Mediclarum
Medicine guide

Voydeya

Kit

  • Prescription only
Active substance
Danicopan
Made by
Alexion Pharmaceuticals Inc.

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2026-05-12

Used for
  • VOYDEYA is indicated as add-on therapy to ravulizumab or eculizumab for the treatment of extravascular hemolysis (EVH) in
The label’s usual adult dose

Start 150 mg three times a day orally, with or without food.

Full directions ↓
Serious warning

SERIOUS INFECTIONS CAUSED BY ENCAPSULATED BACTERIA VOYDEYA, a complement inhibitor, increases the risk of serious infections, especially those caused by encapsulated bacteria, such as Neisseria meningitidis , Streptococcus pneumoniae , and…

All warnings ↓
Good to know
  • Prescription only
  • FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
1other products contain Danicopan — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

  • VOYDEYA is indicated as add-on therapy to ravulizumab or eculizumab for the treatment of extravascular hemolysis (EVH) in
  • adults with paroxysmal nocturnal hemoglobinuria (PNH).
  • VOYDEYA is a complement factor D inhibitor indicated as add-on therapy to ravulizumab or eculizumab for the treatment of extravascular hemolysis (EVH) in
  • adults with paroxysmal nocturnal hemoglobinuria (PNH) ( 1 ).
  • Limitations of Use VOYDEYA has not been shown to be effective as monotherapy and should only be prescribed as an add-on to ravulizumab or eculizumab.
  • Limitations of Use VOYDEYA has not been shown to be effective as monotherapy and should only be prescribed as an add-on to ravulizumab or eculizumab.

From the official label · 2026-05-12 · DailyMed

How it works

From this product’s own US prescribing label.

Danicopan binds reversibly to complement Factor D and selectively inhibits the alternative complement pathway.

Danicopan prevents the cleavage of complement Factor B into the Ba and Bb fragments which are required for the formation of the alternative pathway (AP) complement component C3 convertase (C3bBb), the generation of downstream effectors including C3 fragment opsonization, and the amplification of the terminal pathway.

Peak level after3.7 h
Half-life7.9 h
Mostly cleared after≈ 39.5 hfive half-lives — our arithmetic
PeakHalf gone39.5 h0
The shape is a standard model drawn from the two times above, not a measurement. How fast a medicine acts and wears off also depends on the dose, the form and the person.
How the body breaks it down

Danicopan is extensively metabolized (96%) via oxidation, reduction, and hydrolysis pathways, with amide hydrolysis being the major pathway of elimination.

How it leaves the body

After a single oral administration of 150 mg [ 14 C]-danicopan in humans, 69% of total radioactivity (danicopan plus metabolites) was excreted in feces and 25% was excreted in urine.

With food

Effect of Food When the danicopan tablet was administered with a high-fat meal, danicopan AUC and C max were approximately 25%, and 93% higher, respectively, compared to the fasted state.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-05-12

Serious warning

The strongest warning the FDA requires. It is printed in a box at the top of the label.

