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▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected new or serious adverse reactions. See the "Undesirable effects" section for advice on the reporting of adverse reactions.

VOYDEYA^®

Composition

Active substances

Danicopan

Excipients

Tablet core

Lactose monohydrate (50 mg film-coated tablet: 60.5 mg; 100 mg film-coated tablet: 121.0 mg), microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, magnesium stearate, silica colloidal anhydrous, hypromellose acetate succinate.

Film-coating

Polyvinyl alcohol, titanium dioxide, macrogol 3350, talc.

Total sodium content: 50 mg film-coated tablet: max. 1.22 mg; 100 mg film-coated tablet: 2.44 mg

Pharmaceutical form and active substance quantity per unit

Voydeya 50 mg film-coated tablets

White to off-white, round film-coated tablets, “DCN” above “50” debossed on one side, plain on the other side.

Each film-coated tablet contains 50 mg of danicopan.

Voydeya 100 mg film-coated tablets

White to off-white, round film-coated tablets, “DCN” above “100” debossed on one side, plain on the other side.

Each film-coated tablet contains 100 mg of danicopan.

Indications/Uses

Voydeya is used as an add-on to ravulizumab or eculizumab for the treatment of clinically relevant extravascular haemolysis (EVH, as defined in current clinical guidelines) after at least 6 months of monotherapy with a C5 inhibitor in adult patients with paroxysmal nocturnal haemoglobinuria (PNH; see “Clinical efficacy”).

Dosage/Administration

Voydeya should be initiated by a physician experienced in the management of patients with haematological disorders.

Dosage

The recommended starting dose is 150 mg three times a day administered orally, approximately 8 hours apart (± 2 hours). The dose can be increased to 200 mg three times a day after a minimum of 4 weeks of treatment depending on clinical response.

PNH is a chronic disease and add-on treatment with Voydeya is recommended to continue for the patient’s lifetime, unless the discontinuation of Voydeya is clinically indicated.

Voydeya must not be administered as monotherapy and should be prescribed as an add-on to ravulizumab or eculizumab.

Discontinuation of treatment

Due to the possibility of alanine aminotransferase (ALT) elevations after treatment cessation, if

Voydeya is discontinued, the dose should be tapered over a 6-day period until complete cessation as follows:

-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.

Patients with hepatic disorders

No dose adjustment is required in patients with mild to moderate hepatic impairment (Child-

Pugh Class A and B) (see the “Pharmacokinetics” section).

Studies have not been conducted in patients with severe hepatic impairment (Child-Pugh Class C); Voydeya is therefore not recommended in this patient population (see the “Warnings and precautions” section).

Patients with renal disorders

No dose adjustment is required in patients with renal impairment (see the “Pharmacokinetics” section).

Elderly patients

No dose adjustment is required in patients ≥65 years of age.

Children and adolescents

The safety and efficacy of Voydeya in patients under 18 years of age have not yet been demonstrated. No data are available.

Delayed administration

If a dose is missed, patients should take it as soon as they remember unless there are less than 3 hours until the next dose in which case patients should skip the missed dose and take the medicine at the next regularly scheduled time. Advise patients not to take 2 or more doses of Voydeya at the same time.

Mode of administration

Voydeya can be taken with or without food (see the “Pharmacokinetics” section).

Contraindications

Hypersensitivity to the active substance or to any of the excipients (see the “Composition”/ “Excipients” section).

Do not initiate Voydeya therapy in patients:

-with unresolved Neisseria meningitidis infection.

-with an unknown history of vaccination or who are not up to date with their meningococcal vaccines as per local guidelines, unless they receive prophylactic treatment with appropriate antibiotics for 2 weeks after vaccination (see the “Warnings and precautions” section).

Warnings and precautions

Serious meningococcal infection

Patients receiving complement inhibitor therapy may have increased susceptibility to meningococcal infections (Neisseria meningitidis). Patients must be up to date with their meningococcal vaccines according to current national guidelines for vaccination use, prior to receiving the first dose of Voydeya.

Patients who initiate Voydeya treatment less than 2 weeks after receiving a meningococcal vaccine, must receive treatment with appropriate prophylactic antibiotics for 2 weeks after vaccination. Patients must be vaccinated against serogroups A, C, Y, and W135 to prevent the most common pathogenic meningococcal serogroups. Vaccination against serogroup B is also recommended. Consideration should be given to official guidance on the appropriate use of antibacterial agents.

