SUNITINIB 12.5MG


Description


Sutent 12.5mg is a prescription drugs which is used under the guidance of medical practioners.
Sutent 12.5mg is a type of targeted therapy and is a receptor protein-tyrosine kinase inhibitor. It prevents the actions of vascular endothelial growth factor (VEGF) and is an angiogenesis inhibitor.
Sunitinib is a generic form of brand name Sutent 12.5mg and the drug is a cancer medicine which prevents the development and spread of cancer cells in the body.


Indication


Sutent 12.5mg is used for the treatment in patients with Gastrointestinal stromal tumor.
Sutent 12.5mg is used for the treatment in patients with Advanced pancreatic neuroendocrine tumor
Sutent 12.5mg is used for the treatment in patients with Advanced renal cell cancer


Mechanism


Sunitinib belongs to type of targeted therapy drug called a tyrosine kinase inhibitor. It performs by inhibiting signals in cancer cells that make them develop and divide. This may support to blocks the cancer development or slow it down. Sunitinib can also prevents cancer cells from producing new blood vessels. This decrease their supply of oxygen and nutrients, so the tumour shrinks or inhibit growing.






Dosage & Administration


The recommended dosage for following condition as follows :
Gastrointestinal Stromal Tumor :
Dose after disease progression on or intolerance to imatinib mesylate
The recommended dose is 50 mg PO qDay for 4 weeks, followed by 2 weeks drug-free, repeat cycle
Renal Cell Carcinoma :
The recommended 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 high risk of recurrent RCC following nephrectomy
• The recommended dose is 50 mg PO qDay for 4 weeks, followed by 2 weeks drug-free, repeat cycle for a maximum of nine 6-week cycles totally
Pancreatic Neuroendocrine Tumor :
The recommended dose is 37.5 mg PO qDay continuously without a scheduled off-treatment period

ADME


Absorption:
peak plasma level of sunitinib is between 6 and 12 hours and the bioavailability of sunitinib has no effect on food.
Distribution:
Bounding of human serum protein was 95 % and 90 % respectively.
Metabolism:
Mainly metabolized by cytochrome P450 enzyme, CYP3A4
Elimination:
The drug sunitinib is eliminated primarily through 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.

Precautions


Control urine protein; interfere with treatment for 24-hr urine protein ≥3 g; stop for repeat episodes of protein ≥3 g despite dose reductions or nephrotic syndrome
Hypothyroidism occurred; check the baseline thyroid function in patients with hypothyroidism or hyperthyroidism and treat per standard medical practice prior to initiating therapy
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
Impaired wound healing resulted; temporary interfere with treatment recommended if go through major surgical procedures

Drug Interaction


Sutent 12.5mg Concomitant use with CYP3A4 inhibitors (ketoconazole0 will increase the sunitinib plasma concentrations.
Sutent 12.5mg Concomitant use with CYP3A4 inducers (rifampin) will decrease Sunitinib plasma concentration

Pregnancy


Advise females of reproductive possible of the probable hazard to a foetus and use of effective contraception.

Side Effects


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
Fast heart beats
Sudden dizziness
Shortness of breath
Unusual bruising
Signs of tumor cell breakdown :
muscle cramps, tiredness, decreased urination, slow heart rate.
Thyroid problem :
severe tiredness, depression, rapid heart rate, , feeling nervous, sweating, nausea, vomiting, diarrhea, loss of hair, weight changes, irregular menstrual periods.

Missed Dose


If dose is missed the have the dose immediately before next dose timing reaches or skip the missed dose and continue the regular schedule. Consult doctors regarding missed dose.



Lactation


Possible of severe side effects in breastfed infants from sunitinib, avoid breast feeding during treatment.


Storage


Stored at controlled temperature at 250C Dispense only in its original carton


Contraindication


Patients are contraindicated with Sutent 12.5mg due to hypersensitivity and renal impairment.


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