  • SERIOUS INFECTIONS CAUSED BY ENCAPSULATED BACTERIA VOYDEYA, a complement inhibitor, increases the risk of serious infections, especially those caused by encapsulated bacteria, such as Neisseria meningitidis , Streptococcus pneumoniae , and Haemophilus influenzae type B [ see Warnings and Precautions (5.1) ].
  • Life-threatening and fatal infections with encapsulated bacteria have occurred in patients treated with complement inhibitors.
  • These infections may become rapidly life-threatening or fatal if not recognized and treated early.
  • Complete or update vaccination for encapsulated bacteria specifically, Neisseria meningitidis and Streptococcus pneumoniae at least 2 weeks prior to the first dose of VOYDEYA, unless the risks of delaying therapy with VOYDEYA outweigh the risk of developing a serious infection.
  • Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for vaccinations against encapsulated bacteria in patients receiving a complement inhibitor.
  • See Warnings and Precautions (5.1) for additional guidance on the management of the risk of serious infections caused by encapsulated bacteria.
  • Patients receiving VOYDEYA are at increased risk for invasive disease caused by encapsulated bacteria, even if they develop antibodies following vaccination.
  • Monitor patients for early signs and symptoms of serious infections and evaluate immediately if infection is suspected.
  • Because of the risk of serious infections caused by encapsulated bacteria, VOYDEYA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the VOYDEYA REMS [see Warnings and Precautions (5.2) ] .
  • WARNING:
  • SERIOUS INFECTIONS CAUSED BY ENCAPSULATED BACTERIA See full prescribing information for complete boxed warning.
  • VOYDEYA increases the risk of serious and life-threatening infections, caused by encapsulated bacteria, including Neisseria meningitidis , Streptococcus pneumoniae , and Haemophilus influenzae type B ( 5.1 ).
  • Complete or update vaccination for encapsulated bacteria at least 2 weeks prior to the first dose of VOYDEYA, unless the risks of delaying VOYDEYA outweigh the risk of developing a serious infection.
  • Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for vaccinations against encapsulated bacteria in patients receiving a complement inhibitor ( 5.1 ).
  • Patients receiving VOYDEYA are at increased risk for invasive disease caused by encapsulated bacteria, even if they develop antibodies following vaccination.
  • Monitor patients for early signs and symptoms of serious infections and evaluate immediately if infection is suspected ( 5.1 ).
  • VOYDEYA is available only through a restricted program called VOYDEYA REMS ( 5.2 ).

Quoted from the official label, section “Boxed Warning”.

Do not take it if

  • VOYDEYA is contraindicated for initiation in patients with unresolved serious infection caused by encapsulated bacteria, including Neisseria meningitidis , Streptococcus pneumoniae , or Haemophilus influenzae type B [see Warnings and Precautions (5.1) ] .
  • Initiation in patients with unresolved serious infection caused by encapsulated bacteria ( 4 ).

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

  • Start 150 mg three times a day orally, with or without food.
  • Depending on clinical response, can increase to 200 mg three times a day.
  • See Full Prescribing Information for instructions on dosage and administration ( 2.1 , 2.2 ).
  • 2.1 Recommended Vaccination and Prophylaxis for Encapsulated Bacterial Infections Vaccinate patients against encapsulated bacteria, including Neisseria meningitidis (serogroups A, C, W, Y, and B) and Streptococcus pneumoniae according to current ACIP recommendations at least 2 weeks prior to initiation of VOYDEYA.
  • If urgent VOYDEYA therapy is indicated in a patient who is not up to date with vaccines for Neisseria meningitidis and Streptococcus pneumoniae according to ACIP recommendations, provide the patient with antibacterial drug prophylaxis and administer these vaccines as soon as possible [see Warnings and Precautions (5.1) ] .
  • Healthcare professionals who prescribe VOYDEYA must enroll in the VOYDEYA REMS [see Warnings and Precautions (5.2) ] .
  • 2.2 Recommended Dosage Starting Dose:
  • The recommended dosage of VOYDEYA is 150 mg three times a day administered orally.
  • VOYDEYA can be taken with or without food.
  • VOYDEYA doses should be taken around the same time every day.
  • Dose Adjustment:
  • The dose can be increased to 200 mg three times a day if the patient's hemoglobin (Hgb) level has not increased by greater than 2 g/dL after 4 weeks of therapy, if the patient required a transfusion during the previous 4 weeks, or to achieve an appropriate Hgb response based on clinical judgement.
  • Missed Doses A patient who misses a dose of VOYDEYA should take it as soon as they remember unless it is within 3 hours prior to their next dose, in which case the patient should skip the missed dose and take VOYDEYA at the next regularly scheduled time.
  • Patients should not take two or more doses of VOYDEYA at the same time.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

