InfoCons Consumer Protection informs you – Voranigo – Package Leaflet

Before anything else

Read all of this leaflet carefully before you start t aking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

ℹ️ 1. What Voranigo is and what it is used for

What Voranigo is and how it works Voranigo is a cancer medicine that contains the active substance vorasidenib.

It is used as treatment for cancers of the brain called astrocytoma or oligodendroglioma in adults and adolescents from 12 years of age and older who weigh at least 40 kg, who have had surgery as their only treatment and who do not need other treatments such as radi otherapy or chemotherapy immediately .

This medicine is only used when the cancer cell s have changes in the genes (mutations ) that make protein s known as IDH1 and IDH2 . The doctor will have a test performed to check if the cells have this mutation before treatment starts. T he IDH1 and IDH2 protein s play an important role in making energy for cells and when the IDH1 gene or IDH2 gene is mutated, these proteins are change d and do not function properly. This results in changes in the cells that can lead to the development of cancer.

The active substance in Voranigo, vorasidenib, blocks the abnormal IDH1 and IDH2 protein s. In patients with astrocytoma or oli godendroglioma brain cancers, these proteins are not working properly, causing the overproduction of a substance called 2 -hydroxyglutarate (2- HG) that plays a part in the process of normal cells turning into cancer cells. By blocking these proteins, vorasidenib stops the abnormal production o f 2-HG which helps to slow or stop the cancer from growing.

⚠️ 2. What you need to know before you take Voranigo

Do not take Voranigo

• if you are allergic to vorasidenib or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor , pharmacist or nurse before taking Voranigo:

• if you have ki dney problem s
• if you have liver problem s Monitor ing of liver function Voranigo may affect how well your liver functions . Your doctor will carry out blood tests to check how well your liver is working before you are treated with Voranigo, and as necessary during the treatment. If necessary, your doctor may l ower your dose or temporarily or permanently stop your treatment.

Tell your doctor, pharmacist or nurse right away if you develop any of the following, which may be signs and symptoms of liver problems:

• yellowing of your skin or the white part of your eyes (jaundice)
• dark “tea -coloured” urine
• loss of appetite
• pain on the upper right side of your stomach area
• feeling weak or very tired Pregnancy and birth control This medicine may cause harm to the baby during pregnancy. Women who are able to become pregnant should use effective birth control during treatment and for at least 2 months after treatment has stopped.

Men who are using Voranigo should also use effective birth control during treatment and for at least 2 months after treatment has stopped if they have a partner who is able to become pregnant (see “Contraception in women and men”) .

Children

Do not give this medicine to children under 12 years old . It has not been studie d in this age group.

Other medicines and Voranigo

Tell your doctor or pharmacist if you are taking , have recently taken or might take any other medicines . This is because Voranigo can affect the way some other medicines work and some other medi cines can affect the way Voranigo works.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines listed below.

The following medicines may increase the risk of side effects with Voranigo by increasing the amount of Voranigo in the blood:

• Ciprofloxacin (used to treat bacterial infections)
• Fluvoxamine (used to treat depression) The following medicines may decrease the effectiveness of Voranigo by decreasing the amount of Voranigo in the blood:
• Rifampicin (used to treat tuberculosis or certain other infections)
• Phenytoin (used to treat epilepsy ) Voranigo may decrease the effectiveness of the following medicines by decreasing the amount of these medicines in the blood:
• Alfentanil (used for anaesthesia in surgery)
• Carbamazepine, fosphenytoin, phenobarbital, phenytoin (used to treat seizures)
• Ciclo sporin , everolimus, sirolimus, tacrolimus (medicines used after organ transplants to help control your body’s immune response)
• Fentanyl (used for severe pain)
• Pimozide (used to treat abnormal thoughts and feelings)
• Quinidine (used to treat abnormal heartbeat)
• Ibrutinib, ifosfamide, tamoxifen (used to treat certain cancers)
• Buspirone (used to treat nervous system disorders and/or relieve anxiety )
• Darunavir, saquinavir, tipranavir (medicines used to treat HIV infection)
• Mida zolam, triazolam (used to help you sleep and/or relieve anxiety)
• Amitr iptyline, dosulepin, imipramine, trimipramine (used to treat depression)
• Bupropion (used to help you stop smoking)
• Celecoxib (used to treat arthritis)
• Repaglinide (used to treat diabetes)
• Rosuvastatin (used to lower blood cholesterol)
• Valproic acid (used to treat epilepsy)
• Warfarin (used to treat blood clots)
• Hormonal contraceptive medicines (medicines used to prevent pregnancy, such as birth control pills). See “Contraception in women and men” section below.

