Is Fezolinetant approved by the FDA?
Fezolinetant, sold under the brand name Veozah, was approved by the FDA on May 12, 2023, specifically for use in menopausal adult women to manage symptoms associated with hot flashes and night sweats.
What is Fezolinetant?
Fezolinetant is an oral medication classified under miscellaneous central nervous system agents. It is designed to alleviate vasomotor symptoms by regulating the body's temperature control mechanisms affected during menopause.
Usage
- Dosage Form: Oral tablet (45 mg)
- Recommended Dose: 45 mg orally once a day
- Administration: The tablet should be swallowed whole with liquids and not crushed, chewed, or broken. It can be taken with or without food but should be taken the same way each time.
Side Effects
Common side effects of fezolinetant may include:
- Abnormal liver function tests
- Stomach or back pain
- Diarrhea
- Sleep problems (insomnia)
- Hot flashes or hot flushes
Serious side effects that require immediate medical attention include:
- 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)
Warnings and Precautions
Before taking fezolinetant, inform your doctor if you have:
- Cirrhosis
- Kidney problems or end-stage kidney disease
Additionally, some drugs should not be used with fezolinetant, including cimetidine, fluvoxamine, and mexiletine. Always inform your doctor about all other medicines you are taking to avoid potential interactions.
Administration and Storage
- Administration: Fezolinetant should be taken as directed by your healthcare provider, with consistent monitoring of liver function before and during treatment.
- Storage: Store at room temperature away from moisture and heat.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if you are more than 12 hours late, skip the missed dose and resume your regular schedule. Do not take two doses at once.
Conclusion
Fezolinetant (Veozah) is an FDA-approved medication for managing moderate to severe vasomotor symptoms due to menopause. It is effective in reducing symptoms like hot flashes and night sweats, making it a valuable option for menopausal women seeking relief from these common symptoms. Always consult with your healthcare provider to ensure safe and effective use of this medication.
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