"The US Food and Drug Administration (FDA) has approved a quarterly injection form of paliperidone (Invega Trinza, Janssen Pharmaceuticals) for schizophrenia, the company announced today.
Janssen Pharmaceuticals already markets a "...
(paliperidone palmitate) Extended-Release Injectable Suspension
INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
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-(6Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-2-methyl-4-oxo-6,7,8,9-tetrahydro-4Hpyrido[1,2-a]pyrimadin-9-yl hexadecanoate. Its molecular formula is C39H57FN4O4 and its molecular weight is 664.89. The structural formula is:
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 available as a white to off-white sterile aqueous extended-release suspension for intramuscular injection in the following dose strengths of paliperidone palmitate (and deliverable volumes of the prefilled syringes): 39 mg (0.25 mL), 78 mg (0.5 mL), 117 mg (0.75 mL), 156 mg (1.0 mL), and 234 mg (1.5 mL). The drug product hydrolyzes to the active moiety, paliperidone, resulting in dose strengths of 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg of paliperidone, respectively. The inactive ingredients are 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.
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).
What are the precautions when taking paliperidone palmitate extended-release injectable suspension (Invega Sustenna)?
See also Warnings section.
Before using paliperidone, tell your doctor or pharmacist if you are allergic to it; or to risperidone; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, low white blood cell count (leukopenia), seizures, Parkinson's disease, dementia, certain eye problems (cataracts, glaucoma).
Also tell your doctor or pharmacist if you or a family member has a history of the following: high blood cholesterol/triglyceride levels, heart disease (such heart attack), high blood pressure, diabetes,...
Last reviewed on RxList: 4/13/2016
This monograph has been modified to include the generic and brand name in many instances.
Additional Invega Sustenna Information
- Invega Sustenna Drug Interactions Center: paliperidone palmitate im
- Invega Sustenna Side Effects Center
- Invega Sustenna Overview including Precautions
- Invega Sustenna FDA Approved Prescribing Information including Dosage
Invega Sustenna - User Reviews
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