Elunate Dosage/Direction for Use

This product must be used under the guidance of an experienced physician in cancer treatment.
Recommended Dose and Method of Administration: The recommended dose is 5mg once daily (1 capsule; each capsule contains 5mg of fruquintinib), for three consecutive weeks followed by one week of drug free period (Every 4 weeks as one treatment cycle). This product may be taken with food or on empty stomach, and it must be swallowed whole. It is recommended to take the drug at the same time each day. If the patient vomits after administering the drug, there is no need to make up for the dose; if a dose is missed, instruct the patient not to make up for the dose in the next day, but to take the next dose at its next scheduled time.
Duration of Treatment: Continue the treatment cycle until disease progression or unacceptable toxicity.
Dose Adjustment: The physician should closely monitor the patient during the course of the treatment, and adjust the dose based on safety and tolerability of individual patient, which includes drug interruption, dose reduction or permanent discontinuation. Dose adjustment should adhere to the principle of drug interruption first followed by dose reduction.
If the adverse reaction is resolved to ≤ Grade 1 within 1 week after drug interruption, the patient should continue to take the drug based on the original dose; if the adverse reaction is resolved to ≤ Grade 1 within 2 weeks, it is recommended to adjust the dose to 4mg a day (4 capsules, each capsule contains 1mg of fruquintinib) under the guidance of a physician in the first dose adjustment; adjust the dose to 3mg a day in the second dose adjustment (3 capsules, each capsule contains 1mg of fruquintinib); discontinue the drug permanently if the patient still experiences intolerance after taking 3mg a day. Refer to Table 3 for the overall dose adjustment principles; refer to Table 4 for the details on the dose adjustment principles for the most commonly seen hand-foot skin reaction (or palmar-plantar erythrodysesthesia syndrome). (See Tables 3 and 4.)

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Special Patient Population: Patients with hepatic impairment: At present, there are no studies of fruquintinib in patients with hepatic impairment. Clinical studies have shown that transaminase level may be elevated in patients treated with fruquintinib. Patients with mild to moderate hepatic impairment should use this product with caution under the guidance of the physician and hepatic function must be closely monitored, and patients with severe hepatic impairment are prohibited from using this product.
Patients with renal impairment: No dose adjustment is recommended for patients with mild renal impairment (creatinine clearance 60 to 89 mL/min). Patients with moderate renal impairment should use this product with caution under the guidance of the physician and kidney function must be closely monitored, and patients with severe renal impairment are prohibited from using this product.
Paediatric patients: At present, there is no clinical data on the use of this product on children or adolescent patients under the age of 18, hence it is not recommended for such patients to take this product.
Elderly patients: It is recommended that elderly patients use this product with caution under the guidance of the physician, and no adjustment is required for the initial dose. Refer to Use in the Elderly under Precautions for details.