LuciVora___LUCIUS PHARMACEUTICALS

Lucius Vorasidenib Patient Information Leaflet

Generic Name: Vorasidenib (VOR-a-SID-e-nib)
Therapeutic Class: Isocitrate Dehydrogenase (IDH) Inhibitor
Manufacturer: Lucius Pharmaceuticals
Dosage: This leaflet covers the 25 mg tablet strength.

1. What is Lucius Vorasidenib and what is it used for?

Lucius Vorasidenib is a prescription medicine used to treat a specific type of brain tumor in adults. It is specifically for:

Residual or Recurrent Grade 2 Glioma with an IDH1 or IDH2 mutation.
- It is used when the tumor cannot be completely removed by surgery alone.
- It is for adults who have not yet received any prior cancer treatment for their glioma (other than surgery).

How it works: Vorasidenib works by blocking the activity of the mutated IDH enzyme. This mutated enzyme produces a chemical that can promote tumor growth. By inhibiting this enzyme, vorasidenib may help slow down or stop the growth of the tumor.

2. Before you take Lucius Vorasidenib

Do NOT take this medicine if you:

Are allergic to vorasidenib or any of the other ingredients in this medicine.

Warnings and Precautions:
Talk to your doctor before taking Lucius Vorasidenib if you have or have had:

Liver Problems: Vorasidenib can cause liver injury. Your doctor will perform regular blood tests to monitor your liver function before and during treatment. Contact your doctor immediately if you experience yellowing of your skin or eyes (jaundice), dark urine, nausea, vomiting, or pain on the right side of your abdomen.
QTc Prolongation: This medicine can affect the electrical activity of your heart, which could lead to an irregular heartbeat. Your doctor will perform tests (ECG) to monitor your heart before and during treatment, especially if you have pre-existing heart conditions.
Other Medications: Inform your doctor about all other medications you are taking, as some can interact with vorasidenib (see Drug Interactions).

Pregnancy and Breastfeeding:

Pregnancy: Based on how it works, Vorasidenib may harm an unborn baby. Use effective contraception during treatment and for at least 2 weeks after your last dose. Discuss contraception options with your doctor.
Breastfeeding: It is unknown if vorasidenib passes into breast milk. Do not breastfeed during treatment and for at least 2 weeks after your last dose to avoid potential harm to the infant.

3. How to take Lucius Vorasidenib

Dosage: The typical dose is 40 mg taken once daily. This may be two 20 mg tablets or another combination, depending on the available strengths.
Administration:
- Take the tablet(s) by mouth with a full glass of water.
- You can take it with or without food.
- Swallow the tablets whole; do not crush, chew, or split them.
Timing: Try to take your dose at approximately the same time every day.
Missed Dose:
- If you miss a dose, take it as soon as you remember on the same day.
- If it is the next day, skip the missed dose and take your next dose at the regular time.
- Do not take a double dose to make up for a missed one.
Vomiting: If you vomit after taking a dose, do not take an extra dose. Continue with your next scheduled dose.

4. Possible Side Effects

Common Side Effects (may affect many people):

Nausea
Headache
Fatigue
Vomiting
Rash
Diarrhea
Liver enzyme elevation (shown in blood tests)

Serious Side Effects (Contact your doctor immediately if you experience any of these):

Signs of Liver Problems: Yellowing of the skin or eyes (jaundice), dark urine, severe nausea or vomiting, pain on the right side of your stomach.
Signs of Heart Problems: Palpitations (feeling your heartbeat), fast or irregular heartbeat, dizziness, fainting.

5. How to Store Lucius Vorasidenib

Store at room temperature in the original container to protect from moisture and light.
Keep out of reach of children and pets.
Do not use this medicine after the expiration date printed on the pack.

6. Contents of the Pack and Other Information

Active Ingredient: Vorasidenib.
Inactive Ingredients: Includes microcrystalline cellulose, mannitol, and other tablet-forming agents.
whatsapp:+852 61905607
wechat:yindu7689