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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 as monotherapy is indicated for the treatment of predominantly non-enhancing Grade 2 astrocytoma or oligodendroglioma with an IDH1 R132 or IDH2 R172 mutation in adult and adolescent patients aged 12 years and older and weighing at least 40 kg who only had surgical intervention and are not in immediate need of…
Verbatim from this product's EMA label. Tap a section to expand.
Treatment should be initiated and supervised by a physician experienced in the use of anti-cancer medicinal products. Before taking Voranigo, patients must have confirmation of an isocitrate dehydrogenase-1 (IDH1) R132 or isocitrate dehydrogenase-2 (IDH2) R172 mutation using an appropriate diagnostic test.
The presence of an IDH1 R132 or IDH2 R172 mutation should be asessed by a CE-marked in vitro diagnostic (IVD) with the corresponding intended purpose. If the CE-marked IVD is not available, IDH1 R132 or IDH2 R172 mutation should be assessed by an alternative validated test.
Posology The recommended dose of Voranigo in adults and adolescents 12 years of age and older is 40 mg once daily for patients weighing at least 40 kg. No dose recommendation can be made in patients weighing less than 40 kg because of the lack of clinical data in this population.
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 once monthly for the first 2 years of treatment, and as clinically indicated thereafter.
4). Dose modifications for adverse reactions Dose interruption or dose reduction may be required based on individual safety and tolerability. The recommended dose reduction levels are provided in Table 1. The recommended Voranigo dose modifications and management for adverse reactions are provided in Table 2.
4) 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.
6%). 0%). 6% of patients who received Voranigo. 6% of patients, respectively. 6% of patients treated with vorasidenib. 0%). 6% of patients. 8%). Tabulated list of adverse reactions The adverse reactions described in this section are derived from study data (INDIGO study [N=167]) and post-marketing experience with Voranigo.
9 The adverse reactions reported in patients treated with vorasidenib 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 *Identified during post-approval use. aLaboratory abnormality is defined as new or worsened by at least one grade from baseline, or baseline is unknown. 4% experienced elevations in AST > 3 times the ULN.
2% had concurrent elevations in ALT or AST > 3 times the ULN and total bilirubin > 2 times the ULN. 4). 0 days (range: 1 – 506 days). 4). System organ class Frequency Adverse reactions Blood and lymphatic system disorders Very common Platelet count decreaseda Metabolism and nutrition disorders Common Hyperglycaemia Decreased appetite Hypophosphataemia Nervous system disorders Very common Dizziness Respiratory, thoracic and mediastinal disorders Common Dyspnoea Gastrointestinal disorders Very common Diarrhoea Abdominal pain Common Gastro-oesophageal reflux disease Hepatobiliary disorders Very common Alanine aminotransferase increaseda Aspartate aminotransferase increaseda Gamma-glutamyl transferase increaseda Common Alkaline phosphatase increaseda Blood bilirubin increaseda Uncommon Hepatic failure Autoimmune hepatitis Hepatic necrosis Not known Drug-induced liver injury* Hepatitis acute* General disorders and administration site conditions Very common Fatigue 10 Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
8). 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 once 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). 3). Carcinogenicity studies have not been conducted yet and long-term clinical safety data are insufficient. Therefore, a carcinogenicity risk in humans could not be excluded.
6 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 2 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 2 months after the last dose.
6). Hepatic impairment The safety and efficacy of vorasidenib have not been established in patients with severe hepatic impairment (Child-Pugh class C). 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’.
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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• 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. 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 of vorasidenib and AGI-69460 have not been studied in patients with severe hepatic impairment (Child-Pugh class C).
Vorasidenib should be used with caution in patients with severe hepatic impairment and this patient population should be closely monitored. 2). 1). Method of administration Voranigo is for oral […]
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.