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VORANIGO is a brand name for Vorasidenib. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: VORANIGO is indicated for the treatment of Grade 2 astrocytoma or oligodendroglioma with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation or isocitrate dehydrogenase-2 (IDH2) mutation in adults and paediatric patients 12 years and older, who are not in need of immediate chemotherapy or radiotherapy following…
Verbatim from this product's MHRA label. Tap a section to expand.
Treatment should be initiated and supervised by a physician experienced in the use of anti-cancer medicinal products. Select patients for the treatment of astrocytoma or oligodendroglioma with Voranigo based on the presence of IDH1 or IDH2 mutations in tumor specimens using an appropriate diagnostic test prior to initiation of treatment with vorasidenib.
Posology The recommended dose of Voranigo in adults: • 40 mg taken orally once daily The recommended dose of Voranigo in adolescents 12 years of age and older: • 40 mg taken orally once daily for patients weighing at least 40 kg • 20 mg taken orally once daily for patients weighing less than 40 kg Treatment should be continued as long as clinical benefit is observed or until treatment is no longer tolerated by the patient.
Missed or delayed doses If a dose is missed or not taken at the usual time, it should be taken as soon as possible within 6 hours after the missed dose. The next dose should be taken at the regularly scheduled time. If a dose is missed by more than 6 hours, it should be skipped and the next dose should be taken at the regularly scheduled time.
If a dose is vomited, replacement tablets should not be taken. The tablets should be taken as usual the following day. Precautions to be taken prior to administration and monitoring Complete blood counts and blood chemistries, including liver enzymes, should be assessed prior to starting treatment, every 2 weeks during the first 2 months and then monthly for the first 2 years of treatment, and as clinically indicated thereafter.
4). 8). Dosage modifications for adverse reactions Dose interruption or dosage reduction may be required based on individual safety and tolerability. The recommended dosage reduction levels are provided in Table 1.
Table 1:
Recommended dosage reduction levels Dosage level Dose and schedule Number and strength of tablets Adult patients and Paediatric patients 12 years and older weighing at least 40 kg Starting dose 40 mg once daily One 40 mg tablet / once daily First dose reduction 20 mg once daily Two 10 mg tablets / once daily Second dose reduction 10 mg once daily One 10 mg tablet / once daily Paediatric patients 12 years and older weighing less than 40 kg Starting dose 20 mg once daily Two 10 mg tablets / once daily First dose reduction 10 mg once daily One 10 mg tablet / once daily Permanently discontinue Voranigo in patients unable to tolerate 10 mg once daily.
6%). 0%). 6% ) who received Voranigo. 6%). 0%). 0%). 2%) treated with Voranigo. 0%). 6%). 8%). Tabulated list of adverse reactions Adverse reactions reported in patients treated with vorasidenib in the INDIGO trial (Study AG881-C-004) are listed below in Table 3 by MedDRA system organ class and by frequency.
Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to < 1/1 000), very rare (< 1/10 000), not known (cannot be estimated from available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Table 3:
Adverse drug reactions reported in patients treated with vorasidenib in the INDIGO trial (Study AG881-C-004) (N=167) a Laboratory abnormality is defined as new or worsened by at least one grade from baseline, or baseline is unknown.
b Grouped term includes hypophosphataemia and blood phosphorus decreased. c Grouped term includes abdominal pain, abdominal pain upper, abdominal discomfort, abdominal pain lower, epigastric discomfort, and abdominal tenderness. d Grouped term includes diarrhoea, feces soft and frequent bowel movements.
e Grouped term includes fatigue and asthenia. 4% (14/167) experienced AST elevations >3 times the ULN. 2% of patients (2/167) had concurrent ALT or AST elevations >3 times the ULN and total bilirubin >2 times the ULN. 4). Reporting of suspected adverse reactions System organ class Frequency Adverse reactions Blood and lymphatic system disorders Very common Platelet count decreaseda Hyperglycaemia Decreased appetite Metabolism and nutrition disorders Common Hypophosphataemiab Abdominal painc Very common Diarrhoead Gastrointestinal disorders Alanine aminotransferase increaseda Aspartate aminotransferase increaseda Very common Gamma-glutamyl transferase increasedaHepatobiliary disorders Common Alkaline phosphatase increaseda General disorders Very common Fatiguee Reporting suspected adverse reactions after authorisation of the medicinal product is important.
