General MedicinePrescription OnlyPregnancy Cat. Not classifiedFDA Yes
Lynkuet
ELINZANETANT
1 INDICATIONS AND USAGE LYNKUET is indicated for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause. LYNKUET is a neurokinin 1 (NK1) and neurokinin 3 (NK3) receptor antagonist indicated for the treatment of moderate to severe vasomotor symptoms due to menopause. ( 1 )
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Brand names:LYNKUET
Quick Reference
Medicine ClassGeneral Medicine
FDA ApprovedYes
PregnancyCategory Not classified
Quick Facts
- Active ingredient
- ELINZANETANT
- Medicine class
- General Medicine
- Brand names
- LYNKUET
- Availability
- Prescription only (Rx)
- Pregnancy category
- Not classified
- Half-life
- half-life was approximately 45 hours in women with vasomotor symptoms
- FDA approved
- Yes
What Is Lynkuet?
1 INDICATIONS AND USAGE LYNKUET is indicated for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause. LYNKUET is a neurokinin 1 (NK1) and neurokinin 3 (NK3) receptor antagonist indicated for the treatment of moderate to severe vasomotor symptoms due to menopause. ( 1 )
Lynkuet (ELINZANETANT) belongs to the General Medicine class of medications. It was first approved by the FDA in Yes. This medication requires a prescription from a licensed healthcare provider.
Key Safety Information
- •Always follow the dose recommended by your healthcare professional. Taking more than prescribed increases the risk of side effects including serious complications.
- •Seek emergency care if you experience signs of an allergic reaction — hives, swelling, difficulty breathing, or rash. Stop the medication and call your doctor immediately.
- •Some medications can increase the risk of cardiovascular events. Tell your doctor if you have high blood pressure, a history of heart attack or stroke, or any pre-existing health condition.
- •Avoid or limit alcohol while taking Lynkuet. Do not drink alcohol without first discussing it with your healthcare provider as it may increase adverse effects.
- •Take Lynkuet with food or a full glass of water if stomach upset occurs. Stop use and talk to your doctor if you experience persistent stomach pain or GI symptoms.
- •Tell your doctor about all medications, supplements, and vitamins you take. Some combinations significantly increase the risk of harm.
This is a summary only. Always read the full prescribing information and consult your healthcare provider for personalized medical advice.
Uses & Indications
Lynkuet is prescribed for the following conditions. Some uses are FDA-approved indications; others may be evidence-based off-label uses. Consult your healthcare provider for personalized guidance.
1 INDICATIONS AND USAGE LYNKUET is indicated for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause.
LYNKUET is a neurokinin 1 (NK1) and neurokinin 3 (NK3) receptor antagonist indicated for the treatment of moderate to severe vasomotor symptoms due to menopause.
Dosage Guide
The following are general dosing guidelines only. Your actual dose should be determined by your healthcare provider based on your condition, renal/hepatic function, and other medications.
AD
Adult Dosage
2 DOSAGE AND ADMINISTRATION The recommended dosage is 120 mg (two 60 mg capsules) orally once daily at bedtime with or without food. ( 2.2 ) Swallow capsules whole. Do not cut, crush, or chew capsules. ( 2.2 ) See full prescribing information for LYNKUET dosage modification due to drug interactions. ( 2.3 ) 2.1 Recommended Evaluation and Testing Before Initiation of LYNKUET Exclude pregnancy in females of reproductive potential [see Contraindications (4) ], Warnings and Precautions (5.3) , and Use in Specific Populations (8.3) ]. 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 [ see Warnings and Precautions (5.2) and Use in Specif
Available Forms
Available Strengths
Side Effects
Common
- 6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Central Nervous System (CNS) Depressant Effect and Daytime Impairment [see Warnings and Precautions (5.1) ] Hepatic Transaminase Elevations [see Warnings and Precautions (5.2) ] The most frequently reported (≥5%) adverse reactions were headache, fatigue, dizziness and somnolence.
- ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bayer HealthCare Pharmaceuticals Inc.
- at 1-888-842-2937 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
- 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
- The safety of LYNKUET was evaluated in three randomized, double-blind, placebo-controlled, multicenter clinical trials (OASIS 1, OASIS 2, OASIS 3 ) in 1420 women .
- In OASIS 1 and OASIS 2 combined, 793 women received LYNKUET or placebo for 12 weeks.
- After the first 12 weeks, 341 women randomized to LYNKUET continued to receive LYNKUET for another 14 weeks, with a total treatment duration of up to 26 weeks.
Serious
- 5 WARNINGS AND PRECAUTIONS CNS Depressant Effect and Daytime Impairment: 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 ( 5.1 ) Hepatic Transaminase Elevations: Perform bloodwork 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 upper limit of normal (ULN).
- Perform follow-up evaluations of hepatic transaminase concentration 3 months after initiation.
- 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.
Rare
Medicine Interactions
Always inform your healthcare provider and pharmacist about ALL medications you take, including prescriptions, OTC medicines, vitamins, and supplements.
MajorModerateMinor
Warnings & Contraindications
5 WARNINGS AND PRECAUTIONS CNS Depressant Effect and Daytime Impairment: 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 ( 5.1 ) Hepatic Transaminase Elevations: Perform bloodwork prior to initiation of LYNKUET
How Lynkuet Works
12.1 Mechanism of Action LYNKUET is a neurokinin 1 (NK1) and neurokinin 3 (NK3) receptor antagonist. Inhibition of Substance P and Neurokinin B through antagonism of NK1 and NK3 receptor signaling on kisspeptin/neurokinin B/dynorphin (KNDy) neurons can modulate neuronal activity in thermoregulation associated with hot flashes. 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).
Pharmacokinetics
Absorption
Absorption Elinzanetant median (min-max) time to maximum plasma concentration (T max ) is 1
Half-Life
half-life was approximately 45 hours in women with vasomotor symptoms
Metabolism
Metabolism Elinzanetant is primarily metabolized by CYP3A4 to yield three major active metabolites, M18/21, M27, and M30/34
Excretion
Excretion Following a single oral dose of radiolabeled elinzanetant in healthy subjects, approximately 90% of the dose was recovered in feces (50% unchanged) and less than 1% with urine
Pregnancy & Breastfeeding Safety
Not classified
Breastfeeding
Many medications pass into breast milk in varying amounts. Before using Lynkuetwhile breastfeeding, discuss the benefits and risks with your healthcare provider or pharmacist — they can weigh your dose, your infant's age, and available lactation safety data to find the safest option for you and your baby.
Storage & Handling
16.2 Storage and Handling Store at 20°C to 25°C (68°F to 77°F) with excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. For patients requiring a dosage modification (i.e., one 60 mg capsule once daily), instruct them to partially peel back the foil covering o
Frequently Asked Questions
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Sources & References
- • FDA Prescribing Information — Official labeling and package insert for Lynkuet
- • U.S. National Library of Medicine — MedlinePlus drug information
- • American Hospital Formulary Service (AHFS) — Clinical pharmacology monograph
- • PubMed / MEDLINE — View clinical studies
Last reviewed by MedCentralHub Medical Review Board · MedCentralHub Editorial Policy
Medical Disclaimer
The information on this page is for educational purposes only and is not intended as medical advice, diagnosis, or treatment. Always consult your doctor, pharmacist, or qualified healthcare provider before starting, stopping, or changing any medication.