Usual Adult Dose for Vasculitis

Recommended dose: 30 mg orally twice a day with food

Comments:

• Obtain liver function tests and screen for hepatitis B prior to treatment initiation.
• Consider monitoring WBC count before starting therapy.
• This drug is used in combination with standard therapy, including glucocorticoids.

Use: As an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis and microscopic polyangiitis) in combination with standard therapy including glucocorticoids; this drug does not eliminate glucocorticoid use.

Renal Dose Adjustments

Mild, Moderate, or Severe Renal Dysfunction: No dose adjustment recommended.

Liver Dose Adjustments

Mild to Moderate Liver Dysfunction (Child-Pugh A or B): No dose adjustment recommended
Severe Liver Dysfunction (Child-Pugh C) or Cirrhosis: Use is not recommended

Dose Adjustments

Concomitant Use of Strong CYP450 450 3A4 Inhibitors:

• Reduce dose to 30 mg once a day

Precautions

CONTRAINDICATIONS:

• In patients with serious hypersensitivity reaction to this drug or to any of the excipients

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

Consult WARNINGS section for additional precautions.

Dialysis

• Data not available; this drug has not been studied in patients who are on dialysis.
• Clearance via dialysis unlikely due to high protein binding

Other Comments

Administration advice:

• The manufacturer product information should be consulted prior to product administration.
• Take with food and swallow capsules whole with water; do not crush, chew, or open.
• It is not recommended to take this medication with grapefruit juice.

Missed doses:

• Instruct patient to wait until usual scheduled time to take the next regular dose. Do not double the next dose.

Storage requirements:

• Store at 20C to 25C (68F to 77F).
• Excursions permitted to 15C to 30C (59F to 86F)
• Do not use if the seal is broken or missing.

General:

• Avoid use of this drug in patients with active, serious infection, including localized infections.
• Use is not recommended in patients with active, untreated and/or uncontrolled chronic liver disease or cirrhosis.
• Consider administering immunizations, including live vaccines, prior to treatment initiation.

Monitoring:

• Assess ALT, AST, alkaline phosphatase and total bilirubin prior to treatment initiation, then every 4 weeks for 6 months, and as clinically indicated thereafter; closely monitor for hepatic reactions.
• Screen patients for HBV infection (i.e., measure HBsAg and antic-HBc) prior to treatment.
• Monitor patients for signs and symptoms of serious infections, including N. meningitis infections.
• Consider assessing WBC for signs of leukopenia, neutropenia, or lymphopenia before and during therapy.
• Observe for signs and symptoms of angioedema and manage accordingly.

Patient advice:

• Read the FDA-approved patient labeling (Medication Guide).
• Patients should be instructed to seek immediate medical attention if experiencing signs and symptoms suggesting angioedema and to discontinue treatment.
• Patients should be instructed to immediately contact their healthcare provider if experiencing liver problems.
• Patients should be advised to report any signs or symptoms of an infection.