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Stivarga 40mg Tablets| Regorafenib Uses & Side effects


STIVARGA 40MG




DESCRIPTION


Stivarga 40mg consist of protein kinase inhibitor with a similar structure to sorafenib. It is hoping to act by prohibiting multiple signalling pathways contains in angiogenesis and tumour growth.
Stivarga 40mg is commonly given after other chemotherapy have been tried without success.
Stivarga 40mg which is used as prescription drugs under the supervision of medical practioners.



INDICATION:


Stivarga 40mg is an anticancer drug which is;
Indicated for the treatment of Hepatocellular carcinoma
Indicated for the treatment of Colorectal cancer
Indicated for the treatment of Gastrointestinal stromal tumor




MECHANISM OF ACTION:


Regorafenib consist of systemic therapy which works throughout your body to promote fight certain cancers. Regorafenib belongs to a multikinase inhibitor, may work by stopping some proteins on certain normal and cancer cells. In this way, Regorafenib may inhibit cancers from growing and spreading for a period.
Cancer contains the uncontrolled growth of certain cells in the body.
Regorafenib may interfere with the signals which inform cancer cells to replicate and may slow the cancer from spreading to other parts of the body.
Regorafenib may also block the creation of new blood vessels that feed cancer cells




ADME



Time to peak plasma is 4 hours and concentration is 2.5mcg/mL for single dose;
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%
The drug Regorafenib is metabolized by CYP3A4 and UGT1A9
Eliminated 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




DOSE MANAGEMENT:


Hepatocellular carcinoma :
The usual dose for Hepatocellular carcinoma 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 for Colorectal cancer is 160mg (four 40mg tablets) Po q Day for the first 21 days of each 28-day cycle.
Gastrointestinal stromal tumor :
The usual dose for Gastrointestinal stromal tumor is 160mg (four 40mg tablets) Po q Day for the first 21 days of each 28-day cycle.




PRECAUTIONS:


• Have high risk for HFSR/PPES and rash; a more incidence of HFSR resulted in Asian patients; stop and then reduce or stop regorafenib depending on severity and persistence of dermatologic toxicity.
• While on treatment with 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.
• When administrating Stivarga 40mg, one case report of reversible posterior leukoencephalopathy syndrome (RPLS) occurred (1 of 1100 treated patients); discontinue therapy if RPLS occurs.
• Using Stivarga 40mg treatment will have Serious 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.
• When administrating Stivarga 40mg will have heavy risk for haemorrhage; stop therapy for severe or life-threatening haemorrhage
• When administrating Stivarga 40mg will have high risk of infections resulted; most common infections includes urinary tract infections, nasopharyngitis, mucocutaneous and systemic fungal infections and pneumonia




Common side effects of Stivarga 40mg :

Diarrhea, Low platelets, Mouth ulcers, Weight loss, High bilirubin in the blood, Hand-foot syndrome , Infection, Anemia, Increased liver enzymes (AST, ALT), Fatigue, High blood pressure, Protein in the urine, Reduced Calcium, Low phosphorous, Low white blood cells, Decreased appetite, Increased lipase & amylase, Voice disorder (Dysphonia), Low sodium, Nausea.
Less common side effects of Stivarga 40mg :
Increased bleeding, Headache, Alopecia, Pain, Fever, Rash, Low potassium, Decreased blood clotting.
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