Riferimento farmaci
Danicopan
Danicopan is a medicine in the class miscellaneous.
- Classe del farmaco: Miscellaneous
Ultimo aggiornamento Fonti: US FDA label
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In breve
- Classe del farmaco
- Miscellaneous
- Codice ATC
- L04AJ09
- Forme farmaceutiche comuni
- compressa
- Dosaggi comuni
- 100 mg
- Interazioni note
- 97 (Moderata: 68 · Minore: 29)
- Nomi commerciali
- 2
- Paesi e mercati
- 2
Come agisce
Danicopan reversibly binds complement Factor D and selectively inhibits the alternative complement pathway. It prevents cleavage of Factor B and formation of C3 convertase (C3bBb), thereby controlling C3 fragment-mediated extravascular hemolysis in PNH.
Dose abituale nell'adulto (sintesi del foglio illustrativo)
Extravascular hemolysis in PNH (add-on to ravulizumab or eculizumab): starting dose 150 mg orally three times a day, with or without food; may increase to 200 mg three times a day
Gravidanza e allattamento
- Gravidanza
- Unknown No human data. Use may be considered after risk-benefit assessment; untreated PNH carries maternal and fetal risks. No adverse developmental effects in rabbits or rats.
- Allattamento
- Unsafe No human milk data; present in animal milk. Advise not to breastfeed during treatment and for 3 days after the last dose.
Effetti indesiderati segnalati
- Headache
- Vomiting
- Pyrexia
- Increased alanine aminotransferase
- Hypertension
- Pain in extremity
Avvertenze in evidenza
- Complement inhibitor that increases the risk of serious, life-threatening or fatal infections with encapsulated bacteria (Neisseria meningitidis, Streptococcus pneumoniae, Haemophilus influenzae type B). Vaccinate against N. meningitidis and S. pneumoniae at least 2 weeks before the first dose unless delaying therapy is riskier, and follow current ACIP recommendations. Risk persists despite vaccination. Monitor for early signs of infection and evaluate immediately. Available only through the VOYDEYA REMS.
Controindicazioni
- Initiation in patients with unresolved serious infection caused by encapsulated bacteria (Neisseria meningitidis, Streptococcus pneumoniae, Haemophilus influenzae type B)
Chi deve prestare attenzione
- Serious encapsulated bacterial infections can occur in vaccinated and unvaccinated patients; if urgent therapy is needed in patients not up to date on vaccines, give antibacterial prophylaxis and vaccinate as soon as possible.
- Hepatic enzyme elevations (ALT) occurred; assess liver enzymes before and periodically during treatment.
- After discontinuation, monitor closely for at least 2 weeks for signs of hemolysis; continue background ravulizumab or eculizumab.
Informare il farmacista o il medico di gravidanza o allattamento, malattie renali o epatiche, allergie e di ogni altro farmaco o integratore assunto.
Interazioni principali (97)
- Amiodarone + Danicopan Moderate
- Apixaban + Danicopan Moderate
- Atorvastatin + Danicopan Moderate
- Brentuximab + Danicopan Moderate
- Carvedilol + Danicopan Moderate
- Cladribine + Danicopan Moderate
- Colchicine + Danicopan Moderate
- Crizotinib + Danicopan Moderate
- Cyclosporin + Danicopan Moderate
- Dabigatran etexilate + Danicopan Moderate
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- Dosing by age, kidney and liver function, and further dose lines
- Renal and hepatic dose adjustments
- Dosing in older adults
- How to give it
- Pharmacokinetics
- Patient counselling points
- Food interactions
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Domande frequenti
What is Danicopan used for?
Danicopan is a medicine in the class miscellaneous.
What side effects have been reported with Danicopan?
Headache, Vomiting, Pyrexia, Increased alanine aminotransferase, Hypertension, Pain in extremity. Serious warning: Complement inhibitor that increases the risk of serious, life-threatening or fatal infections with encapsulated bacteria (Neisseria meningitidis, Streptococcus pneumoniae, Haemophilus influenzae type B).
Can Danicopan be taken in pregnancy or while breastfeeding?
Pregnancy: Unknown. No human data. Use may be considered after risk-benefit assessment; untreated PNH carries maternal and fetal risks. No adverse developmental effects in rabbits or rats. Breastfeeding: Unsafe. No human milk data; present in animal milk. Advise not to breastfeed during treatment and for 3 days after the last dose.
What does Danicopan interact with?
MediHelp lists 97 known interactions for Danicopan. Moderate: 68 · Minor: 29. The most serious include Amiodarone, Apixaban, Atorvastatin.
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