OLANZAPINE injection, powder, lyophilized, for solution

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

OLANZAPINE (UNII: N7U69T4SZR) (OLANZAPINE - UNII:N7U69T4SZR)

Disponible depuis:

American Regent, Inc.

DCI (Dénomination commune internationale):

OLANZAPINE

Composition:

OLANZAPINE 10 mg in 2 mL

Mode d'administration:

INTRAMUSCULAR

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Olanzapine for injection is indicated for the treatment of acute agitation associated with schizophrenia and bipolar I mania. Efficacy was demonstrated in 3 short-term (24 hours of intramuscular treatment) placebo-controlled trials in agitated adult inpatients with: schizophrenia or bipolar I disorder (manic or mixed episodes) [see Clinical Studies (14.3)]. “Psychomotor agitation” is defined in DSM-IV as “excessive motor activity associated with a feeling of inner tension.” Patients experiencing agitation often manifest behaviors that interfere with their diagnosis and care, e.g., threatening behaviors, escalating or urgently distressing behavior, or self-exhausting behavior, leading clinicians to the use of intramuscular antipsychotic medications to achieve immediate control of the agitation. - None with olanzapine monotherapy. - For specific information about the contraindications of lithium or valproate, refer to the Contraindications section of the package inserts for these other products. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including olanzapine, during pregnancy. Healthcare providers are encouraged to register patients by contacting the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/. Risk Summary Neonates exposed to antipsychotic drugs, including olanzapine, during the third trimester are at risk for extrapyramidal and/or withdrawal symptoms following delivery (see Clinical Considerations). Overall available data from published epidemiologic studies of pregnant women exposed to olanzapine have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data). There are risks to the mother associated with untreated schizophrenia or bipolar I disorder and with exposure to antipsychotics, including olanzapine, during pregnancy (see Clinical Considerations). Olanzapine was not teratogenic when administered orally to pregnant rats and rabbits at doses that are 9- and 30-times the daily oral maximum recommended human dose (MRHD), based on mg/m2 body surface area; some fetal toxicities were observed at these doses (see Data ). The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-associated maternal and embryo/fetal risk There is a risk to the mother from untreated schizophrenia or bipolar I disorder, including increased risk of relapse, hospitalization, and suicide. Schizophrenia and bipolar I disorder are associated with increased adverse perinatal outcomes, including preterm birth. It is not known if this is a direct result of the illness or other comorbid factors. Fetal/Neonatal adverse reactions Extrapyramidal and/or withdrawal symptoms, including agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder have been reported in neonates who were exposed to antipsychotic drugs, including olanzapine, during the third trimester of pregnancy. These symptoms have varied in severity. Monitor neonates for extrapyramidal and/or withdrawal symptoms and manage symptoms appropriately. Some neonates recovered within hours or days without specific treatment; others required prolonged hospitalization. Data Human Data Placental passage has been reported in published study reports; however, the placental passage ratio was highly variable ranging between 7% to 167% at birth following exposure during pregnancy. The clinical relevance of this finding is unknown. Published data from observational studies, birth registries, and case reports that have evaluated the use of atypical antipsychotics during pregnancy do not establish an increased risk of major birth defects. A retrospective cohort study from a Medicaid database of 9258 women exposed to antipsychotics during pregnancy did not indicate an overall increased risk for major birth defects. Animal Data In oral reproduction studies in rats at doses up to 18 mg/kg/day and in rabbits at doses up to      30 mg/kg/day (9 and 30 times the daily oral MRHD based on mg/m2 body surface area, respectively), no evidence of teratogenicity was observed. In an oral rat teratology study, early resorptions and increased numbers of nonviable fetuses were observed at a dose of 18 mg/kg/day (9 times the daily oral MRHD based on mg/m2 body surface area), and gestation was prolonged at 10 mg/kg/day (5 times the daily oral MRHD based on mg/m2 body surface area). In an oral rabbit teratology study, fetal toxicity manifested as increased resorptions and decreased fetal weight, occurred at a maternally toxic dose of 30 mg/kg/day (30 times the daily oral MRHD based on mg/m2 body surface area). Risk Summary Olanzapine is present in human milk. There are reports of excess