LYNAVOY Film-coated tablet Ref.[117086] Active ingredients: Linerixibat

Posology

The recommended dose of Lynavoy is 40 mg twice daily.

Alternative treatment should be considered in patients for whom no treatment benefit can be established following 3 months of continuous daily treatment with linerixibat.

Concomitant administration with bile acid binding resins

It is recommended that Lynavoy is taken at least 4 hours before or 4 hours after taking a bile acid binding resin (see sections 4.5 and 5.2).

Missed doses

If a dose is missed, it may be taken as soon as possible. However, a double dose must not be taken to make up for a missed dose.

Special populations

Elderly

No dose adjustment is required for patients 65 years of age or older (see section 5.2). Limited data are available in patients over 65 years of age.

Renal impairment

No dose adjustment is required for patients with renal impairment (see section 5.2).

Hepatic impairment

No dose adjustment is required for patients with mild or moderate (Child-Pugh A or B) hepatic impairment. Linerixibat is not recommended in severe hepatic impairment (Child-Pugh C) or in patients at high risk of liver decompensation (see sections 4.4 and 5.2).

Paediatric population

The safety and efficacy of Lynavoy have not been established in children and adolescents less than 18 years of age. No data are available.

Method of administration

Oral use.

It is recommended that Lynavoy is swallowed whole with water and taken approximately 30 minutes before any food or beverage (other than water). This is to allow linerixibat to enter the gastrointestinal lumen prior to release of bile acids (see section 5.2).

Symptoms

An overdose may result in symptoms from an exaggeration of the known adverse reactions of the medicinal product, mainly gastrointestinal effects.

In clinical studies, linerixibat was given to adults with cholestatic pruritus in PBC at doses up to 180 mg daily (single and/or divided doses), and a dose dependent increase in the incidence of gastrointestinal adverse reactions was observed (see section 4.8).

Management

There is no specific antidote. In the event of an overdose, linerixibat must be discontinued, the patient monitored for any signs and symptoms and general supportive measures instituted if needed. Further management should be as clinically indicated or as recommended by the national poisons centre, where available.

4 years.

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

Store in the original package in order to protect from moisture. Keep the bottle tightly closed in order to protect from moisture.

Opaque, white high-density polyethylene (HDPE) bottles with polypropylene child-resistant closures and polyethylene induction heat seal liner, containing a HDPE canister with silica gel desiccant.

Pack sizes available:

• Single bottles containing 28 or 60 film-coated tablets.
• Multipacks containing 180 (3 bottles of 60) film-coated tablets.

Not all pack sizes may be marketed.

No special requirements for disposal.

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