LYNKUET Soft capsule Ref.[116026] Active ingredients: Elinzanetant

Posology

The recommended daily dose is 120 mg (two 60 mg capsules) elinzanetant taken at bedtime.

Benefits of symptomatic treatment should be periodically assessed (e.g. during routine and/or cancer follow-up care) as the need for treatment can vary by individual or change over time.

Co-administration with moderate CYP3A4 inhibitors

The recommended daily dose when used with moderate CYP3A4 inhibitors is 60 mg (one 60 mg capsule) elinzanetant at bedtime (see section 4.5). After discontinuation of the moderate inhibitor (after 3 to 5 half-lives of the inhibitor), elinzanetant should be used at the usual dose of 120 mg once daily.

Missed dose

If a dose is missed, the next dose should be taken as scheduled on the following day. Patients should not take 2 doses on the same day to make up for a missed dose.

Elderly

The safety and efficacy of elinzanetant in women over 65 years of age has not been established. No dose recommendation can be made for this population.

Hepatic impairment

No dose modification is required for patients with mild (Child-Pugh A) chronic hepatic impairment.

Elinzanetant is not recommended for use in patients with moderate (Child-Pugh B) or severe (Child-Pugh C) chronic hepatic impairment (see section 5.2).

Renal impairment

For patients with moderate to severe (eGFR less than 60 mL/min/1.73 m²) renal impairment the recommended daily dose is 60 mg (one 60 mg capsule) elinzanetant at bedtime (see section 5.2).

No dose modification is required for patients with mild (eGFR 60-89 mL/min/1.73 m²) renal impairment.

Paediatric population

There is no relevant use of elinzanetant in the paediatric population in the indications moderate to severe VMS associated with menopause or caused by AET.

Method of administration

Lynkuet is for oral use.

The capsules should be taken orally once daily at bedtime.

The capsules should be swallowed whole with water. The capsules should not be cut, chewed or crushed as they contain an oily solution.

The capsules can be taken with or without food (see section 5.2) but should not be taken with grapefruit or grapefruit juice (see section 4.5).

Single doses of elinzanetant up to 600 mg have been tested in clinical studies in healthy volunteers.

Adverse reactions at higher doses were similar to those observed with the therapeutic dose, but occurred slightly more often and with moderately higher intensity. Safety and tolerability of multiple once daily doses up to 240 mg over 5 days were similar compared to the recommended daily dose of 120 mg elinzanetant.

In the case of overdose, the patient should be closely monitored, and supportive treatment should be considered based on signs and symptoms.

There is no specific antidote for Lynkuet.

30 months.

This medicinal product does not require any special temperature storage conditions. Store in the original blister in order to protect from moisture.

PVC/PCTFE-Aluminium/PET/paper blister containing 12 soft capsules (6 × 2 as unit dose).

Each pack contains 24 or 60 soft capsules.

Each multipack contains 180 (3 packs of 60) soft capsules.

Not all pack sizes may be marketed.

This medicinal product may pose a risk to the environment (see section 5.3). Any unused medicinal product or waste material should be disposed of in accordance with local requirements.