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Stivarga 40mg (Regorafenib )

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STIVARGA 40 MG

Description

Stivarga 40mg is a cancer medicine whichinhibits the growth and spread of cancer cells in the body.

Stivarga 40mg is usually administer after other cancer medications have been tried without success.

Stivarga 40mg is a prescription drugs which is used under the supervision of medical practioners.

Indication

Stivarga 40mg is indicated for the treatment following conditions

Hepatocellular carcinoma

Colorectal cancer

Gastrointestinal stromal tumor

Dosage and administration

Hepatocellular carcinoma

The prescribed dose is 160mg (four 40mg tablets) Po q Day for the first 21 days of each 28-day cycle.

Follow the treatment of this conditions until disease progression or undesirable toxicity

Colorectal cancer

The usual dose is 160mg (four 40mg tablets) Po q Day for the first 21 days of each 28-day cycle.

Gastrointestinal stromal tumor

The usual dose is 160mg (four 40mg tablets) Po q Day for the first 21 days of each 28-day cycle.

Mechanism of action

Regorafenib belongs to targeted cancer drug. It works by preventing proteins on cancer cells which encourages the cancer to develop. These proteins are called protein kinases. Therefore, regorafenib is called a protein kinase inhibitor (TKI) or cancer growth blocker. 

It also inhibits the cancer cells from growing blood vessels which they required. Preventing blood vessel growth is called anti-angiogenesis treatment. 

Regorafenib may decrease the cancer or stops it growing for a time.  

ADME Properties

Time to peak plasma is 4 hours and concentration is 2.5mcg/mL for single dose; 3.9mcg/mL for steady state and bioavailability is 69-83%

Regorafenib has protein bounding about 99.5% and M-2 active metabolite is 99.8%; M-5 active metabolite is 99.95%

Regorafenib is metabolized by CYP3A4 and UGT1A9

Excreted via feces 71%; 19% urine (within 12 days of single dose)

Half-life of

Regorafenib is 28 hr

M-2 active metabolite is 25 hr

M-5 active metabolite is 51hr

Side effects

Common side effects occurring in greater than 30%

Less common side effects occurring in about 10-29% of patients receiving Stivarga 40mg

Drug interaction

Interaction of Stivarga 40mg with strong CYP3A4 inducers will decrease Regorafenib plasma concentrations and increased plasma concentration of active metabolite M-2; M-5.

Interaction of Stivarga 40mg with strong CYP3A4 inhibitor will increase Regorafenib plasma concentration and decreased plasma concentration of active metabolite M-2; M-5.

Interaction of Stivarga 40mg with BCRP substrate will increased the plasma concentration of the BCRP substrate.

Precautions

  • While therapy with Stivarga will have high risk for HFSR/PPES and rash; a more incidence of HFSR reported in Asian patients; stop and then reduce or stop regorafenib depending on severity and persistence of dermatologic toxicity
  • When administrating Stivarga 40mg will occur Myocardial ischemia and infarction seen in clinical trials; withhold Stivarga for new or acute cardiac ischemia/infarction and restart only after resolution of acute ischemic events
  • While therapy with Stivarga, one case report of reversible posterior leukoencephalopathy syndrome (RPLS) occurred (1 of 1100 treated patients); discontinue therapy if RPLS occurs
  • Severe drug-induced liver injury with fatal outcome appeared in Stivarga-treated patients in clinical trials. Some of the cases, liver dysfunction occurred within the first 2 months of treatment and was characterized by a hepatocellular pattern of injury.
  • While treatment with Stivarga will have heavy risk for haemorrhage; stop therapy for severe or life-threatening haemorrhage
  • While therapy with Stivarga will Increased risk of infections reported; most common infections includes urinary tract infections, nasopharyngitis, mucocutaneous and systemic fungal infections and pneumonia

Pregnancy

There are no data available on use in pregnant women. Advise female about the possible hazard to a foetus.

Lactation

Excretion into human milk is unknown

Avoid breast feeding during the treatment with Stivarga 40mg

Storage

Store the Stivarga 40mg at 250C (770C)

Keep the drug in its original container bottle

Keep the bottle tightly closed after one time used

Missed dose

If dose is missed, patients must consult with medical practitioner and follow the instructions given by them.

thereby missed dose should be avoid and follow the regular dosing schedule

  • Trade name Stivarga 40mg
  • Substance Regorafenib
  • Manufacturer Bayer Pharmaceuticals Pvt
  • Packaging 84 tablets
  • Country of origin India
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