IMPORTANT SAFETY INFORMATION

Do not take LYNKUET® if you:

are pregnant

Before you use LYNKUET, tell your healthcare provider about all of your medical conditions, including if you:

have liver problems
have a history of seizures
are pregnant or planning to become pregnant. LYNKUET may harm your unborn baby. Women who can become pregnant should talk to their healthcare provider to exclude pregnancy before starting treatment with LYNKUET and use effective birth control during and for 2 weeks after stopping treatment.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. LYNKUET may affect the way other medicines work, and other medicines may affect how LYNKUET works.

What should I avoid while taking LYNKUET?

Avoid eating grapefruit or drinking grapefruit juice during treatment with LYNKUET.
LYNKUET may cause you to feel drowsy, if you experience this avoid driving and other hazardous activities until these effects go away.

LYNKUET can cause serious side effects, including:

Central nervous system (CNS) effects and daytime impairment. LYNKUET can cause difficulty staying awake (somnolence) and other nervous system effects including fatigue, having a spinning feeling (vertigo), dizziness, and feeling faint (presyncope). If you experience these effects, you should not drive or do hazardous activities until these effects go away.
Increased liver blood test values. LYNKUET may cause increased liver enzymes. Your healthcare provider will do a blood test to check your liver before you start and 3 months after taking LYNKUET. Stop taking LYNKUET and tell your healthcare provider right away if you have the following signs or symptoms that suggest liver problems:
- feeling more tired than you do usually
- decreased appetite
- nausea
- vomiting
- itching
- yellowing of the eyes or skin (jaundice)
- pale feces
- dark urine
- pain in the stomach (abdomen)
Risk of pregnancy loss. Taking LYNKUET while pregnant may cause loss of pregnancy or stillbirth. If you think you are pregnant, stop taking LYNKUET and tell your healthcare provider right away.
Risk of seizures in people with a history of seizures. Seek medical attention right away if you have loss of consciousness or seizure.

Common side effects of LYNKUET include:

headache
fatigue
dizziness
feeling drowsy or sleepy
stomach (abdominal) pain
rash
diarrhea
muscle spasms

Tell your healthcare provider if you have any side effects that do not go away. These are not all the possible side effects of LYNKUET.

INDICATION

What is LYNKUET (elinzanetant)?

LYNKUET is a prescription medicine used to reduce moderate to severe hot flashes (also known as vasomotor symptoms) due to menopause. LYNKUET is not a hormone. Hot flashes are feelings of warmth in the face, neck, and chest, or sudden intense feelings of heat and sweating.

For important information about LYNKUET, please see the Full Prescribing Information

LYNKUET is available by prescription only.

You are encouraged to report side effects or quality complaints of products to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088. For Bayer products, you can report these directly to Bayer by clicking here.

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