All patients treated with Voydeya 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 instructed to seek medical care immediately if they occur. This information is provided in the patient information leaflet.

Other serious infections

Danicopan is to be used with caution in patients with active systemic infections. Danicopan selectively blocks activation of the alternative complement pathway; patients may therefore have increased susceptibility to severe infections (except for Neisseria meningitidis). It is recommended that patients be vaccinated according to current guidelines prior to the use of danicopan as an add-on to treatment with ravulizumab or eculizumab.

Laboratory tests

Alanine aminotransferase (ALT) elevations have been observed in clinical trials (see the “Undesirable effects” section). It is recommended that liver enzyme tests be performed before treatment begins. Following initiation of treatment, routine chemistry laboratory monitoring as per PNH management is recommended. Consider treatment interruption or discontinuation if liver enzyme elevations are clinically significant or if patients become symptomatic (for example, in patients who, in the absence of haemolysis, develop persistent elevations in alanine aminotransferase (ALT) ≥5 ´ ULN or elevations in ALT ≥3 ´ ULN accompanied by abdominal pain, nausea, vomiting, increased conjugated bilirubin >2 ´ ULN, or an increased international normalised ratio (INR) >1.5 × ULN). Studies have not been conducted in patients with severe hepatic impairment (see the “Dosage/Administration” section).

Excipients

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.

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

Interactions

Available nonclinical data showed non-CYP450-based metabolism is the predominant clearance pathway for danicopan. The minimal contribution of CYP metabolism in human hepatocytes suggests a very low likelihood of danicopan being subject to CYP-based drug-drug interactions.

As a P-gp substrate with high permeability and a low efflux ratio in vitro, the oral exposure of danicopan does not appear to be affected by P-gp efflux in the gastrointestinal tract.

Danicopan is not a substrate of BCRP, OATP1B1 or OATP1B3. Thus, danicopan is considered to have no or a low likelihood of being subject to drug-drug interactions due to inhibition of these drug transporters.

Co-administration of ravulizumab or eculizumab does not appear to impact danicopan plasma concentrations.

Effects of the active substance danicopan on the pharmacokinetics of other agents

Concomitant use with caution

P-gp substrates

Co-administration of a single oral dose of 180 mg fexofenadine, a P-gp substrate, and danicopan 150 mg three times daily resulted in increased fexofenadine C_max and AUC_0-inf by 1.42-fold and 1.62-fold, respectively.

Co-administration of a single oral dose of 2 mg tacrolimus, a P-gp substrate, and danicopan 200 mg three times daily resulted in increased tacrolimus C_max and AUC_0-inf by 1.13-fold and 1.49-fold, respectively.

BCRP substrates

Co-administration of a single oral dose of 20 mg rosuvastatin, a BCRP substrate, and danicopan 200 mg three times daily resulted in an increase in rosuvastatin C_max and AUC_0-inf of 3.29-fold and 2.25-fold, respectively. This result suggests that danicopan is an inhibitor of BCRP.

The Table below shows the geometric mean ratios (GMR) for the pharmacokinetic parameters during administration with/without concomitant medication with 90% confidence intervals (CI).

Table: Interactions between the active substance of the medicinal product danicopan and other medicinal products

Abbreviations: GMR = geometric mean ratio; Cl = confidence interval; P-gp = P-glycoprotein; BCRP = Breast cancer resistance protein; C_max = maximum plasma concentration; AUC_0-inf = area under the concentration-time curve from zero extrapolated to infinity.

Other interactions

Danicopan is not an inhibitor of CYP1A2, CYP2C8 or CYP2D6. Dedicated clinical pharmacology studies confirmed that no clinically significant drug interactions were observed with danicopan as an inhibitor of other enzymes (CYP2B6, CYP2C9, CYP2C19, CYP3A4, UGT1A1 and UGT2B7).

Danicopan is not an inhibitor of transporters OATP1B1, OATP1B3, OAT1, OAT3, OCT2, MATE1 and MATE2-K.

Pregnancy, lactation

Women of childbearing potential

Women of childbearing potential should use effective contraception methods during treatment with Voydeya and for 3 days after discontinuation.

