Sutent 12.5mg (Sunitinib)
Sunitinib is an anti-cancer drugs which prohibits the development and spread of cancer cells in the body.
Sutent 12.5mg is a is an oral, small-molecule, multi-targeted receptor tyrosine kinase (RTK) inhibitor which was approved by the FDA for the therapy of renal cell carcinoma (RCC) and imatinib-resistant gastrointestinal stromal tumor (GIST).
Sutent 12.5mg is a prescription drugs which is used under the guidance of medical practioners
Sutent 12.5mg is indicated for the treatment of advanced renal cell carcinoma as well as the treatment of gastrointestinal stromal tumor after disease progression on or intolerance to imatinib mesylate.
Dosage and administration
Gastrointestinal Stromal Tumor
Dose after disease development on or intolerance to imatinib mesylate
The usual dose is 50 mg PO qDay for 4 weeks, continued by 2 weeks drug-free, repeat cycle
Renal Cell Carcinoma
The usual dose is 50 mg PO qDay for 4 weeks, followed by 2 weeks drug-free, repeat cycle
Adjuvant treatment of RCC
- Used for the adjuvant therapy of adult patients at maximum risk of relapsed RCC following nephrectomy
- The usual dose is 50 mg PO qDay for 4 weeks, continued by 2 weeks drug-free, repeat cycle for a maximum of nine 6-week cycles totally
Pancreatic Neuroendocrine Tumor
Required for progress, well-differentiated pancreatic neuroendocrine tumor (pNET) in patients with unresectable locally advanced or metastatic disease
The usual dose is 37.5 mg PO qDay continuously without a scheduled off-treatment period
Mechanism of action
Sunitinib belongs to the kind of tyrosine kinase inhibitor. Its action by inhibiting indicating in cancer cells which make them grow and divide. This may help to blocks the cancer developing or slow it down.
Sunitinib can also block cancer cells from developing new blood vessels. This decrease their supply of oxygen and nutrients, so the tumor shrinks or stops developing.
Time to plasma concentration of sunitinib is between 6 and 12 hours and the bioavailability of sunitinib has no effect on food.
Human plasma protein binding was 95 % and 90 % respectively.
Mainly metabolized by cytochrome P450 enzyme, CYP3A4
The drug sunitinib is eliminated mainly via feces 61% and renal excretion is 16% of administrated dose.
Sunitinib half-life is 40 – 60 hours
Primary active metabolite half-life was 80 – 110 hours
Common side effects
Signs of allergic reactions: hives, breathing difficulty, sore throat, skin pain, red or purple skin rash
Liver problem: upper stomach pain, itching, tried feeling, decreased appetite, dark urine, jaundice.
Serious side effects
Swelling in ankles or feet
Shortness of breath
Fast heart beats
Slow heart rate.
Interaction of Sutent 12.5mg with CYP3A4 inhibitors (ketoconazole0 will increase the sunitinib plasma concentrations.
Interaction of Sutent 12.5mg with CYP3A4 inducers (rifampin) will decrease Sunitinib plasma concentration
Patients are contraindicated with Sutent 12.5mg due to hypersensitivity and renal impairment.
- Due use of Sutent Hypothyroidism resulted; monitor the baseline thyroid function in patients with hypothyroidism or hyperthyroidism and treat per standard medical practice prior to initiating therapy
- Due use of Sutent will have Impaired wound healing resulted; temporary interfere with treatment recommended if go through major surgical procedures
- Sutent 12.5mg treatment will causes severe hepatotoxicity involving liver failure; check liver function tests before starting treatment.
- Haemorrhagic events involving tumor-related haemorrhage resulted; test the serial complete blood counts and physical examinations
- Adrenal haemorrhage occurred in animal studies; check the adrenal function in case of stress such as surgery, trauma or severe infection
- Regulate urine protein; Inhibit treatment for 24-hr urine protein ≥3 g; stop for repeat episodes of protein ≥3 g despite dose reductions or nephrotic syndrome
Advise females of reproductive possible of the probable hazard to a foetus and use of effective contraception. In pregnant women there is no available data established by along risk in animal development and reproductive studies.
Decision should be taken about discontinue the nursing or to stop the drug considering the important of the drug to the mother.
Possible of severe side effects in breastfed infants from sunitinib, avoid breast feeding during treatment.
Stored at controlled temperature at 250C
Dispense only in its original carton
If dose is forgot to take, then have the dose immediately before next dose timing reaches or skip the missed dose and continue the regular schedule.
Should be discuss with doctors regarding missed dose.
- Trade name Sutent 12.5mg
- Substance Sunitinib
- Manufacturer Pfizer’s Ltd
- Packaging 28 tablets
- Country of origin India