Fezolinetant is a neurokinin 3 (NK3) receptor antagonist that blocks neurokinin B (NKB) binding on the kisspeptin/neurokinin B/dynorphin (KNDy) neuron to modulate neuronal activity in the hermoregulatory center. Fezolinetant has high affinity for the NK3 receptor, which is more than 450-fold higher than binding affinity to NK1 or NK2 receptors.

Moderate to severe vasomotor symptoms due to menopause.

One tablet daily orally with or without food.

Known cirrhosis, Severe renal impairment or end-stage renal disease, Concomitant use with CYP1A2 inhibitors.

There are no data on Fezolinetant use in pregnant women to evaluate for a drug-associated risk. It is not known if Fezolinetant is present in human milk.

The efficacy and safety of Fezolinetant in individuals less than 18 years of age have not been established

Treatment of overdose consists of discontinuation of Fezolinetant therapy with institution of appropriate symptomatic care.

Felitan® Tablet 45 mg : Each box contains 3 X 10’s tablets in Alu-Alu blister strips.

Hepatotoxicity has occurred with the use of Fezolinetant in the post marketing surveillance. • To evaluate hepatic function and injury hepatic laboratory tests should be performed prior to the initiation of treatment. The Intake of Fezolinetant cannot be started if either aminotransferase is ≥ 2 x UPPER LIMIT OF NORMAL or if the total bilirubin is ≥ 2 x UPPER LIMIT OF NORMAL for the evaluating laboratory • The hepatic laboratory test should be Performed & follow-up monthly for the first 3 months, at 6 months, and 9 months of treatment • The patients should be advised to discontinue Fezolinetant immediately and seek medical attention including hepatic laboratory tests if they experience signs or symptoms that may suggest liver injury (new onset fatigue, decreased appetite, nausea, vomiting, pruritus, jaundice, pale feces, dark urine, or abdominal pain • This intake Fezolinetant of should be discontinued if transaminase elevations are > 5 x UPPER LIMIT OF NORMAL, or if transaminase elevations are > 3 x UPPER LIMIT OF NORMAL and the total bilirubin level is > 2 x UPPER LIMIT OF NORMAL. • If transaminase elevations > 3 x UPPER LIMIT OF NORMAL occur, more frequent follow-up of hepatic laboratory

Store at temperatures not exceeding 30º C in a dry place. Protect from light and moisture. Medicine: Keep out of reach of children