As Voydeya is used as add-on to ravulizumab or eculizumab, the corresponding information for healthcare professionals should be consulted with regard to women of childbearing potential (please refer to the information for healthcare professionals for ravulizumab and eculizumab).

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 (see the “Preclinical data” section). As a precautionary measure, it is preferable to avoid the use of Voydeya during pregnancy.

Lactation

Available pharmacodynamic/toxicological data in animals have shown excretion of danicopan and its metabolites in milk (see the “Preclinical data” section). A risk to the newborns/infants cannot be excluded. Voydeya should not be used during breastfeeding and breastfeeding should not be initiated until at least 3 days after treatment discontinuation.

Fertility

No human data on the effect of danicopan on fertility are available. Animal studies do not indicate any potential direct effect on fertility of males or females at therapeutically relevant dose (see the “Preclinical data” section).

Effects on ability to drive and use machines

Voydeya is expected to have no or negligible influence on the ability to drive and use machines.

Undesirable effects

As Voydeya is used as add-on to ravulizumab or eculizumab, the corresponding information for healthcare professionals should be consulted with regard to the undesirable effects associated with ravulizumab or eculizumab (please refer to the information for healthcare professionals for ravulizumab and eculizumab).

Summary of the safety profile

The safety profile of Voydeya is based on completed clinical trials in 143 patients who received Voydeya. The most common adverse drug reactions (≥10%) across all clinical trials were pyrexia (29%), headache (27%), diarrhoea (17%), nausea (16%), upper respiratory tract infection (13%), fatigue (13%), arthralgia (13%), vomiting (12%), oropharyngeal pain (11%), anaemia (10%), asthenia (10%) and hepatic enzyme increased (10%).

Tabulated list of adverse reactions

In Table 1, adverse reactions with Voydeya are listed by system organ class and preferred term using MedDRA frequency convention "very common" (≥1/10), "common" (≥1/100, <1/10), "uncommon" (≥1/1,000, <1/100), “rare” (≥1/10,000, <1/1,000), and “very rare” (<1/10,000). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

Table 1: Tabulated list of adverse reactions in clinical trials^a

^a Part of the safety pool received an add-on therapy with danicopan and a C5 inhibitor.

^b Identified adverse reactions from other clinical trial experience. These adverse reactions have not been reported in patients with PNH.

^c Hepatic enzyme increased includes preferred terms alanine aminotransferase increased, hepatic function abnormal, hepatic enzyme increased, and transaminases increased.

Description of specific adverse reactions

Hepatic enzyme increased

In the 12-week randomized controlled period of Study ALXN2040-PNH-301 (see the “Pharmacodynamics” section), laboratory abnormalities related to elevations in alanine aminotransferase (ALT) levels were observed in 14.0% of patients on Voydeya compared to 3.4% of patients on placebo. In Voydeya-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. There were no elevations >10 × ULN. All patients were asymptomatic, and all elevations were transient. Some elevations occurred in the context of haemolysis. Patients with PNH may have elevated hepatic enzymes during haemolysis as part of the natural history and clinical presentation of the disease; patients with high transfusion requirements may also develop hepatic enzyme abnormalities associated with transfused iron and subsequent liver iron overload.

Reporting suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is very important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected new or serious adverse reactions online via the ElViS portal (Electronic Vigilance System). You can obtain information about this at www.swissmedic.ch.

Overdose

Single doses up to 1200 mg and multiple doses up to 800 mg twice a day have been taken by 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 dysfunction 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.

Properties/Effects

ATC code

L04AJ09

Mechanism of action

Danicopan binds reversibly to complement factor D and acts as a selective inhibitor of FD function. By inhibiting FD, danicopan blocks the activation of complement alternative pathway (AP) and the production of multiple effectors, including C3 fragments. The deposition of C3 fragments on red blood cells is a key cause of the EVH which can become clinically significant in a small subset of patients with PNH on a complement component 5 (C5) inhibitor.

Pharmacodynamics

Pharmacodynamic data from studies in healthy volunteers and patients with PNH demonstrate that danicopan significantly inhibits the AP of the complement system, as demonstrated by the ex vivo biomarker of serum AP activity and in vivo biomarker of plasma Bb concentration. Additionally, studies in patients with PNH have established that danicopan reduces complement C3 fragment deposition on circulating red blood cells (RBCs) in PNH.

