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Drug overview for LYBALVI (olanzapine/samidorphan malate):
Generic name: olanzapine/samidorphan malate (oh-LAN-za-peen/SAM-i-DOR-fan)
Drug class: Antipsychotics
Therapeutic class: Central Nervous System Agents
Olanzapine is considered an atypical or second-generation antipsychotic agent.
Olanzapine is used orally for the symptomatic management of psychotic disorders (e.g., schizophrenia) in adults and adolescents 13-17 years of age. In addition, oral olanzapine is used alone in adults and adolescents 13-17 years of age or in conjunction with lithium or valproate in adults for the management of acute manic or mixed episodes associated with bipolar I disorder; the drug also is used for longer-term maintenance monotherapy in patients with this disorder. Short-acting olanzapine injection is used IM for the management of acute agitation in patients with bipolar disorder or schizophrenia.
Long-acting olanzapine pamoate injection is used IM for the management of schizophrenia in adults. Olanzapine is used orally in combination with fluoxetine for the treatment of acute depressive episodes associated with bipolar I disorder in adults and pediatric patients 10-17 years of age. The drug also is used orally in combination with fluoxetine for the acute and maintenance therapy of treatment-resistant depression.
Olanzapine has been used orally in combination with other antiemetic agents for the prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy+, including high-dose cisplatin therapy in adults. The drug also has been used as rescue antiemetic therapy in patients with breakthrough cancer chemotherapy-induced nausea and vomiting+.
Generic name: olanzapine/samidorphan malate (oh-LAN-za-peen/SAM-i-DOR-fan)
Drug class: Antipsychotics
Therapeutic class: Central Nervous System Agents
Olanzapine is considered an atypical or second-generation antipsychotic agent.
Olanzapine is used orally for the symptomatic management of psychotic disorders (e.g., schizophrenia) in adults and adolescents 13-17 years of age. In addition, oral olanzapine is used alone in adults and adolescents 13-17 years of age or in conjunction with lithium or valproate in adults for the management of acute manic or mixed episodes associated with bipolar I disorder; the drug also is used for longer-term maintenance monotherapy in patients with this disorder. Short-acting olanzapine injection is used IM for the management of acute agitation in patients with bipolar disorder or schizophrenia.
Long-acting olanzapine pamoate injection is used IM for the management of schizophrenia in adults. Olanzapine is used orally in combination with fluoxetine for the treatment of acute depressive episodes associated with bipolar I disorder in adults and pediatric patients 10-17 years of age. The drug also is used orally in combination with fluoxetine for the acute and maintenance therapy of treatment-resistant depression.
Olanzapine has been used orally in combination with other antiemetic agents for the prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy+, including high-dose cisplatin therapy in adults. The drug also has been used as rescue antiemetic therapy in patients with breakthrough cancer chemotherapy-induced nausea and vomiting+.
DRUG IMAGES
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The following indications for LYBALVI (olanzapine/samidorphan malate) have been approved by the FDA:
Indications:
Bipolar disorder
Schizophrenia
Professional Synonyms:
Bipolar affective disorder
Bipolar affective illness
Bipolar mood disorder
Dementia praecox
Manic-depressive illness
Parergasia
Indications:
Bipolar disorder
Schizophrenia
Professional Synonyms:
Bipolar affective disorder
Bipolar affective illness
Bipolar mood disorder
Dementia praecox
Manic-depressive illness
Parergasia
The following dosing information is available for LYBALVI (olanzapine/samidorphan malate):
Olanzapine is commercially available as the base and as the pamoate salt; the dosage of olanzapine pamoate is expressed in terms of olanzapine.
Conventional olanzapine tablets and orally disintegrating tablets of the drug are bioequivalent. However, IM administration of a 5-mg dose of the commercially available short-acting olanzapine injection results in a maximum plasma olanzapine concentration that is about fivefold higher than that resulting from a 5-mg oral dose of the drug.
Dosage of olanzapine for psychiatric indications (e.g., psychotic disorders, bipolar disorder, treatment-resistant depression) must be adjusted carefully according to individual requirements and response, using the lowest possible effective dosage.
The manufacturer states that because only minimal amounts of olanzapine (about 7%) are excreted in urine and because the pharmacokinetics of olanzapine appear not to be altered in patients with renal or hepatic impairment, dosage adjustment is not necessary in such patients.
The manufacturer states that the extended-release IM formulation of olanzapine pamoate (Zyprexa(R) Relprevv) has not been specifically studied in patients with renal and/or hepatic impairment.
Conventional olanzapine tablets and orally disintegrating tablets of the drug are bioequivalent. However, IM administration of a 5-mg dose of the commercially available short-acting olanzapine injection results in a maximum plasma olanzapine concentration that is about fivefold higher than that resulting from a 5-mg oral dose of the drug.
Dosage of olanzapine for psychiatric indications (e.g., psychotic disorders, bipolar disorder, treatment-resistant depression) must be adjusted carefully according to individual requirements and response, using the lowest possible effective dosage.
