Sutent

Generic Name: Sunitinib
Product Name: Sutent

Indication

Sutent is a medication used to treat advanced renal cell carcinoma (RCC).

It may also be used in the treatment of gastrointestinal stromal tumour (GIST); however, it is only used to treat this condition if other treatments fail.

Sutent is further used to treat pancreatic neuroendocrine tumours (pancreatic NET) in patients with well differentiated pancreatic NET that cannot be surgically treated.

For more information on renal cell carcinoma, see Kidney Cancer.

Action

Sutent contains the active ingredient sunitinib.

Sunitinib works by inhibiting the action of receptor tyrosine kinases which play an important role in the division and replication of cancer cells. By interfering with the process by which cancer cells replicate, Sutent reduces the growth and spread of the cancer.

Dose advice

Dose information

A doctor must prescribe Sutent.

If you are being treated for gastrointestinal stromal tumour or renal cell carcinoma, Sutent will typically be prescribed in a six-week cycle, where Sutent is taken every day for four weeks, followed by a two-week rest period during which Sutent is not taken. The doctor will always monitor your response to the medication, and may adjust the dose if you start to develop liver or other problems. Always take the dose recommended by the doctor.

If you are being treated for pancreatic NET, Sutent is usually prescribed continuously. However, the doctor will always monitor your response to the medication, and may adjust the dose or recommend a rest period if the you start to develop liver or other problems. Always take the dose recommended by the doctor.

People often experience skin, hair and urine discolouration as a result of Sutent use, although these usually return to normal after treatment is discontinued.

Consult your doctor immediately if you experience any of the following while taking Sutent:

Unusual bleeding;
Numbness in hands or feet;
Tingling sensations in hands or feet;
Pain in hands or feet; or
Redness, blistering or swelling in hands or feet.

Contraindications

Sutent should not be used by people who are allergic to any of the ingredients.

Precautions

Certain conditions require careful consideration when taking Sutent. Tell your doctor if you have:

Bleeding disorders;
Metastatic non-small cell lung cancer;
A high tumour burden;
Hypertension or high blood pressure;
Low platelet or neutrophil count;
Cardiovascular problems;
Irregular heartbeats;
Electrolyte disturbances;
Thyroid dysfunction;
Pancreatitis;
Liver disorders;
Kidney disorders;
Seizures;
Major surgery scheduled, including dental surgery;
Recently been, are being or will be treated with medicine containing bisphosphonates;
Use of any other medication while undergoing Sutent treatment, including over-the-counter medications, supplements and herbal preparations.

Pregnancy

Sutent is a Pregnancy Category D medication. It should not be used by pregnant women. Tell your doctor if you are or are planning to become pregnant.

Breastfeeding

The safety of Sutent for use during breastfeeding has not been established. Tell your doctor if you are breastfeeding.

Schedule

Sutent is a Schedule 4 medication.¹

Common side effects

All drugs can cause side effects. Anti-cancer drugs have a particularly toxic effect on the body and cause more side effects than other drugs. Your doctor will assess the potential benefits and costs of the treatment before prescribing a medication.

Very common side effects are those which occur in more than 10% of people given Sutent. These include:

Fatigue;
Fever;
Nausea or vomiting;
Indigestion (dyspepsia);
Diarrhoea or constipation;
Flatulence;
Pain, ulcers or inflammation in the mouth (including oral mucositis and stomatitis);
Abdominal pain;
High blood pressure (hypertension);
Cardiovascular problems (including left ventricular dysfunction and peripheral oedema);
Abnormal sense of taste;
Headache;
Yellow discolouration of skin and urine;
Skin or hair colour changes;
Dry skin;
Rash;
Swelling of hands and feet (hand–foot syndrome);
Back, joint or limb pain (including arthralgia and myalgia);
Bleeding at all sites, including the nose (epistaxis);
Low white blood cell count (neutropenia);
High blood sugar (hyperglycaemia);
Low platelet count (thrombocytopenia);
Low white blood cell count (leukopenia);
Low red blood cell count (anaemia);
Appetite and weight loss;
Insomnia;
Lack of strength (asthenia);
Abnormalities in enzymes that help with digestion;
Cough;
Shortness of breath (dyspnoea).

Common side effects are those which occur in 1–10% of people given Sutent. These include:

Adverse events involving veins (venous thromboembolic events, including deep vein thrombosis);
Thyroid disorders;
Chills;
Hair loss (alopecia);
Skin blistering;
Dizziness;
Depression;
Nerve damage (peripheral neuropathy);
Swelling around the eyes (periorbital oedema);
Increased shedding of tears (increased lacrimation);
Oral pain;
Bleeding from the tumour.

Uncommon side effects

Side effects that occur in 0.1–1% of people given Sutent are considered uncommon. People do not necessarily experience any of these side effects, so do not become alarmed by this list:

Inflammation of the pancreas (pancreatitis);
Excess protein in the urine (proteinuria);
Cardiovascular events, including heart failure;
Liver failure.

Rare side effects are those which occur in 0.01–0.1% of people given Sutent. These include:

Gastrointestinal perforation;
Localised brain swelling (reversible posterior leukoencephalopathy syndrome);
Heart rhythm irregularity (prolonged QT interval);
Seizures;
Bleeding disorders and other blood abnormalities (including osteonecrosis of the jaw and thrombotic microangiopathy);
Disorders affecting the blood vessels (including pulmonary embolism and arterial thromboembolic events);
Muscle disorders (including myopathy and rhabdomyolysis);
Abnormal connection between two organs or vessels (fistula);
Hypersensitivity reactions, including angioedema;
Severe infection at sites commonly affected in people with cancer (e.g. blood, skin, urinary tract and respiratory system);
Kidney damage (nephrotic syndrome).

Very rare side effects are those which occur in less than 0.01% of people given Sutent. These include:

Torsades de pointes (a cardiac disorder characterised by abnormal heart rhythms).

References:

Sutent [online]. St Leonards, NSW: MIMS Online; 7 April 2009 [cited 5 September 2009]. Available from: URL link
Sutent [online]. Adelaide, SA: Australian Medicines Handbook; July 2009 [cited 5 September 2009]. Available from: URL link
Product Information: Sutent. West Ryde, NSW: Pfizer Australia Pty Ltd; 11 January 2012.