Voydeya 50 mg + 100 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Voydeya 50mg film-coated tablets

Voydeya 100mg film-coated tablets

danicapan

This medicine is subject to additional monitoring, which will allow for quicker detection of new information on its safety. You can help by reporting any side effects you may experience. Section 4 at the end of this leaflet contains information on how to report side effects.

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Voydeya is and what it is used for
2. What you need to know before taking Voydeya
3. How to take Voydeya
4. Possible side effects
5. How to store Voydeya
6. Contents of the pack and other information

1. What Voydeya is and what it is used for

What Voydeya is

Voydeya contains the active substance danicopan. Danicopan blocks a protein called factor D, which is part of the body's defence system known as the "complement system". By blocking factor D, danicopan prevents the complement system from instructing the body's immune system to destroy red blood cells (hemolysis).

What Voydeya is used for

Voydeya is used to treat adult patients with paroxysmal nocturnal hemoglobinuria (PNH) who are being treated with another type of PNH medicine known as a C5 inhibitor (ravulizumab or eculizumab) and who have residual hemolytic anemia (low red blood cell count due to destruction by the body's immune system). Voydeya is given in addition to ravulizumab or eculizumab.

2. What you need to know before taking Voydeya

Do not take Voydeya

• If you are allergic to danicopan or to any of the other ingredients of this medicine (listed in section 6).
• If you have not been vaccinated against meningococcal infection.
• If you currently have a meningococcal infection.

Warnings and precautions

Talk to your doctor or pharmacist before starting this medicine.

Serious infections

Before starting to take Voydeya, inform your doctor if you have any infection.

Meningococcal infections

Since this medicine acts on the complement system, which is part of the body's defense system against infections, using this medicine may increase the risk of a meningococcal infection caused by Neisseria meningitidis. This is a serious infection affecting the membranes surrounding the brain, which may lead to brain inflammation (encephalitis), and can spread throughout the bloodstream and body (sepsis).

Talk to your doctor before starting this medicine to ensure you are up to date with vaccinations against Neisseria meningitidis at least 2 weeks before starting treatment. If it is not possible for you to be vaccinated 2 weeks in advance, your doctor will prescribe antibiotics to reduce the risk of infection for up to 2 weeks after vaccination. If you have received these vaccines in the past, you may need additional booster doses before starting Voydeya. You should also be aware that vaccination does not always prevent this type of infection.

The following are symptoms of a meningococcal infection. If you experience any of these symptoms, inform your doctor immediately:

• Headache with nausea (feeling sick) or vomiting
• Headache and fever
• Headache with neck or back stiffness
• Fever
• Fever and rash
• Confusion
• Muscle pain with flu-like symptoms
• Sensitivity of the eyes to light

Treatment of meningococcal infection while travelling

If you are travelling to an area where you cannot contact your doctor or access medical treatment promptly, your doctor may prescribe an antibiotic against Neisseria meningitidis for you to carry with you. If you experience any of the symptoms listed above, you should take the antibiotic as instructed. However, you must still seek medical attention as soon as possible, even if you feel better after taking the antibiotic.

Other serious infections

According to national recommendations, your doctor may consider that you need additional preventive measures to protect against other infections.

Kidney problems

Talk to your doctor if you have severe kidney problems. Your doctor may need to adjust your dose and monitor you during treatment with Voydeya due to increased levels of danicopan in the blood.

Low body weight

Talk to your doctor if you have a low body weight below 60 kg. Your doctor may monitor you during treatment with Voydeya due to increased levels of danicopan in the blood.

Blood tests

This medicine may increase the levels of certain liver enzymes in the blood. Your doctor will perform blood tests to monitor your liver function before starting treatment. Voydeya is not recommended in patients with severe hepatic impairment.

Children and adolescents

Do not give this medicine to children and adolescents under 18 years of age, as there is no information available on its safety and effectiveness in this age group.

Other medicines and Voydeya

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

In particular, inform your doctor if you are taking any of the following medicines, so they can decide whether your treatment needs to be adjusted:

• Dabigatran and edoxaban, medicines used to prevent blood clots
• Digoxin, a medicine used to treat irregular heartbeats
• Fexofenadine, a medicine used to treat allergy symptoms
• Tacrolimus, a medicine used to suppress the immune system
• Rosuvastatin, a medicine used to lower blood cholesterol levels
• Sulfasalazine, a medicine used to treat inflammatory bowel disease or rheumatoid arthritis

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

The effects of this medicine on the unborn baby are unknown. As a precautionary measure, you should not take Voydeya if you are pregnant.

This medicine may be excreted in breast milk. Do not use Voydeya during breastfeeding. You should not start breastfeeding until 3 days after stopping Voydeya.

