Danicopan Application Scope

Voydeya is approved as an add-on therapy to ravulizumab or eculizumab for the treatment of extravascular hemolysis (EVH) in adults with paroxysmal nocturnal hemoglobinuria (PNH).

Danicopan Characteristics

Ingredients:
- Active Ingredient: Danicopan
- Excipients: Colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl methylcellulose acetate succinate, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate.
- Film Coating: Polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide.
Properties: White to off-white, round, film-coated tablets.
Packaging Specification: Available in bottles containing 90 tablets of either 50 mg or 100 mg strength.
Storage: Store at room temperature between 20°C and 25°C (68°F and 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F).
Expiry Date: Refer to the expiration date printed on the packaging.
Executive Standard: Approved by the U.S. Food and Drug Administration (FDA) on March 29, 2024.
Approval Number: NDA 218037.
Date of Revision: Refer to the latest prescribing information for the most recent revision date.
Manufacturer: Alexion Pharmaceuticals, Inc., a subsidiary of AstraZeneca.

Guidelines for the Use of Danicopan

Dosage and Administration:
- Starting Dose: 150 mg taken orally three times daily (TID).
- Dose Adjustment: If hemoglobin levels have not increased by more than 2 g/dL after 4 weeks, or if a transfusion was needed during the previous 4 weeks, the dose may be increased to 200 mg TID.
- Administration: Can be taken with or without food. Swallow tablets whole; do not crush, chew, or split.
Adverse Reactions:
- Common (≥10%): Headache.
- Less Common (1% to 10%): Hypertension, vomiting.
- Serious Adverse Reactions (reported in 5% of patients): Pancreatitis, cholecystitis, increased blood bilirubin.
Contraindications: Patients with unresolved serious infections caused by encapsulated bacteria, including Neisseria meningitidis, Streptococcus pneumoniae, or Haemophilus influenzae type B.
Precautions:
- Voydeya increases susceptibility to serious, life-threatening, or fatal infections caused by encapsulated bacteria.
- Ensure patients are vaccinated against Neisseria meningitidis, Streptococcus pneumoniae, and Haemophilus influenzae type B prior to initiating therapy.
- Monitor liver function tests and lipid profiles during treatment.

Danicopan Interactions

Drug Interactions:
Danicopan is an inhibitor of breast cancer resistance protein (BCRP) and P-glycoprotein (P-gp) transporters.
May increase plasma concentrations of BCRP and P-gp substrates, potentially requiring dose adjustments of concomitant medications such as rosuvastatin, fexofenadine, and tacrolimus.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.