VOYDEYA 50 mg/100 mg Film-Coated Tablets

Содержание инструкции

1. Voydeya 50 mg film-coated tablets, 100 mg film-coated tablets
   1. What is Voydeya and what is it used for
   2. What you need to know before you take Voydeya
   3. How to take Voydeya
   4. Possible side effects
   5. How to store Voydeya
   6. Contents of the pack and other information

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

danicopan

Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicine. See the end of section 4 for
information on how to report adverse effects.

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is Voydeya and what is it used for

What is Voydeya
Voydeya contains the active substance danicopan. Danicopan blocks factor D, a protein, which is
part of the body's defense system called the “complement system”. By blocking
factor D, danicopan prevents the complement system from ordering the body's immune
system to destroy red blood cells (hemolysis).

What is Voydeya used for
Voydeya is used for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH)
who are treated with another type of medicine for PNH called a C5 inhibitor (ravulizumab or
eculizumab) and have residual hemolytic anemia (low red blood cell count in the blood due
to their destruction by the body's immune system). Voydeya is administered in
combination with ravulizumab or with eculizumab.

2. What you need to know before you take Voydeya

Do not take Voydeya

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Voydeya.

Serious infections
Before starting treatment with Voydeya, tell your doctor if you have any ongoing infections.
Meningococcal infections
Because the medicine targets the complement system, which is part of the body's defenses
against infections, the use of this medicine may increase the risk of meningococcal infection
caused by Neisseria meningitidis. These are serious infections that affect the membranes
surrounding the brain and can cause inflammation of the brain (encephalitis) and spread
into the blood and throughout the body (sepsis).
Talk to your doctor before starting to take this medicine to make sure you are up to date
with vaccinations against Neisseria meningitidisat least 2 weeks before starting therapy. If
you cannot be vaccinated 2 weeks before, your doctor will prescribe you 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 still need additional vaccinations (booster doses) before starting
Voydeya. You should also know that vaccination may not always prevent this type of infection.
The following are symptoms of a meningococcal infection. If you experience any of these symptoms,
you should tell your doctor immediately:

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

Treatment of meningococcal infection during travel
If you are traveling to a region where you will not be able to contact your doctor or will be in
temporary inability to receive medical treatment, your doctor may prescribe you an antibiotic
against Neisseria meningitidisthat you should carry with you. If any of the symptoms
described above occur, you should take the course of antibiotics as prescribed. You should keep in mind that
you will still need to see 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 determine the need for additional
measures to prevent other infections.

Kidney problems
If you have severe kidney problems, talk to your doctor. Due to the higher level 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, your doctor may monitor you during treatment with
Voydeya due to the higher level of danicopan in the blood.

Blood tests
The medicine may increase the amount of certain liver enzymes in the blood. Your doctor will prescribe
some blood tests to check your liver before starting treatment. Voydeya is not
recommended in patients with severe liver impairment.

Children and adolescents
Do not give this medicine to children under 18 years of age because safety and efficacy data are not available in this age group.

Other medicines and Voydeya
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
In particular, tell 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 to prevent blood clots
• digoxin, a medicine for treating irregular heartbeat
• fexofenadine, a medicine for treating allergy symptoms
• tacrolimus, a medicine used to suppress the immune system
• rosuvastatin, a medicine used to reduce cholesterol levels in the blood
• sulfasalazine, a medicine used to treat inflammatory bowel disease or rheumatoid arthritis

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
The effects of the medicine on the unborn child are unknown. If you are pregnant, as a precaution, you should not take Voydeya. This medicine can 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 does not impair or negligibly impairs the ability to drive vehicles and operate machines.

Voydeya contains lactose monohydrate
If you have been diagnosed with intolerance to certain sugars, contact your doctor 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 following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.

Dosage
The recommended initial dose of Voydeya is 150 mg, three times a day, approximately 8 hours (plus or
minus 2 hours) apart. Depending on your response to treatment, your doctor may decide to increase the dose
to 200 mg, three times a day.
If you have severe kidney disease, the recommended initial dose of Voydeya is 100 mg, three times a
day, approximately 8 hours (plus or minus 2 hours) apart. Depending on your response to treatment, your
doctor may decide to increase the dose to 150 mg, 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

Taking the medicine
You must take the tablets with food (meal or snack).
If Voydeya has been supplied to you in a blister, follow these instructions to remove the tablets from the
package:

• 1. Press on the black semicircle.
• 2. Turn the blister over and peel off the tab to expose the foil.
• 3. Press on the plastic blister to remove the tablets.