The medicines listed here may not be the only ones that could interact with Voranigo. Ask your doctor or pharmacist for advice before taking any medicine.

Pregnancy

Voranigo should not be used during pregnancy as it could harm the unborn baby. If you are a woman able to have children, your doctor should perform a pregnancy test before you start treatment.

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or nurse for advice before taking this medicine . Contact your doctor or nurse right away if you become pregnant while taking Voranigo.

Contraception in women and men Voranigo should not be used in pregnancy as it could harm the unborn baby. Women who can become pregnant or men with partners who can become pregnant must use effective contraception to avoid pregnancy during treatment with Voranigo and for at least 2 months after the last dose. Voranigo may stop hormonal contraceptives (such as birth control pills, contraceptive patches or implants) from working properly. If you or your partner use a hormonal contraceptive, you must also use a barrier method ( such as condoms or a diaphragm) to avoid pregnancy.

Talk to your doctor or nurse about the right methods of contraception for you and your partner .

Breast -feeding It is not known if Voranigo passes into breast milk. Do not breast -feed while taking Voranigo and for at least 2 months after the last dose.

Fertility

Voranigo may affect your ability to have a baby. Talk to your doctor for advice before using it.

Driving and using machines

Voranigo is not expected to affect your ability to drive or use machines.

Voranigo contains lactose

This medicine contains lactose (found in milk or dairy products). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Voranigo contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, that is to say essentially ‘sodium -free’.

💊 3. How to take Voranigo

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose for adults and adolescents (12 years of age and older) is:

• For patients who weigh at least 40 kg, take 40 mg (one 40 mg tablet) once a day.
• Patients who weigh less than 40 kg should not take Voranigo.

If you get ce rtain side effect s while you are taking Voranigo (see section 4 “Possible side effects ”), your doctor may lower your dose or temporarily or permanently stop your treatment . Do not change your dose or stop taking Voranigo without talking to your doctor first.

How and when to take Voranigo

• Voranigo is taken by mouth once a day. You should try to take the medicine at the same time each day.
• Swallow the tablet whole with a glass of water. Do not split, crush or chew the tablet ; you may not get the full dose you need unless you swallow a whole tablet .
• Do not eat food for at least 2 hours before and 1 hour after you take the tablet .
• If you vomit after taking your usual dose, do not take an extra dose. Take the next dose at your scheduled time.

Do not swallow the desiccant package found in the bottle.

If you take more Voranigo than you should

If you accidentally take too many tablets, tell your doctor, pharmacist or nurse right away. You may require urgent medical attention.

If you forget to take Voranigo

Take care not to miss a dose of Voranigo. If you miss a dose by less than 6 hours, take it as soon as you remember , and then take the next dose at your scheduled time. If you miss a dose by more than 6 hours , you should skip the dose and wait to take the next dose at your scheduled time.

If you stop taking Voranigo

Do not stop taking Voranigo unless your doctor tells you to. It is important to take Vora nigo every day for as long as your doctor prescribes it to you.

If you have any further questions on the use of this medicine , ask your doctor , pharmacist or nurse .

❗ 4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Tell your doctor, pharmacist or nurse if you notice any of the following side effects:

Serious side effects

If you experience any serious side effects, stop taking this medicine and tell your doctor right away.

Your doctor may lower your dose, pause treatment or stop treatment completely.

Very common (may affect more than 1 in 10 people)

• Increased amount of liver enzymes , as measured in blood tests (see section 2, “Monitoring of liver function ”)

Other side effects

Very common (may affect more than 1 in 10 people)

• Abdominal pain (belly pain)
• Diarrhoea
• Decreased amount of blood platelets , components that help the blood to clot, as measured in blood tests; this can cause bleeding and bruising
• Tiredness
• Dizziness (lightheadedness)

Common (may affect up to 1 in 10 people)

• Increased blood sugar levels (hyperglycaemia )
• Decreased appetite
• Low blood phosphate levels as measured in blood tests (hypophospha taemia); this can cause confusion or muscle weakness
• Difficulty breathing
• Disease where stomach acid rises up in to the oesophagus

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V . By reporting side effects you can help provide more information on the safety of this medicine.