In single-ascending and multiple-ascending dose studies in healthy volunteers, danicopan conferred dose-dependent inhibition of AP activity across a variety of dosing regimens. In addition, the Bb concentration was substantially reduced in all dosing cohorts. As Bb is a cleavage product formed directly by the action of FD, this reduction provides a direct demonstration that danicopan inhibits FD in vivo.

In patients with PNH and clinically significant EVH treated with danicopan (Voydeya) at doses ranging from 100 mg three times a day to 200 mg three times a day, administered with an existing regimen of ravulizumab or eculizumab treatment, the results showed inhibition of AP activity. The plasma Bb level, an in vivo biomarker for FD inhibition, was reduced from baseline after adding danicopan (Voydeya). Moreover, the fraction of circulating PNH red blood cells with measured C3 fragment deposition was notably decreased by treatment with danicopan (Voydeya).

Cardiac electrophysiology

Single oral doses of danicopan administered at 400 mg, 800 mg, or 1200 mg did not prolong the QTc interval. There were no categorical alerts of concern regarding electrocardiogram intervals or wave form abnormalities.

Clinical efficacy

The efficacy and safety of danicopan (Voydeya) as an add-on to ravulizumab or eculizumab in adult patients with PNH who have clinically relevant EVH were assessed in a multiple-region, randomised, double-blind, placebo-controlled, phase 3 study (ALXN2040-PNH-301). The study enrolled 86 patients with PNH who had been treated with a stable dose of ravulizumab or eculizumab for at least the previous 6 months and had anaemia (haemoglobin [Hgb] ≤9.5 g/dL) with absolute reticulocyte count ≥120 × 10⁹/L with or without transfusion support.

Danicopan (Voydeya) was administered in accordance with the recommended dosing described in the “Dosage/Administration” section (150 mg three times a day, and up to a maximum of 200 mg three times a day depending on the clinical response).

Patients were evaluated in relation to their history of vaccination and had to be vaccinated against meningococcal infection prior to or at the time of initiating treatment with danicopan (Voydeya) if vaccination status within the previous 3 years could not be verified.

Patients were randomised to danicopan (Voydeya) or placebo three times a day in a 2:1 ratio for 12 weeks in addition to background ravulizumab or eculizumab treatment in both groups. After week 12, all patients received danicopan (Voydeya) as an add-on to their background ravulizumab or eculizumab treatment up to week 24. At the end of the treatment periods (week 24), patients were given the opportunity to enter a long-term extension (LTE) period and to continue to receive danicopan (Voydeya) with background ravulizumab or eculizumab.

Demographic or baseline characteristics were generally balanced between treatment groups. PNH medical history was similar between the danicopan (Voydeya) treatment group and the placebo control group. The mean age at baseline was 52.8 years and the majority of patients were female (62.8%). The mean haemoglobin level at baseline was 7.75 g/dL [4.81 mmol/L] and the mean reticulocyte count was 239.40 × 10⁹/L. Within 24 weeks prior to the first dose, 76 patients (88.4%) had pRBC/whole blood transfusions and the mean number of transfusions was 2.6. The LDH level was 298.13 U/L and FACIT-Fatigue score was 33.24. The study enrolled 51 patients (59.3%) on ravulizumab and 35 patients (40.7%) on eculizumab.

The primary endpoint was the change in Hgb level from baseline to week 12. Key secondary endpoints were the proportion of patients with a Hgb increase of ≥2 g/dL [1.2 mmol/L] at week 12 in the absence of transfusions, the proportion of patients with transfusion avoidance through week 12, the change from baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scores at week 12, and change from baseline in absolute reticulocyte count at week 12. Transfusion avoidance was considered as achieved only by patients who did not receive a transfusion and did not meet the protocol-specified guidelines for transfusion from baseline through 12-week treatment period 1.

The primary evidence for efficacy analysis is based on a pre-specified analysis performed when the first 63 randomised participants reached the end (either completed or discontinued) of the 12-week treatment period 1.

