Abbreviated Prescribing Information
Voydeya (Danicopan)

Presentation: 50mg or 100mg film-coated tablet. Indications: Add-on to ravulizumab or eculizumab for treatment of adults with PNH who have residual haemolytic anaemia. Dosage: Recommended starting dose is 150 mg TID orally, approx. 8 hrs apart (± 2 hrs). Dose can be increased to 200 mg TID after a min. of 4 wks of treatment depending on clinical response. Administration: Oral use. To be taken with food. Contraindications: Hypersensitivity to danicopan or any excipients; unresolved Neisseria meningitidis, Streptococcus pneumoniae, or Haemophilus influenzae B infection; unvaccinated against Neisseria meningitidis and Streptococcus pneumoniae unless receiving prophylactic antibiotics until 2 wks after vaccination. Special Warnings and Precautions: Danicopan should only be prescribed as an add-on to ravulizumab or eculizumab. Complete or update vaccination against encapsulated bacteria, specifically Neisseria meningitidis and Streptococcus pneumoniae >2 wks prior to administration of 1st dose of danicopan. Revaccinate patients in accordance with local recommendations considering duration of therapy with danicopan. If urgent danicopan therapy is indicated in a patient who is not up to date with vaccines against encapsulated bacteria, provide patient with antibacterial drug prophylaxis and administer vaccines as soon as possible. Severe Renal Impairment: Patients with severe renal impairment that dose escalate to 150 mg TID 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 AEs during treatment with danicopan due to higher exposure expected in these patients. Hepatic Enzymes Increase: ALT elevations observed in clinical trials. Liver enzyme tests to be performed before treatment begins. Discontinuation: At doses >200 mg TID, ALT elevations occurred after treatment cessation without dose tapering in healthy subjects. Upon discontinuation, dose should be tapered over 6 days. Interaction: Caution should be exercised when co-administering medicinal products known to be substrates of P-gp (e.g., dabigatran, digoxin, edoxaban, fexofenadine, tacrolimus) and substrates of BCRP (e.g., rosuvastatin and sulfasalazine). Pregnancy: No data in pregnant women. Breast-feeding: Should not be used during breast-feeding and breast-feeding should not be initiated until 3 days after treatment discontinuation. Fertility: No human data are available. Adverse Reactions: Very common (≥10%): Headache, hepatic enzyme increased, pain in extremity, pyrexia. Common (≥1% to <10%): Hypertension, vomiting. Full local prescribing information is available upon request. API.HK.VOY.0125

HK-11397  01/2025