🌡️ 5. How to store Voranigo

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the bottle label and carton after EXP.

The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

📦 6. Contents of the pack and other information

What Voranigo contains

The active substance is vorasidenib.

• Voranigo 10 mg: Each film -coated tablet contains 10 mg of vorasidenib (as hemicitric acid, hemihydrate) .
• Voranigo 40 mg: Each film -coated tablet contains 40 mg of vorasidenib (as hemicitric acid, hemihydrate) .

The other ingredients are:

• Tablet core: m icrocrystalline cellulose (E460) , croscarmellose sodium, silicified microcrystalline cellulose, magnesium stearate ( E470b) and sodium lauryl sulfate (E487)
• Film -coating: hypromellose, titanium dioxide (E171), lactose monohydrate and macrogol (E1521)
• Printing ink: black iron oxide (E172) , propylene glycol (E1520) and hypromellose (E464)

See section 2 “Voranigo contains lactose” and “Voranigo contains sodium”.

What Voranigo looks like and contents of the pack

10 mg film -coated tablets

• White to off -white, round tablets, imprinted with ‘10’ on one side.

40 mg film -coated tablets

• White to off -white, oblong tablets, imprinted with ‘40’ on one side.

Voranigo is available in a plastic bottle with child -resistant closure containing 30 film-coated tablets and 3 desiccant canisters. The bottles are packaged in a cardboard box. Each box contains 1 bottle.

Marketing Authorisation Holder

Les Laboratoires Servier 50, rue Carnot 92284 Suresnes cedex France

Manufacturer

Servier (Ireland) Industries Ltd.

Gorey Road Arklow Co. Wicklow Y14 E284 Ireland For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien S.A. Servier Benelux N.V.

Tél/Tel: +32 (0)2 529 43 11 Lietuva UAB S ervier Pharma Tel: +370 (5) 2 63 86 28 България Сервие Медикал ЕООД Тел.: +359 2 921 57 00 Luxembourg/Luxemburg S.A. Servier Benelux N.V.

Tél/Tel: +32 (0)2 529 43 11 Česká republika Servier s.r.o.

Tel: +420 222 118 111 Magyarország Servier Hungaria Kft.

Tel.: +36 1 238 7799 Danmark Servier Danmark A/S Tlf.: +45 36 44 22 60 Malta V.J. Salomone Pharma Ltd Tel: + 356 21 22 01 74 Deutschland Servier Deutschland GmbH Tel: +49 (0)89 57095 01 Nederland Servier Nederland Farma B.V.

Tel: +31 (0)71 5246700 Eesti Servier Laboratories OÜ Tel:+ 372 664 5040 Norge Servier Danmark A/S Tlf: +45 36 44 22 60 Ελλάδα ΣΕΡΒΙΕ ΕΛΛΑΣ ΦΑΡΜΑΚΕΥΤΙΚΗ ΕΠΕ Τηλ: +30 210 939 1000 Österreich Servier Austria GmbH Tel: +43 (1) 524 39 99 España Laboratorios Servier S.L.

Tel: +34 91 748 96 30 Polska Servier Polska Sp. z o.o.

Tel.: +48 (0) 22 594 90 00 France Les Laboratoires Servier Tél: +33 (0)1 55 72 60 00 Portugal Servier Portugal, Lda Tel: +351 21 312 20 00 Hrvatska Servier Pharma, d. o. o.

Tel: +385 (0)1 3016 222 Ireland Servier Laboratories (Ireland) Ltd.

Tel: +353 (0)1 663 8110 România Servier Pharma SRL Tel: +4 021 528 52 80 Slovenija Servier Pharma d. o. o.

Tel: +386 (0)1 563 48 11 Ísland Servier Laboratories c/o Icepharma hf Sími: +354 540 8000 Slovenská republika Servier Slovensko spol. s r.o.

Tel:+421 (0) 2 5920 41 11 Italia Servier Italia S.p.A.

Tel: +39 06 669081 Suomi/Finland Servier Finland Oy Puh /Tel: +358 (0)9 279 80 80 Κύπρος C.A. Papaellinas Ltd.

Τηλ: +357 22741741 Sverige Servier Sverige AB Tel: +46 (0)8 522 508 00 Latvija SIA Servier Latvia Tel: +371 67502039

This leaflet was last revised in

Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu .

This leaflet is available in all EU/EEA languages on the European Medicines Agency website.

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Voranigo (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/25/1912).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.