Danicopan (Voydeya) as an add-on to ravulizumab or eculizumab was superior to placebo as an add-on to ravulizumab or eculizumab and resulted in a statistically significant and clinically meaningful increase in Hgb from baseline to week 12. The least squares (LS) mean (standard error [SE]) increase in Hgb was 2.94 (0.211) g/dL in the danicopan (Voydeya) group compared with 0.50 (0.313) g/dL in the placebo group. The treatment group difference was 2.44 (0.375) g/dL (p<0.0001) (see Table 2). A statistically significant difference was observed as early as week 1 and a clinically meaningful effect on Hgb was seen as early as week 2.

Danicopan (Voydeya) also achieved a statistically significant improvement compared to placebo for all 4 key secondary endpoints (Table 2).

Supplemental results at week 12 based on all randomised patients (N = 86) are consistent with those from the primary efficacy analysis (N = 63).

During the 12-week treatment period 1, 14 of 57 (24.6%) patients in the danicopan (Voydeya) add-on group were dose escalated from 150 mg to 200 mg three times a day. Four patients (2 randomised to danicopan (Voydeya) and 2 randomised to placebo) discontinued treatment during treatment period 1. There were no discontinuations due to haemolysis.

Table 2: Analysis of primary and key secondary endpoints at week 12

* Based on mixed-effect model for repeated measures.

** Difference in rates and associated 95% CI are calculated using Miettinen and Nurminen method adjusting for stratification factors. P value is based on the Cochrane-Mantel-Haenszel test.

Abbreviations: CI = confidence interval; FACIT = Functional Assessment of Chronic Illness Therapy; MMRM = mixed-effect model for repeated measures

The results at week 24 were consistent with those at week 12 and support maintenance of the effect. Among the 55 patients with PNH who received danicopan (Voydeya) for 24 weeks, the LS mean change in Hgb from baseline at week 24 was 2.95 g/dL [1.83 mmol/L] (95% CI: 2.42 [1.50], 3.48 [2.16]).

A total of 80 patients entered the LTE, during which all patients received danicopan (Voydeya).

Efficacy results up to week 72 are consistent with those at week 12 and week 24. In patients who received danicopan (Voydeya) for 72 weeks (N = 38), the mean change in Hgb from baseline to week 72 was 2.81 g/dL [1.74 mmol/L].

Pharmacokinetics

Absorption

Danicopan is well absorbed and the maximum plasma concentration is reached about 3 hours after oral dosing. Danicopan exposure is dose proportional over the dose range of 150 to 200 mg. Steady-state conditions are reached approximately on day 2 after dosing with no accumulation with the 200 mg dose. When the danicopan tablet was administered with a high-fat meal, the AUC and C_max observed after drug administration were approximately 25%, and 93% higher, respectively, compared to the fasted state. The median T_max was comparable when danicopan was administered in the fed or fasted state at approximately 3.0 and 2.5 hours, respectively. These changes are not considered to be clinically meaningful (see the “Dosage/Administration” section).

Distribution

Danicopan is highly bound to plasma proteins (91.5% to 94.3%) and is mainly distributed in plasma with a ratio of whole blood to plasma mean AUC_0-inf of 0.545. Danicopan plasma concentrations appeared to decline in a biphasic manner after T_max. The estimated apparent oral volume of distribution for a 75 kg person using the population-PK model was 165 L for Vc/F and 232 L for Vp/F (397 L total volume), suggesting moderate distribution of danicopan to peripheral tissue.

Metabolism

Danicopan is extensively metabolized (96%) after oral dosing via oxidation, reduction and hydrolysis pathways, with amide hydrolysis identified as the major elimination pathway. Metabolism by CYP-mediated mechanisms is minimal.

Elimination

Following oral administration, the principal route of elimination is in the faeces (approximately 69% of the administered dose, compared to approximately 25% of the administered dose in urine). In the population pharmacokinetic (PK) analysis in patients with PNH who had clinically significant EVH, the t_½ had an estimated mean value of 7.88 hours with a range from 4.3 to 12.2 hours and the oral CL/F was estimated at 79.5 L/hr.

Kinetics in specific patient groups

No clinically significant differences in the pharmacokinetics of danicopan were observed based on sex, age (16.9 to 82 years) or race based on population PK assessment.

Hepatic impairment

No significant difference in danicopan exposure is observed in subjects with moderate hepatic impairment (Child-Pugh Class B) compared to subjects with normal hepatic function (see the “Dosage/Administration” section). Studies have not been conducted in patients with severe hepatic impairment (Child-Pugh Class C).

