Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Voydeya 100 mg Tablet film-coated
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Danicopan may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
What is Voydeya 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). What is Voydeya used for 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. 2.
What you need to know before you take it
e 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 meningococcal infection. Warnings and precautions Talk to your doctor or pharmacist before taking this medicine.
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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. Kidney problems 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. Low body weight 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. Blood tests 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. Children and adolescents 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. 2
Other medicines and Voydeya 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 Pregnancy and breast-feeding 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. Driving and using machines Voydeya has no or negligible influence on the ability to drive or use machines. Voydeya contains lactose monohydrate If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. Voydeya contains sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'. 3.
How to take it
Voydeya
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. How much to take 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 Taking this medicine You should take your tablets with food (meal or snack). 3
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 take more Voydeya than you should 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 forget to take Voydeya 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. If you stop taking Voydeya 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 have any further questions on 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 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 Other side effects 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) 4
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Arm and leg pain (pain in extremities) Vomiting High blood pressure
Reporting of side effects 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. 5.
How to store it
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 blister wallet 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 throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6.
Contents of the pack and other information
What Voydeya contains 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. What Voydeya looks like and contents of the pack 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).
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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 any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Alexion Pharma UK Ltd. Tel: +44 (0) 800 028 4394 This leaflet was last revised in 05/2025.
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Frequently asked questions about Voydeya 100 mg Tablet film-coated
How do I take Voydeya 100 mg Tablet film-coated?
Voydeya 100 mg Tablet film-coated comes as tablet containing 100mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Voydeya 100 mg Tablet film-coated?
The active substance in Voydeya 100 mg Tablet film-coated is danicopan.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Voydeya 100 mg Tablet film-coated, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Voydeya 100 mg Tablet film-coated without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: danicopan
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Voydeya is indicated as an add-on to ravulizumab or eculizumab for the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who have residual haemolytic anaemia (see section 5.1).
4.2. Posology and method of administration
Treatment should be initiated by a healthcare professional experienced in the management of patients with haematological disorders.
Posology
The recommended starting dose is 150 mg three times a day administered orally, approximately 8 hours apart (± 2 hours). Dose can be increased to 200 mg three times a day after a minimum of 4 weeks of treatment depending on clinical response.
Missed doses
If a dose is missed, patients should be advised to take it as soon as it is remembered unless it is almost time for the next dose in which case patients should skip the missed dose and take the medicinal product at the next regularly scheduled time. Patients should be advised not to take 2 doses or more at the same time.
Discontinuation
Due to the possibility of alanine aminotransferase (ALT) elevations after treatment cessation (see section 4.4), if treatment is discontinued, the dose should be tapered over a 6-day period until complete cessation, as follows:
- 100 mg regimen: 100 mg twice a day for 3 days, followed by 100 mg once a day for 3 days.
- 150 mg regimen: 100 mg three times a day for 3 days, followed by 50 mg three times a day for 3 days.
- 200 mg regimen: 100 mg three times a day for 3 days, followed by 100 mg twice a day for 3 days.
Special populations
Elderly
No dose adjustment is required in elderly patients. However, experience with danicopan in patients ≥ 65 years of age is limited (see section 5.1).
Renal impairment
No dose adjustment is required in patients with mild (estimated glomerular filtration rate [eGFR] ≥ 60 to < 90 mL/min/1.73 m2) or moderate (eGFR ≥ 30 to < 60 mL/min/1.73 m2) renal impairment. In patients with severe renal impairment (eGFR < 30 mL/min/1.73 m2), the recommended starting dose is 100 mg three times a day administered orally, approximately 8 hours apart (± 2 hours). Dose can be increased to 150 mg three times a day after a minimum of 4 weeks of treatment depending on clinical response (see sections 4.4 and 5.2).
Hepatic impairment
No dose adjustment is required in patients with mild (Child-Pugh Class A) to moderate (Child-Pugh Class B) hepatic impairment (see section 5.2). Studies have not been conducted in patients with severe (Child-Pugh Class C) hepatic impairment. Therefore, danicopan is not recommended in this patient population (see section 4.4).
Paediatric population
The safety and efficacy of Voydeya in children aged less than 18 years have not yet been established. No data are available.
Method of administration
Oral use.
Tablets should be taken with food (meal or snack) (see section 5.2).
4.3. Contraindications
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
- Patients with unresolved Neisseria meningitidis infection at treatment initiation (see section 4.4).
- Patients who are not currently vaccinated against Neisseria meningitidis unless they receive prophylactic treatment with appropriate antibiotics until 2 weeks after vaccination (see section 4.4).
4.4. Special warnings and precautions for use
General
Danicopan must not be administered as monotherapy as the efficacy has not been established. It should only be prescribed as an add-on to ravulizumab or eculizumab.
Serious infections
Meningococcal infections
Patients receiving complement inhibitor therapy may have increased susceptibility to meningococcal infections (Neisseria meningitidis). Patients must be up to date on their meningococcal vaccines according to current national guidelines for vaccination use, prior to receiving the first dose of danicopan.
Patients who initiate treatment less than 2 weeks after receiving a meningococcal vaccine must receive treatment with appropriate prophylactic antibiotics until 2 weeks after vaccination. Patients must be vaccinated against serogroups A, C, Y, and W135 to prevent the commonly pathogenic meningococcal serogroups. Vaccination against serogroup B, where available, is also recommended. Consideration should be given to official guidance on the appropriate use of antibacterial agents.
All patients treated with danicopan should be monitored for early signs of meningococcal infection and sepsis, evaluated immediately if infection is suspected, and treated with appropriate antibiotics. Patients should be informed of these signs and symptoms and steps should be taken to seek medical care immediately.
