Formulary
Danicopan: Indications, Dosing, Side Effects and Interactions
Danicopan is a complement inhibitor which binds to factor D and prevents activation of the complement alternative pathway, thereby inhibiting the complement...
MedNext Academy | 3 min read
Danicopan: Indications, Dosing, Side Effects and Interactions
Danicopan is a complement inhibitor which binds to factor D and prevents activation of the complement alternative pathway, thereby inhibiting the complement...
Drug action
Danicopan is a complement inhibitor which binds to factor D and prevents activation of the complement alternative pathway, thereby inhibiting the complement cascade that leads to haemolysis.
Indications and dose
**Paroxysmal nocturnal haemoglobinuria (initiated by a specialist)**
- **Adult** (By Mouth): 150 mg 3 times a day, increased if necessary to 200 mg 3 times a day, dose may be increased after a minimum of 4 weeks, according to response.
Cautions
Active systemic infection; patients weighing less than 60 kg (risk of increased exposure) Cautions, further information Meningococcal infection Vaccinate against Neisseria meningitidis at least 2 weeks before treatment (vaccines against serotypes A, C, Y, W135, and B where available, are recommended); revaccinate according to current medical guidelines. Patients receiving danicopan less than 2 weeks after receiving meningococcal vaccine must be given prophylactic antibiotics until 2 weeks after vaccination. Other immunisations should also be up to date. M
Contraindications
Patients unvaccinated against Neisseria meningitidis ; unresolved Neisseria meningitidis infection
Side effects
Common or very common Fever; headache; hepatic function abnormal; hypertension; pain in extremity; vomiting
Interactions
**Other interactions (6):**
- Effects of danicopan on other medicinal products P-gp substrates Co-administration of a single oral dose of 180 mg fexofenadine, a P-gp substrate, with 150 mg three times daily doses of danicopan...
- The results suggest that danicopan is a mild inhibitor of P-gp.
- Caution may be needed in co-administering medicinal products that are known to be substrates of P-gp (such as dabigatran, digoxin, edoxaban, fexofenadine, tacrolimus).
- BCRP substrates Co-administration of a single oral dose of 20 mg rosuvastatin, a BCRP substrate, with 200 mg three times daily doses of danicopan resulted in increased rosuvastatin C max and AUC...
- This result suggests that danicopan is an inhibitor of BCRP.
- Caution may be needed in co-administering medicinal products that are known to be substrates of BCRP (such as rosuvastatin and sulfasalazine).
Pregnancy
Avoid (limited information available). M
Breast feeding
Avoid during and for 3 days after treatment (present in milk in animal studies). M
Hepatic impairment
Avoid in severe impairment (no information available). M
Renal impairment
Dose adjustments If eGFR less than 30 mL/minute/1.73 m 2 , reduce dose to 100 mg 3 times a day; dose may be increased to 150 mg 3 times a day after a minimum of 4 weeks, according to response. Monitor for adverse reactions (risk of increased exposure). M See Prescribing in renal impairment .
Medicinal forms
Tablet
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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