Frequently Asked Questions

LYNKUET is indicated for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause.¹

LYNKUET is a neurokinin 1 (NK1) and neurokinin 3 (NK3) receptor antagonist.¹

Inhibition of Substance P and Neurokinin B through antagonism (blocking) of NK1 and NK3 receptor signaling on kisspeptin/neurokinin B/dynorphin (KNDy) neurons can modulate neuronal activity in thermoregulation associated with hot flashes.¹

Elinzanetant has higher affinity for human NK1 receptors (pKi values of 8.7 to 10.2) and NK3 receptors (pKi values of 8.0 to 8.8) than for human NK2 receptors (pKi values of approximately 6.0).¹

The co-primary endpoints in the OASIS 1 and OASIS 2 clinical trials were the mean change in the frequency and severity of moderate to severe VMS from baseline to Weeks 4 and 12, including day and night hot flashes, measured using the Hot Flash Daily Diary. Please see

• Exclude pregnancy in females of reproductive potential
• Perform baseline hepatic laboratory tests to evaluate for hepatic function and injury [including serum alanine aminotransferase (ALT), serum aspartate aminotransferase (AST), serum alkaline phosphatase (ALP), and serum bilirubin (total and direct)] before initiating treatment with LYNKUET. Do not start LYNKUET if ALT or AST is ≥2 times upper limit of normal (ULN) or if the total bilirubin is ≥2 times ULN

The recommended dosage of LYNKUET is 120 mg (two 60 mg soft gel capsules) orally once daily at bedtime at about the same time each day. If a dose is missed at bedtime, take the next dose as scheduled on the following day. Two doses should not be taken on the same day to make up for a missed dose.¹

LYNKUET can be taken with or without food. Capsules should be taken with water and swallowed whole. Do not cut, crush, or chew capsules.¹
 

Moderate CYP3A4 Inhibitors: Reduce LYNKUET dosage to 60 mg once daily at bedtime. After discontinuation of the moderate CYP3A4 inhibitor (after 3 to 5 half-lives of the inhibitor), LYNKUET should be used at the usual dosage of 120 mg once daily.¹

Strong and Moderate CYP3A4 Inducers: Avoid concomitant use with LYNKUET.¹

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Perform baseline hepatic laboratory tests to evaluate for hepatic function and injury [including serum alanine aminotransferase (ALT), serum aspartate aminotransferase (AST), serum alkaline phosphatase (ALP), and serum bilirubin (total and direct)] before initiating treatment with LYNKUET. Do not start LYNKUET if ALT or AST is ≥2 times upper limit of normal (ULN) or if the total bilirubin is ≥2 times ULN. Perform follow-up evaluations of hepatic transaminase concentration 3 months after initiation of therapy.¹

The following warnings are associated with LYNKUET¹:


The Common Adverse Reactions Reported in ≥2% in LYNKUET and Greater than 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%), somnolence (5.1% vs 1.3%), abdominal pain (4.5% vs 2.5%), rash (4.2% vs 1.6%), diarrhea (3.8% vs 1.0%), and muscle spasms (3.2% vs 0.6%).¹

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LYNKUET is contraindicated in pregnancy. Exposure to LYNKUET may cause pregnancy loss or stillbirth when administered during pregnancy.¹

Elinzanetant is primarily metabolized via CYP3A4 enzyme.¹

Prevention or Management

• Strong CYP3A4 Inhibitors and grapefruit (juice): Avoid concomitant use
• Moderate CYP3A4 Inhibitors: Reduce the LYNKUET dosage

Clinical Effect(s)

• Strong and moderate CYP3A4 inhibitors increase elinzanetant exposure, which may increase the risk of LYNKUET-associated adverse reactions

Prevention or Management

• Strong and moderate CYP3A4 inducers: Avoid concomitant use

Clinical Effect(s)

• Strong and moderate CYP3A4 inducers decrease elinzanetant exposure, which may reduce the effectiveness of LYNKUET

Elinzanetant is a weak inhibitor of CYP3A4. Concomitant use of LYNKUET increases exposure of CYP3A4 substrates, which may increase the risk of adverse reactions related to these substrates.

The LYNKUET resources page has tools to help you, your office, and your eligible patients get started with LYNKUET such as an access guide and sample letters to walk your office through completing coverage requests on behalf of your patients.

LYNKUET may not be covered by all commercial plans right away, but Bayer is dedicated to ensuring all appropriate women can access it. Through our partnership with BlinkRx, a digital pharmacy service, patients can get LYNKUET at the lowest available cost. See the Savings & Support page for more details.

As a

Commercially insured patients may be eligible for the Copay Savings Program for LYNKUET, which may reduce their copay to as little as $25 per month.*

Commercial patients who use BlinkRx will be automatically enrolled in the Copay Savings Program.

Patients using retail pharmacies must apply for the Copay Savings Program by visiting LynkuetSavings.com and provide the copay card to their pharmacy when picking up their prescription.

*Patients are eligible if they are commercially insured. Benefit limitations apply. Patients who are enrolled in any type of government insurance or reimbursement programs are not eligible. Full terms and conditions apply. Call 844-LYNKUET or visit  

LynkuetSavings.com

 for more information.

BlinkRx works with all appropriate patients to determine coverage,

• With BlinkRx, eligible commercial patients may pay as little as $25 per month for LYNKUET.*
• If the patient’s government health insurance plan does not cover LYNKUET or there are challenges affording their prescription cost, BlinkRx can provide affordability options to patients to access LYNKUET at the lowest available cost.

*Terms and Conditions apply. Not available in Puerto Rico. Patient Affordability Program only available through BlinkRx. Click

here

for full Terms and Conditions.

Learn more at Savings & Support page.