Lynkuet (Elinzanetant)
Hormone-free treatment for menopausal hot flashes and night sweats
Lynkuet (elinzanetant) is a first-in-class, hormone-free medication approved for the treatment of moderate to severe vasomotor symptoms (hot flashes and night sweats) associated with menopause. It also treats vasomotor symptoms caused by adjuvant endocrine therapy for breast cancer. Lynkuet works by blocking neurokinin 1 and 3 receptors on specific neurons in the brain that regulate body temperature, offering an alternative to hormone replacement therapy.
Quick Facts
Key Takeaways
- Lynkuet is the first hormone-free neurokinin receptor antagonist approved for moderate to severe menopausal vasomotor symptoms.
- It is also approved for hot flashes caused by adjuvant endocrine therapy (such as tamoxifen or anastrozole) in breast cancer patients.
- The standard dose is two 60 mg capsules (120 mg total) taken once daily at bedtime; swallow whole, do not crush or chew.
- Avoid grapefruit and strong CYP3A4 inhibitors while taking Lynkuet, as they can increase drug levels and side effect risk.
- Lynkuet must not be taken during pregnancy; effective contraception is required during treatment.
What Is Lynkuet and What Is It Used For?
Lynkuet contains the active substance elinzanetant, a dual neurokinin 1,3 (NK1,3) receptor antagonist. It represents a new class of non-hormonal treatments specifically designed to address vasomotor symptoms — the sudden sensations of heat, intense flushing, and sweating that are among the most common and disruptive complaints associated with menopause.
Vasomotor symptoms (VMS) affect approximately 75–80% of women during the menopausal transition. These symptoms manifest as sudden episodes of heat, primarily felt in the face, neck, and chest, often accompanied by profuse sweating during both daytime and nighttime. Night sweats can significantly disrupt sleep quality, leading to fatigue, mood disturbances, and reduced quality of life. For many women, these symptoms persist for years and can be severe enough to interfere with daily activities and work.
Lynkuet is approved for two distinct clinical indications. First, it treats moderate to severe vasomotor symptoms associated with natural menopause. Second, it is indicated for vasomotor symptoms caused by adjuvant endocrine therapy for breast cancer. Adjuvant endocrine therapy — which includes hormone-lowering medications such as tamoxifen (a selective estrogen receptor modulator) and anastrozole (an aromatase inhibitor) — is used to prevent cancer recurrence after primary breast cancer treatment. A common and often debilitating side effect of these cancer treatments is the induction or worsening of hot flashes and night sweats.
How Does Lynkuet Work?
The mechanism of action of Lynkuet centers on the hypothalamic thermoregulatory pathway. In the hypothalamus — the brain region responsible for regulating body temperature — a population of specialized neurons called KNDy neurons (kisspeptin/neurokinin B/dynorphin neurons) plays a critical role. These neurons use neurokinin B as a key signaling molecule to influence the body's thermostat.
During menopause, declining estrogen levels cause KNDy neurons to become hyperactive, releasing excessive amounts of neurokinin B. This hyperactivity narrows the thermoneutral zone — the range of core body temperatures within which the body does not activate cooling mechanisms. As a result, even small fluctuations in core temperature trigger inappropriate heat-dissipation responses, experienced as hot flashes and sweating.
Elinzanetant works by simultaneously blocking both neurokinin 1 (NK1) and neurokinin 3 (NK3) receptors on these neurons. By inhibiting both receptor subtypes, it effectively reduces the hyperactivity of KNDy neurons, widening the thermoneutral zone and thereby decreasing the frequency and severity of vasomotor symptoms. Because this mechanism is entirely independent of estrogen signaling, Lynkuet does not carry the hormonal risks associated with traditional hormone replacement therapy (HRT), making it particularly suitable for women who cannot or prefer not to use estrogen-based treatments.
Clinical trials (OASIS 1, OASIS 2, and OASIS 3) have demonstrated that elinzanetant significantly reduces both the frequency and severity of moderate to severe vasomotor symptoms compared to placebo, with improvements observed as early as the first week of treatment. Additionally, the dual NK1/NK3 receptor antagonism of elinzanetant may provide secondary benefits for sleep quality, as NK1 receptors are also involved in sleep regulation.
What Should You Know Before Taking Lynkuet?
Before starting treatment with Lynkuet, it is essential to discuss your complete medical history and current medications with your healthcare provider. Several important considerations and contraindications must be evaluated to ensure safe and effective use of this medication.
