12.5 mg, 25 mg, 37.5 mg, 50 mg hard capsules
sunitinib
What Sunitinib Sandoz is and what it is used for
Sunitinib Sandoz contains the active substance sunitinib, which is a protein kinase inhibitor. It is used in the treatment of cancer to prevent the activity of a certain type of protein known to be active in the growth and spread of cancer cells.
Sunitinib Sandoz is used to treating the following cancers in adults:
- gastrointestinal stromal cell tumor ( GIST ), a type of cancer of the stomach and intestines. Sunitinib Sandoz is used if imatinib (another cancer medicine) no longer works or if you cannot take imatinib.
- metastatic renal cell carcinoma (MRCC), is a type of kidney cancer that has spread to other parts of the body.
- pancreatic neuroendocrine tumor (pNET) (tumor of the hormone-producing cells of the pancreas), when cancer has worsened or cannot be operated on.
If you have any questions about how Sunitinib Sandoz works or why this medicine has been prescribed for you, contact your doctor.
The sunitinib contained in Sunitinib Sandoz may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Sunitinib Sandoz
Do not use Sunitinib Sandoz
- if you are allergic to sunitinib or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using Sunitinib Sandoz:
- If you have high blood pressure. Sunitinib Sandoz can raise blood pressure et. Your doctor may want to check your blood pressure during treatment with Sunitinib Sandoz and you may receive treatment to lower your blood pressure if needed.
- If you have or have had a blood disorder or problems with bleeding or bruising. Treatment with Sunitinib Sandoz can lead to a higher risk of bleeding or a change in the number of certain cells in the blood, which can cause anemia ( lack of blood ) or affect the blood’s ability to be livered. If you take medicines that thin the blood to prevent blood clots, e.g. warfarin or acenocoumarol, the risk of bleeding may be increased. Tell your doctor if you bleed while being treated with Sunitinib Sandoz.
- If you have heart problems. Sunitinib Sandoz can cause heart problems. Tell your doctor if you feel very tired, short of breath, or have swollen feet and ankles.
- If the heart rhythm becomes abnormal. Sunitinib Sandoz can cause abnormal heart rhythm. Your doctor may take an ECG to assess these problems during treatment with Sunitinib Sandoz. Tell your doctor if you feel dizzy, faint, or have an abnormal heartbeat while taking Sunitinib Sandoz.
- If you have recently had problems with blood clots in your veins and/or arteries (different types of blood vessels), including stroke, heart attack, embolism, or thrombosis. Contact your doctor immediately if you experience any 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, trouble speaking, headache or dizziness while you are being treated with Sunitinib Sandoz.
- If you have or have had an aneurysm (enlargement and weakening of a vessel wall) or a rupture in a vessel wall.
- If you have or have had damage to the smallest blood vessels, which is called thrombotic microangiopathy (TMA). Tell your doctor if you develop fever, fatigue, tiredness, bruising, bleeding, swelling, confusion, vision loss, and seizures.
- If you have thyroid problems. Sunitinib Sandoz can cause problems with the thyroid gland. Tell your doctor if you get tired more easily, get colder than others or if your voice deepens when you take Sunitinib Sandoz. Thyroid function should be checked before taking Sunitinib Sandoz and regularly while taking it. If your thyroid gland does not produce enough thyroid hormone, you may be treated with thyroid hormone replacement.
- If you have or have had a disease of the pancreas or gallbladder. Tell your doctor if you get any of the following signs or symptoms: pain in the area around your stomach (upper abdomen), nausea, vomiting, and fever. These can be caused by an inflammation of the pancreas or gall bladder.
- If you have or have had liver problems. Tell your doctor if you get any of the following signs or symptoms of liver problems during treatment with Sunitinib Sandoz: itching, yellowing of the eyes or skin, dark urine, and pain or discomfort in the upper right part of the abdomen. Your doctor should take blood tests to check liver function before and during treatment with Sunitinib Sandoz, as needed.
- Suppose you have or have had kidney problems. Your doctor will monitor your kidney function.