  • Hepatic Enzyme Increases:
  • Assess liver enzymes before treatment initiation and periodically during treatment.
  • Consider treatment interruption or discontinuation if elevations are clinically significant or if the patient becomes symptomatic ( 5.3 ).
  • Hyperlipidemia:
  • Monitor serum lipids periodically during treatment and initiate cholesterol-lowering medication if indicated ( 5.4 ).
  • 5.1 Serious Infections Caused by Encapsulated Bacteria VOYDEYA, a complement inhibitor, increases a patient's susceptibility to serious, life-threatening, or fatal infections caused by encapsulated bacteria including Neisseria meningitidis (caused by any serogroup, including non-groupable strains), Streptococcus pneumoniae , and Haemophilus influenzae type B.
  • Life-threatening and fatal infections with encapsulated bacteria have occurred in both vaccinated and unvaccinated patients treated with complement inhibitors.
  • The initiation of VOYDEYA treatment is contraindicated in patients with unresolved serious infections caused by encapsulated bacteria.
  • Complete or update vaccination against encapsulated bacteria, specifically Neisseria meningitidis and Streptococcus pneumoniae at least 2 weeks prior to administration of the first dose of VOYDEYA, according to the current ACIP recommendations for patients receiving a complement inhibitor.
  • Revaccinate patients in accordance with ACIP recommendations considering the duration of therapy with VOYDEYA.
  • Note that ACIP recommends an administration schedule in patients receiving complement inhibitors that differs from the administration schedule in the vaccine prescribing information.
  • If urgent VOYDEYA therapy is indicated in a patient who is not up to date with vaccines against encapsulated bacteria according to ACIP recommendations, provide the patient with antibacterial drug prophylaxis and administer these vaccines as soon as possible.
  • Various durations and regimens of antibacterial drug prophylaxis have been considered, but the optimal durations and drug regimens for prophylaxis and their efficacy have not been studied in unvaccinated or vaccinated patients receiving complement inhibitors, including VOYDEYA.
  • The benefits and risks of treatment with VOYDEYA, as well as the benefits and risks of antibacterial drug prophylaxis in unvaccinated or vaccinated patients, must be considered against the known risks for serious infections caused by encapsulated bacteria.
  • Vaccination does not eliminate the risk of serious encapsulated bacterial infections, despite development of antibodies following vaccination.
  • Closely monitor patients for early signs and symptoms of serious infection and evaluate patients immediately if an infection is suspected.
  • Inform patients of these signs and symptoms and instruct patients to seek immediate medical care if these signs and symptoms occur.
  • Promptly treat known infections.
  • Serious infection may become rapidly life-threatening or fatal if not recognized and treated early.
  • Consider interruption of VOYDEYA in patients who are undergoing treatment for serious infections.
  • VOYDEYA is available only through a restricted program under a REMS [see Warnings and Precautions (5.2) ] .
  • 5.2 VOYDEYA REMS VOYDEYA is available only through a restricted program under a REMS called VOYDEYA REMS, because of the risk of serious infections caused by encapsulated bacteria [see Warnings and Precautions (5.1) ] .
  • Notable requirements of the VOYDEYA REMS include the following:
