Fezolinetant

Fezolinetant is used in adult women who are menopausal to treat symptoms of "hot flashes" and night sweats.

Fezolinetant may also be used for other 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.

Fezolinetant is usually taken once per day. Follow your doctor's instructions.

Swallow the tablet whole with liquids and do not crush, chew, or break it.

You may take fezolinetant with or without food, but take it the same way each time.

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

Read and carefully follow the instructions provided with fezolinetant about how to safely dispose of any unused portion.

Store at room temperature away from moisture and heat.

Tell your doctor about all the other medicines you are taking. Some drugs should not be used with fezolinetant.

You should not use fezolinetant if you have:

• cirrhosis; or
• kidney problems or end-stage kidney disease.

Some drugs should not be used with fezolinetant. Your treatment plan may change if you also:

• take certain medicines such as cimetidine, fluvoxamine, and mexiletine.

There may be other reasons you should not use fezolinetant together with certain medicines. Ask your doctor if you are unsure.

Tell your doctor if you have other medical conditions.

Tell your doctor if you are pregnant or breastfeeding.

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

Fezolinetant may cause serious side effects. Call your doctor immediately if you have:

• liver problems--loss of appetite, nausea, vomiting, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects of fezolinetant may include:

• abnormal liver function tests;
• stomach or back pain;
• diarrhea;
• sleep problems (insomnia); or
• hot flashes or hot flush.

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 Postmenopausal Symptoms:

Recommended dose: 45 mg orally once a day Comments:-Evaluate liver function prior to treatment initiation and as recommended. -The benefit and duration of treatment should be periodically assessed based on the history and course of the vasomotor symptoms (VMS); no data available beyond 12 months.Use: For the treatment of moderate to severe VMS associated with menopause

Take the medicine as soon as you can, but if you are more than 12 hours late for the dose, skip the missed dose and return to your regular schedule. Do not use two doses at one time.

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

Follow your doctor's instructions about any restrictions on food, drinks, or activities.

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

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