sedation, irritability, poor feeding and extrapyramidal symptoms (tremors and abnormal muscle movements) in infants exposed to olanzapine through breast milk (see Clinical Considerations). There is no information on the effects of olanzapine on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for olanzapine and any potential adverse effects on the breastfed child from olanzapineor from the mother’s underlying condition. Clinical Considerations Infants exposed to olanzapine should be monitored for excess sedation, irritability, poor feeding, and extrapyramidal symptoms (tremors and abnormal muscle movements). Olanzapine binds with high affinity to the following receptors: serotonin 5HT2A/2C , 5HT6 (Ki =4, 11, and 5 nM, respectively), dopamine D1-4 (Ki =11 to 31 nM), histamine H1 (Ki =7 nM), and adrenergic α1 receptors (Ki =19 nM). Olanzapine is an antagonist with moderate affinity binding for serotonin 5HT3 (Ki =57 nM) and muscarinic M1-5 (Ki =73, 96, 132, 32, and 48 nM, respectively). Olanzapine binds with low affinity to GABAA , BZD, and β-adrenergic receptors (Ki >10 μM). Compared to patients from adult clinical trials, adolescents were likely to gain more weight, experience increased sedation, and have greater increases in total cholesterol, triglycerides, LDL cholesterol, prolactin and hepatic aminotransferase levels [see Warnings and Precautions (5.5, 5.15, 5.17) and Adverse Reactions (6.1)] . When deciding among the alternative treatments available for adolescents, clinicians should consider the increased potential (in adolescents as compared with adults) for weight gain and dyslipidemia. Clinicians should consider the potential long-term risks when prescribing to adolescents, and in many cases this may lead them to consider prescribing other drugs first in adolescents. Safety and effectiveness of olanzapine in children <13 years of age have not been established [see Patient Counseling Information (17)] . Of the 2500 patients in premarketing clinical studies with oral olanzapine, 11% (263) were 65 years of age or over. In patients with schizophrenia, there was no indication of any different tolerability of olanzapine in the elderly compared to younger patients.  Studies in elderly patients with dementia-related psychosis have suggested that there may be a different tolerability profile in this population compared to younger patients with schizophrenia. Elderly patients with dementia-related psychosis treated with olanzapine are at an increased risk of death compared to placebo. In placebo-controlled studies of olanzapine in elderly patients with dementia-related psychosis, there was a higher incidence of cerebrovascular adverse events (e.g., stroke, transient ischemic attack) in patients treated with olanzapine compared to patients treated with placebo. In 5 placebo-controlled studies of olanzapine in elderly patients with dementia-related psychosis (n=1184), the following adverse reactions were reported in olanzapine-treated patients at an incidence of at least 2% and significantly greater than placebo-treated patients: falls, somnolence, peripheral edema, abnormal gait, urinary incontinence, lethargy, increased weight, asthenia, pyrexia, pneumonia, dry mouth and visual hallucinations. The rate of discontinuation due to adverse reactions was greater with olanzapine than placebo (13% vs 7%). Elderly patients with dementia-related psychosis treated with olanzapine are at an increased risk of death compared to placebo. Olanzapine is not approved for the treatment of patients with dementia-related psychosis [see Boxed Warning, Warnings and Precautions ( 5.1) , and Patient Counseling Information (17)]. Also, the presence of factors that might decrease pharmacokinetic clearance or increase the pharmacodynamic response to olanzapine should lead to consideration of a lower starting dose for any geriatric patient [see Boxed Warning, and Warnings and Precautions (5.1)] . In studies prospectively designed to assess abuse and dependence potential, olanzapine was shown to have acute depressive CNS effects but little or no potential of abuse or physical dependence in rats administered oral doses up to 15 times the daily oral MRHD (20 mg) and rhesus monkeys administered oral doses up to 8 times the daily oral MRHD based on mg/m2 body surface area. Olanzapine has not been systematically studied in humans for its potential for abuse, tolerance, or physical dependence. While the clinical trials did not reveal any tendency for any drug-seeking behavior, these observations were not systematic, and it is not possible to predict on the basis of this limited experience the extent to which a CNS-active drug will be misused, diverted, and/or abused once marketed. Consequently, patients should be evaluated carefully for a history of drug abuse, and such patients should be observed closely for signs of misuse or abuse of olanzapine (e.g., development of tolerance, increases in dose, drug-seeking behavior).

