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For the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause¹

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Study Designs

VMS Experience

Mechanism of Action

Dosing & Administration

ABOUT [Br][/Br]LYNKUET

Frequency & Severity

Data Over Time

PROMIS SD SF 8b Data

CLINICAL [Br][/Br]DATA

Save On  Lynkuet

SAFETY

Resources  & Info

SAVINGS &[Br][/Br] SUPPORT

Downloadable Resources

Video Library

FAQs

RESOURCES

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LYNKUET logo

<h3> IMPORTANT SAFETY INFORMATION</h3> Contraindications: LYNKUET® is contraindicated in pregnancy. Exposure to LYNKUET may cause pregnancy loss or stillbirth when administered during pregnancy. Warnings and Precautions: &nbsp; Central Nervous System Depressant Effect and Daytime Impairment: &nbsp; In the three OASIS trials, nervous system effects (including somnolence, fatigue, vertigo, dizziness and presyncope) occurred in 11.9% of patients on LYNKUET compared to 3.5% on placebo. Advise patients about the potential for somnolence and other nervous system effects. Advise patients who experience these effects to refrain from driving or engaging in hazardous occupations or activities until the effects have resolved. &nbsp; Hepatic Transaminase Elevations: &nbsp; Elevations in serum transaminase [alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST)] concentrations equal to or greater than three times the upper limit of normal (ULN) occurred in 0.6% of patients receiving LYNKUET and 0.4% of patients receiving placebo up to 12 weeks in three clinical trials. Perform baseline bloodwork (including ALT, AST, alkaline phosphatase, and total and direct bilirubin) prior to initiation of LYNKUET to evaluate for hepatic function and injury. Do not start therapy if serum transaminase concentration is equal to or exceeds two times the ULN or if the total bilirubin is equal to or exceeds two times the ULN. Perform follow-up evaluations of hepatic transaminase concentration 3 months after initiation of therapy. Advise patients to discontinue LYNKUET immediately and seek medical attention including hepatic laboratory tests if they experience signs or symptoms that may suggest liver injury (new onset fatigue, decreased appetite, nausea, vomiting, pruritus, jaundice, pale feces, dark urine, or abdominal pain). Discontinue LYNKUET if transaminase elevations exceed five times the ULN or if transaminase elevations exceed three times the ULN and total bilirubin exceeds two times the ULN.&nbsp; &nbsp; Risk of Pregnancy Loss: &nbsp; LYNKUET is contraindicated for use in pregnancy. Findings from animal studies suggest that LYNKUET can cause pregnancy loss or stillbirth. Exclude pregnancy in females of reproductive potential prior to initiating LYNKUET. Advise females of reproductive potential to use effective contraception during treatment with LYNKUET and for 2 weeks after stopping LYNKUET. &nbsp; Risk of Seizure: &nbsp; Seizure was reported in patients taking LYNKUET. In addition, convulsions were observed in studies conducted in male and female rats. Advise patients about the potential risk of seizure. Use LYNKUET with caution in patients with a history of seizures or with conditions that potentially lower the seizure threshold.&nbsp; &nbsp; Most Common Adverse Reactions: &nbsp; The most frequently reported (≥5%) adverse reactions with LYNKUET vs placebo in a 52-week study were: headache (9.6% vs 7.0%), fatigue (7.3% vs 2.9%), dizziness (6.1% vs 1.9%) and somnolence (5.1% vs 1.3%). &nbsp; Drug Interactions: &nbsp; Effects of Other Drugs on LYNKUET &nbsp; Strong CYP3A4 Inhibitors and Grapefruit (Juice): Concomitant use of LYNKUET with strong CYP3A4 inhibitors and grapefruit (juice) should be avoided as it may increase the risk of LYNKUET-associated adverse reactions. Moderate CYP3A4 Inhibitors: Reduce LYNKUET dose if administered concomitantly with moderate CYP3A4 inhibitors as it may increase the risk of LYNKUET-associated adverse reactions. Strong and Moderate CYP3A4 Inducers: Avoid concomitant use of LYNKUET with strong and moderate CYP3A4 inducers. &nbsp; Effects of LYNKUET on Other Drugs &nbsp; CYP3A4 Substrates: Avoid concomitant use unless otherwise recommended in the Prescribing Information for CYP3A4 substrates where minimal concentration changes may lead to serious adverse reactions, as it may increase the risk of adverse reactions related to these substrates. &nbsp; Use in Specific Populations: &nbsp; Pregnancy &nbsp; LYNKUET is contraindicated in pregnancy. If pregnancy occurs during the use of LYNKUET, discontinue treatment. &nbsp; Hepatic Impairment &nbsp; LYNKUET is not recommended in patients with moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment. &nbsp; Renal Impairment &nbsp; The effect of end-stage renal disease (eGFR &lt;15 mL/min), with or without hemodialysis, on the pharmacokinetics of LYNKUET has not been studied. &nbsp;<h3>INDICATION</h3>LYNKUET (elinzanetant) is indicated for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause. &nbsp;For important information about LYNKUET, please see the <a href="https://labeling.bayerhealthcare.com/html/products/pi/Lynkuet_PI.pdf?inline" target="_blank">Full Prescribing Information</a>.

Mean age	Race / ethnicity	Prior procedures or treatment
54.6 (range 40-65) years	80.4% White	38.8% Hysterectomy
	17.1% Black or African American	20.6% Uni-/bilateral oophorectomy
	0.5% Asian	31.4% Menopausal hormone therapy
	8.5% Hispanic or Latino

LYNKUET^® was evaluated across three Phase 3 clinical trials¹

OASIS 1 and OASIS 2 were efficacy and safety trials, and OASIS 3 was a long-term safety trial.^1,2

Overview¹

Select inclusion criteria¹

Trial design¹

Co-primary endpoints¹

Select key secondary endpoints³

Patient demographics and treatment history¹

LYNKUET® was evaluated across three Phase 3 clinical trials1

OASIS 1 and OASIS 2 were efficacy and safety trials, and OASIS 3 was a long-term safety trial.1,2

Overview1

Select inclusion criteria1

Trial design1

Co-primary endpoints1

Select key secondary endpoints3

Patient demographics and treatment history1