Version May 2024
Note: Perform LFTs prior to initiation; do not initiate therapy in patients with ALT, AST, and/or total bilirubin ≥2 times the ULN.
Vasomotor symptoms associated with menopause: Oral: 45 mg once daily.
Missed doses: If a dose is missed, administer the dose as soon as remembered; if there is <12 hours before the next scheduled dose, skip the missed dose and return to the regular schedule the following day.
GFR ≥30 mL/minute/1.73 m2: No dosage adjustment necessary.
GFR <30 mL/minute/1.73 m2: Use is contraindicated.
Hepatic impairment prior to treatment initiation:
Mild to moderate impairment (Child-Pugh class A or B): Use is contraindicated; increased exposure of fezolinetant has been reported.
Severe impairment (Child-Pugh class C): Use is contraindicated (has not been studied).
ALT, AST, and/or total bilirubin ≥2 times the ULN: Withhold treatment.
Hepatotoxicity during treatment:
ALT, AST, and/or total bilirubin ≥2 times the ULN: Withhold treatment.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.
1% to 10%:
Endocrine & metabolic: Hot flash (3%)
Gastrointestinal: Abdominal pain (4%), diarrhea (4%)
Hepatic: Increased serum transaminases (2%)
Nervous system: Insomnia (4%)
Neuromuscular & skeletal: Back pain (3%)
Known cirrhosis; severe renal impairment or end-stage renal disease; concomitant use with CYP1A2 inhibitors.
Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Concerns related to adverse effects:
• Hepatic transaminase elevation: Hepatic serum transaminase elevations (ie, ALT and AST) >3 times the ULN have occurred. Elevations are typically asymptomatic and resolve with continued therapy, dose interruption, or discontinuation.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral:
Veozah: 45 mg
No
Tablets (Veozah Oral)
45 mg (per each): $22.00
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Oral: Administer at about the same time each day with liquids; administer with or without food. Swallow tablet whole; do not cut, crush, or chew.
Vasomotor symptoms associated with menopause: Treatment of moderate to severe vasomotor symptoms due to menopause.
Substrate of CYP1A2 (major), CYP2C19 (minor), CYP2C9 (minor), P-glycoprotein/ABCB1 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Aldesleukin: May increase the serum concentration of CYP Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk C: Monitor therapy
CYP1A2 Inhibitors (Moderate): May increase the serum concentration of Fezolinetant. Risk X: Avoid combination
CYP1A2 Inhibitors (Strong): May increase the serum concentration of Fezolinetant. Risk X: Avoid combination
CYP1A2 Inhibitors (Weak): May increase the serum concentration of Fezolinetant. Risk X: Avoid combination
Elranatamab: May increase the serum concentration of CYP Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk C: Monitor therapy
Epcoritamab: May increase the serum concentration of CYP Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk C: Monitor therapy
Filgotinib: May increase the serum concentration of CYP1A2 Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk C: Monitor therapy
Glofitamab: May increase the serum concentration of CYP Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk C: Monitor therapy
Leniolisib: May increase the serum concentration of CYP1A2 Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk X: Avoid combination
Mosunetuzumab: May increase the serum concentration of CYP Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk C: Monitor therapy
Pacritinib: May increase the serum concentration of CYP1A2 Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk X: Avoid combination
Ritlecitinib: May increase the serum concentration of CYP1A2 Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk C: Monitor therapy
Talquetamab: May increase the serum concentration of CYP Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk C: Monitor therapy
Teclistamab: May increase the serum concentration of CYP Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk C: Monitor therapy
Fezolinetant is approved for moderate to severe vasomotor symptoms in postmenopausal patients.
It is not known if fezolinetant is present in breast milk.
LFTs (including ALT, AST, total and direct serum bilirubin) prior to initiation of therapy; after initiation of therapy at 3, 6, and 9 months; and when symptoms suggest liver injury (eg, nausea, vomiting, yellowing of the skin or eyes).
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 thermoregulatory center.
Distribution: Vz/F: 189 L.
Protein binding: 51%.
Metabolism: Primarily by CYP1A2; CYP2C9 and CYP2C19 to a lesser extent.
Half-life elimination: 9.6 hours.
Time to peak: Median 1.5 (1 to 4) hours.
Excretion: Urine: 76.9% (1.1% as unchanged drug); feces: 14.7% (0.1% as unchanged drug).
Clearance: 10.8 L/hour.
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