Contraindications
- You are allergic to elinzanetant or any of the other ingredients in this medicine.
- You are pregnant or think you may be pregnant.
Lynkuet is absolutely contraindicated in pregnancy. If there is any possibility that you could be pregnant, you must not start this medication. A pregnancy test should be performed before initiating treatment if there is any uncertainty about pregnancy status.
Warnings and Precautions
Speak with your doctor or pharmacist before taking Lynkuet if any of the following apply to you:
- CYP3A4 inhibitor medications: You are taking medicines that inhibit the liver enzyme CYP3A4. These drugs can cause Lynkuet to remain in your body longer, potentially increasing the risk of side effects. Examples include certain antifungals (itraconazole), antibiotics (clarithromycin), HIV medications (ritonavir, cobicistat), and breast cancer treatments (ribociclib).
- Estrogen hormone therapy: You are currently taking estrogen-based hormone replacement therapy for menopausal symptoms. The combined use has not been extensively studied and may not be necessary since Lynkuet addresses the same symptoms through a different mechanism.
- Liver function: Although specific liver impairment studies are ongoing, any pre-existing liver conditions should be discussed with your healthcare provider, as the medication is metabolized through hepatic pathways.
This medication is not intended for use in children and adolescents under 18 years of age, as safety and efficacy have not been established in this population.
Pregnancy and Breastfeeding
Pregnancy: Do not take Lynkuet if you are pregnant or suspect you may be pregnant. The effects of elinzanetant on fetal development have not been adequately studied in humans, and the potential risks are unknown. If you are of childbearing potential, you or your partner must use effective contraception while taking this medication. Discuss the most appropriate contraceptive method with your healthcare provider. If you become pregnant while taking Lynkuet, discontinue the medication immediately and contact your doctor.
Breastfeeding: If you are breastfeeding or planning to breastfeed, consult your doctor before starting Lynkuet. It is not known whether elinzanetant passes into breast milk or what effects it might have on a nursing infant. Your healthcare provider will help you weigh the benefits of treatment against any potential risks to your child.
Driving and Operating Machinery
Lynkuet may cause fatigue or somnolence (drowsiness) in some patients. If you experience these effects, exercise particular caution when driving or operating machinery. It is advisable to assess your individual response to the medication before engaging in activities that require full alertness.
Sorbitol Content
Each Lynkuet capsule contains 71 mg of sorbitol. Sorbitol is a source of fructose and may affect how well other medications work when taken simultaneously. If your doctor has told you that you have an intolerance to some sugars, consult your healthcare provider before taking this medicine.
How Does Lynkuet Interact with Other Drugs?
Drug interactions are an important consideration when taking Lynkuet. Elinzanetant is metabolized by the cytochrome P450 enzyme system, primarily CYP3A4, and it can also affect the metabolism of certain other drugs. Informing your doctor about all medications — prescription, over-the-counter, vitamins, supplements, and herbal remedies — is essential to prevent potentially harmful interactions.
Major Interactions
The following drug interactions are considered clinically significant and may require dose adjustments or avoidance of concurrent use:
| Drug | Category | Interaction Effect | Clinical Action |
|---|---|---|---|
| Itraconazole | Antifungal | Strong CYP3A4 inhibitor; significantly increases elinzanetant exposure | Consult doctor; dose reduction may be needed |
| Clarithromycin | Antibiotic | Strong CYP3A4 inhibitor; increases elinzanetant levels | Consult doctor; dose reduction may be needed |
| Ritonavir | HIV Antiretroviral | Strong CYP3A4 inhibitor; markedly increases elinzanetant exposure | Consult doctor; dose reduction may be needed |
| Cobicistat | Pharmacokinetic enhancer | Strong CYP3A4 inhibitor; increases elinzanetant levels | Consult doctor; dose reduction may be needed |
| Ribociclib | Breast cancer treatment | Strong CYP3A4 inhibitor; increases elinzanetant exposure | Consult doctor; dose reduction may be needed |
Moderate Interactions
The following interactions are of moderate clinical significance. Your doctor should be informed if you are taking any of these medications, and monitoring may be required:
| Drug | Category | Interaction Effect | Clinical Action |
|---|---|---|---|
| Erythromycin | Antibiotic | Moderate CYP3A4 inhibitor; may increase elinzanetant levels | Monitor for increased side effects |
| Ciprofloxacin | Antibiotic | Moderate CYP3A4 inhibitor; may affect elinzanetant metabolism | Monitor and inform doctor |
| Fluconazole | Antifungal | Moderate CYP3A4 inhibitor; may increase elinzanetant exposure | Monitor for increased side effects |
| Verapamil | Cardiovascular | Moderate CYP3A4 inhibitor; may increase elinzanetant levels | Monitor and inform doctor |
| Ciclosporin | Immunosuppressant | Lynkuet may affect ciclosporin metabolism | Monitor drug levels; dose adjustment may be needed |
| Tacrolimus | Immunosuppressant | Lynkuet may affect tacrolimus metabolism | Monitor drug levels; dose adjustment may be needed |
| Fentanyl | Opioid analgesic | Lynkuet may affect fentanyl metabolism | Monitor for opioid-related effects; inform doctor |
Food Interactions
Do not eat grapefruit or drink grapefruit juice while taking Lynkuet. Grapefruit inhibits the CYP3A4 enzyme, which can cause elinzanetant to remain in your body for a longer period. This increases your overall drug exposure and may raise the risk of side effects. This applies to all forms of grapefruit products, including fresh fruit, juice, and grapefruit-containing supplements.