If you take more Voydeya than you should
If you have taken more Voydeya than you should, contact your doctor immediately. Bring the
package with you to more easily describe 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 the next dose, skip the
forgotten dose. Then take the 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 taking Voydeya unless your doctor tells you to. If you stop
taking this medicine, the symptoms of residual hemolytic anemia may reappear. If you need to
stop taking this medicine, your doctor will gradually reduce the dose.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

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

• headache with nausea (feeling sick) or vomiting
• headache and fever
• headache with stiff neck or back
• fever
• fever and rash
• confusion
• muscle aches 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 an increase in liver enzymes
• Pain in arms and legs (limb pain)

Common(may affect up to 1 in 10 people)

• Vomiting
• High blood pressure

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly through the national reporting system detailed 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 which is stated on the package and on the bottle or on the
wallet blister after “Exp.”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions. After the first
opening of the bottle, use the medicine within 48 days.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Voydeya contains
The active ingredient is danicopan. Each film-coated tablet contains 50 mg or 100 mg of
danicopan.
The other ingredients are:

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

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

Bottle

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

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 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
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Alexion Pharma Belgium
Tél/Tel: +32 0 800 200 31

Lietuva
UAB AstraZeneca Lietuva
Tel: +370 5 2660550

България
АстраЗенека България ЕООД
Teл.: +359 24455000

Luxembourg/Luxemburg
Alexion Pharma Belgium
Tél/Tel: +32 0 800 200 31

Česká republika
AstraZeneca Czech Republic s.r.o.
Tel: +420 222 807 111

Magyarország
AstraZeneca Kft.
Tel.: +36 1 883 6500

Danmark
Alexion Pharma Nordics AB
Tlf: +46 0 8 557 727 50

Malta
Alexion Europe SAS
Tel: +353 1 800 882 840

Deutschland
Alexion Pharma Germany GmbH
Tel: +49 (0) 89 45 70 91 300

Nederland
Alexion Pharma Netherlands B.V.
Tel: +32 (0)2 548 36 67

Norge
Alexion Pharma Nordics AB
Tlf: +46 (0)8 557 727 50

Ελλάδα
AstraZeneca A.E.
Τηλ: +30210 6871500

Eesti
AstraZeneca
Tel: +372 6549 600

Österreich
Alexion Pharma Austria GmbH
Tel: +41 44457 40 00

España
Alexion Pharma Spain, S.L.
Tel: +34 93 272 30 05

Polska
AstraZeneca Pharma Poland Sp. z o.o.
Tel.: +48 22 245 73 00

France
Alexion Pharma France SAS
Tel: +33 1 47 32 36 21

Portugal
Alexion Pharma Spain, S.L. - Sucursal em
Portugal
Tel: +34 93 272 30 05

Hrvatska
AstraZeneca d.o.o.
Tel: +385 1 4628 000

România
AstraZeneca Pharma SRL
Tel: +40 21317 60 41

Ireland
Alexion Europe SAS
Tel: +353 1 800 882 840

Slovenija
AstraZeneca UK Limited
Tel: +386 1 51 35600

Ísland
Alexion Pharma Nordics AB
Sími: +46 0 8 557 727 50

Slovenská republika
AstraZeneca AB, o.z.
Tel: +421 2 5737 7777

Italia
Alexion Pharma Italy srl
Tel: +39 02 7767 9211

Suomi/Finland
Alexion Pharma Nordics AB
Puh/Tel: +46 0 8 557 727 50

Κύπρος
Alexion Europe SAS
Τηλ: +357 22490305

Sverige
Alexion Pharma Nordics AB
Tel: +46 0 8 557 727 50

Latvija
SIA AstraZeneca Latvija
Tel: +371 67377100

United Kingdom (Northern Ireland)
Alexion Europe SAS
Tel: +44 (0) 800 028 4394

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines
Agency, http://www.ema.europa.eu/ . Furthermore, links to other websites on rare diseases and related
therapeutic treatments are provided.