The manufacturer states that because only minimal amounts of olanzapine (about 7%) are excreted in urine and because the pharmacokinetics of olanzapine appear not to be altered in patients with renal or hepatic impairment, dosage adjustment is not necessary in such patients.
The manufacturer states that the extended-release IM formulation of olanzapine pamoate (Zyprexa(R) Relprevv) has not been specifically studied in patients with renal and/or hepatic impairment.
No enhanced Administration information available for this drug.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| LYBALVI 5-10 MG TABLET | Maintenance | Adults take 1 tablet by oral route once daily |
| LYBALVI 10-10 MG TABLET | Maintenance | Adults take 1 tablet by oral route once daily |
| LYBALVI 15-10 MG TABLET | Maintenance | Adults take 1 tablet by oral route once daily |
| LYBALVI 20-10 MG TABLET | Maintenance | Adults take 1 tablet by oral route once daily |
No generic dosing information available.
The following drug interaction information is available for LYBALVI (olanzapine/samidorphan malate):
There are 2 contraindications.
These drug combinations generally should not be dispensed or administered to the same patient. A manufacturer label warning that indicates the contraindication warrants inclusion of a drug combination in this category, regardless of clinical evidence or lack of clinical evidence to support the contraindication.
| Drug Interaction | Drug Names |
|---|---|
| Opioid Antagonists/Opioid Analgesics SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient. MECHANISM OF ACTION: Naltrexone, nalmefene, and samidorphan are opioid antagonists and thus inhibit the effects of opioid analgesics.(1-3) CLINICAL EFFECTS: Concurrent administration or the administration of naltrexone within 7-10 days of opioids may induce acute abstinence syndrome or exacerbate a pre-existing subclinical abstinence syndrome.(1,4) Patients taking naltrexone may not experience beneficial effects of opioid-containing medications.(4) Samidorphan can precipitate opioid withdrawal in patients who are dependent on opioids. In patients who use opioids, delay initiation of samidorphan for a minimum of 7 days after last use of short-acting opioids and 14 days after last use of long-acting opioids.(3) Concurrent use of nalmefene tablets with opioid agonists may prevent the beneficial effects of the opioid.(2) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The manufacturer of naltrexone states that the administration of naltrexone concurrently with opioids or to patients dependent on opioids is contraindicated.(1,4) Patients previously dependent on short-acting opioids should be opioid-free for a minimum of seven to ten days before beginning naltrexone therapy. Patients previously on buprenorphine or methadone may be vulnerable to withdrawal symptoms for as long as 2 weeks.(1,4) The manufacturer of naltrexone states that the naloxone challenge test, described in the naltrexone prescribing information, can be administered to determine if patients are opioid free.(1) The manufacturer of samidorphan states the concurrent use of samidorphan in patients using opioids or undergoing acute opioid withdrawal is contraindicated. Prior to initiating samidorphan, there should be at least a 7-day opioid free interval from the last use of short-acting opioids, and at least a 14-day opioid free interval from the last use of long-acting opioids.(3) The UK manufacturer of nalmefene tablets (for reduction of alcohol consumption) states the concurrent use of opioid analgesics is contraindicated.(2) Suspend the use of nalmefene tablets for 7 days prior to the anticipated use of opioids (e.g., elective surgery).(2) DISCUSSION: A double-blind, randomized, placebo-control study evaluated pain relief and side effects of 35 opioid-naive patients undergoing cesarean section. All patients received spinal anesthesia (bupivacaine and morphine) and were randomized to also receive placebo, naltrexone 3 mg, or naltrexone 6 mg. Patients treated with naltrexone experienced shorter duration of pain relief (not statistically significant), however incidence of opioid-induced side effects was reduced. Patients in the naltrexone 6 mg group had lower rates of pruritus, vomiting, and somnolence (all statistically significant) compared to the placebo group.(5) In a double-blind, randomized, placebo-control trial ten recreational opioid users were studied to determine the effects of hydromorphone (4 mg and 16 mg), tramadol (87.5 mg, 175 mg, and 350 mg), and placebo after pretreatment with naltrexone (50 mg) or placebo. Results show that lower doses of hydromorphone and tramadol acted similar to placebo. Hydromorphone 16 mg alone caused euphoria and miosis which were blocked by naltrexone. Tramadol 350 mg produced a lower magnitude of euphoria and miosis compared to hydromorphone. Naltrexone partially diminished the euphoria caused by tramadol, while it enhanced some of the unpleasant monoaminergic effects (flushing, malaise, vomiting).