Voydeya 50 mg Tablet film-coated

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

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

Voydeya is used to treat 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 have residual haemolytic anaemia (low red blood cell count due to their destruction by the body’s immune system). Voydeya is given in addition to ravulizumab or eculizumab.

• 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 meningococcal infection.

Talk to your doctor or pharmacist before taking this medicine.

Serious infections

Before starting Voydeya, inform your doctor if you have any infections.

Meningococcal infections

Because the medicine targets the complement system, which is part of the body’s defences against infections, the use of this medicine may increase your risk of meningococcal infection caused by Neisseria meningitidis. These are severe infections affecting the linings of the brain which can cause inflammation of the brain (encephalitis) and can spread throughout the blood and body (sepsis).

Talk to your doctor before you start taking this medicine to be sure that you are up-to-date with your vaccinations against Neisseria meningitidis at least 2 weeks before beginning therapy. If you cannot be vaccinated 2 weeks beforehand, your doctor will prescribe antibiotics to reduce the risk of infection until 2 weeks after you have been vaccinated. If you have had these vaccines in the past, you might still need additional vaccinations (booster) before starting Voydeya. You should also be aware 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 immediately inform your doctor:

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

Treatment for meningococcal infection while travelling

If you are travelling in a region where you are unable to contact your doctor or will be temporarily unable to receive medical treatment, your doctor may prescribe an antibiotic against Neisseria meningitidis to bring with you. If you experience any of the symptoms described above, you should take the course of antibiotics as prescribed. You should bear in mind that you should still see a doctor as soon as possible, even if you feel better after having taken the antibiotics.

Other serious infections

In accordance with national recommendations, your doctor might consider that you need supplementary measures to prevent any other infections.

Talk to your doctor if you have severe kidney problems. Your doctor may revise your dose and monitor you during treatment with Voydeya due to higher level of danicopan in the blood.

Talk to your doctor if you have a low body weight of less than 60 kg, your doctor may monitor you during treatment with Voydeya due to higher level of danicopan in the blood.

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

Do not give this medicine to children under 18 years of age as no data on its safety and effectiveness are available in this age group.

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

In particular, you should tell your doctor if you are taking any of the following medicines so that the doctor can decide if your treatment needs to change:

• Dabigatran and edoxaban, medicines to prevent blood clots
• Digoxin, a medicine to treat irregular heartbeat
• Fexofenadine, a medicine 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 to treat inflammatory bowel disease or rheumatoid arthritis

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

The effects of the medicine on an unborn child are not known. As a precautionary measure, you should not take Voydeya if you are pregnant.

This medicine may be passed into breast milk. Do not use Voydeya during breast-feeding.

Breast-feeding should not be started until 3 days after you stop taking Voydeya.

Voydeya has no or negligible influence on the ability to drive or use machines.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

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

The recommended starting dose of Voydeya is 150 mg three times a day, approximately 8 hours apart (plus or minus 2 hours). 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 kidney disease, the recommended starting dose of Voydeya is 100 mg three times a day, approximately 8 hours apart (plus or minus 2 hours). 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 dose prescribed, 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

You should take your tablets with food (meal or snack).

If you have been given Voydeya in a blister pack, follow these instructions to take the tablets out of the packaging:

1. Push through black half-circle.
2. Turn card over and peel tab to expose foil.
3. Push on plastic blister to remove tablets.

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

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

Do not stop treatment with Voydeya unless your doctor tells you to. If you stop taking this medicine, symptoms of residual haemolytic anaemia may come back. If you have to stop taking this medicine, your doctor will reduce the dose gradually.

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

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

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

• Fever or high temperature (pyrexia)
• Headache
• Blood test showing increased level of liver enzymes

Common (may affect up to 1 in 10 people)

• Arm and leg pain (pain in extremities)
• Vomiting
• High blood pressure

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

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

The other ingredients are:

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

Voydeya 50 mg film-coated tablets are white to off-white, round film-coated tablets with “DCN” above “50” debossed on one side, and plain on the other side.

Voydeya 100 mg film-coated tablets are white to off-white, round film-coated tablets with “DCN” above “100” debossed on one side, and plain on the other side.

The tablets may be supplied either in a bottle or in a blister pack.

Bottle (combination pack)

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

Blister

• Voydeya 50 mg film-coated tablets + 100 mg film-coated tablets: each pack contains 168 tablets (4 blister wallet cards each containing 21 × 50 mg tablets and 21 × 100 mg tablets).
• Voydeya 100 mg film-coated tablets: each pack contains 168 tablets (4 blister wallet cards each containing 42 × 100 mg tablets).

Not all pack sizes may be marketed.