v3 · current
C. Laurent (Regulatory Affairs Lead) · 08 Apr 2024 · 934b375eda1d…
Added double-dosing warning to missed dose section following PSUR 1 review; minor wording update to renal impairment
The recommended dose of Veraxanib is 50 mg taken orally once daily, with or without food. Treatment should be continued until disease progression or unacceptable toxicity. Missed doses: If a dose is missed, it should be taken as soon as the patient remembers unless it is within 12 hours of the next scheduled dose. In that case, the missed dose should be skipped and the next dose taken at the usual scheduled time. Patients should not take two doses on the same day to make up for a missed dose. Dose modifications: Dose reductions to 25 mg once daily may be required due to adverse reactions (see section 4.8). Veraxanib should be permanently discontinued in patients who cannot tolerate 25 mg once daily. Hepatic impairment: No dose adjustment is required in patients with mild or moderate hepatic impairment. Veraxanib has not been studied in patients with severe hepatic impairment and is not recommended in this population. Renal impairment: No dose adjustment is required in patients with mild to moderate renal impairment. Limited data are available in severe renal impairment; use with caution. Paediatric population: The safety and efficacy of Veraxanib in children and adolescents below 18 years of age have not been established. No data are available.
v2
Dr. A. Müller (MAH Medical Affairs) · 12 Sept 2023 · baba3f975d78…
Updated to include food effect (no restriction), refined missed dose wording, added hepatic/renal impairment subsections per CHMP Day 120 LoQ
The recommended dose of Veraxanib is 50 mg taken orally once daily, with or without food. Treatment should be continued until disease progression or unacceptable toxicity. Missed doses: If a dose is missed, it should be taken as soon as the patient remembers unless it is within 12 hours of the next scheduled dose. In that case, the missed dose should be skipped and the next dose taken at the usual scheduled time. Dose modifications: Dose reductions to 25 mg once daily may be required due to adverse reactions (see section 4.8). Veraxanib should be permanently discontinued in patients who cannot tolerate 25 mg once daily. Hepatic impairment: No dose adjustment is required in patients with mild or moderate hepatic impairment. Veraxanib has not been studied in patients with severe hepatic impairment and is not recommended in this population. Renal impairment: No dose adjustment is required in patients with mild to moderate renal impairment. Limited data are available in severe renal impairment. Paediatric population: The safety and efficacy of Veraxanib in children and adolescents below 18 years of age have not been established. No data are available.
v1
Dr. A. Müller (MAH Medical Affairs) · 15 Mar 2023 · dfaa1188e88e…
Initial submission
The recommended dose of Veraxanib is 50 mg taken orally once daily. Treatment should be continued until disease progression or unacceptable toxicity. Missed doses: If a dose is missed, it should be taken as soon as the patient remembers unless it is within 12 hours of the next scheduled dose. In that case, the missed dose should be skipped. Dose modifications: Dose reductions to 25 mg once daily may be required due to adverse reactions. Veraxanib should be permanently discontinued in patients who cannot tolerate 25 mg once daily. Paediatric population: The safety and efficacy of Veraxanib in children and adolescents below 18 years of age have not been established. No data are available.