Driving and using machines

The effect of Voydeya on the ability to drive and use machines is none or negligible.

Voydeya contains lactose monohydrate

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Voydeya contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.

3. How to take Voydeya

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

How much to take

The recommended initial dose of Voydeya is 150 mg three times a day, with an approximate interval of 8 hours between doses (2 hours before or after). Your doctor may decide to increase the dose to 200 mg three times a day depending on your response to treatment.

If you have severe renal disease, the recommended initial dose of Voydeya is 100 mg three times a day, with an approximate interval of 8 hours between doses (2 hours before or after). Your doctor may decide to increase the dose to 150 mg three times a day depending on your response to treatment.

Depending on the prescribed dose, the number of tablets per dose will be as follows:

• 100 mg: one 100 mg tablet
• 150 mg: one 50 mg tablet and one 100 mg tablet
• 200 mg: two 100 mg tablets

How to take this medicine

You must take the tablets with food (a meal or snack).

If you have been given Voydeya in a blister pack, follow these instructions to remove the tablets from the packaging:

1. Press the black semicircle.
2. Turn the blister over and pull the tab to expose the aluminum.
3. Press on the plastic blister to push the tablet out.

If you take more Voydeya than you should

If you have taken more Voydeya than you should, contact your doctor immediately. Take the medicine container with you so that you can clearly describe what you have taken.

If you forget to take Voydeya

If you miss a dose, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and take the next dose at your usual time. Do not take a double dose to make up for missed doses.

If you stop taking Voydeya

Do not stop treatment with Voydeya unless instructed by your doctor. If you stop taking this medicine, symptoms of residual haemolytic anaemia may return. If you need to stop taking this medicine, your doctor will gradually reduce your dose.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Serious adverse effects

If you experience any of the symptoms of meningococcal infection (see section 2, "Symptoms of meningococcal infection"), inform your doctor immediately:

• headache with nausea (feeling sick) or vomiting
• headache and fever
• headache with neck or back stiffness
• fever
• fever and rash
• confusion
• muscle pain with flu-like symptoms
• sensitivity of the eyes to light

Other adverse effects

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

• Fever or high temperature (pyrexia)
• Headache
• Blood tests showing increased levels of liver enzymes

Common (may affect up to 1 in 10 people)

• Pain in arms and legs (limb pain)
• Vomiting
• High blood pressure

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Voydeya

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

Do not use this medicine after the expiry date stated on the carton and bottle or blister pack, following EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions. After first opening the bottle, use the medicine within 48 days.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Voydeya

The active substance is danicopan. Each film-coated tablet contains 50 or 100 mg of danicopan.

The other components are:

• Tablet core: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, magnesium stearate, colloidal anhydrous silica, hypromellose acetate succinate. See section 2: Voydeya contains lactose monohydrate and sodium.
• Coating: polyvinyl alcohol, titanium dioxide (E171), macrogol 4000, talc.

Appearance of the product and contents of the container

Voydeya 50 mg film-coated tablets are white to off-white, round, film-coated tablets with the inscription «DCN» above «50» engraved on one side and no inscription on the other.

Voydeya 100 mg film-coated tablets are white to off-white, round, film-coated tablets with the inscription «DCN» above «100» engraved on one side and no inscription on the other.

The tablets are supplied in a bottle or in a blister pack.

Bottle

• Voydeya 50 mg film-coated tablets + Voydeya 100 mg film-coated tablets: each pack contains 180 tablets (1 bottle with 90 tablets of 50 mg and 1 bottle with 90 tablets of 100 mg).
• Voydeya 100 mg film-coated tablets: each pack contains 180 tablets (2 bottles with 90 tablets of 100 mg each).

Blister pack

• Voydeya 50 mg film-coated tablets + Voydeya 100 mg film-coated tablets: each pack contains 168 tablets (4 folding blister packs, each containing 21 tablets of 50 mg and 21 tablets of 100 mg).
• Voydeya 100 mg film-coated tablets: each pack contains 168 tablets (4 folding blister packs, each containing 42 tablets of 100 mg).

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Alexion Europe SAS
103-105, rue Anatole France
92300 Levallois-Perret
France

Manufacturer

Alexion Pharma International Operations Limited
College Business and Technology Park
Blanchardstown Road North
Dublin 15
D15 R925
Ireland

Further information about this medicinal product is available upon request to the local representative of the Marketing Authorization Holder:

Date of the latest review of this leaflet

Other sources of information

Detailed information on this medicine is available on the website of the European Medicines Agency: https://www.ema.europa.eu. There are also links to other websites on rare diseases and orphan medicinal products.