Danicopan Dosage

Medically reviewed by Drugs.com. Last updated on Apr 19, 2024.

Usual Adult Dose for Paroxysmal Nocturnal Hemoglobinuria

Initial dose: 150 mg orally 3 times a day
Maintenance dose: May increase to 200 mg orally 3 times a day based on the following parameters:

• If hemoglobin (Hgb) level has not increased greater than 2 g/dL after 4 weeks of therapy, OR
• If a transfusion was required during the previous 4 weeks, OR
• To achieve an appropriate Hgb response based on clinical judgement.

Comments:

• Limitations of use: This drug has not been shown to be effective as monotherapy and should only be prescribed as an add-on treatment.
• Vaccination against encapsulated bacteria should be completed at least 2 weeks prior to starting therapy.

Use: As add-on therapy with ravulizumab or eculizumab, for the treatment of extravascular hemolysis in patients with paroxysmal nocturnal hemoglobinuria (PNH)

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Mild to moderate liver dysfunction (Child-Pugh A or B): No adjustment recommended
Severe liver dysfunction (Child-Pugh C): Use should be avoided; this population was not studied.

If clinically significant or symptomatic liver enzyme elevations occur during treatment, consider interruption or discontinuation of therapy.

Precautions

The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for this drug. It includes elements to assure safe use and implementation system. For additional information: www.accessdata.fda.gov/scripts/cder/rems/index.cfm

US BOXED WARNINGS:

• INCREASED RISK OF SERIOUS INFECTION: This drug, a complement inhibitor, increases the risk of serious infections, especially those caused by encapsulated bacteria, such as Neisseria meningitidis, Streptococcus pneumoniae, and Haemophilus influenzae type B. Life-threatening and fatal infections with encapsulated bacteria have occurred in patients treated with complement inhibitors. These infections may become rapidly life-threatening or fatal if not recognized and treated early.
• VACCINATION PRIOR TO TREATMENT: Complete or update vaccination for encapsulated bacteria specifically for N meningitidis and S pneumoniae at least 2 weeks prior to the first dose, unless the risk of delaying therapy outweighs the risk of developing a serious infection. Comply with the most current US CDC Advisory Committee on Immunization Practices (ACIP) recommendations for vaccinations against encapsulated bacteria in patients receiving a complement inhibitor.
• INCREASED RISK OF INVASIVE DISEASE: Patients receiving this drug are at increased risk for invasive disease caused by encapsulated bacteria, even if they develop antibodies following vaccination. Monitor patients for early signs and symptoms of serious infections and evaluate immediately if infection is suspected.
• REMS PROGRAM: Because of the risk of serious infections caused by encapsulated bacteria, this drug is available only through a restricted program under a REMS called VOYDEYA REMS.

CONTRAINDICATIONS:

• Initiation in patients with unresolved serious infection caused by encapsulated bacteria, including N meningitidis, S pneumoniae, or Haemophilus influenzae type B

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Health care professionals must enroll in the REMS program to prescribe this drug.
• For oral use; administer with or without food.
• At least 2 weeks prior to treatment: Complete or update vaccination against encapsulated bacteria, including N meningitidis (serogroups A, C, W, Y, and B) and S pneumoniae.
• If urgent treatment with this drug is indicated in a patient who is not up to date on vaccination, provide the patient with antibacterial drug prophylaxis and vaccinate as soon as possible.
• Review the manufacturer product information for complete guidance on mitigating the risk of serious infection before and during therapy.
• If administration of this drug is discontinued, ensure close patient monitoring for at least 2 weeks for signs or symptoms of hemolysis.

Missed dose:

• Administer the missed dose as soon as possible; however, if it is within 3 hours of the next dose, skip the missed dose and administer the next dose the regularly scheduled time.
• Patients should not take 2 or more doses at the same time.

Storage requirements:

• Store and dispense in the original container at 20C to 25C (68F to 77F); excursions are permitted between 15C and 30C (59F and 86F).

General:

• Follow the most current US CDC ACIP guidance for vaccination schedule and recommendations.
• This drug is only available through a restricted program under a US FDA REMS due to the serious risk of infections caused by encapsulated bacteria. Notable requirements of the program include prescriber certification and training, assessment of patient vaccination status and/or vaccination, patient counseling requirements, and certification of dispensing pharmacies.

Monitoring:

• Hematologic: For hemolysis (at least 2 weeks after treatment discontinuation)
• Hepatic: Liver enzymes (prior to initiation and periodically during treatment)
• Infection: For early signs/symptoms of serious infection (during treatment)
• Metabolic: Serum lipid parameters (during treatment)

Patient advice:

• Read the US FDA-approved patient labeling (Medication Guide).
• Complete or update vaccinations against encapsulated bacteria at least 2 weeks prior to first dose.
• If urgent treatment is required and vaccinations are not up to date, understand that antimicrobial prophylaxis is required.
• Seek immediate medical attention if signs and/or symptoms of infection occur.
• Know that monitoring after treatment discontinuation is recommended for at least 2 weeks.
• Carry the Patient Safety Card at all times during treatment and for 1 week after last dose.
• Understand that monitoring of liver enzymes and cholesterol levels is recommended.
• Patients of childbearing potential: Notify your health care provider of a known/suspected pregnancy.

See also:

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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