Voranigo
Pronunciation: vo-rah-NEE-goh
Generic name: vorasidenib
Dosage form: tablets (10mg, 40mg)
What is Voranigo?
Voranigo tablets are used to treat brain cancers called astrocytoma or oligodendroglioma that have a specific mutation called IDH1 or IDH2. Voranigo is a once-daily pill used to help manage cancer after surgery. Astrocytoma and oligodendroglioma are two types of gliomas, which are tumors that develop from cells within the central nervous system (CNS).
Mutations in the genes IDH1 and IDH2 stop cells from turning into the kind of brain cells they are supposed to become, and instead, they begin to grow out of control and may result in tumors. Voranigo works by blocking mutant IDH1 and IDH2 enzymes and their activity, which helps control the disease.
Voranigo is from a class of medicines called isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitors. Voranigo mechanism of action is by blocking IDH1 and IDH2 enzymes this decreases the production of 2-hydroxyglutarate (2-HG) and partially restores cellular differentiation to have its clinical effect.
What is Voranigo used for?
Voranigo (vorasidenib) is FDA-approved for use in patients 12 years and older with Grade 2 astrocytoma or oligodendroglioma with susceptible isocitrate dehydrogenase-1 (IDH1) or isocitrate dehydrogenase-2 (IDH2) mutations. It is used after surgery, including biopsy, sub-total resection, or gross total resection.
How well does Voranigo work?
The Phase 3 INDIGO clinical trial showed that the Voranigo patient group had significantly extended progression-free survival of 27.7 months (median) compared to 11.1 months (median) for patients in the placebo group. The Voranigo patient group also had a decrease in tumor volume of 2.5% every 6 months compared to the placebo group, which had an increase of 13.9% (mean) every 6 months.
Voranigo Side effects
Common Voranigo side effects
The most common Voranigo side effects are tiredness, headache, COVID-19, muscle or joint pain, diarrhea, nausea, and seizures. Changes in laboratory tests (Grade 3 or 4) were ALT increased, AST increased, GGT increased, and neutrophils decreased.
Serious side effects
This medicine may cause serious side effects, including:
Liver problems. Changes in liver function blood tests may happen during treatment with Voranigo and can be serious. Your healthcare provider will do blood tests to check your liver function before and during treatment with this medicine. Tell your healthcare provider right away if you develop any of the following signs and symptoms of liver problems:
- yellowing of your skin or the white part of your eyes (jaundice)
- dark tea-colored urine
- loss of appetite
- pain on the upper right side of your stomach area
- feeling very tired or weak
Your healthcare provider may change your dose, temporarily stop or permanently stop treatment with this medicine if you have certain side effects.
Voranigo may affect fertility in females and males, which may affect the ability to have children. Talk to your healthcare provider if this is a concern for you.
These are not all of the possible side effects of Voranigo. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Related/similar drugs
carmustine, Gliadel
Before taking this medicine
Tell your healthcare provider about all of your medical conditions, including if you:
- have liver problems
- have kidney problems or are on dialysis
- smoke tobacco
Pregnancy
Tell your healthcare provider if you are pregnant or plan to become pregnant. Voranigo can harm your unborn baby.
Females who are able to become pregnant:
- Your healthcare provider will do a pregnancy test before you start treatment with Voranigo.
- You should use effective nonhormonal birth control during treatment with these tablets and for 3 months after the last dose.
- Voranigo may affect how hormonal contraceptives (birth control) work and cause them to not work well. Talk to your healthcare provider about birth control methods that may be right for you during treatment with this medicine.
Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with this medicine.
Males with female partners who are able to become pregnant:
- You should use effective birth control during treatment with Voranigo and for 3 months after the last dose.
- Tell your healthcare provider right away if your partner becomes pregnant or thinks she may be pregnant during your treatment with this medicine.
Breastfeeding
Tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if this medicine passes into breast milk. Do not breastfeed during treatment with Voranigo and for 2 months after the last dose.
How should I take this medicine?
Voranigo Instructions. Voranigo tablets are taken once daily at about the same time. They should be swallowed whole with water and can be taken with or without food. Do not split, crush, or chew the tablets.
Missed Dose. Take tablets at about the same time each day. If a dose is missed, take the missed dose as soon as possible within 6 hours. If a dose is missed by more than 6 hours, skip the missed dose and take the next dose at the scheduled time.
Vomiting. If vomiting occurs after taking a dose, do not take a replacement dose, and take the next dose at the scheduled time on the following day.
Voranigo is available in 10 mg and 40 mg tablets.
Voranigo Dosing Information
Recommended Voranigo dose
Adults: 40 mg orally once daily until disease progression or unacceptable toxicity.
Pediatric Patients 12 Years and Older: dose is based on body weight:
- Patients weighing ≥40 kg: 40 mg orally once daily
- Patients weighing <40 kg: 20 mg orally once daily
Continue treatment with Voranigo until disease progression or unacceptable toxicity.
What other drugs will affect Voranigo?
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Voranigo may affect the way other medicines work and other medicines may affect how Voranigo works. Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.
Storage
- Store at room temperature between 68°F to 77°F (20°C to 25°C).
- This medicine comes with desiccant canisters (drying agent) in the bottle to help keep the medicine dry (protect from moisture). Do not remove the desiccant canisters from the bottle. Do not swallow the desiccant canisters.
- The bottle has a child-resistant cap. Keep this medicine and all medicines out of reach of children.
Ingredients
Active ingredient: vorasidenib
Inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, silicified microcrystalline cellulose, and sodium lauryl sulfate
Tablet coating: hypromellose, lactose monohydrate, macrogol, and titanium dioxide
Black printing ink: black iron oxide, hypromellose, and propylene glycol
Company
Manufactured for: Servier Pharmaceuticals LLC, Boston, MA 02210.
References
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
