Product
Invega Sustenna
Approval Date
July 31, 2009
Release Date
Janssen claims that it plans to launch Invega Sustenna soon.
Company
Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.
Class
Atypical antipsychotic
Indication
Extended-release injectable suspension for the acute and maintenance treatment of schizophrenia in adults.
Active Ingredient
Paliperidone palmitate
Agency Roster
Blue Diesel
Marketing Strategy/Execution
The US Food and Drug Administration approved Invega Sustenna extended-release injectable suspension for the acute and maintenance treatment of schizophrenia in adults on Friday, July 31, 2009. It is the first once-monthly, long-acting, injectable atypical antipsychotic approved in the US for this use. Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc, will market Invega Sustenna in the US.
Physician Outlook
Invega Sustenna (paliperiodone palmitate) will be the first once-monthly injectable atypical antipsychotic available for the treatment of schizophrenia. The long-acting injectable should provide physicians with a treatment option capable of managing schizophrenia symptoms while also improving patient compliance, a critical unmet need in the market.
—Paul V. Wojciak, Director, Research, GfK Healthcare
Also in the Pipeline (courtesy of Adis R&D Insight)
Drug: AbilifyÂ
Manufacturer: Otsuka Pharmaceutical/ Bristol-Myers Squibb
Indication: Bipolar disorders—Treatment of moderate-to-severe manic episodes in bipolar I disorder and the prevention of relapse of manic episodes in bipolar I disorder.
Active ingredient: Aripiprazole
Phase: Launched
Drug: LY 170053
Manufacturer: Eli Lilly
Indication: Aggression
Active ingredient: Olanzapine
Phase: Launched
Source: Wolters Kluwer Pharma Solutions
Adverse Reactions
Insomnia, headache, agitation, somnolence/sedation, dizziness, akathisia, GI upset; may cause neuroleptic malignant syndrome, tardive dyskinesia, QT prolongation, hyperglycemia, orthostatic hypotension, syncope, hyperprolactinemia, priapism. Also Sustenna: inj site reactions.
Adults
Establish tolerability with oral paliperidone or oral risperidone prior to initiating. Give by deep deltoid IM inj, initially 234mg on day 1, then 156mg on week later. Maintenance: Give by deep deltoid or gluteal IM inj once monthly. 117mg; may increase or decrease in the range of 39–234mg. Renal impairment: mild (CrCl ≥50mL/min– <80mL/min): initially 156mg on day 1, then 117mg one week later, then 78mg monthly; moderate to severe (CrCl<50mL/min): not recommended. Missed doses or switching from other antipsychotics: see literature.
Children
<18yrs: not recommended.
Precautions
Avoid in congenital long QT syndrome, cardiac arrhythmias. Diabetes risk factors (obtain baseline fasting blood sugar). Monitor for hyperglycemia. Cardio- or cerebrovascular disease. Pre-existing low WBCs or history of leukopenia/neutropenia; monitor CBCs during 1st few months of treatment; discontinue if WBCs decline. Orthostatic hypotension. Parkinson’s disease. Dementia with Lewy bodies. History of seizures. Patients at risk for aspiration pneumonia. Renal insufficiency. Severe hepatic impairment. Exposure to extreme temperatures. May have antiemetic effect. Suicidal patients. Tabs: Pre-existing severe GI narrowing: not recommended. Reevaluate periodically. Elderly (not for dementia-related psychosis); consider monitoring renal function and for orthostatic effects. Pregnancy (Cat.C). Nursing mothers: not recommended.
Interactions
Avoid alcohol, drugs that prolong QT interval (eg, Class 1A and Class III antiarrhythmics, chlorpromazine, thioridazine, gatifloxacin, moxifloxacin). Caution with other CNS drugs, drugs that may cause orthostatic hypotension. May be antagonized by carbamazepine; adjust dose. May antagonize levodopa, other dopamine agonists.
