Dosage and Administration of Voranidenib (Voranigo)
Recommended Dosage
Adult Patients
The recommended dosage is 40 mg once daily, to be administered continuously until disease progression or unacceptable toxicity occurs.
Pediatric Patients Aged 12 Years and Older
Dosage should be adjusted based on body weight:
For patients with body weight ≥ 40 kg: 40 mg once daily.
For patients with body weight < 40 kg: 20 mg once daily.
Treatment should also continue until disease progression or unacceptable toxicity occurs.
Administration Precautions
The tablets should be swallowed whole with water, and must not be split, crushed, or chewed.
If a dose is missed by less than 6 hours, it should be taken immediately. If the delay exceeds 6 hours, the missed dose should be skipped, and the next dose should be taken at the regularly scheduled time.
If vomiting occurs after administration, no additional dose is needed. Resume dosing the next day at the original scheduled time.
Dose Modification of Voranidenib (Voranigo)
Dose Reduction Schedule
For adult and pediatric patients with body weight ≥ 40 kg: Reduce the dose to 20 mg once daily for the first dose reduction.
If further dose reduction is required, decrease to 10 mg once daily.
For pediatric patients with body weight < 40 kg: Reduce the dose to 10 mg once daily for the first dose reduction.
If the patient is unable to tolerate the 10 mg once daily dose, permanent discontinuation of treatment is required.
Dose Modifications for Adverse Reactions
Grade 1 elevation: Continue the original dose, and monitor weekly until recovery.
Grade 2 elevation: Withhold treatment for the first occurrence; resume at the original or reduced dose after recovery. For recurrence, resume at a reduced dose.
Grade 3 elevation: Withhold treatment for the first occurrence; resume at a reduced dose if recovery occurs within 28 days, otherwise discontinue treatment permanently. For recurrence, discontinue treatment permanently.
Grade 4 elevation or evidence of hepatocellular injury (e.g., ALT/AST > 3 times the upper limit of normal accompanied by increased bilirubin): Permanent treatment discontinuation is required.
For other grade 3 non-hematologic adverse reactions: Withhold treatment for the first occurrence; resume at a reduced dose after recovery. For recurrence, discontinue treatment permanently. Grade 4 adverse reactions require permanent treatment discontinuation.
Use in Special Populations
Patients with Hepatic or Renal Impairment
Patients with mild or moderate hepatic impairment (Child-Pugh Class A or B) do not require dosage adjustment.
Limited data are available for patients with severe hepatic impairment (Child-Pugh Class C); close monitoring is recommended during use, and dosage adjustment should be made based on adverse reactions.
Patients with a creatinine clearance (CLcr) > 40 mL/min do not require dosage adjustment.
The pharmacokinetics of voranidenib have not been studied in patients with CLcr ≤ 40 mL/min or those requiring dialysis; close monitoring for adverse reactions is necessary, and dosage adjustment should be performed as appropriate.
Pregnant, Lactating Patients and Patients with Reproductive Potential
Voranidenib has embryo-fetal toxicity and is contraindicated in pregnant women.
Females of reproductive potential should undergo pregnancy testing prior to initiating treatment, and use effective non-hormonal contraception during treatment and for 3 months after the last dose (as this product may reduce the efficacy of hormonal contraceptives).
Male partners of females of reproductive potential should also use effective contraception during treatment and for 3 months after the last dose.
Breastfeeding should be discontinued during treatment and for 2 months after the last dose.
