Resihance 40mg tablets | Regorafenib | MHP

RESIHANCE 40MG

DESCRIPTION

Resihance 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.
Resihance 40mg Tablet is commonly given after other chemotherapy have been tried without success.
Resihance 40mg which is used as prescription drugs under the supervision of medical practioners.

INDICATION:

Resihance 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.

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.

DOSAGE 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.

PREACAUTIONS:

• 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 Resihance 40mg will occur Myocardial ischemia and infarction seen in clinical trials; withhold Resihancefor new or acute cardiac ischemia/infarction and restart only after resolution of acute ischemic events.
• When administrating Resihance 40mg, one case report of reversible posterior leukoencephalopathy syndrome (RPLS) occurred (1 of 1100 treated patients); discontinue therapy if RPLS occurs.
• Using Resihance 40mg treatment will have Serious drug-induced liver injury with fatal outcome appeared in Resihance-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 Resihance 40mg will have heavy risk for haemorrhage; stop therapy for severe or life-threatening haemorrhage
• When administrating Resihance 40mg will have high risk of infections resulted; most common infections includes urinary tract infections, nasopharyngitis, mucocutaneous and systemic fungal infections and pneumonia

SIDE EFFECTS:

Common side effects of Resihance 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 Resihance 40mg :
Increased bleeding, Headache, Alopecia, Pain, Fever, Rash, Low potassium, Decreased blood clotting.