  • Prescribers must enroll in the REMS.
  • Prescribers must counsel patients about the risk of serious infections caused by encapsulated bacteria.
  • Prescribers must provide patients with the REMS educational materials.
  • Prescribers must assess patient vaccination status for vaccines against encapsulated bacteria and vaccinate if needed according to current ACIP recommendations two weeks prior to the first dose of VOYDEYA.
  • Prescribers must provide a prescription for antibacterial drug prophylaxis if treatment must be started urgently, and the patient is not up to date with vaccines against encapsulated bacteria according to current ACIP recommendations at least two weeks prior to the first dose of VOYDEYA.
  • Pharmacies that dispense VOYDEYA must be certified in the VOYDEYA REMS and must verify prescribers are certified.
  • Patients must receive counseling from the prescriber about the need to receive vaccinations against encapsulated bacteria per ACIP recommendations, the need to take antibiotics as directed by the prescriber, and the early signs and symptoms of serious infections.
  • Further information is available by telephone:
  • 1-888-765-4747 or online at www.VoydeyaREMS.com.
  • 5.3 Hepatic Enzyme Increases Hepatic enzyme elevations have been observed in patients treated with VOYDEYA [see Adverse Reactions (6.1) ] .
  • Fourteen percent of patients receiving VOYDEYA in Study ALXN2040-PNH-301 had elevations in serum alanine aminotransferase (ALT).
  • ALT elevations > 3 × the upper limit of normal (ULN) and ≤ 5 × ULN occurred in 9% of VOYDEYA-treated patients, and ALT elevations > 5 × ULN and ≤ 10 × ULN occurred in 5% of VOYDEYA-treated patients.
  • Assess liver enzyme test results prior to the initiation of VOYDEYA and periodically during treatment.
  • Consider treatment interruption or discontinuation if elevations are clinically significant or if the patient becomes symptomatic.
  • VOYDEYA has not been studied in patients with severe hepatic impairment [see Use in Specific Populations (8.7)] .
  • 5.4 Monitoring of PNH Manifestations After VOYDEYA Discontinuation After discontinuing treatment with VOYDEYA, closely monitor patients for at least 2 weeks after the last dose for signs and symptoms of hemolysis.
  • If discontinuation of VOYDEYA is necessary, continue background treatment with ravulizumab or eculizumab or consider alternative therapy if necessary.
  • The signs and symptoms of hemolysis may include a sudden decrease in hemoglobin or fatigue.
  • If hemolysis occurs after discontinuation of VOYDEYA, consider restarting treatment with VOYDEYA if appropriate.
  • 5.5 Hyperlipidemia VOYDEYA increases total cholesterol and LDL-cholesterol.
  • Of the 50 VOYDEYA-treated patients who had a normal total cholesterol level at baseline in Study ALXN2040-PNH-301, 30% developed Grade 1 hypercholesterolemia.
  • Of the 6 VOYDEYA treated patients who had Grade 1 hypercholesterolemia at baseline in Study ALXN2040-PNH-301, 1 patient experienced increased total cholesterol that worsened to Grade 2.
  • Of the 54 VOYDEYA-treated patients who had LDL-cholesterol ≤130 mg/dL at baseline in Study ALXN2040-PNH-301, 13% developed LDL-cholesterol >130-160 mg/dL and 9% developed LDL-cholesterol >160-190 mg/dL.
  • Some patients required cholesterol-lowering medications.
  • Monitor serum lipid parameters periodically during treatment with VOYDEYA and initiate cholesterol lowering medication, if indicated.