(6) A case report describes a 28 year-old ex-heroin addict who was stable on methadone 100 mg daily and simultaneously stopped using heroin and began drinking alcohol. He was admitted to the hospital for alcohol detoxification and, by mistake, was given naltrexone 100 mg instead of methadone 100 mg. The patient experienced withdrawal symptoms including chills, agitation, muscle and abdominal pain, generalized piloerection, and dilated pupils. Treatment of withdrawal was titrated to treat symptoms and required administration 78 mg of parenteral hydromorphone, after which the patient experienced relief for the following six hours.(8) Intentional administration of an opioid antagonist, naloxone, with opioid analgesics has been performed with close monitoring to lower required opioid dose by inducing withdrawal. Three case reports describe patients who had improved pain relief on significantly reduced doses of opioid analgesics.(8) In a double-blind controlled trial, 267 trauma patients were randomized to receive 0.05 mg/kg intravenous morphine either alone or in combination with 5 mg naltrexone oral suspension. Evaluated endpoints include reduction of pain and incidence of side effects. Results indicate that ultra-low dose naltrexone does not alter opioid requirements for pain control, but does lower incidence of nausea [2 (1.16%) vs 16 (11.6%), p<0.001].(9) |
ACETAMIN-CAFF-DIHYDROCODEINE, ACETAMINOPHEN-CODEINE, APADAZ, ASA-BUTALB-CAFFEINE-CODEINE, ASCOMP WITH CODEINE, BELBUCA, BELLADONNA-OPIUM, BENZHYDROCODONE-ACETAMINOPHEN, BRIXADI, BUPRENORPHINE, BUPRENORPHINE HCL, BUPRENORPHINE-NALOXONE, BUTALB-ACETAMINOPH-CAFF-CODEIN, BUTORPHANOL TARTRATE, BUTRANS, CARISOPRODOL-ASPIRIN-CODEINE, CODEINE PHOSPHATE, CODEINE SULFATE, CONZIP, DEMEROL, DIHYDROCODEINE BITARTRATE, DILAUDID, DIPHENOXYLATE-ATROPINE, DISKETS, DSUVIA, DURAMORPH, ENDOCET, FENTANYL, FENTANYL CITRATE, FENTANYL CITRATE-0.9% NACL, FENTANYL CITRATE-D5W, FENTANYL CITRATE-STERILE WATER, FENTANYL CITRATE-WATER, FENTANYL-BUPIVACAINE-0.9% NACL, FENTANYL-BUPIVACAINE-NACL, FENTANYL-ROPIVACAINE-0.9% NACL, FENTANYL-ROPIVACAINE-NACL, FIORICET WITH CODEINE, HYCODAN, HYDROCODONE BITARTRATE, HYDROCODONE BITARTRATE ER, HYDROCODONE-ACETAMINOPHEN, HYDROCODONE-CHLORPHENIRAMNE ER, HYDROCODONE-HOMATROPINE MBR, HYDROCODONE-IBUPROFEN, HYDROMET, HYDROMORPHONE ER, HYDROMORPHONE HCL, HYDROMORPHONE HCL-0.9% NACL, HYDROMORPHONE HCL-D5W, HYDROMORPHONE HCL-NACL, HYDROMORPHONE HCL-WATER, HYSINGLA ER, INFUMORPH, LEVORPHANOL TARTRATE, LOMOTIL, MEPERIDINE HCL, MEPERIDINE HCL-0.9% NACL, METHADONE HCL, METHADONE HCL-0.9% NACL, METHADONE HCL-NACL, METHADONE INTENSOL, METHADOSE, MITIGO, MORPHINE SULFATE, MORPHINE SULFATE ER, MORPHINE SULFATE-0.9% NACL, MORPHINE SULFATE-NACL, MOTOFEN, MS CONTIN, NALBUPHINE HCL, NALOCET, NUCYNTA, NUCYNTA ER, OLINVYK, OPIUM TINCTURE, OXYCODONE HCL, OXYCODONE HCL ER, OXYCODONE HYDROCHLORIDE, OXYCODONE-ACETAMINOPHEN, OXYCONTIN, OXYMORPHONE HCL, OXYMORPHONE HCL ER, PENTAZOCINE-NALOXONE HCL, PERCOCET, PRIMLEV, PROLATE, PROMETHAZINE-CODEINE, QDOLO, REMIFENTANIL HCL, ROXICODONE, ROXYBOND, SUBLOCADE, SUBOXONE, SUFENTANIL CITRATE, TRAMADOL HCL, TRAMADOL HCL ER, TRAMADOL HCL-ACETAMINOPHEN, TREZIX, TUXARIN ER, ULTIVA, XTAMPZA ER, ZUBSOLV |
| Iomeprol/Neuroleptics SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient. MECHANISM OF ACTION: Neuroleptics may lower seizure threshold.(1) CLINICAL EFFECTS: Use of iomeprol in a patient receiving a neuroleptic may increase the risk of seizure.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The manufacturer of iomeprol states that neuroleptics should be discontinued 48 hours before iomeprol use. Treatment with a neuroleptic should not be resumed until 24 hours post-procedure.(1) DISCUSSION: Because neuroleptics may lower seizure threshold, neuroleptics should be discontinued 48 hours before iomeprol use. Treatment with a neuroleptic should not be resumed until 24 hours post-procedure.(1) |
IOMERON 350 |
There are 5 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Cabergoline/Selected Dopamine Blockers SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Dopamine (D2) blockers such as the phenothiazines, butyrophenones, thioxanthenes and atypical antipsychotics may decrease the effects of cabergoline, a dopamine agonist.(1) CLINICAL EFFECTS: Concurrent administration of cabergoline with dopamine blockers (e.g. phenothiazines, butyrophenones, or thio xanthines) may decrease the effectiveness of cabergoline.(1) Cabergoline may decrease the effectiveness of antipsychotic treatment. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The manufacturer of cabergoline states cabergoline(1) should not be administered concurrently with dopamine antagonists. Avoid concurrent use when possible. If cabergoline is started in a patient receiving long term antipsychotic treatment, monitor closely for loss of antipsychotic efficacy. If an antipsychotic is required for a patient on long term cabergoline therapy, consider use of a shorter half-life, less potent dopamine (D2) blocking atypical antipsychotic (e.g. clozapine, quetiapine) and monitor closely. DISCUSSION: The manufacturer of cabergoline state that it should not be administered concurrently with dopamine antagonists. |
CABERGOLINE |
| Metoclopramide/Antipsychotics; Phenothiazines; Rivastigmine SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: These agents block dopamine (D2) receptors. D2 blockade can cause extrapyramidal reactions, such acute dystonic reactions, pseudoparkinsonian tremors, akathisia, or tardive dyskinesia. Neuroleptic malignant syndrome may also occur in patients receiving D2 blockers. The risk of these adverse effects may be increased by concurrent use.(1-3) CLINICAL EFFECTS: Concurrent use may increase the risk of extrapyramidal reactions (e.g. acute dystonic reactions, pseudoparkinsonian tremors, akathisia, or tardive dyskinesia) and neuroleptic malignant syndrome. Tardive dyskinesia, which may be permanent, typically affects the facial muscles and may result in uncontrollable lip smacking, chewing, puckering of the mouth, frowning or scowling, sticking out the tongue, blinking and moving the eyes, and shaking of the arms and/or legs.(1-3) Symptoms of neuroleptic malignant syndrome include hyperpyrexia, muscle rigidity, altered mental status, an autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac arrhythmias), elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure.(1) PREDISPOSING FACTORS: Patients with Parkinson's or Lewy Body Disease may be more likely to have extrapyramidal reactions or unmasking of their primary disease symptoms. The risk of extrapyramidal symptoms is also increased in patients on metoclopramide for longer than 12 weeks. Elderly patients, especially elderly women, and diabetics are at higher risk of developing tardive dyskinesia. Other extrapyramidal symptoms, like acute dystonia, have occurred more frequently in patients younger than 30 years old.(1) PATIENT MANAGEMENT: The concurrent use of metoclopramide and agents likely to cause extrapyramidal reactions should be avoided.(1) If concurrent use is warranted, monitor patients closely for extrapyramidal reactions and neuroleptic malignant syndrome. The manufacturer of metoclopramide says to avoid treatment with metoclopramide for longer than 12 weeks, and to use the lowest possible dose.(1) Discontinue therapy if symptoms occur. Instruct patients to seek immediate medical attention if symptoms develop. Symptoms of extrapyramidal reactions, including tardive dyskinesia, include involuntary movements of limbs and facial grimacing, torticollis, oculogyric crisis, rhythmic protrusion of the tongue, bulbar type of speech, trismus, and/or dystonic reactions resembling tetanus/stridor/dyspnea.(3) DISCUSSION: Both metoclopramide and phenothiazines can cause extrapyramidal reactions, such as tardive dyskinesia, and neuroleptic malignant syndrome. The risk may be increased by concurrent use.(1,2) Extrapyramidal symptoms have been reported with concurrent metoclopramide and neuroleptics, prochlorperazine, and chlorpromazine.(4-6) |
GIMOTI, METOCLOPRAMIDE HCL, REGLAN |
| Selected Dopamine Agonists/Selected Antipsychotics SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Selected dopamine agonists are used to treat neurologic conditions such as Parkinson Disease (PD)or restless legs syndrome, and endocrine disorders such as hyperprolactinemia by directly or indirectly increasing dopamine concentrations at D2 receptors in the central nervous system (CNS). Antipsychotic agents counteract this effect by blocking dopamine activity at CNS D2 receptors.(1-5) CLINICAL EFFECTS: The efficacy of either agent may be decreased, leading to exacerbation of the disease being treated. In patients with Parkinson disease motor symptoms may worsen, increasing the risk for falls, dysphagia or aspiration.(4,7) Compared with Parkinson patients not receiving antipsychotic therapy, Parkinson patients receiving antipsychotics appear to have an increased mortality risk.(6) Patients with other conditions such as restless legs syndrome or a psychotic disorder may also experience symptom exacerbation due to this combination. PREDISPOSING FACTORS: Patients with Parkinson or Diffuse Lewy Body (DLB) disease are particularly susceptible to adverse effects of dopamine blockade by antipsychotics. PATIENT MANAGEMENT: Reassess the need for antipsychotic therapy. If psychosis or hallucinations are due to an antiparkinson agent, when possible consider reducing the dose or changing the antiparkinson agent before initiating antipsychotic therapy. In patients with PD and dementia, addition of a cholinesterase inhibitor (e.g. rivastigmine) may improve psychosis. If an antipsychotic is required, then an atypical antipsychotic should be used.