Vibegron is a selective β3-adrenergic receptor agonist developed by Urovant Sciences. It was first approved for marketing in the United States in 2020. As an innovative drug, it provides a new treatment option for patients with overactive bladder (OAB).
Indications of Vibegron (Vibegron)
Primary Indications
(1) The primary indication of vibegron is for the treatment of overactive bladder (OAB) in adults, specifically manifesting as the following symptoms:
(2) Urgency urinary incontinence (a strong urge to urinate accompanied by urine leakage or wetting accidents);
(3) Urgency (a sudden, compelling need to urinate);
(4) Frequency (increased number of urination episodes).
Specifications and Properties of Vibegron (Vibegron)
Basic Dosage Form Characteristics
(1) Each tablet contains 75 mg of the active ingredient vibegron.
(2) It appears as a light green, oval-shaped film-coated tablet.
(3) One side is imprinted with "V75", while the other side has no imprint.
(4) The tablet can be swallowed whole or crushed and mixed with applesauce for administration.
Packaging Specifications
(1) 30-tablet pack: 60 cc high-density polyethylene (HDPE) bottle with a child-resistant cap.
(2) 90-tablet pack: 60 cc high-density polyethylene (HDPE) bottle with a child-resistant cap.
Drug Ingredients
(1) Active Ingredient: Vibegron (Chemical Name: (6S)-N-[4-[[(2S,5R)-5-[(R)-hydroxy(phenyl)methyl]pyrrolidin-2-yl]methyl]phenyl]-4-oxo-7,8-dihydro-6H-pyrrolo[1,2-a]pyrimidine-6-carboxamide).
(2) Excipients: Croscarmellose sodium, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, etc.
(3) Film-Coating Ingredients: FD&C Blue No. 2 Aluminum Lake, hypromellose, yellow iron oxide, lactose monohydrate, titanium dioxide, triacetin, etc.
Storage Conditions for Vibegron (Vibegron)
Drug Storage
(1) Storage temperature: 20°C to 25°C (68°F to 77°F).
(2) Short-term exposure (during transportation) to environments ranging from 15°C to 30°C (59°F to 86°F) is permitted.
(3) Must be kept in the original packaging.
(4) Keep out of the reach and sight of children.
Disposal
(1) Unused drugs are recommended to be disposed of through drug take-back programs.
(2) If no take-back program is available, disposal can be done in accordance with the FDA’s guidelines for household trash disposal.
(3) Random disposal is strictly prohibited.
