Elinzanetant

Elinzanetant is used in adult women to lower moderate to severe "hot flashes" caused by menopause.

Elinzanetant may also be used for reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Elinzanetant is usually taken once per day, at bedtime. Follow your doctor's instructions.

Swallow the capsule whole with water and do not cut, crush, or chew it.

You may take elinzanetant with or without food, but take it at the same time each day.

You will need frequent blood tests to check your liver function before and during treatment with elinzanetant.

If you are taking certain medicines, your doctor may reduce your dose. Always follow your doctor's dosing and storage instructions.

Store at room temperature away from moisture and heat.

Do not use if you are pregnant.

Use effective birth control.

Do not use elinzanetant if you are pregnant.

Tell your doctor if you have or have ever had:

• seizures; or
• liver or kidney disease (or if you are on dialysis).

You may need a pregnancy test to confirm that you are not pregnant.

Do not use if you are pregnant. Elinzanetant may increase your risk of miscarriage or stillbirth during pregnancy. Use effective birth control while taking elinzanetant and for at least 2 weeks after your last dose. Inform your doctor if you become pregnant.

Ask a doctor if it is safe to breastfeed while taking this medicine.

Get emergency medical help if you have signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

Stop taking elinzanetant and tell your doctor if you experience symptoms of liver problems, such as loss of appetite, nausea, vomiting, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Elinzanetant may cause serious side effects. Call your doctor at once if you have:

• extreme drowsiness, vertigo (spinning sensation), dizziness, feeling faint; or
• loss of consciousness or seizure.

Common side effects of elinzanetant may include:

• headache, tiredness, dizziness, drowsiness;
• stomach pain, diarrhea;
• rash; or
• muscle spasm.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Menopausal Flushing:

120 mg orally once a day at bedtimeUse: For the treatment of moderate to severe vasomotor symptoms due to menopause

Skip the missed dose and take your next dose at the usual time. Do not take two doses at once.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

• Avoid driving or hazardous activity until you know how elinzanetant will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

• Grapefruit may interact with elinzanetant and cause side effects. Avoid consuming grapefruit products.

Sometimes, it is not safe to use certain medicines together. Some drugs can change the blood levels of other drugs, which may increase side effects or make the medicines less effective.

Other drugs may affect elinzanetant, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you are using.