Other serious infections
Danicopan should be administered with caution to patients with active systemic infections. Danicopan selectively blocks the activation of the complement alternative pathway; therefore, patients may have increased susceptibility to serious infections (other than Neisseria meningitidis). Prior to initiating danicopan as add-on to ravulizumab or eculizumab, it is recommended that patients initiate immunisation according to current immunisation guidelines.
Severe renal impairment
Patients with severe renal impairment that dose escalate to 150 mg three times a day should be monitored for adverse events during treatment with danicopan due to higher exposure expected in these patients.
Low body weight
Patients weighing < 60 kg should be monitored for adverse events during treatment with danicopan due to higher exposure expected in these patients.
Hepatic enzymes increase
Alanine aminotransferase (ALT) elevations have been observed in clinical trials (see section 4.8). It is recommended that liver enzyme tests are performed before treatment begins. Following initiation of treatment, routine chemistry laboratory monitoring as per PNH management is recommended. Treatment interruption or discontinuation should be considered if elevations are clinically significant or if patients become symptomatic. Danicopan is not recommended in patients with severe hepatic impairment (see section 4.2).
Discontinuation
At doses higher than 200 mg three times a day, ALT elevations occurred after treatment cessation without dose tapering in healthy subjects (see section 4.9). Upon discontinuation, the dose should be tapered over 6 days (see section 4.2).
Excipients with known effect
Lactose
This medicinal product contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Sodium
This medicinal product contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially 'sodium-free'.
4.5. Interaction with other medicinal products and other forms of interaction
Effects of danicopan on other medicinal products
P-gp substrates
Co-administration of a single oral dose of 180 mg fexofenadine, a P-gp substrate, with 150 mg three times daily doses of danicopan resulted in increased fexofenadine Cmax and AUC0-inf by 1.42-fold and 1.62-fold, respectively. The results suggest that danicopan is a mild inhibitor of P-gp. Caution may be needed in co-administering medicinal products that are known to be substrates of P-gp (such as dabigatran, digoxin, edoxaban, fexofenadine, tacrolimus).
BCRP substrates
Co-administration of a single oral dose of 20 mg rosuvastatin, a BCRP substrate, with 200 mg three times daily doses of danicopan resulted in increased rosuvastatin Cmax and AUC0-inf by 3.29-fold and 2.25-fold, respectively. This result suggests that danicopan is an inhibitor of BCRP. Caution may be needed in co-administering medicinal products that are known to be substrates of BCRP (such as rosuvastatin and sulfasalazine).
4.6. Fertility, pregnancy and lactation
Pregnancy
There are no data from the use of danicopan in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity at therapeutically relevant dose (see section 5.3). As a precautionary measure, it is preferable to avoid the use of Voydeya during pregnancy.
Breast-feeding
Available pharmacodynamic/toxicological data in animals have shown excretion of danicopan/metabolites in milk (see section 5.3). A risk to the newborns/infants cannot be excluded. Voydeya should not be used during breast‑feeding and breast‑feeding should not be initiated until 3 days after treatment discontinuation.
Fertility
No human data on the effect of danicopan on fertility are available. Animal studies have shown potential effects on male fertility and reproductive performance (see section 5.3).
4.7. Effects on ability to drive and use machines
Voydeya has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
Summary of the safety profile
The most common adverse reactions are pyrexia (28.1%), headache (25.0%) and hepatic enzyme increased (11.5%).
Tabulated list of adverse reactions
Table 1 includes adverse reactions reported in clinical trials with danicopan. Adverse reactions are listed by system organ class and preferred term using MedDRA frequency convention very common (≥ 1/10), common (≥ 1/100 to < 1/10), and uncommon (≥ 1/1 000 to < 1/100). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Table 1: Tabulated list of adverse reactions
MedDRA system order Class
Very common
(≥ 1/10)
Common
(≥ 1/100 to < 1/10)
Nervous system disorders
Headache
Vascular disorders
Hypertension
Gastrointestinal disorders
Vomiting
Hepatobiliary disorders
Hepatic enzyme increaseda
Musculoskeletal and connective tissue disorders
Pain in extremity
General disorders and administration site conditions
Pyrexia
a Hepatic enzyme increased includes preferred terms alanine aminotransferase increased, hepatic function abnormal, hepatic enzyme increased, and transaminases increased.
Description of selected adverse reactions
Hepatic enzyme increase
During the 12-week randomised controlled period of study ALXN2040-PNH-301 laboratory abnormalities related to elevations in ALT levels were observed in 14.0% of patients on danicopan. In danicopan-treated patients, ALT elevations > 3 × the upper limit of normal (ULN) and ≤ 5 × ULN occurred in 8.8% of patients, and > 5 × ULN and ≤ 10 × ULN in 5.3% of patients. All patients were asymptomatic, and all elevations were transient. Some elevations occurred in the context of haemolysis.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions 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.
4.9. Overdose
Single doses up to 1 200 mg and multiple doses up to 800 mg twice a day have been taken in healthy volunteers. ALT elevations occurred after treatment cessation without a taper in 2 subjects who received 500 mg and 800 mg twice a day for 14 days. All abnormal ALT findings were transient, with no evidence of hepatic function abnormality and resolved spontaneously.
In case of overdose, elevations in aminotransferase and other liver parameters may occur. General supportive measures are recommended. It is not known whether danicopan can be removed by dialysis.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
- VOYDEYA 100 mg prescriptionDANICOPANUM · taken by mouth
- VOYDEYA 50 mg+100 mg prescriptionDANICOPANUM · taken by mouth
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
- VoydeyaDanicopanum · taken by mouth
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Voydeya 100 mg Tablet film-coated. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.