Nublexa 40mg

Nublexa 40mg is indicated for the treatment following conditions : Colorectal cancer, Gastrointestinal stromal tumor, Hepatocellular carcinoma.

Regorafenib

Nublexa

40mg

Bayer Pharma




DESCRIPTION

Regorafenib is a generic form of brand name Nublexa.
Nublexa 40mg is an orally-administered inhibitor of multiple kinases. It is required for the treatment of metastatic colorectal cancer and advanced gastrointestinal stromal tumours.
Nublexa 40mg is a prescription drugs which is used under the supervision of medical practioners.

Mechanism of action

Regorafenib is a type of targeted therapy whichaims and links to tyrosine kinase receptors and prevents epidermal growth factor receptor (EGFR) and vascular endothelial growth factor (VEGF), receptors on the surface of the cell. By binding to these receptors regorafenib stops an important pathway which promotes cell division.



Pharmacokinetic

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.



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drug
Brand Nublexa
Ingredients Regorafenib
Strength 40mg
Manufactured Bayer Pharma
Rating

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

Side effects

Common side effects occurring in greater than 30% :
Protein in the urine, Low calcium, Low phosphorous, Low white blood cells, Decreased appetite, Increased lipase & amylase, High bilirubin in the blood, Hand-foot syndrome , Diarrhea, Low platelets, Mouth sores/inflammation, Weight loss, Infection, Anemia, Increased liver enzymes (AST, ALT), Fatigue, High blood pressure, Voice disorder (Dysphonia), Low sodium, Nausea.
Less common side effects occurring in about 10-29% of patients receiving Nublexa 40mg :
Pain, Fever, Rash, Low potassium, Decreased blood clotting, Increased bleeding, Headache, Alopecia.

Precautions

serious drug-induced liver injury with fatal outcome appeared in Nublexa-treated patients in clinical trials. Some of the cases, liver dysfunction resulted within the first 2 months of treatment and was characterized by a hepatocellular pattern of injury. While treatment with Nublexa will Increases risk for haemorrhage; stop therapy for severe or life-threatening haemorrhage
While treatment with Nublexa will Increased risk of infections resulted; most common infections contains urinary tract infections, nasopharyngitis, mucocutaneous and systemic fungal infections and pneumonia
While treatment with Nublexa will Increases risk for HFSR/PPES and rash; a higher incidence of HFSR resulted in Asian patients; discontinue and then decrease or stop regorafenib depending on severity and persistence of dermatologic toxicity
Myocardial ischemia and infarction seen in clinical trials; withhold Nublexa for new or acute cardiac ischemia/infarction and restart only after resolution of acute ischemic events
While treatment with Nublexa, One case report of reversible posterior leukoencephalopathy syndrome (RPLS) reported (1 of 1100 treated patients); interrupt therapy if RPLS occurs

DRUG – DRUG INTERACTION

  • Nublexa 40mg Co administration with strong CYP3A4 inducers will decrease Regorafenib plasma concentrations and increased plasma concentration of active metabolite M-2; M-5.
  • Nublexa 40mg Co administration with strong CYP3A4 inhibitor will increase Regorafenib plasma concentration and decreased plasma concentration of active metabolite M-2; M-5.
  • Nublexa 40mg Co administration with BCRP substrate will increased the plasma concentration of the BCRP substrate.



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

Excretion into human milk is unknown Avoid breast feeding during the treatment with Nublexa 40mg

Store the Nublexa 40mg at 25°C(77°C). Keep the drug in its original container bottle Keep the bottle tightly closed after one time used

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


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