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

  • Risk Summary There are no available data on VOYDEYA use in pregnant individuals to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.
  • There are risks to the mother and fetus associated with untreated PNH in pregnancy (see Clinical Considerations ) .
  • The use of VOYDEYA in pregnant women or women planning to become pregnant may be considered following an assessment of the risks and benefits.
  • In animal reproduction studies, oral administration of danicopan to pregnant New Zealand White (NZW) rabbits and Wistar Hans (WH) rats during organogenesis at exposures 18 or 25-times, respectively, above the human exposure at the maximum recommended human dose (MRHD) of 200 mg three times a day (based on AUC) resulted in no adverse developmental effects (see Data ) .
  • The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
  • All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
  • In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
  • Clinical Considerations Disease-Associated Maternal and/or Fetal/Neonatal Risk PNH in pregnancy is associated with adverse maternal outcomes, including worsening cytopenias, thrombotic events, infections, bleeding, miscarriages, and increased maternal mortality, and adverse fetal outcomes, including fetal death and premature delivery.
  • Data Animal Data There were no effects on early embryonic development and fetal development in NZW rabbits (where danicopan is pharmacodynamically active) up to a mean maternal systemic exposure 18-times the exposure at the MRHD (based on AUC) or during post-natal development up to a mean maternal systemic exposure 9-times the exposure at the MRHD (based on AUC).
  • In WH rats (where danicopan lacks pharmacodynamic activity), there were no effects on embryo-fetal development up to a mean maternal exposure 25-times the exposure at the MRHD (based on AUC).
  • IN SPECIFIC POPULATIONS Hepatic Impairment:
  • Avoid use in patients with severe hepatic impairment (Child-Pugh C) ( 8.6 ).
  • 8.1 Pregnancy Risk Summary There are no available data on VOYDEYA use in pregnant individuals to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.
  • There are risks to the mother and fetus associated with untreated PNH in pregnancy (see Clinical Considerations ) .
  • The use of VOYDEYA in pregnant women or women planning to become pregnant may be considered following an assessment of the risks and benefits.
  • In animal reproduction studies, oral administration of danicopan to pregnant New Zealand White (NZW) rabbits and Wistar Hans (WH) rats during organogenesis at exposures 18 or 25-times, respectively, above the human exposure at the maximum recommended human dose (MRHD) of 200 mg three times a day (based on AUC) resulted in no adverse developmental effects (see Data ) .
  • The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
  • All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
  • In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
  • Clinical Considerations Disease-Associated Maternal and/or Fetal/Neonatal Risk PNH in pregnancy is associated with adverse maternal outcomes, including worsening cytopenias, thrombotic events, infections, bleeding, miscarriages, and increased maternal mortality, and adverse fetal outcomes, including fetal death and premature delivery.
  • Data Animal Data There were no effects on early embryonic development and fetal development in NZW rabbits (where danicopan is pharmacodynamically active) up to a mean maternal systemic exposure 18-times the exposure at the MRHD (based on AUC) or during post-natal development up to a mean maternal systemic exposure 9-times the exposure at the MRHD (based on AUC).
  • In WH rats (where danicopan lacks pharmacodynamic activity), there were no effects on embryo-fetal development up to a mean maternal exposure 25-times the exposure at the MRHD (based on AUC).
  • 8.2 Lactation Risk Summary There are no data on the presence of danicopan in human milk, the effects on the breastfed child, or the effect on milk production.
  • Danicopan is present in animal milk.
  • When a drug is present in animal milk, it is likely that the drug will be present in human milk.
  • Because of the potential for serious adverse reactions in the breastfed child, including serious infections with encapsulated bacteria and liver enzyme increases, advise patients not to breastfeed during treatment with VOYDEYA, and for 3-days after the last dose.
  • Data Animal Data Danicopan was excreted into the milk of lactating rabbits following oral administration from lactation day 4 to lactation day 10, with mean milk concentrations at approximately 2 hours following dose administration 5- and 3.5-times higher than the mean maternal plasma concentrations at 50 and 250 mg/kg/day, respectively.
  • Mean milk concentrations in dams were 19- and 43-times higher than the systemic exposure at the MRHD (based on rabbit concentration at 2 hours vs. human C max ).
  • 8.4 Pediatric Use Safety and effectiveness of VOYDEYA for the treatment of PNH in pediatric patients have not been established.
  • 8.5 Geriatric Use There were 22 patients 65 years of age and older in the clinical studies for PNH [see Clinical Studies (14) ] .
  • Of the total number of VOYDEYA-treated patients in these studies, 16 (28.1%) were 65 years of age and older, and 7 (12.3%) were 75 years of age and older.
  • Clinical studies of VOYDEYA did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects.
  • 8.6 Hepatic Impairment No dose adjustment is required in patients with mild to moderate hepatic impairment (Child-Pugh Class A and B).
  • Studies have not been conducted in patients with severe hepatic impairment, therefore,
  • avoid use of VOYDEYA in this patient population [see Warnings and Precautions (5.3) ] .

