Vorasidenib (Specialist drug)

eMC SPC for Voranigo 10 mg film coated tablets. Treatment should be initiated and supervised by a physician experienced in the use of anti-cancer medicinal products. Select patients for treatment of astrocytoma or oligodendroglioma based on the presence of IDH1 or IDH2 mutations in tumour specimens using an appropriate diagnostic test prior to initiation. ADOLESCENTS 12 YEARS AND OLDER (weight-banded fixed doses, not a per-kg dose): 40 mg orally once daily for patients weighing at least 40 kg; 20 mg orally once daily for patients weighing less than 40 kg. Safety and efficacy in children under 12 years of age have not been established and no data are available; only limited data are available in adolescents aged 12 to under 18 years. Verify any under-18 use against a children's formulary. MISSED DOSE: take as soon as possible within 6 hours of the missed dose, then take the next dose at the regularly scheduled time; if missed by more than 6 hours, skip it. If a dose is vomited, do not take replacement tablets — take the tablets as usual the following day. DOSE REDUCTIONS (§4.2 Table 1): adults and patients 12 years and older weighing at least 40 kg — starting dose 40 mg once daily, first reduction 20 mg once daily, second reduction 10 mg once daily; patients 12 years and older weighing less than 40 kg — starting dose 20 mg once daily, first reduction 10 mg once daily. Permanently discontinue in patients unable to tolerate 10 mg once daily. HEPATOTOXICITY MODIFICATIONS (§4.2 Table 2): Grade 1 ALT/AST rise (>ULN to 3 × ULN without bilirubin >2 × ULN) — continue at the current dose with weekly liver enzyme monitoring; Grade 2 (>3 to 5 × ULN) — withhold and monitor twice weekly until recovery to ≤ Grade 1 or baseline, resuming at the same dose if recovery is within 28 days or at a reduced dose if longer (reduced dose on any recurrence); Grade 3 (>5 to 20 × ULN) — withhold, resume at a reduced dose if recovered within 28 days, otherwise discontinue permanently, and discontinue permanently on recurrence; permanently discontinue for Grade 4 (>20 × ULN) or for any ALT/AST >3 to 20 × ULN with concurrent total bilirubin >2 × ULN with no clear alternative explanation. OTHER REACTIONS: Grade 3 — withhold until recovery to ≤ Grade 1 or baseline then resume at a reduced dose; permanently discontinue on recurrence or for Grade 4. MONITORING: complete blood counts and blood chemistries including liver enzymes before starting, every 2 weeks during the first 2 months, then monthly for the first 2 years, and as clinically indicated thereafter. HEPATIC IMPAIRMENT: no starting dose adjustment in mild or moderate (Child-Pugh A or B) impairment; vorasidenib should NOT be used in patients with pre-existing severe hepatic impairment (Child-Pugh C). Voranigo contains lactose. eMC §4.5 was not captured in the fetched bundle.