8). Hepatic failure and hepatic necrosis were observed in one patient treated with vorasidenib and autoimmune hepatitis was observed in one patient treated with vorasidenib. Liver enzymes (including ALT, AST and gamma-glutamyl transferase (GGT)) and total bilirubin must be monitored prior to starting treatment, every 2 weeks during the first 2 months of treatment and then monthly for the first 2 years of treatment, and as clinically indicated thereafter.
Consider weekly monitoring for ALT or AST elevations ≤ 3 times the ULN. 2). Women of childbearing potential / Contraception Vorasidenib could cause foetal harm when administered to a pregnant woman. Pregnancy testing is recommended in women of childbearing potential prior to starting treatment.
Women of childbearing potential should use effective contraception during treatment and for at least 3 months after the last dose. Women who are planning to conceive a child should be advised to seek reproductive counselling. 6). Male patients Males with female partners of childbearing potential should use effective contraception during treatment and for at least 3 months after the last dose.
2). 73 m2) or renal impairment requiring dialysis. 2). Lactose Voranigo contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Sodium This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’. Paediatric population Adolescents from 12 to less than 18 years of age Only limited data are available on the safety and effectiveness of Voranigo in adolescent patients aged 12 years to less than 18 years for IDH1 or IDH2 mutant astrocytoma or oligodendroglioma.
1). At the recommended doses, exposure of vorasidenib is expected to be similar between adults and adolescent patients aged 12 years and older. The course of IDH1 or IDH2 mutant astrocytoma or oligodendroglioma is sufficiently similar in adults and adolescent patients to allow extrapolation of data in adults to adolescent patients.
1.
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The recommended Voranigo dosage modifications and management for adverse reactions are provided in Table 2.
Table 2:
Recommended Voranigo Dosage Modifications and Management for Adverse Reactions Adverse Reaction Severitya Management and Dosage Modifications Grade 1 ALT or AST increase >ULN to 3 x ULN without concurrent total bilirubin >2 x ULN Continue Voranigo at current dose.
Monitor liver enzymes weekly until recovery to <Grade 1. Grade 2 ALT or AST >3 to 5 x ULN without concurrent total bilirubin >2 x ULN First Occurrence: Withhold Voranigo and monitor liver enzymes twice per week until recovery to ≤Grade 1 or baseline.
• Recovery in ≤28 days, resume Voranigo at the same dose. • Recovery in >28 days, resume Voranigo at reduced dose (see Table 1).
Recurrence:
Withhold Voranigo and monitor liver enzymes twice per week until recovery to ≤Grade 1 or baseline, and resume Voranigo at reduced dose (see Table 1). Grade 3 ALT or AST >5 to 20 x ULN without concurrent total bilirubin >2 x ULN First Occurrence: Withhold Voranigo and monitor liver enzymes twice per week until recovery to ≤Grade 1 or baseline.
• Recovery in ≤28 days, resume Voranigo at reduced dose (see Table 1). • If not recovered in ≤28 days, permanently discontinue Voranigo.
Recurrence:
Permanently discontinue Voranigo and monitor liver enzymes twice per week until recovery to ≤Grade 1 or baseline. b Permanently discontinue Voranigo and monitor liver enzymes twice per week until recovery to ≤Grade 1 or baseline. 4) Grade 4 Any ALT or AST >20 x ULN Permanently discontinue Voranigo and monitor liver enzymes twice per week until recovery to ≤Grade 1 or baseline.
Other Adverse Reactions Grade 3 First Occurrence:
Withhold Voranigo until recovery to ≤Grade 1 or baseline. • Resume Voranigo at reduced dose (see Table 1).
Recurrence:
Permanently discontinue Voranigo. Grade 4 Permanently discontinue Voranigo. 0. b If an alternative aetiology is identified, consider resuming Voranigo at reduced dose (see Table 1) following resolution to Grade 1 or baseline. 2). 73 m2).
73 m2 or renal impairment requiring dialysis. 2). Hepatic impairment No starting dose adjustment is recommended for patients with mild or moderate (Child-Pugh class A or B) hepatic impairment. The pharmacokinetics and safety of vorasidenib and AGI-69460 have not been studied in patients with severe hepatic impairment (Child-Pugh class C).
Vorasidenib should not be used in patients with pre-existing severe hepatic impairment […]
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Children under 12 years of age The safety and effectiveness of Voranigo has not been established in the paediatric population under 12 years of age with predominantly non-enhancing astrocytoma or oligodendroglioma who have an IDH1 or IDH2 mutation.
Use in children less than 12 years of age is not recommended.