Clinical Pharmacology Details


Regorafenib


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Indications & Dose:

Treatment of patients with metastatic colorectal cancer (CRC) who have been previously treated with


fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherap


. ORALLY


Adult


160 mg orally, once daily for the first 21 days of each 28-day cycle. with food (a low-fat breakfast). 


 

Contraindications:

None

Side Effects:

The most common adverse reactions  are asthenia/fatigue, decreased appetite and food intake, hand-foot skin reaction (HFSR) palmar-plantar erythrodysesthesia (PPE), diarrhea, mucositis, weight loss, infection,


hypertension, and dysphonia.  


 

Cautions:

Precautions:

. Hemorrhage. Permanently discontinue  for severe or life-threatening hemorrhage.  


. Dermatological toxicity. Interrupt and then reduce or discontinue depending on severity and persistence of dermatologic toxicity. 


. Hypertension. Temporarily or permanently discontinue  for severe or uncontrolled hypertension.  


. Cardiac ischemia and infarction. Withhold  for new or acute cardiac ischemia/infarction and resume only after resolution of acute ischemic events.


. Reversible Posterior Leukoencephalopathy Syndrome (RPLS). Discontinue


. Gastrointestinal perforation or fistulae. Discontinue . 


. Wound healing complications: Stop  before surgery. Discontinue in patients with wound dehiscence. 


. Embryofetal toxicity. Can cause fetal harm. Advise women of potential risk to a fetus.  


 

Interaction:

Warnings:

Adverse Effects:

Lactations:

Special Precautions:

Counselling:

Side Effects Or Adverse Reactions:

Patient And Carer Advice: