Brand Name
ZYPREXA Relprevv
Generic Name
Olanzapine pamoate
View Brand Information FDA approval date: December 11, 2009
Form: Kit
What is ZYPREXA Relprevv (Olanzapine pamoate)?
ZYPREXA RELPREVV is available only through a restricted distribution program [see Warnings and Precautions.
Approved To Treat
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Brand Information
ZYPREXA (Olanzapine pamoate)
1INDICATIONS AND USAGE
ZYPREXA RELPREVV is available only through a restricted distribution program
1.1Schizophrenia
ZYPREXA RELPREVV is indicated for the treatment of schizophrenia. Efficacy was established in two clinical trials in patients with schizophrenia: one 8-week trial in adults and one maintenance trial in adults
2DOSAGE FORMS AND STRENGTHS
ZYPREXA RELPREVV is a powder for suspension for intramuscular use only. ZYPREXA RELPREVV is present as a yellow solid in a glass vial equivalent to 210, 300, or 405 mg olanzapine single-dose per vial. The diluent is a clear, colorless to slightly yellow solution in a glass vial
3CONTRAINDICATIONS
None.
4DESCRIPTION
ZYPREXA RELPREVV is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 10H-thieno[2,3-b][1,5]benzodiazepine, 2-methyl-4-(4-methyl-1-piperazinyl)-,4,4′-methylenebis[3-hydroxy-2-naphthalenecarboxylate] (1:1), monohydrate. The formula is C
ZYPREXA RELPREVV is a long-acting form of olanzapine and is intended for deep intramuscular gluteal injection only.
ZYPREXA RELPREVV includes a single-dose vial of the drug product and a vial of the sterile diluent for ZYPREXA RELPREVV.
The drug product is olanzapine pamoate monohydrate, present as a yellow solid in a glass vial equivalent to 210, 300, or 405 mg olanzapine base per vial. The diluent for ZYPREXA RELPREVV is a clear, colorless to slightly yellow solution in a glass vial and is composed of carboxymethylcellulose sodium, mannitol, polysorbate 80, sodium hydroxide and/or hydrochloric acid for pH adjustment, and water for injection. The drug product is suspended in the diluent for ZYPREXA RELPREVV to a target concentration of 150 mg olanzapine per mL prior to intramuscular injection.
5PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (
Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking ZYPREXA RELPREVV. Patients should be advised to call their doctor if they do not think they are getting better or have concerns about their condition.
Post-Injection Delirium/Sedation Syndrome
During premarketing clinical studies, reactions that presented with signs and symptoms consistent with olanzapine overdose have been reported in patients following an injection of ZYPREXA RELPREVV. It is mandatory that patients be enrolled in the ZYPREXA RELPREVV Patient Care Program to receive ZYPREXA RELPREVV treatment. Patients should be advised of the risk of post-injection delirium/sedation syndrome each time they receive an injection
Elderly Patients with Dementia-Related Psychosis: Increased Mortality and Cerebrovascular Adverse Events (CVAE), Including Stroke
Patients and caregivers should be advised that elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Patients and caregivers should be advised that elderly patients with dementia-related psychosis treated with ZYPREXA had a significantly higher incidence of cerebrovascular adverse events (e.g., stroke, transient ischemic attack) compared with placebo.
ZYPREXA RELPREVV is not approved for elderly patients with dementia-related psychosis
Neuroleptic Malignant Syndrome (NMS)
Patients and caregivers should be counseled that a potentially fatal symptom complex sometimes referred to as NMS has been reported in association with administration of antipsychotic drugs, including ZYPREXA. Signs and symptoms of NMS include hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia)
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
Patients should be advised to report to their health care provider at the earliest onset of any signs or symptoms that may be associated with Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
Hyperglycemia and Diabetes Mellitus
Patients should be advised of the potential risk of hyperglycemia-related adverse reactions related to ZYPREXA RELPREVV. Patients should be monitored regularly for worsening of glucose control. Patients who have diabetes should follow their doctor's instructions about how often to check their blood sugar while taking ZYPREXA RELPREVV
Dyslipidemia
Patients should be counseled that dyslipidemia has occurred during treatment with ZYPREXA RELPREVV. Patients should have their lipid profile monitored regularly
Weight Gain
Patients should be counseled that weight gain has occurred during treatment with ZYPREXA RELPREVV. Patients should have their weight monitored regularly
Orthostatic Hypotension
Patients should be advised of the risk of orthostatic hypotension, and in association with the use of concomitant drugs that may potentiate the orthostatic effect of ZYPREXA RELPREVV, e.g., diazepam or alcohol
Potential for Cognitive and Motor Impairment
Because ZYPREXA RELPREVV has the potential to impair judgment, thinking, or motor skills, patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that ZYPREXA RELPREVV therapy does not affect them adversely. Additionally, due to the risk of post-injection delirium/sedation syndrome, patients should not drive or operate heavy machinery for the remainder of the day of each injection
Body Temperature Regulation
Patients should be advised regarding appropriate care in avoiding overheating and dehydration. Patients should be advised to call their doctor right away if they become severely ill and have some or all of these symptoms of dehydration: sweating too much or not at all, dry mouth, feeling very hot, feeling thirsty, not able to produce urine
Concomitant Medication
Patients should be advised to inform their healthcare providers if they are taking, or plan to take, ZYPREXA or Symbyax
Alcohol
Patients should be advised to avoid alcohol while taking ZYPREXA RELPREVV
Use in Specific Populations
Pregnancy — Advise women to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with ZYPREXA RELPREVV. Advise patients that ZYPREXA RELPREVV may cause extrapyramidal and/or withdrawal symptoms (agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder) in a neonate. Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ZYPREXA RELPREVV during pregnancy [see Use in Specific Populations (.
Lactation — Advise breastfeeding women using ZYPREXA RELPREVV to monitor infants for excess sedation, irritability, poor feeding and extrapyramidal symptoms (tremors and abnormal muscle movements) and to seek medical care if they notice these signs [see Use in Specific Populations (.
Infertility — Advise females of reproductive potential that ZYPREXA RELPREVV may impair fertility due to an increase in serum prolactin levels. The effects on fertility are reversible [see Use in Specific Populations (.
Pediatric Use — Safety and effectiveness of ZYPREXA RELPREVV in patients under 18 years have not been established [see Use in Specific Populations (.
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