Voydeya 100 mg film-coated tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Voydeya 50mg film-coated tablets
Voydeya 100mg film-coated tablets
danicopan
This medicinal product is subject to additional monitoring, which will allow rapid identification of new information on its safety. You can help by reporting any adverse reactions you may experience. Information on how to report adverse reactions is included at the end of section 4.
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
Leaflet contents
- What Voydeya is and what it is used for
- What you need to know before taking Voydeya
- How to take Voydeya
- Possible side effects
- How to store Voydeya
- 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 receiving treatment 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 their 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 around the brain, which may lead to brain inflammation (encephalitis), and may spread throughout the blood 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) vaccinations 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 temporarily, 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 treatment as instructed. You should be aware that you still need to see a doctor as soon as possible, even if you feel better after taking the antibiotics.
Other serious infections
According to national recommendations, your doctor may consider that you need additional measures to prevent other infections.
Kidney problems
Talk to your doctor if you have severe kidney problems. Your doctor may review your dose and monitor you during treatment with Voydeya due to the higher 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 the higher 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 or adolescents under 18 years of age, as there is no information available on its safety and efficacy 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, you must 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 negligible or none.
Voydeya contains lactose monohydrate
If your doctor has informed 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 using this medicine as 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 approximately 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 how you respond to treatment.
If you have severe renal disease, the recommended initial dose of Voydeya is 100 mg three times a day, with approximately 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 how you respond 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 (meal or snack).
If you have been given Voydeya in a blister pack, follow these instructions to remove the tablets from the packaging:
- Press the black semicircle.
- Turn the blister over and pull the tab to expose the aluminum.
- 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. Bring the medicine packaging with you so that you can easily 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 regular scheduled time. Do not take a double dose to make up for a missed dose.
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 may cause adverse effects, although not everybody gets 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 (pain in extremities)
- 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 which is stated on the carton and bottle or on the blister pack after 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 when they are no longer needed. This helps 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 side.
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 side.
The tablets are supplied in a bottle or 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 Authorisation 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 by contacting the local representative of the Marketing Authorisation Holder:
Belgium/Belgium/Belgium Alexion Pharma Belgium Tel/Tel: +32 0 800 200 31 | Lithuania UAB AstraZeneca Lietuva Tel: +370 5 2660550 |
| Luxembourg/Luxembourg Alexion Pharma Belgium Tel/Tel: +32 0 800 200 31 |
Czech Republic AstraZeneca Czech Republic s.r.o. Tel: +420 222 807 111 | Hungary AstraZeneca Kft. Tel.: +36 1 883 6500 |
Denmark Alexion Pharma Nordics AB Tlf.: +46 0 8 557 727 50 | Malta Alexion Europe SAS Tel: +353 1 800 882 840 |
Germany Alexion Pharma Germany GmbH Tel: +49 (0) 89 45 70 91 300 | Netherlands Alexion Pharma Netherlands B.V. Tel: +32 (0)2 548 36 67 |
Estonia AstraZeneca Tel: +372 6549 600 | Norway Alexion Pharma Nordics AB Tlf: +46 (0)8 557 727 50 |
Greece AstraZeneca A.E. Tel: +30 210 6871500 | Austria Alexion Pharma Austria GmbH Tel: +41 44 457 40 00 |
Spain Alexion Pharma Spain, S.L.U. Tel: +34 93 272 30 05 | Poland AstraZeneca Pharma Poland Sp. z o.o. Tel.: +48 22 245 73 00 |
France Alexion Pharma France SAS Tél: +33 1 47 32 36 21 | Portugal Alexion Pharma Spain, S.L. - Sucursal em Portugal Tel: +34 93 272 30 05 |
Croatia AstraZeneca d.o.o. Tel: +385 1 4628 000 | Romania AstraZeneca Pharma SRL Tel: +40 21 317 60 41 |
Ireland Alexion Europe SAS Tel: +353 1 800 882 840 | Slovenia AstraZeneca UK Limited Tel: +386 1 51 35 600 |
Iceland Alexion Pharma Nordics AB Sími: +46 0 8 557 727 50 | Slovakia AstraZeneca AB, o.z. Tel: +421 2 5737 7777 |
Italy Alexion Pharma Italy srl Tel: +39 02 7767 9211 | Finland Alexion Pharma Nordics AB Puh/Tel: +46 0 8 557 727 50 |
Cyprus Alexion Europe SAS Tel: +357 22490305 | Sweden Alexion Pharma Nordics AB Tel: +46 0 8 557 727 50 |
Latvia SIA AstraZeneca Latvija Tel: +371 67377100 |
Date of the most recent 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.