TAVNEOS Hard capsule Ref.[28343] Active ingredients: Avacopan

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 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.

For details on doses, concomitant glucocorticoids and data on efficacy and safety for the combinations, please see sections 4.8 and 5.1.

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).

Hepatic impairment

No dose adjustment is required for patients with mild or moderate hepatic impairment (see section 5.2).

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).

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. 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).

Avacopan was studied in healthy subjects at a maximum total daily dose of 200 mg (given as 100 mg twice daily) for 7 days without evidence of dose limiting toxicities. In case of an overdose, it is recommended that the patient is monitored for any signs or symptoms of adverse effects, and appropriate symptomatic treatment and supportive care are provided.

3 years.

This medicinal product does not require any special temperature storage conditions.

Store in the original bottle in order to protect from light.

High density polyethylene (HDPE) bottle with child-resistant closure and induction seal.

Pack sizes of 30 or 180 hard capsules.

Not all pack sizes may be marketed.

No special requirements.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.