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

  • BCRP substrates:
  • Monitor patients more frequently for adverse reactions and consider dose reduction of the BCRP substrate drug.
  • For rosuvastatin, the dose should not exceed 10 mg once daily ( 7.1 ).
  • P-gp substrates:
  • Dose adjustment might be necessary for P-gp substrates where minimal concentration changes may lead to serious adverse reactions ( 7.2 ).
  • 7.1 BCRP Substrates Danicopan is a Breast Cancer Resistance Protein (BCRP) inhibitor.
  • Concomitant use of VOYDEYA with a BCRP substrate increases the plasma concentrations of the BCRP substrate [see Clinical Pharmacology (12.3) ] , which may increase the risk for adverse reactions associated with the BCRP substrate.
  • If used together, monitor patients more frequently for adverse reactions associated with the BCRP substrate, and consider dose reduction of the BCRP substrate according to its prescribing information.
  • Rosuvastatin Danicopan significantly increased rosuvastatin exposure.
  • The dose of rosuvastatin should not exceed 10 mg once daily when concomitantly used with VOYDEYA [see Clinical Pharmacology (12.3) ] .
  • 7.2 P-gp Substrates Danicopan is an inhibitor of P-glycoprotein (P-gp).
  • Concomitant administration of VOYDEYA with a P-gp substrate may increase the plasma concentration of the P-gp substrate.
  • Dose adjustment might be necessary for P-gp substrates where minimal concentration changes may lead to serious adverse reactions [see Clinical Pharmacology (12.3) ] .

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

  • Serum ALT elevations occurred after treatment cessation without a taper in 2 healthy subjects who received danicopan 500 mg and 800 mg twice a day.
  • These abnormal ALT findings were transient, with no evidence of hepatic function abnormality and resolved spontaneously.
  • In case of overdose, elevations in liver enzymes may occur.
  • General supportive measures are recommended.
  • It is not known if VOYDEYA can be removed by dialysis.

Quoted from the official label, section “Overdosage”.

Use in children

Safety and effectiveness of VOYDEYA for the treatment of PNH in pediatric patients have not been established.

Quoted from the official label, section “Pediatric Use”.

Use in older people

  • There were 22 patients 65 years of age and older in the clinical studies for PNH [see Clinical Studies (14) ] .
  • Of the total number of VOYDEYA-treated patients in these studies, 16 (28.1%) were 65 years of age and older, and 7 (12.3%) were 75 years of age and older.
  • Clinical studies of VOYDEYA did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects.

Quoted from the official label, section “Geriatric Use”.

Side effects

  • The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling:
  • Serious Infections Caused by Encapsulated Bacteria [see Warnings and Precautions (5.1) ] Hepatic Enzyme Increases [see Warnings and Precautions (5.3) ] Hyperlipidemia [see Warnings and Precautions (5.4) ] Most frequent adverse reaction (incidence ≥10%) was headache ( 6 ).
  • To report SUSPECTED ADVERSE REACTIONS, contact Alexion Pharmaceuticals, Inc. at 1-844-259-6783 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
  • 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
  • The safety of VOYDEYA was evaluated in 86
  • adults with PNH in Study ALXN2040-PNH-301 [see Clinical Studies (14) ] .
  • Study ALXN2040-PNH-301 enrolled
  • adults with PNH with clinically significant EVH who had been treated with a stable dose of ravulizumab or eculizumab for at least the previous 6 months.
  • Patients were randomly assigned 2:1 to receive double-blind VOYDEYA 150 mg (n=57) or placebo (n=29) orally three times a day in addition to ravulizumab or eculizumab for 12 weeks.
  • Patients received either US-approved or non-US-approved ravulizumab or eculizumab in the trial.
  • Among patients who were randomized to receive VOYDEYA, 84% were exposed for at least 12 weeks.
  • Serious adverse reactions were reported in 5% of patients who received VOYDEYA and included pancreatitis, cholecystitis, and blood bilirubin increased.
  • No specific serious adverse reaction was reported in more than 1 patient treated with VOYDEYA.
  • Permanent discontinuation of VOYDEYA due to an adverse reaction occurred in 5% of patients and included 1 patient with blood bilirubin increase and pancreatitis, 1 patient with hepatic enzyme increased, and 1 patient with ALT increased and aspartate aminotransferase increased.
  • Dosage reduction due to an adverse reaction occurred in 1 patient and the adverse reaction was COVID-19.
  • Among the 57 patients treated with VOYDEYA in Study ALXN2040-PNH-301, the most common adverse reaction (≥10%) was headache.
  • Table 1 describes adverse reactions reported in ≥5% of patients treated with VOYDEYA and greater than placebo in the randomized, controlled period of Study ALXN2040-PNH-301.
  • Table 1 Adverse Reactions Reported in ≥5% of VOYDEYA-Treated Patients with PNH and Greater than Placebo Adverse Reactions Common Toxicity Criteria Adverse Events (CTCAE) VOYDEYA (with ravulizumab or eculizumab) N = 57 Placebo (ravulizumab or eculizumab only) N = 29 n (%) n (%) Headache 6 (11) 3 (10) Vomiting Represents a composite of multiple, related adverse reactions 4 (7) 0 (0) Pyrexia 4 (7) 0 (0) Alanine aminotransferase increased 3 (5) 1 (3) Hypertension 3 (5) 1 (3) Pain in extremity 3 (5) 0 (0) Clinically relevant adverse reactions in <5% of patients include increased serum triglycerides.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

