VOYDEYA® (danicopan) is the first and only oral add-on to ULTOMIRIS® (ravulizumab)* that addresses residual anaemia due to extravascular haemolysis.1
The recommended starting dose of VOYDEYA® for adult patients is 150mg three times daily (TID), approximately 8 hours apart (±2 hours)†. Depending on clinical response, doses can be increased up to 200mg TID after a minimum of 4 weeks of treatment.1 VOYDEYA® is available in 50mg and 100mg round, film-coated tablets.1
If your patient misses a dose of VOYDEYA®, advise them to take it as soon as they remember. If it is almost time for their next dose, they should skip the missed dose and take VOYDEYA® at the next regularly scheduled time.1 Advise your patient not to take two doses or more of VOYDEYA® at the same time.1
Due to the possibility of alanine aminotransferase (ALT) elevations after treatment cessation, the dose should be tapered over a 6-day period until complete cessation:1
*VOYDEYA® may also be taken with SOLIRIS® (eculizumab).1
†In patients with severe renal impairment (eGFR <30 mL/min/1.73 m2), the recommended starting dose is 100 mg TID administered orally, approximately 8 hours apart (±2 hours).1
†In patients with severe renal impairment (eGFR <30 mL/min/1.73 m2), the recommended starting dose is 100 mg TID administered orally, approximately 8 hours apart (±2 hours).1
Meningococcal infections: Monitor for early signs of meningococcal infection and sepsis and evaluate immediately if infection is suspected, and commence treatment with appropriate antibiotics. Inform patients of the signs and symptoms of meningitis the need to seek medical care immediately.1
Other serious infections: Recommend patients be immunised according to current immunisation guidelines prior to initiating VOYDEYA® as add-on to ULTOMIRIS® or SOLIRIS®, because of their increased susceptibility to serious infections (other than Neisseria meningitidis). Administer VOYDEYA® with caution to patients with active systemic infections.1
Low body weight: Monitor patients weighing <60kg for adverse events due to higher exposure expected in these patients.1
Severe renal impairment: Monitor patients with severe renal impairment (eGFR <30mL/min/1.73m2) taking 150mg TID for adverse events due to higher exposure expected in these patients.1
Hepatic enzymes increase: Perform liver enzyme tests prior to initiating treatment with VOYDEYA® and then monitor routinely (as per PNH management). Consider interrupting or discontinuing treatment if elevations are clinically significant or patients become symptomatic.1 No dose adjustment is required in patients with mild (Child-Pugh Class A) to moderate (Child-Pugh Class B) hepatic impairment. Studies have not been conducted in patients with severe (Child-Pugh Class C) hepatic impairment. Therefore, Voydeya is not recommended in this patient population.1
Other serious infections: Recommend patients be immunised according to current immunisation guidelines prior to initiating VOYDEYA® as add-on to ULTOMIRIS® or SOLIRIS®, because of their increased susceptibility to serious infections (other than Neisseria meningitidis). Administer VOYDEYA® with caution to patients with active systemic infections.1
Low body weight: Monitor patients weighing <60kg for adverse events due to higher exposure expected in these patients.1
Severe renal impairment: Monitor patients with severe renal impairment (eGFR <30mL/min/1.73m2) taking 150mg TID for adverse events due to higher exposure expected in these patients.1
Hepatic enzymes increase: Perform liver enzyme tests prior to initiating treatment with VOYDEYA® and then monitor routinely (as per PNH management). Consider interrupting or discontinuing treatment if elevations are clinically significant or patients become symptomatic.1 No dose adjustment is required in patients with mild (Child-Pugh Class A) to moderate (Child-Pugh Class B) hepatic impairment. Studies have not been conducted in patients with severe (Child-Pugh Class C) hepatic impairment. Therefore, Voydeya is not recommended in this patient population.1
For more information on ULTIMIRIS® and SOLIRIS®, please refer to the relevant SmPCs.1–3
Do you know how the efficacy and safety of VOYDEYA® was evaluated?
VOYDEYA® Study design
Adverse Event Reporting
Please report any adverse events via your national reporting system. Adverse events can also be reported to Alexion,AstraZeneca Rare Disease by contacting: https://contactazmedical.astrazeneca.com/
ALT, alanine aminotransferase; BID, twice daily; TID, three-times daily; QD, once a day, eGFR, estimated glomerular filtration rate.
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