No other specific food interactions have been identified with Lynkuet. The medication can be taken with or without food, although it should be taken at bedtime as directed.
What Is the Correct Dosage of Lynkuet?
Always take Lynkuet exactly as your doctor or pharmacist has instructed. If you are unsure about any aspect of your dosing regimen, consult your healthcare provider for clarification. Correct dosing is essential for achieving optimal symptom control while minimizing the risk of adverse effects.
Adults
Standard Dose
120 mg daily (two 60 mg soft capsules) taken once at bedtime.
- Swallow the capsules whole with a glass of water.
- Do not split, chew, or crush the capsules, as they contain a lipid-based solution.
- Take at bedtime to optimize tolerability and to leverage the potential sleep benefits of the medication.
Reduced Dose
60 mg daily (one 60 mg soft capsule) taken at bedtime. This reduced dose may be prescribed if:
- You are taking concomitant medications that interact with Lynkuet (particularly CYP3A4 inhibitors).
- You have kidney problems (renal impairment).
Your doctor will determine the appropriate dose based on your individual clinical profile.
Children and Adolescents
Lynkuet is not recommended for use in children and adolescents under 18 years of age. Vasomotor symptoms are a condition of menopause and do not apply to pediatric populations. Safety and efficacy data are not available for this age group.
Elderly
No specific dose adjustment is required for elderly patients based on age alone. However, older patients are more likely to have concomitant medical conditions and to be taking multiple medications. Healthcare providers should carefully evaluate potential drug interactions and kidney function when prescribing Lynkuet to older adults. As with all patients, the standard 120 mg bedtime dose applies unless specific clinical factors warrant a dose reduction to 60 mg.
Missed Dose
If you forget to take your dose at bedtime, skip the missed dose and take the next dose as planned the following evening. Do not take a double dose to make up for a forgotten dose. Taking more than the prescribed amount does not improve efficacy and increases the risk of side effects.
Overdose
If you take more Lynkuet than prescribed, the risk of side effects and their severity may increase. In the event of an overdose, contact your doctor, pharmacist, or local poison control center immediately. Provide information about how many capsules were taken and when. There is no specific antidote for elinzanetant overdose; treatment is supportive and symptomatic.
Stopping Treatment
Do not stop taking Lynkuet unless your doctor advises you to do so. If you wish to discontinue treatment before the planned course is completed, speak with your healthcare provider first. Abrupt cessation is not expected to cause withdrawal symptoms, but your vasomotor symptoms may return if treatment is stopped. Your doctor can discuss the best approach for managing your symptoms long-term.
What Are the Side Effects of Lynkuet?
Like all medicines, Lynkuet can cause side effects, although not everybody gets them. The safety profile has been established through clinical trials involving thousands of patients. Most side effects are mild to moderate in severity and tend to resolve as the body adjusts to the medication. Below is a comprehensive overview of reported adverse effects, organized by frequency.