(6,7) In patients with major psychotic disorders, consider reducing the dose, changing or stopping the dopamine agonist. The US manufacturer of ropinirole recommends treatment with dopamine agonists only if potential benefits outweigh risks.(1) The US manufacturer of entacapone states it should not ordinarily be used in patients with major psychotic disorders as entacapone may lead to an exacerbation of psychosis.(4) DISCUSSION: An epidemiologic study evaluated 21,043 elderly patients with Parkinson disease to determine if recent initiation of a typical or atypical antipsychotic was associated with increased mortality. They found an adjusted odds ratio of 2.0 for death associated with atypical antipsychotics versus no antipsychotic They found an adjusted odds ratio of 2.4 for death associated with typical versus atypical antipsychotics. The authors noted the increased mortality found with typical antipsychotics supports current treatment recommendations to use atypical antipsychotic agents in patients with Parkinson disease.(6,7) |
APOKYN, APOMORPHINE HCL, BROMOCRIPTINE MESYLATE, CARBIDOPA-LEVODOPA, CARBIDOPA-LEVODOPA ER, CARBIDOPA-LEVODOPA-ENTACAPONE, CREXONT, CYCLOSET, DHIVY, DUOPA, INBRIJA, LEVODOPA, MIRAPEX ER, NEUPRO, ONAPGO, PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE ER, ROPINIROLE ER, ROPINIROLE HCL, RYTARY, SINEMET, VYALEV |
| Sodium Oxybate/Agents that May Cause Respiratory Depression SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Oxybate by itself may be associated with severe somnolence or respiratory depression. Concurrent use with other CNS depressants may further increase the risk for respiratory depression or loss of consciousness.(1-3) CLINICAL EFFECTS: Concurrent use of sodium oxybate and sedative hypnotics or alcohol may further increase the risk for profound sedation, respiratory depression, coma, and/or death.(1,2) Fatalities have been reported.(3) PREDISPOSING FACTORS: Based upon FDA evaluation of deaths in patients taking sodium oxybate, risk factors may include: use of multiple drugs which depress the CNS, more rapid than recommended oxybate dose titration, exceeding the maximum recommended oxybate dose, and prescribing for unapproved uses such as fibromyalgia, insomnia or migraine. Note that in oxybate clinical trials for narcolepsy 78% - 85% of patients were also receiving concomitant CNS stimulants.(1-3) PATIENT MANAGEMENT: Avoid use of concomitant opioids, benzodiazepines, sedating antidepressants, sedating antipsychotics, general anesthetics, or muscle relaxants, particularly when predisposing risk factors are present. If combination use is required, dose reduction or discontinuation of one or more CNS depressants should be considered. If short term use of an opioid or general anesthetic is required, consider interruption of sodium oxybate treatment.(1,2) Respiratory depression can occur at any time during opioid therapy, especially during therapy initiation and following dosage increases. Consider this risk when using concurrently with other agents that may cause CNS depression.(4) Discuss naloxone with all patients when prescribing or renewing an opioid analgesic or medicine to treat opioid use disorder (OUD). Consider prescribing naloxone to patients prescribed medicines to treat OUD or opioid analgesics (such as those taking CNS depressants) who are at increased risk of opioid overdose and when a patient has household members/close contacts at risk for accidental overdose.(5) DISCUSSION: The FDA evaluated sodium oxybate postmarket fatal adverse event reports from the FDA Adverse Event Reporting System(AERS)and from the manufacturer. Although report documentation was not always optimal or complete, useful information was obtained. Factors which may have contributed to fatal outcome: concomitant use of one or more drugs which depress the CNS, more rapid than recommended oxybate dose titration, exceeding the maximum recommended oxybate dose, and prescribing for unapproved uses such as fibromyalgia, insomnia or migraine. Many deaths occurred in patients with serious psychiatric disorders such as depression and substance abuse. Other concomitant diseases may have also contributed to respiratory and CNS depressant effects of oxybate.(3) |
LUMRYZ, LUMRYZ STARTER PACK, SODIUM OXYBATE, XYREM, XYWAV |
| Samidorphan/Strong CYP3A4 Inducers SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Samidorphan is a substrate of CYP3A4. Strong inducers of CYP3A4 may increase the metabolism of samidorphan.(1) For co-formulations of samidorphan with olanzapine, strong CYP3A4 inducers that also induce CYP1A2 (e.g., carbamazepine, phenytoin, rifampin), may increase olanzapine metabolism.(1,2) CLINICAL EFFECTS: The concurrent administration of a strong CYP3A4 inducer may result in decreased levels and effectiveness of samidorphan.(1) In co-formulations of samidorphan with olanzapine, dual inducers of CYP1A2 and CYP3A4 (e.g., carbamazepine, phenytoin, rifampin) may decrease the levels and effectiveness of olanzapine.(1,2) PREDISPOSING FACTORS: Induction effects may be more likely with regular use of the inducer for longer than 1-2 weeks. PATIENT MANAGEMENT: The manufacturer of olanzapine-samidorphan states that concurrent use with strong CYP3A4 inducers is not recommended. (1) DISCUSSION: In a clinical study of healthy subjects, rifampin (600 mg daily for 7 days, a strong CYP3A4 inducer and moderate CYP1A2 inducer) decreased the area-under-curve (AUC) and maximum concentration (Cmax) of single-dose samidorphan 10 mg by 73% and 44%, respectively, and the AUC and Cmax of single-dose olanzapine 10 mg by 48% and 11%.(1,3) Concurrent use of carbamazepine increased olanzapine clearance by 50%, probably due to CYP1A2 induction by carbamazepine.(1,4) Strong inducers of CYP3A4 include: apalutamide, barbiturates, carbamazepine, encorafenib, enzalutamide, fosphenytoin, ivosidenib, lumacaftor, mitotane, phenobarbital, phenytoin, primidone, rifampin, rifapentine, and St. John's wort.(2,5) |
ASA-BUTALB-CAFFEINE-CODEINE, ASCOMP WITH CODEINE, BRAFTOVI, BUTALB-ACETAMINOPH-CAFF-CODEIN, BUTALBITAL, BUTALBITAL-ACETAMINOPHEN, BUTALBITAL-ACETAMINOPHEN-CAFFE, BUTALBITAL-ASPIRIN-CAFFEINE, CARBAMAZEPINE, CARBAMAZEPINE ER, CARBATROL, CEREBYX, DILANTIN, DILANTIN-125, DONNATAL, EPITOL, EQUETRO, ERLEADA, FIORICET, FIORICET WITH CODEINE, FOSPHENYTOIN SODIUM, LYSODREN, MITOTANE, MYSOLINE, ORKAMBI, PENTOBARBITAL SODIUM, PHENOBARBITAL, PHENOBARBITAL SODIUM, PHENOBARBITAL-BELLADONNA, PHENOBARBITAL-HYOSC-ATROP-SCOP, PHENOHYTRO, PHENYTEK, PHENYTOIN, PHENYTOIN SODIUM, PHENYTOIN SODIUM EXTENDED, PRIFTIN, PRIMIDONE, RIFADIN, RIFAMPIN, SEZABY, TEGRETOL, TEGRETOL XR, TENCON, TIBSOVO, XTANDI |
There are 4 moderate interactions.
The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.
| Drug Interaction | Drug Names |
|---|---|
| Bupropion/Antipsychotics SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Both bupropion and the antipsychotics are known to lower the seizure threshold.(1,2) Bupropion is also a strong inhibitor of CYP2D6.(3) CLINICAL EFFECTS: Concurrent use of bupropion and an antipsychotic may result in additive effects on the seizure threshold, increasing the risk of seizures.(1,2) PREDISPOSING FACTORS: The risk of seizures may be increased in patients with a history of head trauma or prior seizure; CNS tumor; severe hepatic cirrhosis; excessive use of alcohol or sedatives; addiction to opiates, cocaine, or stimulants; use of over-the-counter stimulants an anorectics; a total daily dose of bupropion greater than 450 mg or single doses greater than 150 mg; rapid escalation of bupropion dosage; diabetics treated with oral hypoglycemics or insulin; or with concomitant medications known to lower seizure threshold (antidepressants, theophylline, systemic steroids).(1,2) The risk of anticholinergic toxicities including cognitive decline, delirium, falls and fractures is increased in geriatric patients using more than one medicine with anticholinergic properties.(3) PATIENT MANAGEMENT: The concurrent use of bupropion and antipsychotics should be undertaken only with extreme caution and with low initial bupropion dosing and small gradual dosage increases.(1,2) Single doses should not exceed 150 mg.(1,2) The maximum daily dose of bupropion should not exceed 300 mg for smoking cessation(2) or 450 mg for depression.(1) DISCUSSION: Because of the risk of seizure from concurrent bupropion and other agents that lower seizure threshold, the manufacturer of bupropion states that the concurrent use of bupropion and antipsychotics should be undertaken only with extreme caution and with low initial bupropion dosing and small gradual dosage increases.(1) |
APLENZIN, AUVELITY, BUPROPION HCL, BUPROPION HCL SR, BUPROPION XL, CONTRAVE, FORFIVO XL, WELLBUTRIN SR, WELLBUTRIN XL |
| Olanzapine/Fluvoxamine SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Fluvoxamine may inhibit the metabolism of olanzapine by CYP1A2.(1-5) CLINICAL EFFECTS: Concurrent use of fluvoxamine may result in elevated levels of and toxicity from olanzapine. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Patients receiving concurrent therapy should be monitored for olanzapine side effects. The dose of olanzapine may need to be adjusted if fluvoxamine is initiated or discontinued. DISCUSSION: In a study in 10 male smokers with schizophrenia, pretreatment with fluvoxamine (100 mg daily for 10 days) increased olanzapine area-under-curve (AUC), maximum concentration (Cmax), and half-life by 30-50%, 12-64%, and by 25-32%, respectively. Olanzapine volume of distribution and clearance were decreased by 4-26% and 26-38%, respectively.(1) In a study in 8 schizophrenic patients, the addition of fluvoxamine (100 mg daily) to olanzapine (10-20 mg daily) increased olanzapine levels from 12-112%. N-desmethylolanzapine levels were not significantly affected.(2) In a retrospective review, 10 patients receiving concurrent fluvoxamine and olanzapine were compared to 134 patients receiving olanzapine alone. The ratio of olanzapine concentration/daily dose was 2.3-fold higher in patients receiving concurrent fluvoxamine.(3) Fluvoxamine has been shown to increase olanzapine Cmax and AUC by 54% and by 52%, respectively, in female nonsmokers. Fluvoxamine has been shown to increase olanzapine Cmax and AUC by 77% and by 108%, respectively, in male smokers.(4,5) |
FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE ER |
| Olanzapine/Ciprofloxacin SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Ciprofloxacin may inhibit the CYP1A2 mediated metabolism of olanzapine.(1-6) CLINICAL EFFECTS: Concurrent use of ciprofloxacin may result in elevated levels of and toxicity from olanzapine. PREDISPOSING FACTORS: Cytokines or other immune modulators secreted in response to infection or inflammation may also inhibit CYP1A2, resulting in additive suppression of CYP1A2 activity.(3-5) PATIENT MANAGEMENT: Patients receiving concurrent therapy should be monitored for olanzapine side effects. The dose of olanzapine may need to be adjusted if ciprofloxacin is initiated or discontinued. DISCUSSION: In a study with fluvoxamine, another CYP1A2 inhibitor, 10 male smokers with schizophrenia, pretreatment with fluvoxamine (100 mg daily for 10 days) increased olanzapine area-under-curve (AUC), maximum concentration (Cmax), and half-life by 30-50%, 12-64%, and by 25-32%, respectively. Olanzapine volume of distribution and clearance were decreased by 4-26% and 26-38%, respectively.(6) In a study in 10 male smokers with schizophrenia, pretreatment with fluvoxamine (100 mg daily for 10 days) increased olanzapine area-under-curve (AUC), maximum concentration (Cmax), and half-life by 30-50%, 12-64%, and by 25-32%, respectively. Olanzapine volume of distribution and clearance were decreased by 4-26% and 26-38%, respectively.(1) In a study in 8 schizophrenic patients, the addition of fluvoxamine (100 mg daily) to olanzapine (10-20 mg daily) increased olanzapine levels from 12-112%. N-desmethylolanzapine levels were not significantly affected.(7) In a retrospective review, 10 patients receiving concurrent fluvoxamine and olanzapine were compared to 134 patients receiving olanzapine alone. The ratio of olanzapine concentration/daily dose was 2.3-fold higher in patients receiving concurrent fluvoxamine.(8) Fluvoxamine has been shown to increase olanzapine Cmax and AUC by 54% and by 52%, respectively, in female nonsmokers. Fluvoxamine has been shown to increase olanzapine Cmax and AUC by 77% and by 108%, respectively, in male smokers.(9,10) |
CIPRO, CIPROFLOXACIN, CIPROFLOXACIN HCL, CIPROFLOXACIN-D5W |
| Olanzapine-Samidorphan/Selected CYP1A2 Inducers SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Inducers of CYP1A2 may increase the metabolism of olanzapine.(1,2) CLINICAL EFFECTS: Concurrent use of a CYP1A2 inducer may result in decreased levels and effectiveness of olanzapine.(1,2) PREDISPOSING FACTORS: Induction effects may be more likely with regular use of the inducer for longer than 1-2 weeks. PATIENT MANAGEMENT: Patients receiving concurrent therapy with olanzapine and a CYP1A2 inducer may require increased dosages of olanzapine. The dosage of olanzapine may need to be adjusted if concurrent therapy with a CYP1A2 inducer is initiated or discontinued.(1,2) If a CYP1A2 inducer is initiated in a patient maintained on olanzapine, monitor for decreased effectiveness of olanzapine. If a CYP1A2 inducer is discontinued in a patient maintained on olanzapine, monitor for olanzapine toxicity. DISCUSSION: Concurrent use of carbamazepine, a CYP1A2 inducer, increased olanzapine clearance by 50%.(1,2) CYP1A2 inducers linked to this monograph include: leflunomide, nelfinavir, ritonavir and teriflunomide.(3,4) |
ARAVA, AUBAGIO, KALETRA, LEFLUNICLO, LEFLUNOMIDE, LOPINAVIR-RITONAVIR, NORVIR, PAXLOVID, RITONAVIR, TERIFLUNOMIDE, VIRACEPT |
The following contraindication information is available for LYBALVI (olanzapine/samidorphan malate):
Drug contraindication overview.
The manufacturer states that there are no contraindications associated with oral or short-acting IM olanzapine monotherapy. When olanzapine is used in combination with fluoxetine, the usual contraindications associated with fluoxetine must be considered. When olanzapine is used as adjunctive therapy with lithium or valproate, the manufacturer advises clinicians to refer to prescribing information for those other drugs. The manufacturer states that there are no contraindications associated with use of the long-acting IM formulation of olanzapine pamoate.