Descriptif du produit:

Olanzapine for Injection is available in a 10 mg vial – NDC 0517-0955-01. Store olanzapine for injection vials (before reconstitution) at controlled room temperature, 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Reconstituted olanzapine for injection may be stored at controlled room temperature, 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] for up to 1 hour if necessary. Discard any unused portion of reconstituted olanzapine for injection. Protect olanzapine for injection from light, do not freeze.

Statut de autorisation:

Abbreviated New Drug Application

Notice patient

American Regent, Inc.
----------
SPL MEDICATION GUIDE
Information pertaining to a Medication Guide has been omitted as it is
not required, and was not part of
American Regent’s ANDA approval.
Revised: 11/2022
Document Id: b8891afa-918e-47f6-9beb-f0dbd68ebfd3
34391-3
Set id: e9ac2bd3-dbff-4b1a-952f-da3909c6e4ee
Version: 15
Effective Time: 20221122
American Regent, Inc.

Résumé des caractéristiques du produit

OLANZAPINE- OLANZAPINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
AMERICAN REGENT, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OLANZAPINE FOR
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
OLANZAPINE FOR
INJECTION.
OLANZAPINE FOR INJECTION, POWDER, FOR SOLUTION FOR INTRAMUSCULAR USE.
INITIAL U.S. APPROVAL: 1996
WARNING: INCREASED MORTALITY IN ELDERLY
PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS TREATED WITH
ANTIPSYCHOTIC DRUGS
ARE AT AN INCREASED RISK OF DEATH. OLANZAPINE FOR INJECTION IS NOT
APPROVED FOR THE
TREATMENT OF PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS. (5.1, 8.5, 17)
RECENT MAJOR CHANGES
Warnings and Precautions, Tardive Dyskinesia (5.6) 10/2019
Warnings and Precautions, Use in Patients with Concomitant Illness
(5.14) Removed 04/2020
Warnings and Precautions, Anticholinergic (antimuscarinic) Effects
(5.14) 04/2020
INDICATIONS AND USAGE
Olanzapine for injection is an atypical antipsychotic indicated for
the:
Treatment of acute agitation associated with schizophrenia and bipolar
I mania. (1.4)
Efficacy was established in three 1-day trials in adults. (14.3)
DOSAGE AND ADMINISTRATION
Agitation associated with
Schizophrenia and Bipolar I Mania
in adults (2.4)
Intramuscular: 10 mg (5 mg or 7.5 mg when clinically warranted)Assess
for orthostatic hypotension prior to subsequent dosing (max. 3 doses 2
to 4 hrs apart)
Lower starting dose recommended in debilitated or pharmacodynamically
sensitive patients or patients
with predisposition to hypotensive reactions, or with potential for
slowed metabolism. (2.4)
DOSAGE FORMS AND STRENGTHS
Intramuscular Injection: 10 mg vial. (3)
CONTRAINDICATIONS
None with olanzapine monotherapy. (4)
When using olanzapine in combination with lithium or valproate, refer
to the Contraindications section of
the package inserts for those products. (4)
WARNINGS AND PRECAUTIONS
_El