  • Advise the patient to read the FDA-approved patient labeling (Medication Guide).
  • Serious Infections Caused by Encapsulated Bacteria Advise patients of the risk of serious infection.
  • Inform patients of the need to complete or update their vaccinations against encapsulated bacteria at least 2 weeks prior to receiving the first dose of VOYDEYA or receive antibacterial drug prophylaxis if VOYDEYA treatment must be initiated immediately and they have not previously been vaccinated.
  • Inform patients of the requirement to be revaccinated according to ACIP recommendations for encapsulated bacteria while on VOYDEYA therapy [see Warnings and Precautions (5.1) ] .
  • Inform patients that vaccination may not prevent serious infection and to seek immediate medical attention if the following signs or symptoms occur [see Warnings and Precautions (5.1) ] :
  • fever with or without chills fever and a rash fever with chest pain and cough fever with breathlessness/fast breathing fever with high heart rate headache with nausea or vomiting headache and a fever headache with a stiff neck or stiff back confusion body aches with flu-like symptoms clammy skin eyes sensitive to light Inform patients that they will be given a Patient Safety Card for VOYDEYA that they should carry with them at all times during and for 1 week following treatment with VOYDEYA.
  • This card describes symptoms which, if experienced, should prompt the patient to seek immediate medical evaluation.
  • VOYDEYA REMS VOYDEYA is available only through a restricted program called VOYDEYA REMS [see Warnings and Precautions (5.2) ] .
  • Inform the patient of the following notable requirements:
  • Patients must receive counseling about the risk of serious infections caused by encapsulated bacteria.
  • Patients must receive written educational materials about this risk.
  • Patients must be instructed to carry the Patient Safety Card with them at all times during treatment and for 1 week following the last dose of VOYDEYA.
  • Patients must be instructed to complete or update vaccines against encapsulated bacteria per ACIP recommendations as directed by the prescriber prior to treatment with VOYDEYA.
  • Patients must receive antibiotics as directed by the prescriber if they are not up to date on vaccinations against encapsulated bacteria and have to start VOYDEYA right away.
  • Importance of Adherence to Dosing Schedule Inform patients with PNH of the importance of taking VOYDEYA as prescribed to minimize the risk of hemolysis.
  • Discontinuation Inform patients with PNH that they may develop serious hemolysis due to PNH if VOYDEYA is discontinued and that they should be monitored by their healthcare providers for at least 2 weeks following discontinuation of VOYDEYA.
  • Inform patients who discontinue VOYDEYA to keep the Patient Safety Card with them for 1 week after the last dose of VOYDEYA.
  • The increased risk of serious infection may continue for a few days after the last dose of VOYDEYA.
  • Hepatic Enzyme Elevations Inform patients that elevation in liver enzymes have occurred in patients treated with VOYDEYA, and liver tests will be obtained before and during VOYDEYA treatment [see Warnings and Precautions (5.3) ] .
  • Hyperlipidemia Inform patients that VOYDEYA may increase their cholesterol and that monitoring of these parameters will be needed periodically during treatment [see Warnings and Precautions (5.4) ] .