- If you are going to have surgery or have recently had surgery. Sunitinib Sandoz can affect wound healing. Sunitinib Sandoz is usually stopped before an operation. Your doctor will decide when you can start taking Sunitinib Sandoz again.
- You may be advised to have a check-up with the dentist before starting treatment with Sunitinib Sandoz.
- If you have or have had pain in your mouth, teeth, and/or jaw, swelling or sores in your mouth, if you feel numbness or heaviness in your jaw, or if a tooth is loose – contact your doctor and dentist immediately.
- If you need to undergo invasive dental treatment or dental surgery. Tell the dentist that you are being treated with Sunitinib Sandoz, especially if you are also receiving or have received bisphosphonates intravenously (in a vessel ). Bisphosphonates are used to prevent bone complications and may have been given to you to treat another condition.
- If you have or have had problems with the skin and subcutaneous tissue a. When taking this medicine, the condition “pyoderma gangrenosum” (painful sores on the skin) or “necrotizing fasciitis” (rapidly progressing skin/soft tissue infection that can be life-threatening) may occur. Contact a doctor immediately if you develop symptoms of infection around a skin injury, including fever, pain, redness, swelling, or if a sore or blood oozes from the wound. This side effect usually disappears when treatment with sunitinib is stopped. Severe skin rashes ( Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) have been reported with sunitinib treatment. These occur initially as reddish circular target-like spots or as round spots with a central blister, on the trunk. The rash can develop into widespread blistering or scaling of the skin and can be life-threatening. If you develop a rash or these skin symptoms, seek medical advice immediately.
- If you have or have had convulsions. Tell your doctor as soon as possible if you have high blood pressure, headaches, or vision loss.
- If you have diabetes. In diabetic patients, blood sugar levels should be checked regularly to determine if the dosage of one of the diabetes medicines needs to be adjusted, to minimize the risk of low blood sugar. Tell your doctor as soon as possible if you experience any signs and symptoms of low blood sugar (fatigue, palpitations, sweating, hunger, and fainting).
Children and young people
Sunitinib Sandoz is not recommended for patients under 18 years of age.
Other medicines and Sunitinib Sandoz
Tell your doctor or pharmacist if you are using, have recently used, or might be using other medicines.
Some medicines can affect the concentration of Sunitinib Sandoz in the body. Tell the doctor if you are using medicines containing the following active substances:
- ketoconazole, itraconazole – for the treatment of fungal infections
- erythromycin, clarithromycin, rifampicin – to treat infection er
- ritonavir – for treating HIV
- dexamethasone – a corticosteroid used for various medical conditions (such as allergies/respiratory problems or skin diseases)
- phenytoin, carbamazepine, phenobarbital – for the treatment of epilepsy and other neurological conditions
- herbal preparations containing St. John’s wort (Hypericum perforatum) – used for mild depression and mild anxiety.
Sunitinib Sandoz with food and drink
Avoid drinking grapefruit juice while being treated with Sunitinib Sandoz.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
If there is a risk of becoming pregnant, you must use reliable contraception during treatment with Sunitinib Sandoz.
If you are breastfeeding, talk to your doctor. You should not breastfeed while you are being treated with Sunitinib Sandoz.
Driving ability and use of machinery
If you feel dizzy or unusually tired, take special care when driving or using machinery.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Sunitinib Sandoz contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose unit, i.e. it is almost ‘sodium-free’.
How to use Sunitinib Sandoz
Always use this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
The doctor will prescribe an appropriate dose for you, depending on the type of cancer you have. If you are treated for
- GIST or renal cell carcinoma (MRCC) is the most common dose of 50 mg once daily, taken for 28 days (four weeks), followed by 14 days (two weeks) off (no medication), for 6-week periods.
- pNET is the usual dose of 37.5 mg once daily without any breaks.
The doctor will decide which dose is suitable for you and when and if you need to stop Sunitinib Sandoz.
Sunitinib Sandoz can be taken with or without food.
If you have taken too much Sunitinib Sandoz
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
If you forget to take Sunitinib Sandoz
Do not take a double dose to make up for a missed dose.
