Suninat 50mg (Sunitinib)

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Sunitinib is an anti-cancer drugs which prohibits the development and spread of cancer cells in the body. Suninat 50mg is a is an oral, small-molecule, multi-targeted receptor tyrosine kinase (RTK)... Read more
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  • Natco Pharma Ltd.
  • Trade name Suninat 50mg
  • Substance Sunitinib
  • Manufacturer Natco Pharma Ltd
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SUNINAT 50MG

Description

Sunitinib is an anti-cancer drugs which prohibits the development and spread of cancer cells in the body.

Suninat 50mg 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).

Suninat 50mg is a prescription drugs which is used under the guidance of medical practioners

Indication

Suninat 50mg 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 thekindof tyrosine kinase inhibitor. Itsaction 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.

ADME Properties

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 mainlyvia 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

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

Shortness of breath

Unusual bruising

Muscle cramps,

Fast heart beats

Sudden dizziness

Tiredness,

decreased urination,

Slow heart rate.

Thyroid problem

Drug interaction

Interaction of Suninat 50mg with CYP3A4 inhibitors (ketoconazole0 will increase the sunitinib plasma concentrations.

Interaction of Suninat 50mg with CYP3A4 inducers (rifampin) will decrease Sunitinib plasma concentration

Contraindication

Patients are contraindicated with Suninat 50mg due to hypersensitivity and renal impairment.

Precautions

  • Due use of Suninat 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 Suninat will have Impaired wound healing resulted; temporary interfere with treatment recommended if go through major surgical procedures
  • Suninat 50mg 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

Pregnancy

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.

Lactation

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.

Storage

Stored at controlled temperature at 250C

Dispense only in its original carton

Missed dose

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 Suninat 50mg
  • Substance Sunitinib
  • Manufacturer Natco Pharma Ltd
  • Packaging 28 tablets
  • Country of origin India
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