Metabolic Changes: Atypical antipsychotic drugs have been associated with metabolic changes including hyperglycemia/diabetes mellitus, dyslipidemia, and weight gain. Clinical monitoring is recommended.
Leukopenia, Neutropenia, and Agranulocytosis: Leukopenia, neutropenia, and agranulocytosis have been reported with antipsychotic use. Perform complete blood count (CBC) in patients with a pre-existing low white blood cell count (WBC) or a history of leukopenia or neutropenia. Consider discontinuing REXULTI if a clinically significant decline in WBC count occurs in the absence of other causative factors.
Orthostatic Hypotension and Syncope: REXULTI should be used with caution in patients with known cardiovascular disease, cerebrovascular disease, or conditions which would predispose them to hypotension.
Seizures: Use cautiously in patients with a history of seizures or with conditions that lower the seizure threshold.
Body Temperature Dysregulation: Appropriate care is advised for patients who may exercise strenuously, be exposed to extreme heat, receive concomitant medication with anticholinergic activity, or be subject to dehydration.
Dysphagia: Esophageal dysmotility and aspiration have been associated with antipsychotic drug use. REXULTI should be used with caution in patients at risk for aspiration pneumonia.
Potential for Cognitive and Motor Impairment: REXULTI may have the potential to impair judgment, thinking, or motor skills. Patients should not drive or operate hazardous machinery until they are certain REXULTI does not affect them adversely.
Alcohol: Advise patients to avoid alcohol while taking REXULTI.
Concomitant Medication: Administer half the dose of REXULTI with strong CYP2D6 or CYP3A4 inhibitors. Administer a quarter of the dose with strong/moderate CYP2D6 inhibitors or known CYP2D6 poor metabolizers taken with strong/moderate CYP3A4 inhibitors. Double the dose with strong CYP3A4 inducers over 1 to 2 weeks.
In clinical trials examining the adjunctive use of REXULTI in the treatment of MDD, dosage was not adjusted for strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine). CYP considerations were already factored into general dosing recommendations for MDD. Thus, REXULTI may be administered without dosage adjustment in these patients.
Most commonly observed adverse reactions: Adult patients with major depressive disorder (adjunctive treatment to antidepressant therapy; ≥5% incidence and at least twice the rate of placebo for REXULTI vs. placebo, respectively): akathisia (9% vs. 2%) and weight increase (7% vs. 2%). Adult patients with schizophrenia (≥4% incidence and at least twice the rate of placebo for REXULTI vs. placebo, respectively): weight increased (4% vs. 2%).
Dystonia: Dystonia may occur in susceptible individuals during the first days of treatment and at low doses.
Pregnancy: Non-Teratogenic Effects – Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. REXULTI should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Lactation: It is not known if REXULTI is excreted in human breast milk. Discontinue the drug or nursing, taking into account the importance of the drug to the mother.
REXULTI is indicated for:
Use as an adjunctive therapy to antidepressants in adults with major depressive disorder
Treatment of schizophrenia in adults
This medication is used to treat certain mental/mood disorders (such as schizophrenia, depression). Brexpiprazole helps you to think more clearly, feel less nervous, and take part in everyday life. It may also help to decrease hallucinations (hearing/seeing things that are not there). In addition, this medication may improve your mood, sleep, appetite, and energy level. Brexpiprazole is a psychiatric medication that belongs to the class of drugs called atypical antipsychotics. It works by helping to restore the balance of certain natural substances in the brain.
IMPORTANT SAFETY INFORMATION AND INDICATIONS for REXULTI® (brexpiprazole)
IMPORTANT SAFETY INFORMATION
Increased Mortality in Elderly Patients with Dementia-Related Psychosis
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death compared to placebo. REXULTI is not approved for the treatment of patients with dementia-related psychosis.
Suicidal Thoughts and Behaviors
Antidepressants increase the risk of suicidal thoughts and behaviors in patients aged 24 years and younger. All patients on antidepressant therapy should be monitored and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Also, families and caregivers should be advised to closely observe these patients and communicate with the prescriber. REXULTI is not approved for use in pediatric patients with depression.
See Full Prescribing Information for complete Boxed WARNING.
Contraindication: Known hypersensitivity reaction to REXULTI or any of its components. Reactions have included: rash, facial swelling, urticaria and anaphylaxis.
Cerebrovascular Adverse Events, Including Stroke: In placebo-controlled trials with risperidone, aripiprazole, and olanzapine in elderly patients with dementia, there was a higher incidence of cerebrovascular adverse reactions (stroke, TIA), including fatalities, compared to placebo-treated patients.
Neuroleptic Malignant Syndrome (NMS): A potentially fatal complex sometimes referred to as NMS has been associated with the administration of antipsychotic drugs. Manage with immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent therapy, intensive symptomatic treatment and medical monitoring.
Tardive Dyskinesia (TD): REXULTI should be prescribed in a manner most likely to minimize the occurrence of TD. If signs and symptoms of TD appear, drug discontinuation should be considered.
Metabolic Changes: Atypical antipsychotic drugs have been ass
If you click on the chart once and look to the left check out "Profile" and go to the company web site. Also click on Key Stats, Headlines etc. If you click on the chart twice then you got to the big chart ...start to become familiar with the indicators, candlestick charts, moving averages etc. If you look near anyones name you will see "Flag"...you can use this to IGNORE bashers and dimwits.
If you want to read a good military book, there is a book titled " Stealth Patrol: The Making Of A Vietnam Ranger " on Amazon written by my buddy Bill Shanahan.
N co 75th Infantry, Long Range Reconnaissance Patrol (LRRP), 173rd Airborne Brigade. '68-69
Uli was the CEO- the buck stops with him and he dropped the ball, he's lucky he didn't end up in court or investigated by the SEC. He totally screwed up the company and was handed his hat. Lucky him. The BB didn't steal anything. They were perfectly happy with the NDA " on track " like everyone else. I am sure they would have preferred the whole thing had never have happened.
Type Value Conf.
resist. 36.09 6
supp 34.98 4
supp 33.98 4
supp 32.44 3
supp 30.19 3
supp 28.70 2
supp 27.63 2
supp 26.88 4
supp 24.61 4
supp 21.76 2
supp 20.89 3
supp 19.23 2
supp 17.32 4
Recent CandleStick Analysis
May-27-2016 Bullish Engulfing
Ind. short Inter Long
EMA VBu VBu VBu
MACD VBe VBu VBu
Fibs Bu Bu Bu
Highs VBu VBe VBe
Lows VBu Be N
Trends N N N
Analysis Overall Short Intermediate Long
Bullish (0.34) Bullish (0.46) Bullish (0.31) Bullish (0.26)
When you think about it...the three of them lied...Uli, Davis and Mills...and that is a conspiracy. Why they never got in trouble with the SEC is beyond me. I am fairly sure the head of the conspiracy was Uli.
Seems similar to what happened with ACAD...when Uli "retired " (Mar2015). And how long did it take for us to recover and then submit the NDA? 6 months(Sept2015). So I would expect AZN to resubmit
AZN will submit again probably by next year....AstraZeneca intends to try a second time to secure ZS-9's approval from FDA, also for the treatment of hyperkalemia, but the company offered no timeline Friday for when that might happen. The FDA rejected ZS-9 because of undisclosed manufacturing issues which need to be fixed, the company said, adding that regulators did not ask for additional clinical trials to be conducted on ZS-9.