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:

• Hemoglobin (Hgb) level has not increased by greater than 2 g/dL after 4 weeks of therapy, OR
• A transfusion was required during the previous 4 weeks, OR
• The dose needs to be increased to achieve an appropriate Hgb response based on clinical judgement.

Comments:

• Vaccination against encapsulated bacteria should be completed at least 2 weeks prior to starting therapy.
• Health care professionals who prescribe this drug must enroll in the REMS program for this product.
• Limitations of use: This drug not been shown to be effective as monotherapy and should only be prescribed as an add-on to ravulizumab or eculizumab.

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.

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, 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

Hemodialysis: Unknown
Peritoneal dialysis: Data not available

Other Comments

Administration advice:

• For oral use
• Administer with or without food.
• At least 2 weeks prior to treatment: Vaccinate patients 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 with vaccines for N meningitidis and S pneumoniae, provide the patient with antibacterial drug prophylaxis and administer these vaccines as soon as possible.

Missed dose:

• Patients should be instructed to take the missed dose as soon as possible.
• If the patient remembers the missed dose within 3 hours of the next dose, advise the patient to skip the missed dose and take the next one at the regularly scheduled time.
• Patients should not take 2 or more doses at the same time.

Storage requirements:

• Store in the original container at 20C to 2C (68F to 77F); excursions permitted between 15C and 30C (59F and 86F).

General:

• Follow the current US CDC Advisory Committee on Immunization Practices (ACIP) guidance on vaccination recommendations.

Monitoring:

• Hematologic: For hemolysis (at least 2 weeks after treatment discontinuation)
• Hepatic: Liver enzymes (before treatment, and then periodically during treatment)
• Infection: For early signs/symptoms of serious infection (during treatment)
• Metabolic: For elevated total cholesterol, LDL cholesterol, or triglycerides

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.
• 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 health care provider of a known/suspected pregnancy.

Further information

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

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