Lynkuet

Posology The recommended daily dose is 120 mg (two 60 mg capsules) elinzanetant taken at bedtime. g. during routine and/or cancer follow-up care) as the need for treatment can vary by individual or change over time. 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. 3 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. 2). 2). 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.

5).

2%). Tabulated list of adverse reactions The safety profile of elinzanetant is based on data from women who received at least 1 dose of 120 mg elinzanetant: - 1 113 treated women with VMS associated with menopause in 3 phase III (OASIS 1, OASIS 2, OASIS 3) and 1 phase II (SWITCH-1) clinical studies and - 465 treated women with VMS caused by AET in a separate phase III clinical study (OASIS 4).

The adverse reactions are listed in table 1. They are classified according to MedDRA System Organ Class. Adverse reactions are grouped according to their frequencies. Frequency groups are defined by the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000); very rare (< 1/10 000), not known (cannot be estimated from available data).

1% of patients treated with placebo. 6% of patients treated with placebo. 5% of patients treated with placebo. 5% of patients treated with placebo. 6% of patients treated with placebo. 6% of patients treated with elinzanetant and in none of the patients treated with placebo.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

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Concomitant use with other medicinal products Cytochrome P450 isoform 3A4 (CYP3A4) inhibitors may decrease the clearance of elinzanetant, resulting in higher exposure. The concomitant use of elinzanetant with strong CYP3A4 inhibitors is not recommended.

5). Elinzanetant in combination with other breast cancer treatments The use of elinzanetant has been evaluated in combination with AET consisting of aromatase inhibitors or tamoxifen, with or without GnRH agonists. A decision to treat women with elinzanetant who receive medication other than those evaluated in the clinical studies should be based on an individual benefit-risk consideration.

4 Concomitant use of hormone replacement therapy (HRT) with oestrogens to treat VMS associated with menopause Concomitant use of elinzanetant and HRT with oestrogens has not been studied, and therefore concomitant use is not recommended.

Local vaginal preparations can be used. Excipient with known effect Sorbitol The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account.

The content of sorbitol in medicinal products for oral use may affect the bioavailability of other medicinal products for oral use when administered concomitantly.

1. 6).