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LYNKUET is a brand name for Elinzanetant. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Lynkuet is indicated for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause (see sections 4.4 and 5.1).
Verbatim from this product's MHRA label. Tap a section to expand.
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.
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.
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).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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.
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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.
During treatment, periodic check-ups should be carried out according to standard clinical practice. Concomitant use with other medicinal products Cytochrome P450 isoform 3A4 (CYP3A4) inhibitors may decrease the clearance of elinzanetant, resulting in higher exposure.
5). 5). , rifampicin, carbamazepine, phenobarbital, St. John´s Wort) reduces elinzanetant exposure and efficacy may be reduced. 5). Oestrogen-dependent tumours and other types of pharmacologically induced menopause Efficacy and safety of elinzanetant in patients with breast cancer or other oestrogen dependent tumours or patients with a history of such malignancies has not been established so far.
This applies, in particular, to patients receiving anti-oestrogen treatment (which is associated with severe VMS and/or other symptoms of oestrogen deficiency). , in those treated with GnRH analogues) are available. The decision to use elinzanetant in such patients should be based on individual benefit-risk considerations.
, chemotherapy, radiation therapy) for breast cancer or other oestrogen-dependent malignancies have not been included in the clinical studies. Therefore, elinzanetant is not recommended for use in this population as the safety and efficacy are unknown.
Concomitant use of hormone replacement therapy with oestrogens (local vaginal preparations excluded) Concomitant use of elinzanetant and hormone replacement therapy with oestrogens has not been studied, and therefore […]