Fezolinetant

Fezolinetant is a prescription medicine used for the treatment of moderate to severe vasomotor symptoms caused by menopause.

• Fezolinetant is available under the following different brand names: Veozah.

Common side effects of Fezolinetant include:

• stomach (abdominal) pain
• diarrhea
• difficulty sleeping (insomnia)
• back pain
• hot flashes or hot flushes
• elevated hepatic transaminases

Serious side effects of Fezolinetant include:

• drug-induced liver injury
• nausea
• vomiting
• yellowing of the eyes or skin (jaundice)
• pain in the right upper stomach (abdomen)

Rare side effects of Fezolinetant include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, light-headedness, or passing out

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Tablet

• 45 mg

Menopausal vasomotor symptoms

Adult dosage

• 45 mg orally once a day

Dosage Considerations – Should be Given as Follows:

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Fezolinetant has severe interactions with at least 98 other drugs.
• Fezolinetant has serious interactions with no other drugs.
• Fezolinetant has moderate interactions with no other drugs.
• Fezolinetant has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• known cirrhosis
• severe renal impairment or ESRD
• coadministration with CYP1A2 inhibitors

Effects of drug abuse

• none

Short-Term Effects

• See “What Are Side Effects Associated with Using Fezolinetant?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Fezolinetant?”

Cautions

• Hepatotoxicity
  • Elevated transaminases were reported in clinical trials; most patients were asymptomatic
  • Patients with cirrhosis were not studied
  • Cases of serious drug-induced liver injury (i.e., increased AST/ALT [50 times ULN and less], alkaline phosphatase [4 times ULN and less], and bilirubin [5 times ULN and less] at peak elevation) occurring within 40 days of starting therapy reported in postmarketing surveillance; signs and symptoms resolved after therapy discontinuation
  • Exclude alternative causes of abnormal liver function tests

• Drug interaction overview
  • CYP1A2 substrate
  • CYP1A2 inhibitors
• Contraindicated
  • Peak plasma concentration and AUC of Fezolinetant are increased if coadministered with drugs that are weak, moderate, or strong CYP1A2 inhibitors

Pregnancy and Lactation

• There are no data on use in pregnant women to evaluate the drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes
• Lactation
  • Data are unavailable on the presence of Fezolinetant in human milk and its effects on breastfed children or milk production
  • Unknown if the drug is present in human milk