Invega Hafyera Description

INVEGA HAFYERA is available as a white to off-white sterile aqueous prolonged-release suspension for intramuscular injection in dose strengths of 700 mg and 1,000 mg paliperidone (as 1,092 mg and 1,560 mg paliperidone palmitate). The drug product hydrolyzes to the active moiety, paliperidone, resulting in dose strengths of 700 mg and 1,000 mg of paliperidone, respectively.
INVEGA HAFYERA is provided in a single-dose prefilled syringe (cyclic-olefin-copolymer) prefilled with either 700 mg (3.5 mL) or 1,000 mg (5.0 mL) paliperidone (as 1,092 mg or 1,560 mg paliperidone palmitate) suspension with a tip cap, plunger rod, backstop and a thin walled 20G, 1½-inch safety needle.
INVEGA HAFYERA contains a racemic mixture of (+)- and (-)-paliperidone palmitate. Paliperidone palmitate is an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. 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.
Excipients/Inactive Ingredients: The inactive ingredients are polysorbate 20 (10 mg/mL), polyethylene glycol 4000 (75 mg/mL), citric acid monohydrate (7.5 mg/mL), sodium dihydrogen phosphate monohydrate (6 mg/mL), sodium hydroxide (5.4 mg/mL), and water for injection.