Sunitinib Accord – Sunitinib uses, dose and side effects


12.5 mg, 25 mg, 37.5 mg and 50 mg hard capsules

What Sunitinib Accord is and what it is used for

Sunitinib Accord 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 Accord is used to treat the following cancers:

  • Gastrointestinal stromal cell tumor ( GIST ), is a type of cancer of the stomach and intestines. Sunitinib Accord is used if imatinib (another cancer medicine) is no longer working 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 Accord works or why this medicine has been prescribed for you, contact your doctor.

What you need to know before you take Sunitinib Accord

Do not take Sunitinib Accord

  • 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 taking Sunitinib Accord:

  • If you have high blood pressure. Sunitinib Accord can raise blood pressure et. Your doctor may want to check your blood pressure during treatment with Sunitinib Accord 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 Accord 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 have a bleed while being treated with Sunitinib Accord.
  • If you have heart problems. Sunitinib Accord 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 Accord can cause abnormal heart rhythm. Your doctor may take an ECG to assess these problems during treatment with Sunitinib Accord. Tell your doctor if you feel dizzy, faint, or have an abnormal heartbeat while taking Sunitinib Accord.
  • 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 Accord.
  • 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 Accord 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 while taking Sunitinib Accord. Thyroid function should be checked before taking Sunitinib Accord 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 Accord: 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 Accord, 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 Accord may affect wound healing. Most often, you stop using Sunitinib Accord before an operation. Your doctor will decide when you can start taking Sunitinib Accord again.
  • You may be advised to have a check-up with the dentist before starting treatment with Sunitinib Accord
  • 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 Accord, especially if you are also receiving or have received bisphosphonates intravenously (into 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. 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 dose of diabetes medication 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 Accord is not recommended for people under 18 years of age.

Other medicines and Sunitinib Accord

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, even those without a prescription.

Some medicines can affect the concentration of the Sunitinib Accord 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 treating epilepsy and other neurological conditions
  • an herbal preparation containing St. John’s wort (Hypericum perforatum) – used for mild depression and mild anxiety.

Sunitinib Accord with food and drink

Avoid drinking grapefruit juice while being treated with Sunitinib Accord.

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 should use reliable contraception during treatment with Sunitinib Accord.

If you are breastfeeding, talk to your doctor. You should not breastfeed while you are being treated with Sunitinib Accord.

Driving ability and use of machinery

If you feel dizzy or unusually tired, take special care when driving or using machinery.

Sunitinib Accord contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium (croscarmellose sodium) per capsule, i.e. it is almost ‘sodium-free’.

How to take Sunitinib Accord

Always take this medicine as directed by your doctor. Consult a doctor if you are unsure.

The doctor will prescribe an appropriate dose for you, depending on the type of cancer you have. If you are being treated for:

  • GIST or kidney cancer (MRCC) the most common dose is 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 Accord.

Sunitinib Accord can be taken with or without food.

If you have taken too much Sunitinib Accord

If you accidentally take too many capsules, contact your doctor immediately. You may need medical attention.

If you forget to take Sunitinib Accord

Do not take a double dose to make up for a missed dose.

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 section 2 What you need to know before you take Sunitinib Accord):

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 get any of these symptoms or if you have a serious bleed during treatment with Sunitinib Accord: 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 Accord are:

Very common (may affect more than 1 in 10 people)

  • Decreased number of platelets, red blood cells, and/or white blood cells (eg 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, and decreased appetite.
  • Decreased activity of the thyroid gland ( hypothyroidism ).
  • Dizziness.
  • Headache.
  • Nosebleed.
  • Back pain, joint pain.
  • Pain in arms and legs.
  • Yellow or discolored skin, increased pigmentation of the skin, changed hair color, rashes on the palms of the hands and the soles of the feet, skin rashes, and dry skin.
  • Cough.
  • Fever.
  • Difficulty falling asleep.

Common (may affect up to 1 in 10 people)

  • Clots in the blood vessels.
  • Lack of blood supply to the heart muscle due to blockage or narrowing of the heart’s coronary arteries.
  • Chest pain.
  • Decrease in the amount of blood that the heart pumps.
  • Fluid accumulation around the lungs.
  • Infection you.
  • A complication of severe infection ( infection in the blood) which can lead to tissue damage, organ failure, and death.
  • Low blood sugar (see section 2).
  • Protein leakage in the urine 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, pain in the rectum, bleeding gums, difficulty or inability to swallow.
  • Burning sensation or pain on the tongue, inflammation of the mucous membrane of the gastrointestinal tract, and 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.
  • Dryness of the nose, and nasal congestion.
  • Increased tear flow.
  • Abnormal sensation in the skin, itching, scaly and inflamed skin, blisters, acne, discoloration of the nails, and 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 people)

  • Life-threatening soft tissue infection, including around the rectum and genitals (see section 2).
  • Stroke.
  • Heart attack is caused by 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 is caused by inflammation of the pancreas.
  • Tumor breakdown leads 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 increases the body’s energy consumption at rest.
  • Problems with wound healing after surgery.
  • Increased levels 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 people)

  • 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 can lead to kidney problems ( rhabdomyolysis ).
  • Abnormal changes in the brain 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 is called thrombotic microangiopathy (TMA).

Frequency not known (cannot be estimated from available data)

  • An enlargement and weakening of a vessel wall or a rupture in a vessel wall ( aneurysms and arterial dissections).

How to store Sunitinib Accord

  • Keep this medicine out of the sight and reach of children.
  • Use before the expiry date which is stated on the carton, can, and 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. Each hard capsule contains 12.5 mg, 25 mg, 37.5 mg, or 50 mg of sunitinib.

Other ingredients are:

  • Capsule content: microcrystalline cellulose, mannitol (E421), croscarmellose sodium, povidone (E1201), magnesium stearate.
  • Capsule shell: gelagin, titanium dioxide (E171), black iron oxide (E172) (for 25 mg and 50 mg), red iron oxide (E172) (for 12.5 mg, 25 mg, 50 mg), yellow iron oxide (E172) (for 25 mg, 37.5 mg, 50 mg).
  • Ink: shellac, titanium dioxide (E171), black iron oxide (E172), propylene glycol, ammonium hydroxide.

Appearance and package sizes of the medicine

Sunitinib Accord 12.5 mg hard capsules

Gelatin capsules (approximately 14.3 mm long) with orange cap and orange body, imprinted with “12.5 mg” in white ink on the body and containing yellow to orange granules.

Sunitinib Accord 25 mg hard capsules

Gelatin capsules (approximately 15.9 mm long) with light brown cap and orange body, imprinted with “25 mg” in white ink on the body and containing yellow to orange granules.

Sunitinib Accord 37.5 mg hard capsules

Gelatin capsules (approximately 18.0 mm long) with yellow cap and yellow body, imprinted with “37.5 mg” in black ink on the body and containing yellow to orange granules.

Sunitinib Accord 50 mg hard capsules

Gelatin capsules (approximately 19.4 mm long) with light brown cap and light brown body, imprinted with “50 mg” in white ink on the body and containing yellow to orange granules.

Sunitinib Accord is supplied in bottles of 30 capsules and blister packs of 28 capsules and perforated unit dose blisters of 28 x 1 capsule.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing Authorisation Holder

Accord Healthcare SLU

World Trade Center, Moll De Barcelona s/n,

Edifici Est, 6 a Planta,

Barcelona, ​​08039,



Remedica Ltd.

Aharnon Street, Limassol Industrial Estate,

Building 10, 3056 Limassol,


Pharmacare Premium Ltd.

HHF003 Hal Far Industrial Estate,

Birzebbugia, BBG3000


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