Voydeya

Package leaflet: Information for the patient

Voydeya 50 mg film-coated tablets, 100 mg film-coated tablets

danicopan
This medicinal product is subject to additional monitoring. This will allow any new safety information to be rapidly identified. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. 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. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this 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 factor D, a protein that is part of the body's defence system called the "complement system". By blocking factor D, danicopan prevents the complement system from instructing the body's immune system to destroy red blood cells (haemolysis).

What Voydeya is used for
Voydeya is used for the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who are being treated with another type of PNH medicine called a C5 inhibitor (ravulizumab or eculizumab) and who have residual haemolytic anaemia (low red blood cell count due to their destruction by the body's immune system). Voydeya is administered in combination with 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 taking Voydeya.
Serious infections
Before starting treatment with Voydeya, inform your doctor if you currently have any infections.
Meningococcal infections
Since this medicine targets the complement system, which is part of the body’s defense against infections, taking this medicine may increase the risk of meningococcal infection caused by Neisseria meningitidis. These are serious infections affecting the membranes covering the brain, which can lead to brain inflammation (encephalitis) and may spread into the bloodstream and throughout the 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 therapy. If you cannot be vaccinated 2 weeks prior, your doctor will prescribe antibiotics to reduce the risk of infection for up to 2 weeks after vaccination. Even if you have received these vaccines in the past, you may still need additional vaccinations (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 meningococcal infection. If any of these symptoms occur, contact your doctor immediately:

• Headache with nausea (feeling unwell) or vomiting
• Headache and fever
• Headache with stiff neck or back
• Fever
• Fever and skin rash
• Confusion
• Muscle pain with flu-like symptoms
• Sensitivity to light

Treatment of meningococcal infection during travel
If you are travelling to an area where you may not be able to contact a doctor or where you may temporarily be unable to receive medical treatment, your doctor may prescribe an antibiotic against Neisseria meningitidis for you to carry with you. If any of the symptoms described above occur, you must take the prescribed course of antibiotics. Keep in mind that you will still need to consult a doctor as soon as possible, even if you feel better after taking the antibiotics.
Other serious infections
Based on national recommendations, your doctor may decide on additional measures to prevent other infections.
Kidney problems
If you have severe kidney problems, talk to your doctor. Because of higher levels of danicopan in the blood, your doctor may adjust your dose of Voydeya and monitor you during treatment.
Low body weight
Talk to your doctor if you weigh less than 60 kg, as your doctor may monitor you during treatment with Voydeya due to 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 order blood tests to monitor 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 under 18 years of age, as there is no information available on safety and efficacy in this age group.
Other medicines and Voydeya
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking any of the following medicines, so that they can decide whether to adjust your treatment:

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

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
The effects of this medicine on the unborn child are unknown. As a precautionary measure, you should not take Voydeya during pregnancy. This medicine may pass into breast milk. Do not use Voydeya while breastfeeding. Breastfeeding should not be started until 3 days after stopping treatment with Voydeya.
Driving and using machines
Voydeya has no effect or a negligible effect on the ability to drive and use machines.
Voydeya contains lactose monohydrate
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
Voydeya contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. essentially ‘sodium-free’.

3. How to take Voydeya

Take this medicine exactly as instructed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Dosage
The recommended starting dose of Voydeya is 150 mg, taken three times a day at approximately 8-hour intervals (plus or
minus 2 hours). Depending on your response to treatment, your doctor may decide to increase the dose
to 200 mg, taken three times a day.
If you have severe renal disease, the recommended starting dose of Voydeya is 100 mg, taken three times a
day at approximately 8-hour intervals (plus or minus 2 hours). Depending on your response to treatment, your
doctor may decide to increase the dose to 150 mg, taken three times a day.
Based on the prescribed dose, the number of tablets per dose is 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 the medicine
You must take the tablets with food (a meal or snack).
If your Voydeya has been supplied in a blister pack, follow these instructions to remove the tablets from
the packaging:

1. Press on the black semicircle.
2. Turn the blister pack over and pull the tab to expose the aluminium foil.
3. Press on the plastic blister to push the tablets out.

