Vorasidenib

Vorasidenib is a prescription medication indicated of grade 2 astrocytoma or oligodendroglioma with susceptible isocitrate dehydrogenase (IDH)-1 or IDH-2 mutation following surgery including biopsy, sub-total resection, or gross total resection in adult and pediatric patients 12 years and older.

• Vorasidenib is available under the following different brand names: Voranigo.

Common side effects of Vorasidenib include:

• increased liver enzyme levels in the blood 
• lack of energy
• tiredness 
• headache 
• COVID-19
• muscle aches or stiffness  
• diarrhea 
• nausea
• seizure

Serious side effects of Vorasidenib include:

• liver problems: symptoms include yellowing of the skin or the white part of the eyes (jaundice), dark tea-colored urine, loss of appetite, pain on the upper right side of the stomach area, feeling very tired or weak

Rare side effects of Vorasidenib include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Tablet

• 10 mg
• 40 mg

Astrocytoma or oligodendroglioma

Adult dosage

• 40 mg orally once a day until disease progression or unacceptable toxicity

Pediatric dosage

• Children more or equal to 40 kg: 40 mg orally once a day
• Children less than 40 kg: 20 mg orally once a day
• Continue until disease progression or unacceptable toxicity
• Safety and efficacy not established in patients below 12 years

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Vorasidenib has no noted severe interactions with any other drugs
• Vorasidenib has no noted serious interactions with any other drugs
• Vorasidenib has no noted moderate interactions with any other drugs
• Vorasidenib has no noted minor interactions with any other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Not available

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Vorasidenib?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Vorasidenib?”

Cautions

• Hepatotoxicity
  • Monitor liver function tests every 2 weeks during the first 2 months of treatment, then monthly for the first 2 years of treatment, and as clinically indicated. Withhold, reduce the dose, or discontinue vorasidenib based on the severity.
• Embryo-Fetal Toxicity
  • Vorasidenib can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective nonhormonal contraception.

Pregnancy and Lactation

• Based on animal embryofetal toxicity studies, fetal harm may occur when administered to pregnant females
• No data available on use in pregnant females to inform a drug-associated risk of major birth defects and miscarriage
• Contraception
  • Females of reproductive potential
  • Advise patients to use effective non-hormonal contraceptive methods during treatment with vorasidenib and for 3 months after the last dose.
  • Vorasidenib can render some hormonal contraceptives ineffective.
  • Use effective contraception during treatment with vorasidenib and for at least 3 months after the last dose.
  • Males with female partners of reproductive potential
  • Use effective contraception during treatment with vorasidenib and for at least 3 months after the last dose.
• Infertility
  • Based on findings in animals, fertility may be impaired in females and males of reproductive potential
  • Unknown whether effects on fertility are reversible
• Lactation
  • There are no data on the presence of vorasidenib or its metabolites in human milk, its effects on breastfed infants, or its effects on milk production
  • Advise women not to breastfeed during treatment with vorasidenib and for at least 2 months after last dose