For Menopausal Vasomotor Symptoms
The following side effects have been observed in clinical trials involving patients with moderate to severe vasomotor symptoms associated with menopause:
Common
May affect up to 1 in 10 users
- Abdominal pain (stomach pain)
- Diarrhea
- Dizziness
- Fatigue (tiredness)
- Headache
- Muscle spasms
- Skin rash
- Somnolence (drowsiness)
Uncommon
May affect up to 1 in 100 users
- Elevated levels of certain liver enzymes (ALT or AST)
- Increased skin sensitivity to sunlight (photosensitivity)
For Breast Cancer Adjuvant Endocrine Therapy-Related Vasomotor Symptoms
In patients taking Lynkuet for vasomotor symptoms caused by adjuvant endocrine therapy for breast cancer, some additional or differently-frequent side effects have been observed:
Very Common
May affect more than 1 in 10 users
- Fatigue (tiredness)
Common
May affect up to 1 in 10 users
- Depression or depressed mood
- Diarrhea
- Elevated levels of certain liver enzymes (ALT)
- Dizziness
- Hair loss (alopecia)
- Muscle spasms
- Somnolence (drowsiness)
- Vertigo (spinning sensation)
Uncommon
May affect up to 1 in 100 users
- Elevated levels of certain liver enzymes (AST)
- Increased skin sensitivity to sunlight (photosensitivity)
When to Seek Medical Attention
While most side effects are manageable, you should contact your healthcare provider promptly if you experience:
- Signs of liver problems: unexplained nausea, vomiting, abdominal pain (especially in the upper right area), dark urine, or yellowing of the skin or eyes (jaundice).
- Severe skin reactions: widespread rash, blistering, or severe photosensitivity reactions after sun exposure.
- Depression or mood changes: particularly in patients taking adjuvant endocrine therapy, new or worsening depression, mood changes, or thoughts of self-harm.
- Severe allergic reactions: difficulty breathing, facial or throat swelling, severe rash, or rapid heartbeat.
Reporting Side Effects
Reporting suspected side effects after a medicine has been approved is important for the ongoing monitoring of its benefit-risk profile. Healthcare professionals and patients are encouraged to report adverse reactions to their national pharmacovigilance authority. In the EU, reports can be submitted through the national reporting systems of each member state. In the US, reports can be filed with the FDA MedWatch program.
How Should You Store Lynkuet?
Proper storage of Lynkuet is essential to maintain the efficacy and safety of the medication throughout its shelf life. Incorrect storage conditions can compromise the integrity of the soft capsules and potentially reduce the medication's effectiveness.
- Temperature: No special temperature storage requirements. Store at room temperature.
- Packaging: Keep the capsules in the original blister packaging to protect them from moisture. The blister is made of PVC/PCTFE-aluminium/PET/paper, designed specifically to prevent moisture exposure.
- Moisture: The capsules are moisture-sensitive. Do not transfer them to other containers such as pill boxes or weekly organizers, as this removes the protective blister barrier.
- Children: Store out of the sight and reach of children at all times.
- Expiration: Do not use Lynkuet after the expiration date printed on the carton and on each blister after “EXP.” The expiration date refers to the last day of the stated month.
- Disposal: Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. These measures help protect the environment.
What Does Lynkuet Contain?
Active Ingredient
Each soft capsule contains 60 mg of elinzanetant, the pharmacologically active component responsible for the therapeutic effect.
Inactive Ingredients (Excipients)
The other ingredients in Lynkuet soft capsules include:
- All-rac-alpha-tocopherol (E 307) — an antioxidant to protect the formulation
- Caprylocaproyl macrogol glycerides — lipid-based solubilizer
- Gelatin — capsule shell material
- Glycerol monocaprylocaprate — lipid excipient
- Glycerol monooleate (E 471) — emulsifier
- Red iron oxide (E 172) and yellow iron oxide (E 172) — colorants giving the capsule its characteristic red color
- Macrogol 400 (E 1521) — co-solvent
- Medium-chain triglycerides — lipid-based vehicle
- Partially dehydrated liquid sorbitol (E 420) and glycerol (E 422) mixture — plasticizer
- Phosphatidylcholine solution 53% in medium-chain triglycerides — emulsifier
- Polysorbate 80 (E 433) — surfactant
- Polyvinyl acetate phthalate — coating agent
- Propylene glycol (E 1520) — co-solvent
- Titanium dioxide (E 171) — opacifier
Appearance and Pack Sizes
Lynkuet soft capsules are opaque red, oblong in shape, and printed with “EZN60” in white ink. They are packaged in PVC/PCTFE-aluminium/PET/paper blisters in cartons containing 24 or 60 soft capsules, or in multi-packs of 180 capsules (3 packs of 60). Each blister contains 6 × 2 capsules as a unit dose.