If you have any further questions about this medicine, ask your doctor or pharmacist.
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 these serious side effects (see also What you need to know before using Sunitinib Sandoz):
Heart problems. Tell your doctor if you feel very tired, short of breath, or have swollen feet and ankles. These can be symptoms of heart problems such as heart failure and problems with the heart muscle ( cardiomyopathy ).
Problems with lungs or breathing. Tell your doctor if you develop a cough, chest pain, sudden shortness of breath, or if you cough up blood. These can be symptoms of pulmonary embolism, which occurs when blood clots travel to the lungs.
Kidney diseases. Tell your doctor if you notice any changes in how often you urinate or if you do not urinate. This may be a symptom of kidney failure.
Bleeding. Tell your doctor if you experience any of these symptoms or if you experience serious bleeding during treatment with Sunitinib Sandoz: painful and swollen abdomen, vomiting blood, black and sticky stools, blood in the urine, headache, altered consciousness or mental state, or coughing up blood or bloody mucus from the lungs or airways.
Tumor breakdown leads to holes in the intestine. Tell your doctor if you develop severe abdominal pain, fever, nausea, vomiting, blood in the stool, or changes in bowel habits.
Other side effects that may occur with Sunitinib Sandoz are:
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 due to fluid accumulation under the skin and around the eyes, deep allergic rash
- pain/irritation in the mouth, mouth ulcers, inflammation of the mouth, dry mouth, taste disturbance, upset stomach, nausea, vomiting, diarrhea, constipation, abdominal pain/swelling, decreased appetite
- decreased activity of the thyroid gland ( hypothyroidism )
- dizziness
- headache
- nosebleed
- back pain, joint pain
- pains in arms and legs
- yellow or discolored skin, increased pigmentation of the skin, change in hair color, rash on the palms of the hands and soles of the feet, rash, dry skin
- cough
- fever
- difficulty falling asleep.
Common (may affect up to 1 in 10 users)
- clots in the blood vessels
- lack of blood supply to the heart muscle due to blockage or narrowing of the coronary arteries of the heart
- chest pain
- reduction in the amount of blood that the heart pumps
- fluid accumulation around the lungs
- infection _
- a complication of severe infection ( infection in the blood) which can lead to tissue damage, organ failure, and death
- low blood sugar level (see section 2)
- protein leakage in the urine which sometimes leads to swelling
- flu-like symptoms
- abnormal blood values, i.a. for pancreatic and liver enzymes
- increased level of uric acid in the blood
- hemorrhoids, rectal pain, bleeding gums, difficulty or inability to swallow
- burning sensation or pain on the tongue, inflammation of the lining of the gastrointestinal tract, increased amount of gas in the stomach or intestines
- weight loss
- musculoskeletal pain (pain in muscles and bones), muscle weakness, muscle fatigue, muscle pain, muscle spasm
- nasal dryness, nasal congestion
- increased tear flow
- abnormal sensation in the skin, itching, scaly and inflamed skin, blisters, acne, discoloration of the nails, hair loss
- abnormal sensation in arms and legs
- abnormally decreased or increased sensitivity, especially to touch
- heartburn
- dehydration
- flushing
- discolored urine
- Depression
- overindulge.
Uncommon (may affect up to 1 in 100 users)
- life-threatening soft tissue infection, including around the rectum and genitals (see section 2)
- stroke
- heart attack is caused by the interrupted or reduced blood supply to the heart
- changes in the heart’s electrical activity or abnormal heart rhythm
- fluid around the heart (pericardial effusion)
- liver failure
- abdominal pain caused by inflammation of the pancreas
- tumor breakdown leading to holes in the intestine ( perforation )
- inflammation (swelling and redness ) of the gallbladder, with or without gallstones
- abnormal channel from one normal body cavity to another or the skin ( fistula )
- pain in the mouth, teeth, and/or jaw, swelling and sores inside the mouth, numbness or a feeling of heaviness in the jaw, or tooth loss. these may be symptoms of bone damage in the jaw ( osteonecrosis ), see section 2
- overproduction of thyroid hormone, which increases the body’s energy consumption at rest
- problems with wound healing after surgery
- increased level of a muscle enzyme (creatine phosphokinase) in the blood
- strong reaction to any allergen including hay fever, rash, itching, hives, swelling of body parts, and difficulty breathing
- inflammation of the colon ( colitis, ischemic colitis ).
