Elinzanetant: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: May 1, 2026🚩 Report this page

Elinzanetant

Other Gynecologicals

Sold as Lynkuet

GB MHRAEU EMACA Health Canada

Drug class: Other Gynecologicals
Availability: See label
Routes: Oral
Markets covered: 3
Products on record: 3

Overview

Elinzanetant is an active pharmaceutical ingredient in the Other Gynecologicals group (G02CX). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
GB United Kingdom	MHRA	1	May 1, 2026
EU European Union	EMA	1	November 27, 2025
CA Canada	Health Canada	1	October 31, 2025

GBUnited Kingdom· MHRA

1 product

Uses

GBOfficial regulatory label· revised May 1, 2026[1]

1).

How to take

GBOfficial regulatory label· revised May 1, 2026

EUEuropean Union· EMA

1 product

Uses

EUOfficial regulatory label· revised November 27, 2025[2]

1).

How to take

EUOfficial regulatory label· revised November 27, 2025

CACanada· Health Canada

1 product

1 product on record with this regulator. Detailed label text (uses, dosage, side effects) is being ingested — the original document is linked under Sources [3].

Brands in Canada (1)

LYNKUETBAYER INC

Sources & citations

[1]MHRA (UK) · PL000100759 · revised May 1, 2026
[2]European Medicines Agency · EMEA/H/C/006298 · revised November 27, 2025
[3]Health Canada (DPD) · 02559714 · revised October 31, 2025

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Side effects & warnings

GBOfficial regulatory label· Adverse reactions· revised May 1, 2026[1]

8%) and fatigue (5%). Tabulated list of adverse reactions The following information is based on data from 1113 treated postmenopausal women with VMS, who received at least one dose of elinzanetant 120 mg, in phase III (OASIS 1, OASIS 2, OASIS 3) or phase II (SWITCH-1) clinical studies.
The adverse reactions observed during clinical studies in women treated with elinzanetant are listed in Table 1. These are classified according to the MedDRA System Organ Class (SOC). 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 the available data).
Table 1:
Adverse reactions observed with elinzanetant System Organ Class (MedDRA) Common Nervous system disorders Dizziness Headache a Somnolence b Gastrointestinal disorders Abdominal pain c Diarrhoea d Skin and subcutaneous tissue disorders Rash e Musculoskeletal and connective tissue disorders Muscle spasms f General disorders and administration site conditions Fatigue g a Including sinus headache, tension headache b Including hypersomnia c Including abdominal discomfort, abdominal pain lower/upper, gastrointestinal pain d Including frequent bowel movements, intestinal transit time decreased e Including rash maculo-papular, rash popular, rash pruritic f Including muscle tension, musculoskeletal stiffness g Including asthenia Seizures or other convulsive disorders A total of 7 patients with a history of seizures were included in the clinical trials.
One of these patients reported generalized tonic-clonic seizure 46 days after initiating treatment with Lynkuet. The patient had not experienced seizures or required anti- seizure medications for at least eight years prior to starting Lynkuet.
A causal relationship between Lynkuet and a risk for seizures has not been established. 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.
uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

GBOfficial regulatory label· Warnings and precautions· revised May 1, 2026[1]

4. 1. 3 PHARMACEUTICAL FORM Soft capsule (capsule). Opaque red, oblong, soft capsule, approximately 24 mm long and 11 mm in diameter with white printing of “EZN60”. 1). 2 Posology and method of administration Posology The recommended dose is 120 mg elinzanetant (two 60 mg capsules) taken orally once daily at bedtime.
Missed dose If a dose is missed, the next dose should be taken as scheduled on the following day at bedtime. Patients should not take two doses on the same day to make up for a missed dose. The benefit of long-term treatment should be periodically assessed since the duration of VMS can vary by individual.
Special populations Elderly The safety and efficacy of Lynkuet has not been established in women over 65 years of age. No dose recommendation can be made for this population. Hepatic impairment No clinically relevant increase in elinzanetant exposure was observed in patients with mild chronic hepatic impairment.
In a clinical pharmacokinetic study, moderate chronic hepatic impairment increased the exposure of elinzanetant. 2). No dose modification is required for individuals with mild (Child-Pugh A) chronic hepatic impairment. 2). 2). Renal impairment Population pharmacokinetic analysis of the clinical study data indicates similar total exposure of elinzanetant in patients with mild or moderate renal impairment compared to patients with normal renal function.
2). 73 m2). 73 m2) renal impairment. 2). 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. 2). Paediatric population The safety and efficacy of elinzanetant in children and adolescents below 18 years of age has not been established.
No data are available. There is no relevant use of Lynkuet in the paediatric population in the indication of treatment of moderate to severe VMS associated with menopause. 2). The capsules are to be swallowed whole with water and not cut, chewed or crushed.
1. Severe hepatic impairment. 5). 6). 4 Special warnings and precautions for use Medical examination/consultation Prior to the initiation of treatment with Lynkuet a careful diagnosis should be made, and complete medical history (including family history) taken.

This is not medical advice. Consult a qualified healthcare professional.

Side effects & warnings

EUOfficial regulatory label· Adverse reactions· revised November 27, 2025[2]

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.
7

EUOfficial regulatory label· Warnings and precautions· revised November 27, 2025[2]

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.

This is not medical advice. Consult a qualified healthcare professional.

Overview

Regulatory status by market

GBUnited Kingdom· MHRA

EUEuropean Union· EMA

CACanada· Health Canada

Drugs in the same class

Sources & citations