Medications Directory

Approved indications: Lynkuet is approved in the U.S. to treat moderate to severe vasomotor symptoms due to menopause, meaning bothersome hot flashes and night sweats in adult women going through or after menopause.

Off-label or emerging uses: Elinzanetant has been studied in phase 3 trials for hot flashes caused by adjuvant endocrine (hormone-blocking) therapy in women with, or at high risk for, hormone receptor–positive breast cancer, where it significantly reduced symptom frequency and improved sleep and quality of life; however, this indication is not yet FDA-approved, so any use in that setting would be off-label and guided by specialist judgment.

Efficacy expectations:

• In large phase 3 trials of postmenopausal women with frequent moderate to severe hot flashes, Lynkuet reduced hot flash frequency by about 3–4 more episodes per day than placebo by week 4, with further improvement by week 12, and also reduced symptom severity.
• Many women notice some relief within the first 1–2 weeks, with clinically meaningful improvement by about 4 weeks and average hot flash frequency reductions of roughly 70% from baseline by around 12 weeks of continuous use, maintained over 6–12 months in extension studies.
• Compared with other options, Lynkuet provides a hormone-free alternative with strong hot-flash reductions similar to other modern non-hormonal agents (such as NK3 antagonists like fezolinetant) and offers potential added sleep benefits through its dual NK1/NK3 mechanism, while avoiding estrogen-related risks seen with systemic hormone therapy.

Typical dose and how to take it: For menopausal vasomotor symptoms, the usual dose of Lynkuet is 120 mg (two 60 mg capsules) taken by mouth once daily at bedtime, at about the same time each night; capsules can be taken with or without food, should be swallowed whole with water, and should not be cut, crushed, or chewed.

Special dosing instructions:

• Before starting, most women will have a pregnancy test (if of childbearing potential) and baseline liver blood tests; the medicine should not be started if liver tests are already significantly elevated.
• If you must take a moderate CYP3A4 inhibitor (certain heart, blood pressure, or antibiotic medicines), the Lynkuet dose is usually reduced to 60 mg (one capsule) at bedtime while you are on that medicine; after the interacting drug is stopped, the dose can generally return to 120 mg nightly.
• Lynkuet should not be used with strong CYP3A4 inhibitors, strong or moderate CYP3A4 inducers, or grapefruit or grapefruit juice, and it is not recommended if you have moderate or severe liver disease or end-stage kidney disease.

Missed dose guidance: If you forget your dose at bedtime, skip it and take your next scheduled dose at the usual bedtime the following night; do not take two doses on the same day to make up for a missed dose.

Overdose: If too many capsules are taken at once or taken by someone for whom they were not prescribed, seek urgent medical care or contact poison control right away so the person can be monitored and treated for symptoms such as marked drowsiness, dizziness, or other unusual effects, as there is no specific antidote.

Common side effects: The most frequent side effects in studies were headache, fatigue, dizziness or balance problems, drowsiness or feeling sleepy, nausea or gastroesophageal reflux, abdominal discomfort, diarrhea, and skin rash or itching; these occurred in roughly 5–10% of women, were usually mild to moderate, and often improved over time.

Serious or rare adverse effects:

• Liver problems: A small number of women developed significant elevations in liver enzymes; everyone should have baseline liver blood tests and repeat tests about 3 months after starting, and the drug should be stopped and urgent care sought if symptoms such as unusual tiredness, loss of appetite, nausea, vomiting, itching, yellowing of the skin or eyes, pale stools, dark urine, or right‑upper abdominal pain occur.
• Pregnancy loss: Lynkuet is contraindicated in pregnancy because animal data suggest it can cause pregnancy loss or stillbirth; treatment must be stopped immediately if pregnancy occurs.
• Seizures: Very rarely, seizures have been reported, mainly in women with a prior seizure history; anyone with a history of seizures or conditions that lower the seizure threshold should use Lynkuet cautiously and report new neurologic symptoms promptly.

Warnings and precautions (special populations and conditions): Lynkuet is not indicated in pediatric patients, and there are limited data in women aged 65 and older. It is contraindicated in pregnancy, and women who can become pregnant should have pregnancy excluded before starting and use effective contraception during treatment and for 2 weeks after the last dose. There are no human data in breastfeeding; because the drug is present in animal milk, nursing should generally be avoided or carefully discussed with a clinician. No dose adjustment is needed for mild hepatic impairment or for mild to severe renal impairment (eGFR 15 to <90 mL/min), but Lynkuet is not recommended in moderate or severe hepatic impairment or in end-stage renal disease. Because it can cause drowsiness and dizziness, women should avoid driving or hazardous activities if they feel impaired after taking it.

