Invega Sustenna Description

INVEGA SUSTENNA is available as a white to off-white sterile aqueous extended-release suspension for intramuscular injection in the following dose strengths of paliperidone (and deliverable volumes of the prefilled syringes): 50 mg (0.5 mL), 75 mg (0.75 mL), 100 mg (1.0 mL), and 150 mg (1.5 mL). The drug product hydrolyzes to the active moiety, paliperidone. Dose strengths of 50 mg, 75 mg, 100 mg, and 150 mg of paliperidone are the hydrolyzed forms of 78 mg, 117 mg, 156 mg, and 234 mg paliperidone palmitate respectively.
INVEGA SUSTENNA is an atypical antipsychotic. INVEGA SUSTENNA contains paliperidone palmitate. The active ingredient, paliperidone palmitate, is a psychotropic agent belonging to the chemical class of benzisoxazole derivatives. INVEGA SUSTENNA contains a racemic mixture of (+)- and (-)- paliperidone palmitate. The chemical name is (9RS)-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-2-methyl-4-oxo-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimadin-9-yl hexadecanoate. Its molecular formula is C₃₉H₅₇FN₄O₄ and its molecular weight is 664.89.
Paliperidone palmitate is very slightly soluble in ethanol and methanol, practically insoluble in polyethylene glycol 400 and propylene glycol, and slightly soluble in ethyl acetate.
INVEGA SUSTENNA is provided in a prefilled syringe (cyclic-olefin-copolymer) with a plunger stopper and tip cap (bromobutyl rubber). The kit also contains 2 safety needles (a 1 ½-inch 22 gauge safety needle and a 1-inch 23 gauge safety needle).
Excipients/Inactive Ingredients: polysorbate 20 (12 mg/mL), polyethylene glycol 4000 (30 mg/mL), citric acid monohydrate (5 mg/mL), disodium hydrogen phosphate anhydrous, sodium dihydrogen phosphate monohydrate, sodium hydroxide, and water for injection.