Granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA)

Active Ingredient: Avacopan

Indication for Avacopan

Population group: only adults (18 years old or older)

Avacopan, in combination with a rituximab or cyclophosphamide regimen, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA).

For this indication, competent medicine agencies globally authorize below treatments:

60 mg in 2 divided doses daily

Route of admnistration

Oral

Defined daily dose

60 - 60 mg

Dosage regimen

From 30 To 30 mg 2 time(s) per day every day

Detailed description

The recommended dose is 30 mg taken orally twice daily, morning and evening, with food.

Avacopan should be administered in combination with a rituximab or cyclophosphamide regimen as follows:

  • rituximab for 4 weekly intravenous doses or,
  • intravenous or oral cyclophosphamide for 13 or 14 weeks, followed by oral azathioprine or mycophenolate mofetil and,
  • glucocorticoids as clinically indicated.

Clinical study data are limited to 52 weeks of exposure followed by 8 weeks of observation.

Missed doses

If a patient misses a dose, the missed dose is to be taken as soon as possible, unless within three hours of the next scheduled dose. If within three hours, then the missed dose is not to be taken.

Dose management

Treatment must be re-assessed clinically and temporarily stopped if:

  • alanine aminotransferase (ALT) or aspartate aminotransferase (AST) is more than 3 times the upper limit of normal (ULN).

Treatment must be temporarily stopped if:

  • ALT or AST >5 × ULN,
  • a patient develops leukopenia (white blood cell count <2 × 109/L) or neutropenia (neutrophils <1 × 109/L), or lymphopenia (lymphocytes <0.2 × 109/L),
  • a patient has an active, serious infection (i.e. requiring hospitalisation or prolonged hospitalisation).

Treatment may be resumed:

  • upon normalisation of values and based on an individual benefit/risk assessment.

If treatment is resumed, hepatic transaminases and total bilirubin are to be monitored closely.

Permanent discontinuation of treatment must be considered if:

  • ALT or AST >8 × ULN,
  • ALT or AST >5 × ULN for more than 2 weeks,
  • ALT or AST >3 × ULN and total bilirubin >2 × ULN or international normalised ratio (INR) >1.5,
  • ALT or AST >3 × ULN with the appearance of fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, and/or eosinophilia (>5%),
  • an association between avacopan and hepatic dysfunction has been established.

Dosage considerations

The hard capsules are to be taken with food and swallowed whole with water and must not be crushed, chewed, or opened.

Active ingredient

Avacopan

Avacopan is a selective antagonist of the human complement 5a receptor (C5aR1 or CD88) and competitively inhibits the interaction between C5aR1 and the anaphylatoxin C5a. The specific and selective blockade of C5aR1 by avacopan reduces the pro-inflammatory effects of C5a, which include neutrophil activation, migration, and adherence to sites of small blood vessel inflammation, vascular endothelial cell retraction and permeability.

Read more about Avacopan

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Summary of Product Characteristics (SPC) 2022: TAVNEOS Hard capsule

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