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

  • FORMS AND STRENGTHS Tablets:
  • 50 mg and 100 mg ( 3 ) Tablets:
  • 50 mg, white to off-white, round, film-coated, printed with "DCN" above "50" debossed on one side, plain on the other side. 100 mg, white to off-white, round film-coated, printed with "DCN" above "100" debossed on one side, plain on the other side.

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

  • VOYDEYA (danicopan) tablets are available in the doses and packages listed in Table 4.
  • Table 4 VOYDEYA Tablet Presentations Dose Tablet Strength Film-Coated Tablet Markings Tablet Color/Shape Pack Size NDC Code Each carton contains two high density polyethylene bottles with desiccant and child resistant seal, with 180 tablets per carton:
  • 150 mg 50 mg Debossed on one side with "DCN 50" White to off-white, round film-coated tablets One bottle with 90 × 50 mg per tablet (25682-040-90) One bottle with 90 × 100 mg per tablet (25682-043-90) 25682-046-92 100 mg Debossed on one side with "DCN 100" 200 mg 100 mg Debossed on one side with "DCN 100" White to off-white, round film-coated tablets Two bottles with 90 tablets per bottle:
  • 90 × 100 mg per tablet (25682-043-90) 25682-043-92 Store and dispense in the original container at 20°C to 25°C (68°F to 77°F) with excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP controlled room temperature].

Quoted from the official label, section “How Supplied”.

How to store it

Store and dispense in the original container at 20°C to 25°C (68°F to 77°F) with excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP controlled room temperature].

Quoted from the official label, section “Storage and Handling”.

What is in it

  • Danicopan is a small molecule complement Factor D inhibitor.
  • Its chemical name is (2S,4R)-1-{[3-acetyl-5-(2-methylpyrimidin-5-yl)-1H-indazol-1-yl] acetyl}-N-(6-bromopyridin-2-yl)-4-fluoropyrrolidine-2-carboxamide.
  • Its molecular formula is C 26 H 23 BrFN 7 O 3 and its molecular weight is 580.4.
  • Danicopan has the following structural formula:
  • Danicopan is a white/off-white to pale yellow powder.
  • In aqueous solutions, danicopan is considered slightly soluble at pH 1.2 and insoluble from pH 4 to pH 7.
  • Danicopan tablets are available as white to off-white, round, film-coated, immediate release tablets in strengths of 50 mg and 100 mg, intended for oral administration.
  • Each tablet contains the following inactive ingredients:
  • colloidal silicon dioxide, croscarmellose sodium, hypromellose acetate succinate, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate.
  • The tablet coating components are polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.
  • Chemical Structure

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

  • Lactoselactose monohydrateMilk sugar: matters with lactose intolerance or a milk allergy.

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

Medicine passport: one printable page to show a pharmacist abroad

European UnionNo exact match for this strength and form

Every strength and form (1)

FranceNo exact match for this strength and form

Every strength and form (2)

CanadaNo exact match for this strength and form

Every strength and form (2)

NetherlandsNo exact match for this strength and form

Every strength and form (2)

Details

Made byAlexion Pharmaceuticals Inc.
Active substanceDanicopan
FormKit
Packs1 KIT in 1 CARTON * 90 TABLET, FILM COATED in 1 BOTTLE * 90 TABLET, FILM COATED in 1 BOTTLE
NDC25682-046

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

2 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

  • Kit1 products
    • —
  • Tablet, Film Coated1 products

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

Voydeya100 mgPrescription onlyTablet, Film Coated Alexion Pharmaceuticals Inc. · Danicopan

See every product with Danicopan