Vorasidenib
Oligodendroglioma, Astrocytoma
.svg)
Drug Status
Government Approvals
US(FDA)
WHO Essential Medicine
NO
Known Teratogen
NO
Pharmaceutical Class
NA
Controlled Drug Substance
No
Vorasidenib
Summary
Vorasidenib is used to treat certain types of brain tumors, specifically astrocytoma and oligodendroglioma in patients 12 years and older. It's used when the tumor has not improved with surgery.
Vorasidenib works by inhibiting enzymes called isocitrate dehydrogenase1 (IDH1) and isocitrate dehydrogenase2 (IDH2) which are involved in tumor growth. By blocking these enzymes, it helps to slow down or stop the growth of the tumor.
For adults, the recommended dosage of Vorasidenib is 40 mg orally once daily. For pediatric patients aged 12 years and older, the dosage is based on body weight: 40 mg orally once daily for those weighing 40 kg or more and 20 mg orally once daily for those weighing less than 40 kg.
Common side effects of Vorasidenib include fatigue, headache, musculoskeletal pain, diarrhea, and nausea. Serious adverse effects can include liver problems such as elevated liver enzymes.
Vorasidenib can cause fetal harm, so effective contraception is advised for both males and females during treatment. Smoking may reduce the drug's effectiveness and certain medications can interact with Vorasidenib requiring dose adjustments. It can also lead to liver failure, so regular liver function tests are recommended.
Indications and Purpose
How does Vorasidenib work?
Vorasidenib works by inhibiting the isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) enzymes. These enzymes are involved in the growth of certain brain tumors. By blocking these enzymes, Vorasidenib helps to slow down or stop the growth of the tumor, allowing for better management of the condition.
Is Vorasidenib effective?
The efficacy of Vorasidenib was evaluated in the INDIGO trial, a randomized, double-blind, placebo-controlled study. The trial included patients with IDH1- or IDH2-mutant Grade 2 astrocytoma or oligodendroglioma. Vorasidenib showed a significant improvement in progression-free survival compared to placebo, demonstrating its effectiveness in treating these brain tumors.
What is Vorasidenib?
Vorasidenib is used to treat certain types of brain tumors, specifically astrocytoma and oligodendroglioma, in patients 12 years and older. It works by inhibiting enzymes called isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2), which are involved in tumor growth. By blocking these enzymes, Vorasidenib helps to slow down or stop the growth of the tumor.
Directions for Use
For how long do I take Vorasidenib?
Vorasidenib is typically used until disease progression or unacceptable toxicity occurs. The exact duration can vary based on individual response and tolerance to the medication.
How do I take Vorasidenib?
Vorasidenib should be taken once daily, at the same time each day, with or without food. Swallow the tablets whole with water, and do not split, crush, or chew them. Patients should talk to their doctor about consuming grapefruit or grapefruit juice, as it may interact with the medication.
How should I store Vorasidenib?
Store Vorasidenib at room temperature, between 68°F to 77°F (20°C to 25°C). Keep it in its original container, tightly closed, and away from excess heat and moisture. Do not remove the desiccant packet from the container, and ensure it is out of reach of children.
What is the usual dose of Vorasidenib?
For adults, the recommended dosage of Vorasidenib is 40 mg orally once daily. For pediatric patients aged 12 years and older, the dosage is based on body weight: 40 mg orally once daily for those weighing 40 kg or more, and 20 mg orally once daily for those weighing less than 40 kg.
Warnings and Precautions
Can I take Vorasidenib with other prescription drugs?
Vorasidenib can interact with strong and moderate CYP1A2 inhibitors, which may increase its plasma concentrations and risk of adverse reactions. It may also decrease the effectiveness of hormonal contraceptives. Patients should avoid using CYP3A substrates and smoking tobacco, as these can affect the drug's effectiveness.
Can Vorasidenib be taken safely while breastfeeding?
Women are advised not to breastfeed during treatment with Vorasidenib and for 2 months after the last dose due to the potential for adverse reactions in breastfed children. There is no data on the presence of Vorasidenib in human milk.
Can Vorasidenib be taken safely while pregnant?
Vorasidenib can cause fetal harm based on animal studies. Women of reproductive potential should use effective nonhormonal contraception during treatment and for 3 months after the last dose. Men with female partners of reproductive potential should also use effective contraception during treatment and for 3 months after the last dose. There is no strong evidence from human studies, but caution is advised.
Is Vorasidenib safe for the elderly?
There is limited information on the use of Vorasidenib in patients aged 65 and older. Clinical studies did not include enough elderly patients to determine if they respond differently from younger patients. Elderly patients should use Vorasidenib under close medical supervision.
Who should avoid taking Vorasidenib?
Key warnings for Vorasidenib include the risk of hepatotoxicity, which can lead to liver failure. Regular liver function tests are recommended. Vorasidenib can also cause fetal harm, so effective contraception is advised for both males and females during treatment. Smoking may reduce the drug's effectiveness, and certain medications can interact with Vorasidenib, requiring dose adjustments.