Marketing Authorization Holder
Bayer AG, 51368 Leverkusen, Germany. Lynkuet is manufactured by Catalent Germany Eberbach GmbH, Gammelsbacher Str. 2, 69412 Eberbach, Germany. For the most current information about this medicine, visit the European Medicines Agency (EMA) website.
Frequently Asked Questions About Lynkuet
Lynkuet (elinzanetant) is a hormone-free medication used to treat moderate to severe hot flashes and night sweats associated with menopause or caused by adjuvant endocrine therapy for breast cancer. It works by blocking neurokinin 1 and 3 (NK1,3) receptors on KNDy neurons in the hypothalamus — the part of the brain that regulates body temperature. By blocking these receptors, it reduces the hyperactivity that causes inappropriate heat-dissipation responses experienced as hot flashes.
No, Lynkuet is not a hormone replacement therapy (HRT). It is a completely hormone-free medication that works through a novel non-hormonal mechanism. This makes it particularly suitable for women who cannot take estrogen (such as breast cancer patients on endocrine therapy) or those who prefer to avoid hormonal treatments due to personal preference or medical contraindications. Unlike HRT, it does not affect estrogen receptors or hormone levels in the body.
Clinical trial data from the OASIS studies suggest that improvements in vasomotor symptoms can be observed as early as the first week of treatment. However, the full therapeutic benefit typically develops over the first few weeks of consistent use. Patients should continue taking the medication as prescribed even if they do not notice immediate relief, as the effect strengthens with continued treatment.
No, you should completely avoid grapefruit and grapefruit juice while taking Lynkuet. Grapefruit contains compounds that inhibit the CYP3A4 enzyme in your liver and intestines, which is the primary enzyme responsible for metabolizing elinzanetant. Inhibiting this enzyme causes higher levels of elinzanetant to accumulate in your body, which increases the risk and severity of side effects. This applies to fresh grapefruit, grapefruit juice, and any products containing grapefruit extract.
Yes, Lynkuet is specifically approved for treating vasomotor symptoms (hot flashes and night sweats) caused by adjuvant endocrine therapy for breast cancer. Medications like tamoxifen and aromatase inhibitors (such as anastrozole) often cause severe vasomotor symptoms as a side effect. Because Lynkuet is hormone-free, it does not interfere with the anticancer effects of these endocrine therapies. However, patients taking ribociclib (a CDK4/6 inhibitor) should inform their doctor, as it is a strong CYP3A4 inhibitor that may require a Lynkuet dose reduction.
If you forget to take your dose at bedtime, simply skip the missed dose and take your next dose at the usual time the following evening. Do not take a double dose to compensate for the one you missed. Taking extra capsules will not improve the effectiveness of the medication and may increase the risk of side effects.
References
- European Medicines Agency (EMA). Lynkuet (elinzanetant) – Summary of Product Characteristics. 2025. Available at: www.ema.europa.eu
- Lederman S, Ottery FD, Cano A, et al. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled trial. Lancet. 2023;401(10382):1091-1104. doi:10.1016/S0140-6736(23)00085-5
- The NAMS 2023 Nonhormone Therapy Position Statement Advisory Panel. The 2023 nonhormone therapy position statement of The North American Menopause Society. Menopause. 2023;30(6):573-590. doi:10.1097/GME.0000000000002200
- Bayer AG. Lynkuet (elinzanetant) – Full Prescribing Information. 2025.
- Prague JK, Roberts RE, Comninos AN, et al. Neurokinin 3 receptor antagonism as a novel treatment for menopausal hot flushes: a phase 2, randomised, double-blind, placebo-controlled trial. Lancet. 2017;389(10081):1809-1820. doi:10.1016/S0140-6736(17)30823-1
- Depypere H, Lademacher C, Gargano E, et al. Elinzanetant for vasomotor symptoms of menopause: OASIS 1 and OASIS 2 randomized clinical trials. JAMA. 2024;332(15):1269-1280.
- World Health Organization (WHO). Model List of Essential Medicines – 23rd List, 2023. Geneva: WHO; 2023.
- International Menopause Society (IMS). 2024 Updated Recommendations on Menopausal Hormone Therapy and Non-Hormonal Alternatives.
- Santoro N, Epperson CN, Mathews SB. Menopausal Symptoms and Their Management. Endocrinol Metab Clin North Am. 2015;44(3):497-515. doi:10.1016/j.ecl.2015.05.001
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