Rare (may affect up to 1 in 1,000 users)
- severe reactions on the skin and/or mucous membranes ( Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme)
- tumor lysis syndrome (TLS) – TLS is a group of metabolic complications that can occur during cancer treatment. They are caused by the breakdown products of dying cancer cells and may include: nausea, shortness of breath, irregular pulse, muscle cramps, seizures, cloudy urine, and fatigue combined with abnormal laboratory values (high potassium, uric acid, and phosphate levels and low calcium levels in the blood). The complications can lead to altered kidney function and acute kidney failure.
- abnormal breakdown of muscle tissue that can lead to kidney problems ( rhabdomyolysis )
- abnormal changes in the brain that can cause several symptoms, including headache, confusion, seizures, and loss of vision (reversible posterior leukoencephalopathy syndrome)
- painful sores on the skin (pyoderma gangrenosum)
- inflammation of the liver ( hepatitis )
- inflammation of the thyroid gland
- damage to the smallest blood vessels, which is called thrombotic microangiopathy (TMA).
Has been reported (occurring in an unknown number of users)
- an enlargement and weakening of a vessel wall or a rupture in a vessel wall ( aneurysms and arterial dissections).
How to store Sunitinib Sandoz
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the carton, can, or blister card after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
Do not use this medicine if you see that the package is damaged or appears to have been opened.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is sunitinib.
Sunitinib Sandoz 12.5 mg hard capsules
Each capsule contains 12.5 mg of sunitinib.
Sunitinib Sandoz 25 mg hard capsules
Each capsule contains 25 mg of sunitinib.
Sunitinib Sandoz 37.5 mg hard capsules
Each capsule contains 37.5 mg of sunitinib.
Sunitinib Sandoz 50 mg hard capsules
Each capsule contains 50 mg of sunitinib.
- Other ingredients are:
Capsule content: cellulose, microcrystalline (E460) , mannitol (E421), croscarmellose sodium, povidone (E1201), magnesium stearate (E470b)
Sunitinib Sandoz 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 Sandoz 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 Sandoz 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 Sandoz 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)
Appearance and package sizes of the medicine
Sunitinib Sandoz 12.5 mg hard capsules (capsules)
Orange gelatin capsule, size 4, containing yellow to orange granules. Marked with “12.5 mg” on the lower part in white ink.
Sunitinib Sandoz 25 mg hard capsules (capsules)
Gelatin capsule, size 3, with caramel cap and orange body, containing yellow to orange granules. Marked with “25 mg” on the lower part in white ink.
Sunitinib Sandoz 37.5 mg hard capsules (capsules)
Yellow gelatin capsule, size 2, containing yellow to orange granules. Marked with “37.5 mg” on the lower part in black ink.
Sunitinib Sandoz 50 mg hard capsules (capsules)
Caramel gelatin capsule, size 1, containing yellow to orange granules. Marked with “50 mg” on the lower part in white printing ink.
Sunitinib Sandoz is supplied in Aluminium-OPA/Alu/PVC blisters containing 28, 30, 50, 56, 60, 70, 84, 90, 98, 100, 110, and 120 hard capsules, in Aluminium-OPA/Alu/PVC perforated single-dose blisters containing 28×1, 30×1, 56×1, 84×1 hard capsules or in HDPE can containing 30 hard capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Sandoz A/S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
Manufacturer
Lek Pharmaceuticals dd, Verovskova ulica 57, Ljubljana 1526, Slovenia
or
Remedica Ltd, Aharon Street, Limassol Industrial Estate, Limassol 3056, Cyprus
or
Pharmacare Premium Ltd, HHF003 Hal Far Industrial Estate, Birzebbugia BBG3000, Malta