Everything you want to know about the new antipsychotic Latuda brought to you by Dr.Stephen Stahl, who lists the manufacturer in his financial disclosures list among most all of the other pharma cos you can imagine.
Considering the source of the "Chalk Talk" series of videos, take note of who is teaching you about the antipsychotic. The Dr.Stahl learning video series is hosted on the drug manufacturer site.
LATUDA "Chalk-talk" Videos
Expert reviews of clinical data
Explore LATUDA with Stephen M. Stahl, MD, PhD as your guide.
Some of the side effects and cautions
LATUDA is contraindicated in any patient with a known hypersensitivity to lurasidone HCl or any components in the formulation. Angioedema has been observed with lurasidone. LATUDA is contraindicated with strong CYP3A4 inhibitors (e.g., ketoconazole) and strong CYP3A4 inducers (e.g., rifampin).
WARNINGS AND PRECAUTIONS
Cerebrovascular Adverse Reactions, Including Stroke: In placebo-controlled trials with risperidone, aripiprazole, and olanzapine in elderly subjects with dementia, there was a higher incidence of cerebrovascular adverse reactions (cerebrovascular accidents and transient ischemic attacks) including fatalities compared to placebo-treated subjects. LATUDA is not approved for the treatment of patients with dementia-related psychosis.
Neuroleptic Malignant Syndrome (NMS): NMS, a potentially fatal symptom complex, has been reported with administration of antipsychotic drugs, including LATUDA. NMS can cause hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia). Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. The management of NMS should include: 1) immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent therapy; 2) intensive symptomatic treatment and medical monitoring; and 3) treatment of any concomitant serious medical problems for which specific treatments are available.
Tardive Dyskinesia (TD): TD is a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements that can develop in patients with antipsychotic drugs. There is no known treatment for established cases of TD, although the syndrome may remit, partially or completely, if antipsychotic treatment is withdrawn. The risk of developing TD and the likelihood that it will become irreversible are believed to increase as the duration of treatment and the total cumulative dose of antipsychotic drugs administered to the patient increase. However, the syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses. Given these considerations, LATUDA should be prescribed in a manner that is most likely to minimize the occurrence of TD. If signs and symptoms appear in a patient on LATUDA, drug discontinuation should be considered.
Metabolic Changes
Hyperglycemia and Diabetes Mellitus: Hyperglycemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics. Patients with risk factors for diabetes mellitus (e.g., obesity, family history of diabetes) who are starting treatment with atypical antipsychotics should undergo fasting blood glucose testing at the beginning of and periodically during treatment. Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Patients who develop symptoms of hyperglycemia during treatment with atypical antipsychotics should undergo fasting blood glucose testing. In some cases, hyperglycemia has resolved when the atypical antipsychotic was discontinued; however, some patients required continuation of anti-diabetic treatment despite discontinuation of the suspect drug.
Dyslipidemia: Undesirable alterations in lipids have been observed in patients treated with atypical antipsychotics.
Weight Gain: Weight gain has been observed with atypical antipsychotic use. Clinical monitoring of weight is recommended.
Hyperprolactinemia: As with other drugs that antagonize dopamine D2 receptors, LATUDA elevates prolactin levels. Galactorrhea, amenorrhea, gynecomastia, and impotence have been reported in patients receiving prolactin-elevating compounds. In short-term, placebo-controlled studies, the increase in prolactin was greater in LATUDA-treated female patients; the median change from baseline to endpoint for females was 1.5 ng/mL and was 1.1 ng/mL in males. The increase in prolactin concentrations was dose-dependent. The proportion of female patients with prolactin elevations ≥5x ULN was 8.3% for LATUDA-treated patients versus 1% for placebo-treated female patients. The proportion of male patients with prolactin elevations > 5x ULN was 1.9% versus 0.6% for placebo-treated male patients.
Leukopenia, Neutropenia, and Agranulocytosis: Leukopenia/neutropenia has been reported during treatment with antipsychotic agents. Agranulocytosis (including fatal cases) has been reported with other agents in the class. Patients with a preexisting low white blood cell count (WBC) or a history of drug induced leukopenia/neutropenia should have their complete blood count (CBC) monitored frequently during the first few months of therapy, and LATUDA should be discontinued at the first sign of a decline in WBC in the absence of other causative factors.
LATUDA and
are registered trademarks of Dainippon Sumitomo Pharma Co. Ltd.Sunovion Pharmaceuticals Inc. is a U.S. subsidiary of Dainippon Sumitomo Pharma Co. Ltd.
Current study for Bipolar 1 Depression
Lurasidone - A 24-week Extension Study of Patients With Bipolar I Depression:
Sponsor: Sunovion
ponsors and Collaborators
Sunovion
Investigators
Study Director: Medical Director, MD Sunovion
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Dr.Stephen Stahl
FRIDAY, SEPTEMBER 10, 2010
FDA Bad ad alert: Stephen Stahl's email and promotion of antipsychotic Lurasidone: not for sale yet!:
"To my fellow Boston area Psychopharmacologists:
Just a head's up about a local educational program I hope you can attend related to schizophrenia. The content is based both upon my textbook, Stahls Essential Psychopharmacology, and two cases from my private practice. Although supported by Pharma and not CME (a new company Sunovion with a drug in the pipeline is the sponsor), there is no mention of any product here, just information on disease state, what I think is a very a cool update (understandable) on genomics, neuroimaging and the prodrome related to schizophrenia, and illustrated after the first didactic lecture with two cases taken from my practice. I will be lecturing, along with my colleague Steve Potkin from the University of California Irvine. We will also be giving the program in New York the next day (Saturday September 25). "
Disclosures: Dr. Stahl receives grant/research support from AstraZeneca, Biovail, Bristol-Myers Squibb, Cephalon, Cyberonics, Eli Lilly, Forest, GlaxoSmithKline, Janssen, Neurocrine Bioscience, Organon, Pfizer, Sepracor, Shire, Somaxon, and Wyeth; is a consultant to Acadia, Amylin, Asahi, AstraZeneca, Biolaunch, Biovail, Boehringer-Ingelheim, Bristol-Myers Squibb, Cephalon, CSC Pharma, Cyberonics, Cypress Bioscience, Eli Lilly, Epix, Fabre Kramer, Forest, GlaxoSmithKline, Jazz, Neurocrine Bioscience, Neuromolecular, Neuronetics, Nova Del Pharma, Novartis, Organon, Otsuka, PamLab, Pfizer, Pierre Fabre, Sanfoi Synthelabo, Schering Plough, Sepracor, Shire, Solvay, Somaxon, Takeda, Tetragenix, and Wyeth; and is on the speaker’s bureau of Pfizer.
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Disclosure statement snapshot from this CME course led by Stahl.
Posts
3 comments:
Is he trying to be funny in his chalk talks? He's a pitiful speaker.
Yeah he thinks he's all that I guess! he prob doesnt care ppl dont really respect greedy ppl like him enough to listen to him anyway. Maybe doctors can look the other way...
Good to see you Lisa!!
Yeah, lately I've been lurking more than commenting. I don't know what has gotten into me, I'm not as mouthy as usual. It's so odd. Probably some kind of axis 2 problem, cluster c avoidance or something. I bet some Latuda would help - taken off label, of course.
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