Avacopan (Tavneos) is a complement 5a receptor (C5aR) antagonist, indicated for the treatment of antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis.

Indications for Avacopan (Tavneos)

Primary Indications

Severe active ANCA-associated vasculitis in adults: Including granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA).

Combination with standard therapy: Must be used in combination with standard therapy containing glucocorticoids, but cannot replace the use of glucocorticoids.

Key Limitations

Not intended for eliminating the use of glucocorticoids.

Contraindication: Patients with a severe allergic reaction to avacopan or any of its excipients.

Dosage Form, Strength and Properties of Avacopan (Tavneos)

Dosage Form and Strength

Capsules: Each capsule contains 10 mg of avacopan. They are opaque, bicolored capsules (yellow and light orange) printed with the black text "CCX168".

Ingredient Characteristics

Active Ingredient: Avacopan (chemical name: (2R,3S)-2-[4-(cyclopentylamino)phenyl]-1-(2-fluoro-6-methylbenzoyl)-N-[4-methyl-3-(trifluoromethyl)phenyl]piperidine-3-carboxamide).

Excipients: Polyethylene glycol 4000 (PEG-4000), hydrogenated castor oil 40.

Physicochemical Properties

White to pale yellow crystalline solid, soluble in organic solvents, almost insoluble in water.

The capsule shell contains gelatin, iron oxide red, iron oxide yellow, and titanium dioxide; the sealing band contains gelatin and polysorbate 80.

Storage Methods for Avacopan (Tavneos)

Unopened Medication

Temperature Requirement:Store at 20°C to 25°C (68°F to 77°F), with short-term exposure to 15°C to 30°C (59°F to 86°F) allowed.

Packaging Form

180 capsules per bottle.

30 capsules per bottle.

Equipped with a child-resistant closure.

Precautions

Avoid packages that are damaged or have missing seals.

Do not freeze or expose to extreme humidity.