TAVNEOS HARD CAPSULE 10MG [SIN17150P]

Product Info

TAVNEOS HARD CAPSULE 10MG

[SIN17150P]

4.1 Therapeutic indications

Tavneos is indicated as an adjunctive treatment of adult patients with severe , active anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA] or microscopic polyangiitis [MPA]) in combination with standard therapy, including glucocorticoids.

4.2 Posology and method of administration

Treatment should be initiated and monitored by healthcare professionals experienced in the diagnosis and treatment of GPA or MPA.

Posology

The recommended dose is 30 mg Tavneos (3 hard capsules of 10 mg each) taken orally twice daily, morning and evening, with food.

Tavneos should be administered in combination with a standard immunosuppression regimen including glucocorticoids as clinically indicated.

For details on doses of the immunosuppression regimen and concomitant glucocorticoids in the study, as well as data on efficacy and safety for the combinations, please see sections 4.8 and 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

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.

Special populations

Elderly

No dose adjustment is required in elderly patients (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Hepatic impairment

No dose adjustment is required for patients with mild or moderate hepatic impairment (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Avacopan has not been studied in subjects with severe hepatic impairment (Child-Pugh Class C) and it is therefore not recommended for use in these patient populations.

Renal impairment

No dose adjustment is needed based on renal function (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Avacopan has not been studied in patients with anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis with an estimated glomerular filtration rate (eGFR) below 15 mL/min/1.73 m², who are on dialysis, in need of dialysis or plasma exchange.

Severe disease manifested as alveolar haemorrhage

Avacopan has not been studied in patients with severe disease manifested as alveolar haemorrhage.

Paediatric population

The safety and efficacy of avacopan in adolescents (12 to 17 years of age) have not yet been established. Currently available data are described in sections 4.8 and 5.1 but no recommendation on a posology can be made – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information. The safety and efficacy of avacopan in children below 12 years of age have not yet been established. No data are available.

Method of administration

This medicinal product is for oral use.

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

Grapefruit and grapefruit juice are to be avoided in patients treated with avacopan (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.