increased blood level of enzyme (creatine phosphokinase) from muscle.
• Inflammation of the colon (colitis, colitis ischaemic).
• Anal fistula - infected tunnel between the skin and the anus.
• Abnormal liver function.
• High levels of thyroid-stimulating hormone.
• Painful skin ulceration (pyoderma gangrenosum).
• Inflammation of the liver (hepatitis).
• Inflammation of the thyroid gland.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8 or by e-mail: [email protected] or telephone: 080 222 6662 (toll free). By reporting side effects, you can help provide more information on the safety of SUNITINIB CIPLA.

Store all medicines out of reach of children.

Store at or below 30 °C.

This medicine does not require any special storage conditions.

Do not use after the expiry date stated on the packaging material.

Return all unused medicine to your pharmacist.

Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).