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Regorafenib: Brands, Price & Uses in Bangladesh
Regorafenib is an oral multikinase inhibitor used to treat certain advanced cancers after prior standard therapies have failed.
About Regorafenib
Indications of Regorafenib
Regorafenib is an oral multikinase inhibitor used to treat certain advanced cancers after prior standard therapies have failed. It is prescribed and monitored by an oncologist and is not used as a first-line cancer treatment.
FDA-Approved (Established) Indications
- Metastatic colorectal cancer (mCRC): in patients previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and (if RAS wild-type) an anti-EGFR therapy.
- Advanced gastrointestinal stromal tumor (GIST): in patients previously treated with imatinib and sunitinib.
- Hepatocellular carcinoma (HCC): in patients previously treated with sorafenib.
Regorafenib is given as monotherapy in each of these settings; it is not combined with other anticancer agents as part of its approved use, and it should only be used after the specified prior treatments have been given and have failed or are no longer tolerated.
Dosage & Administration of Regorafenib
General Dosing Principle
The recommended dose of Regorafenib is the same across its approved indications: 160 mg (four 40 mg tablets) taken orally once daily, for the first 21 days of each 28-day treatment cycle (21 days on, 7 days off), continued as long as clinical benefit is observed or until unacceptable toxicity occurs.
| Indication | Adult Dose |
|---|---|
| Metastatic colorectal cancer | 160 mg orally once daily, days 1–21 of each 28-day cycle |
| Advanced GIST | 160 mg orally once daily, days 1–21 of each 28-day cycle |
| Hepatocellular carcinoma | 160 mg orally once daily, days 1–21 of each 28-day cycle |
Administration
Regorafenib tablets should be taken at the same time each day after a low-fat, low-calorie meal (containing less than approximately 30% fat and under 600 calories). Tablets should be swallowed whole with water; do not crush or split tablets.
Dose Modification
Dose interruption and/or reduction (in 40 mg decrements, to a minimum of 80 mg daily) is used to manage toxicity such as hand-foot skin reaction, hypertension, or liver enzyme elevation; this must be individualized by the treating oncologist.
Missed Dose
If a dose of Regorafenib is missed, it should not be taken if less than 12 hours remain until the next scheduled dose; do not double the dose to make up for a missed one.
Renal and Hepatic Adjustment
No dose adjustment is needed for mild-to-moderate renal impairment or mild-to-moderate (Child-Pugh A/B) hepatic impairment; Regorafenib is not recommended in severe (Child-Pugh C) hepatic impairment due to lack of safety data.
Side Effects of Regorafenib
Side effects of Regorafenib are common and can be serious; regular monitoring by the treating oncologist is essential.
Very Common Side Effects
- Hand-foot skin reaction (palmar-plantar erythrodysesthesia)
- Fatigue and weakness (asthenia)
- Hypertension (high blood pressure)
- Diarrhea
- Decreased appetite and weight loss
- Nausea, vomiting, and mouth sores (mucositis)
- Voice changes (dysphonia)
- Rash and dry skin
- Infection
Serious Side Effects
These require urgent medical attention and are described in detail under Precautions and Warnings: severe or fatal liver injury (hepatotoxicity), serious or fatal bleeding, gastrointestinal perforation or fistula, hypertensive crisis, cardiac ischemia/infarction, reversible posterior leukoencephalopathy syndrome (RPLS), and wound-healing complications.
Contraindications of Regorafenib
Regorafenib is contraindicated in patients with known hypersensitivity to regorafenib or to any component of the tablet formulation. No other absolute contraindications are established; other risk factors (e.g., significant bleeding risk, recent surgery, uncontrolled hypertension, severe hepatic impairment) require careful clinical judgment and are addressed under Precautions and Warnings rather than as absolute contraindications.
Frequently Asked Questions about Regorafenib
What is Regorafenib used for?
Regorafenib is used to treat adults with metastatic colorectal cancer, advanced gastrointestinal stromal tumor (GIST), or hepatocellular carcinoma (liver cancer) after other standard cancer treatments have already been tried and have stopped working.
How should I take Regorafenib?
Take Regorafenib exactly as prescribed by your oncologist, usually 160 mg (four 40 mg tablets) once daily for 21 days followed by 7 days off, in a repeating 28-day cycle. Take it after a low-fat meal, swallow tablets whole with water, and take it at the same time each day.
What are the most serious risks of Regorafenib?
Regorafenib carries a boxed warning for severe and sometimes fatal liver injury, and can also cause serious bleeding, gastrointestinal perforation or fistula, high blood pressure, hand-foot skin reaction, wound-healing problems, and heart-related problems. Your doctor will monitor your liver function, blood pressure, and overall health closely during treatment.
Can Regorafenib be used during pregnancy?
Regorafenib can harm an unborn baby and should not be used during pregnancy unless your physician decides the potential benefit clearly outweighs the risk and no safer option exists. Effective contraception is required during treatment with Regorafenib and for a period afterward; breastfeeding is not recommended while taking this medicine.
What should I do if I miss a dose of Regorafenib?
If you miss a dose of Regorafenib, skip it if less than 12 hours remain before your next scheduled dose. Do not take a double dose to make up for the one you missed. Contact your doctor if you are unsure.
Is Regorafenib safe for children?
No. The safety and efficacy of Regorafenib have not been established in children, so it is not recommended for pediatric use.
Disclaimer
The information provided is accurate to the best of our knowledge, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy, and the absence of specific information about a drug should not be taken as an endorsement. We are not responsible for any consequences arising from this information, so please consult a healthcare professional for any concerns or questions.