Comparative safety: Lynkuet is non-hormonal and in trials did not show increased risk of endometrial cancer or major liver injury, and it has not demonstrated clinically meaningful QT interval prolongation at approved doses; however, it is a new medication and long-term real-world safety experience is still limited, so ongoing monitoring is important, especially relative to long-established hormone therapies and antidepressant options.

Reporting side effects and safety updates: Side effects should be reported to the prescribing clinician and can also be reported directly to the FDA’s MedWatch program (via the FDA website or 1-800-FDA-1088) or to Bayer using the number listed in the package insert, where updated safety information and any new warnings will also be reflected.

Drug, food, and supplement interactions:

• Lynkuet is broken down mainly by the CYP3A4 enzyme, so strong CYP3A4 inhibitors (such as some antifungal, antibiotic, HIV, or hepatitis C medicines) and grapefruit or grapefruit juice can raise Lynkuet levels and increase side-effect risk and should be avoided; if a moderate CYP3A4 inhibitor is required, the Lynkuet dose is usually reduced to 60 mg nightly.
• Strong or moderate CYP3A4 inducers (including certain seizure medicines, rifampin-type antibiotics, and herbal products like St. John’s wort) can lower Lynkuet levels and reduce its effectiveness and should not be used with Lynkuet.
• Because Lynkuet can cause drowsiness or dizziness, combining it with alcohol, cannabis, sedatives, sleep medicines, or other central nervous system depressants may increase these effects, so all such products should be reviewed with the prescriber.

Precautions and conditions where use may be unsafe or need extra care: Lynkuet is contraindicated in pregnancy and should be stopped immediately if pregnancy occurs. It is not recommended in women with moderate or severe hepatic impairment or end-stage renal disease, and should be used cautiously in women with a history of seizures or other factors that lower seizure threshold. It is not indicated for pediatric patients, and data in women over 65 are limited.

Monitoring needs: Before starting Lynkuet, most women will have baseline liver function tests and, if they can become pregnant, a pregnancy test; liver tests are typically repeated about 3 months after starting and may be checked again if symptoms suggest liver injury. There are no routine requirements for ECGs or blood pressure monitoring specifically due to Lynkuet, but all current medicines and health conditions should be reviewed with each provider, including before surgery, anesthesia, or diagnostic imaging, to ensure there are no additional precautions.

Q: Who is Lynkuet for, and what symptoms does it treat?
A: Lynkuet is for adult women going through or after menopause who have moderate to severe hot flashes and night sweats; it is a non-hormonal pill taken once daily at bedtime to reduce how often and how intensely these vasomotor symptoms occur.

Q: How long does it take for Lynkuet to start working?
A: Some women notice fewer or milder hot flashes within the first 1–2 weeks, but the most noticeable improvements typically build over 4–12 weeks of consistent nightly use.

Q: Is Lynkuet a hormone, and will it affect my risk of breast cancer?
A: Lynkuet is not a hormone and does not contain estrogen or progestin; instead, it works on brain receptors that regulate body temperature, and in trials it provided hot-flash relief without evidence of stimulating the uterus, although long-term data on breast cancer risk are still being collected.

Q: Do I need blood tests or other monitoring while taking Lynkuet?
A: Most women will have liver blood tests before starting Lynkuet and again about 3 months after initiation, and additional testing may be done if you develop symptoms of liver problems; other monitoring is based on your overall health and medicines.

Q: Can I keep taking my other medicines, including antidepressants or sleep aids, with Lynkuet?
A: Many medicines can be used with Lynkuet, but some drugs that strongly affect the CYP3A4 enzyme, as well as grapefruit products and other sedating medicines or alcohol, may require dose changes or avoidance, so every prescription, over-the-counter medicine, and supplement should be reviewed with your clinician or pharmacist.

Q: What happens if I become pregnant or want to breastfeed while taking Lynkuet?
A: Lynkuet must not be used during pregnancy because it can cause pregnancy loss in animal studies, so treatment should be stopped immediately if you become pregnant and effective contraception should be used during treatment and for 2 weeks after the last dose; because the drug is expected to enter breast milk and its effects on infants are unknown, breastfeeding is generally not recommended while taking Lynkuet.