Fezolinetant

On September 12th, 2024, FDA issued a drug safety communication about the risk of rare, but serious, liver injury with the use of fezolinetant. This warning is based on a post marketing report of a patient with elevated liver function test values and signs and symptoms of liver injury after taking the medicine for about 40 days. Patients should stop taking fezolinetant immediately and contact your health care professional who prescribed the medicine if you experience signs and symptoms that suggest liver problems. These include feeling more tired than usual; nausea; vomiting; unusual itching; light-colored stools; yellowing of the eyes or skin, called jaundice; dark urine; swelling in the stomach or belly area, called the abdomen; or pain in the right upper abdomen. Updated prescribing information for fezolinetant will also included increased frequency of liver blood tests. For additional information see the FDA safety communication at: https://www.fda.gov/safety/medical-product-safety-information/fda-adds-warning-about-rare-occurrence-serious-liver-injury-use-veozah-fezolinetant-hot-flashes-due?utm_medium=email&utm_source=govdelivery

Fezolinetant is used to treat moderate to severe vasomotor symptoms (hot flashes and night sweats) associated with menopause. Fezolinetant is in a class of medications called neurokinin 3 (NK3) receptor antagonist. It works by altering the nerve response that triggers the thermoregulatory center causing vasomotor symptoms.

Fezolinetant comes as a tablet to take by mouth. It is usually taken once a day with or without food. Take fezolinetant at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take fezolinetant exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the tablets whole with liquids; do not split, chew, or crush them.

Your doctor will do blood work before starting fezolinetant and periodically during treatment. Based on the results, your doctor may tell you not to take or to stop taking fezolinetant.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking fezolinetant,

• tell your doctor and pharmacist if you are allergic to fezolinetant, any other medications, or any of the ingredients in fezolinetant tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• Some medications should not be taken with fezolinetant. Make sure you have discussed any medications you are currently taking or plan to take before starting fezolinetant with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking fezolinetant, please get the advice of your doctor or pharmacist.
• tell your doctor if you have cirrhosis (scarring and damage to your liver) or liver or kidney disease. Your doctor may tell you not to take fezolinetant depending on the status of your condition.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking fezolinetant, call your doctor.

Unless your doctor tells you otherwise, continue your normal diet.

Take the missed dose as soon as you remember it. However, if it is less than 12 hours until the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Fezolinetant may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• abdominal pain
• diarrhea
• trouble sleeping
• back pain

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• yellowing of the skin or eyes, nausea or vomiting, lower abdominal pain

Fezolinetant may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to fezolinetant.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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