If you take more Voydeya than you should
If you have taken more Voydeya than prescribed, contact your doctor immediately. Bring the
packaging with you to help describe more clearly which medicine you have taken.
If you forget to take Voydeya
If you forget a dose, take it as soon as possible. If it is almost time for your next dose, skip the missed
dose. Then take your next dose at the usual time. Do not take a double dose to make up for the 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 reappear. If you need to stop taking this medicine, your doctor will gradually reduce the dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

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

• headache with nausea (feeling unwell) or vomiting
• headache and fever
• headache with stiff neck or back
• fever
• fever and skin rash
• confusion
• muscle pain with flu-like symptoms
• eyes sensitive to light

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

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

Common (may affect up to 1 in 10 people)

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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, bottle, or wallet blister after "Exp.". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions. After first opening the bottle, use the medicine within 48 days.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Voydeya contains
The active substance is danicopan. Each film-coated tablet contains 50 mg 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.
• Film coating: polyvinyl alcohol, titanium dioxide (E171), macrogol 4000, talc.

Description of the appearance of Voydeya and pack contents
Voydeya 50 mg film-coated tablets are round, white to off-white, film-coated tablets with “DCN” above “50” imprinted on one side and smooth on the other side.
Voydeya 100 mg film-coated tablets are round, white to off-white, film-coated tablets with “DCN” above “100” imprinted on one side and smooth on the other side.
The tablets may be supplied in a bottle or in a blister pack.
Bottle

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

Blister

• Voydeya 50 mg film-coated tablets + 100 mg film-coated tablets: each pack contains 168 tablets (4 wallet blisters, 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 wallet blisters, each containing 42 tablets of 100 mg).

Not all 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
For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:
België/Belgique/Belgien Lietuva
Alexion Pharma Belgium UAB AstraZeneca Lietuva
Tél/Tel: +32 0 800 200 31 Tel: +370 5 2660550
България Luxembourg/Luxemburg
АстраЗенека България ЕООД Alexion Pharma Belgium
Teл.: +359 24455000 Tél/Tel: +32 0 800 200 31
Česká republika Magyarország
AstraZeneca Czech Republic s.r.o. AstraZeneca Kft.
Tel: +420 222 807 111 Tel.: +36 1 883 6500
Danmark Malta
Alexion Pharma Nordics AB Alexion Europe SAS
Tlf:: +46 0 8 557 727 50 Tel: +353 1 800 882 840
Deutschland Nederland
Alexion Pharma Germany GmbH Alexion Pharma Netherlands B.V.
Tel: +49 (0) 89 45 70 91 300 Tel: +32 (0)2 548 36 67
Eesti Norge
AstraZeneca Alexion Pharma Nordics AB
Tel: +372 6549 600 Tlf: +46 (0)8 557 727 50
Ελλάδα Österreich
AstraZeneca A.E. Alexion Pharma Austria GmbH
Τηλ: +30210 6871500 Tel: +41 44457 40 00
España Polska
Alexion Pharma Spain, S.L.U. AstraZeneca Pharma Poland Sp. z o.o.
Tel: +34 93 272 30 05 Tel.: +48 22 245 73 00
France Portugal
Alexion Pharma France SAS Alexion Pharma Spain, S.L. - Sucursal em
Tel: +33 1 47 32 36 21 Portugal
Tel: +34 93 272 30 05
Hrvatska România
AstraZeneca d.o.o. AstraZeneca Pharma SRL
Tel: +385 1 4628 000 Tel: +40 21317 60 41
Ireland Slovenija
Alexion Europe SAS AstraZeneca UK Limited
Tel: +353 1 800 882 840 Tel: +386 1 51 35600
Ísland Slovenská republika
Alexion Pharma Nordics AB AstraZeneca AB, o.z.
Sími: +46 0 8 557 727 50 Tel: +421 2 5737 7777
Italia Suomi/Finland
Alexion Pharma Italy srl Alexion Pharma Nordics AB
Tel: +39 02 7767 9211 Puh/Tel: +46 0 8 557 727 50
Κύπρος Sverige
Alexion Europe SAS Alexion Pharma Nordics AB
Τηλ: +357 22490305 Tel: +46 0 8 557 727 50
Latvija
SIA AstraZeneca Latvija
Tel: +371 67377100
Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu/. Links to other websites on rare diseases and their treatments are also provided.