VEOZAH Dosage & Rx Info | Uses, Side Effects

Veozah Generic Name & Formulations

Legal Class

General Description

Fezolinetant 45mg; tabs.

Pharmacological Class

Neurokinin 3 (NK3) receptor antagonist.

How Supplied

Tabs—30, 90

Storage

Store at 20°C to 25°C (68°F to 77°F) with excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Manufacturer

Astellas Pharma US, Inc.

Generic Availability

Mechanism of Action

Veozah 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 thermoregulatory center.

Veozah Indications

Indications

Moderate to severe vasomotor symptoms due to menopause.

Veozah Dosage and Administration

Adult

Swallow whole. 45mg once daily.

Children

<18yrs: not established.

Veozah Contraindications

Contraindications

Cirrhosis. Severe renal impairment (eGFR 15–<30mL/min/1.73m²) or ESRD (eGFR <15mL/min/1.73m²). Concomitant CYP1A2 inhibitors.

Veozah Boxed Warnings

Not Applicable

Veozah Warnings/Precautions

Warnings/Precautions

Evaluate liver function and injury (including ALT, AST, serum bilirubin) prior to initiation. ALT/AST ≥2xULN or elevated total bilirubin: not recommended. Perform follow-up bloodwork at 3 months, 6 months, and 9 months during treatment and when symptoms suggest liver injury. Hepatic impairment. Pregnancy. Nursing mothers.

Veozah Pharmacokinetics

Absorption

Median time to reach maximum serum concentration: 1.5 (1 to 4) hours.

Distribution

Mean apparent volume of distribution: 189 L.
51% plasma protein bound.

Metabolism

Hepatic (CYP1A2).

Elimination

Renal (76.9%), fecal (14.7%).
Half-life: 9.6 hours.

Veozah Interactions

Interactions

See Contraindications. Potentiated by CYP1A2 inhibitors.

Veozah Adverse Reactions

Adverse Reactions

Abdominal pain, diarrhea, insomnia, back pain, hot flush, hepatic transaminase elevation.

Veozah Clinical Trials

Clinical Trials

The approval was based on data from the randomized, double-blind, placebo-controlled SKYLIGHT 1 and 2 studies which evaluated the efficacy and safety of fezolinetant (30mg and 45mg) orally once daily in 1022 women aged 40 to 65 years with moderate to severe vasomotor symptoms. The first 12 weeks of each trial were double-blinded and placebo-controlled and were followed by a 40-week active treatment extension period.

Findings from both trials showed statistically significant and clinically meaningful (≥2 hot flashes over 24 hours) reduction from baseline in the frequency of moderate to severe vasomotor symptoms with fezolinetant 45mg compared with placebo at weeks 4 and 12. The 45mg dosage strength was also associated with a statistically significant reduction from baseline in the severity of moderate to severe vasomotor symptoms (over 24 hours) compared with placebo at weeks 4 and 12.

Veozah Note