Renal impairment

Following oral administration of danicopan 200 mg in subjects with severe renal impairment (creatinine clearance [CL] <30 mL/min), the total danicopan exposure (AUC) increased by approximately 50% compared to subjects with normal renal function. There were no clinically meaningful changes in C_max, T_max, or t_½. Renal excretion is not the major route for eliminating danicopan from the body, even in subjects with normal renal function (see the “Dosage/Administration” section).

Preclinical data

Reversible hepatobiliary cholestasis was observed in dogs with a safety margin of 5 relative to clinical exposure at 200 mg three times a day.

Genotoxicity

Danicopan was not genotoxic in the Ames bacterial reverse mutation assay, in vitro micronucleus assay in human peripheral blood lymphocytes or in the in vivo micronucleus assay in rats.

Carcinogenicity

Danicopan was not carcinogenic in the 6-month carcinogenicity study in TgRasH2 mice and 2-year carcinogenicity study in Wistar Han rats. Exposure multiples at NOAELs in these studies relative to the human exposure at the 200 mg three times a day dose were approximately 39- to 77-fold in TgRasH2 mice and approximately 15 to 23-fold in WH rats, respectively.

Impairment of fertility

In a rabbit study, no effects were noted in male and female fertility and copulation/conception indices at a NOAEL of 250 mg/kg/day at exposures approximately 8-fold above the human exposure.

The highest dose of 500 mg/kg/day was not tolerated well and danicopan-related toxicities were apparent at doses ≥250 mg/kg/day in male animals and at 500 mg/kg/day in female animals. These were evidenced by adverse mean body weight losses and lower mean body weight gains, with corresponding lower mean body weights, reduced mean food consumption and decreased defecation. The severity of these effects resulted in mortality and/or moribundity at these dose levels. Based on these results, the NOAEL for systemic toxicity was considered to be 125 mg/kg/day for males and 250 mg/kg/day for females. Based on poor male and female reproductive performance, likely secondary to poor tolerability at 500 mg/kg/day, the NOAEL for male and female reproductive toxicity was considered to be 250 mg/kg/day. There were no test article-related effects on intrauterine survival at any dosage level. Therefore, a dosage level of 500 mg/kg/day (the highest dosage level tested) was considered to be the NOAEL for early embryonic toxicity.

Reproductive toxicity

There were no effects on early embryonic development, fetal development or post-natal development in rabbits up to mean maternal systemic exposure approximately 18-fold above human exposure (500 mg/kg/day) or during post-natal development (250 mg/kg/day). In rats, there were no effects on embryo-fetal development up to maternal exposure approximately 28-fold above human exposure at 200 mg three times a day (at the 1000 mg/kg/day dose).

Other data

Danicopan was excreted into the milk of lactating rabbits following oral administration from lactation day 4 to 10, with milk concentrations approximately 5 and 3.5 times higher compared to maternal plasma concentrations at 50 and 250 mg/kg/day, respectively.

Other information

Incompatibilities

Not applicable.

Shelf life

Do not use this medicine after the expiry date ("EXP") stated on the pack.

Shelf life after first opening (only for the bottles pack)

Use within 48 days after opening.

Special precautions for storage

Do not store above 30°C.

Keep out of the reach of children.

Authorisation number

69301 (Swissmedic)

Packs

Voydeya 50 mg + 100 mg film-coated tablets in blisters

Each pack contains 4 blister wallet cards, each containing 21 film-coated tablets of 50 mg and 21 film-coated tablets of 100 mg (A)

Voydeya 100 mg film-coated tablets in blisters

Each pack contains 4 blister wallet cards, each containing 42 film-coated tablets of 100 mg (A)

Voydeya 50 mg + 100 mg film-coated tablets in bottles

Each pack contains 1 bottle of 90 film-coated tablets of 50 mg and 1 bottle of 90 film-coated tablets of 100 mg (A)

Voydeya 100 mg film-coated tablets in bottles

Each pack contains 2 bottles of 90 film-coated tablets of 100 mg (A)

Marketing authorisation holder

Alexion Pharma GmbH

6340 Baar

Schweiz

Date of revision of the text

August 2026