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VORANIGO® IMPORTANT SAFETY INFORMATION AND INDICATIONS
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Hepatotoxicity: VORANIGO can cause hepatic transaminase elevations, which can lead to hepatic failure, hepatic necrosis, and autoimmune hepatitis. Monitor liver laboratory tests (AST, ALT, GGT, total bilirubin, and alkaline phosphatase) prior to the start of VORANIGO, every 2 weeks during the first 2 months of treatment, then monthly for the first 2 years of treatment, and as clinically indicated, with more frequent testing in patients who develop transaminase elevations. Reduce the dose, withhold, or permanently discontinue VORANIGO based on severity.
Embryo-Fetal Toxicity: Based on findings from animal studies, VORANIGO can cause fetal harm when administered to a pregnant woman. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective nonhormonal contraception during treatment with VORANIGO and for 3 months after the last dose, since VORANIGO can render some hormonal contraceptives ineffective. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with VORANIGO and for 3 months after the last dose.
ADVERSE REACTIONS
The most common (≥15%) adverse reactions included fatigue,
headache, COVID-19, musculoskeletal pain, diarrhea, nausea,
and seizure. Grade 3 or 4 (≥2%) laboratory abnormalities
were ALT increased, AST increased, GGT increased, and
neutrophils decreased.
DRUG INTERACTIONS
Avoid concomitant use of VORANIGO with strong and moderate
CYP1A2 inhibitors. Avoid concomitant use with moderate
CYP1A2 inducers and smoking tobacco. Avoid concomitant use
with CYP3A substrates, where a minimal concentration change
can reduce efficacy. If concomitant use of hormonal
contraception cannot be avoided, use nonhormonal
contraception methods.
LACTATION
Advise women not to breastfeed during VORANIGO treatment and
for 2 months after the last dose.
IMPAIRED FERTILITY
VORANIGO may impair fertility of females and males of
reproductive potential.
INDICATIONS
VORANIGO (40 mg tablets) is indicated for the treatment of adult and pediatric patients 12 years and older with Grade 2 astrocytoma or oligodendroglioma with a susceptible isocitrate dehydrogenase-1 (IDH1) or isocitrate dehydrogenase-2 (IDH2) mutation following surgery including biopsy, sub-total resection, or gross total resection.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Hepatotoxicity: VORANIGO can cause hepatic transaminase elevations, which can lead to hepatic failure, hepatic necrosis, and autoimmune hepatitis. Monitor liver laboratory tests (AST, ALT, GGT, total bilirubin, and alkaline phosphatase) prior to the start of VORANIGO, every 2 weeks during the first 2 months of treatment, then monthly for the first 2 years of treatment, and as clinically indicated, with more frequent testing in patients who develop transaminase elevations. Reduce the dose, withhold, or permanently discontinue VORANIGO based on severity.
Embryo-Fetal Toxicity: Based on findings from animal studies, VORANIGO can cause fetal harm when administered to a pregnant woman. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective nonhormonal contraception during treatment with VORANIGO and for 3 months after the last dose, since VORANIGO can render some hormonal contraceptives ineffective. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with VORANIGO and for 3 months after the last dose.
ADVERSE REACTIONS
The most common (≥15%) adverse reactions included
fatigue, headache, COVID-19, musculoskeletal pain,
diarrhea, nausea, and seizure. Grade 3 or 4 (≥2%)
laboratory abnormalities were ALT increased, AST
increased, GGT increased, and neutrophils decreased.
DRUG INTERACTIONS
Avoid concomitant use of VORANIGO with strong and
moderate CYP1A2 inhibitors. Avoid concomitant use with
moderate CYP1A2 inducers and smoking tobacco. Avoid
concomitant use with CYP3A substrates, where a minimal
concentration change can reduce efficacy. If
concomitant use of hormonal contraception cannot be
avoided, use nonhormonal contraception methods.
LACTATION
Advise women not to breastfeed during VORANIGO
treatment and for 2 months after the last dose.
IMPAIRED FERTILITY
VORANIGO may impair fertility of females and males of
reproductive potential.
INDICATIONS
VORANIGO (40 mg tablets) is indicated for the treatment of adult and pediatric patients 12 years and older with Grade 2 astrocytoma or oligodendroglioma with a susceptible isocitrate dehydrogenase-1 (IDH1) or isocitrate dehydrogenase-2 (IDH2) mutation following surgery including biopsy, sub-total resection, or gross total resection.
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