FRUZAQLA CAPSULE 5MG [SIN17113P]

Product Info

FRUZAQLA CAPSULE 5MG

[SIN17113P]

4.1 Therapeutic Indications
Fruquintinib is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF agent, and, if RAS wild-type, an anti-EGFR agent.

4.2 Posology and Method of Administration
Posology
Fruquintinib should be initiated by a physician experienced in the administration of anticancer therapy.

The recommended dose of fruquintinib is 5 mg (one 5 mg capsule) once daily at approximately the same time each day for 21 consecutive days, followed by a 7-day rest period to comprise a complete cycle of 28 days.

Duration of treatment
Treatment with fruquintinib should be continued until disease progression or unacceptable toxicity occurs.

Missed doses or vomiting.
If a dose is missed by less than 12 hours, it should be taken, and the next dose should be taken as scheduled.

If a dose is missed by more than 12 hours, it should be skipped, and the next dose should be taken as scheduled.
If a patient vomits after taking a dose, the patient should not repeat the dose on the same day, but resume the usual dosing as scheduled on the following day.

Dose Adjustments for Adverse Reactions
The dose should be modified based on safety and tolerability. Fruquintinib should be permanently discontinued in patients unable to tolerate a dose of 3 mg once daily. The recommended dose reduction schedule for adverse reactions is provided in Table 1.

The recommended dose modifications for adverse reactions are provided in Table 2.

Special Patient Populations
Elderly Patients
No dose adjustment is required in patients aged 65 years or above.

Pediatric Patients
The safety and efficacy of fruquintinib in children aged 0 to <18 years have not been established. No data are available.

Impaired Renal Function
No dose adjustment is required for patients with mild, moderate, or severe renal impairment (see Pharmacokinetic Properties, 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Impaired Hepatic Function
No dose adjustment is required for patients with mild hepatic impairment (total bilirubin less than or equal to the ULN with AST greater than ULN or total bilirubin greater than 1 to 1.5 times ULN with any AST). A dedicated PK study in a limited sample size showed no clinically meaningful differences in the dose-normalised AUC of fruquintinib between patients with moderate hepatic impairment (total bilirubin greater than 1.5 times and less than 3 times ULN and any AST) and those with normal hepatic function (see Pharmacokinetic Properties, 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). However, patients with moderate hepatic impairment were excluded from clinical studies. . Fruquintinib is not recommended for use in patients with severe hepatic impairment (total bilirubin greater than 3 times ULN and any AST) as fruquintinib has not been studied in this population.

Method of Administration
Fruquintinib is for oral use.

Fruquintinib capsules can be taken with or without food and should be swallowed whole.

4.3 Contraindications

Hypersensitivity to the active substance or any of the excipients in the section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.