The manufacturer states that there are no contraindications associated with oral or short-acting IM olanzapine monotherapy. When olanzapine is used in combination with fluoxetine, the usual contraindications associated with fluoxetine must be considered. When olanzapine is used as adjunctive therapy with lithium or valproate, the manufacturer advises clinicians to refer to prescribing information for those other drugs. The manufacturer states that there are no contraindications associated with use of the long-acting IM formulation of olanzapine pamoate.
There are 5 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Neuroleptic malignant syndrome |
| Opioid dependence |
| Opioid use last 4 hours in narcotic-dependent patient |
| Opioid withdrawal symptoms |
| Parkinsonism |
There are 24 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Acute myocardial infarction |
| Angle-closure glaucoma |
| Benign prostatic hyperplasia |
| Cardiac arrhythmia |
| Cerebrovascular disorder |
| Chronic heart failure |
| Dehydration |
| Diabetes mellitus |
| Esophageal dysmotility |
| Hypotension |
| Hypovolemia |
| Leukopenia |
| Lower seizure threshold |
| Myocardial ischemia |
| Neutropenic disorder |
| Orthostatic hypotension |
| Paralytic ileus |
| Predisposition to aspiration |
| Restless leg syndrome |
| Seizure disorder |
| Senile dementia |
| Suicidal ideation |
| Tardive dyskinesia |
| Transient cerebral ischemia |
There are 10 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Bradycardia |
| Disease of liver |
| Hypercholesterolemia |
| Hyperlipidemia |
| Hyperprolactinemia |
| Hypertriglyceridemia |
| Obesity |
| Sinus tachycardia |
| Tobacco smoker |
| Weight gain |
The following adverse reaction information is available for LYBALVI (olanzapine/samidorphan malate):
Adverse reaction overview.
No enhanced Common Adverse Effects information available for this drug.
No enhanced Common Adverse Effects information available for this drug.
There are 55 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Akathisia Parkinsonism Personality disorders |
Altered mental status Chest pain Euphoria Extrapyramidal disease Fever Memory impairment Peripheral edema Tardive dyskinesia |
| Rare/Very Rare |
|---|
|
Accidental fall Accommodation disorder Acquired dystonia Agranulocytosis Anaphylaxis Angioedema Cerebrovascular accident Cholestatic hepatitis Diabetes mellitus Diabetic ketoacidosis DRESS syndrome Dysphagia Dyspnea Eosinophilia Esophageal dysmotility Exfoliative dermatitis Facial edema Heat stroke Hepatic failure Hepatitis Hyperbilirubinemia Hyperglycemia Hyperlipidemia Hyperosmolar hyperglycemic state Ileus Jaundice Leukopenia Lymphadenopathy Menstrual disorder Neuroleptic malignant syndrome Neutropenic disorder Oculogyric crisis Osteoporosis Pancreatitis Priapism Rhabdomyolysis Seizure disorder Skin rash Sleep apnea Steatosis of liver Thrombocytopenic disorder Thromboembolic disorder Urinary retention Visual changes |
There are 63 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Back pain Constipation Disturbance of attention Dizziness Drowsy Fatigue General weakness Headache disorder Hyperprolactinemia Hypertriglyceridemia Increased appetite Orthostatic hypotension Rhinitis Sedation Toxic amblyopia Tremor Weight gain Xerostomia |
Abdominal pain with cramps Abnormal hepatic function tests Arthralgia Chills Cough Dysarthria Dyspepsia Ecchymosis Edema Erectile dysfunction Gait abnormality Hypersomnia Hypertension Hypertonia Hypotension Insomnia Muscle rigidity Nausea Nervousness Pain in extremities Paresthesia Pharyngitis Polydipsia Sialorrhea Tachycardia Urinary incontinence Urinary tract infection Vomiting |
| Rare/Very Rare |
|---|
|
Acute cognitive impairment Alopecia Anticholinergic toxicity Epistaxis Fecal incontinence Galactorrhea not associated with childbirth Gynecomastia Increased urinary frequency Libido changes Mastalgia Pruritus of skin Restless leg syndrome Skin photosensitivity Sleep walking disorder Stuttering Urticaria Vasodilation of blood vessels |
The following precautions are available for LYBALVI (olanzapine/samidorphan malate):
No enhanced Pediatric Use information available for this drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Limited experience to date with olanzapine administration during pregnancy has been encouraging and has not revealed evidence of any obvious teratogenic risks; however, additional cases of olanzapine exposure during pregnancy need to be evaluated to more fully determine the relative safety of olanzapine and other antipsychotic agents when administered during pregnancy. The manufacturer states that there have been 7 pregnancies reported during clinical trials with olanzapine, including 2 resulting in normal births, one resulting in neonatal death due to a cardiovascular defect, 3 therapeutic abortions, and one spontaneous abortion. In a separate compilation of pregnancy exposures to olanzapine reported to the manufacturer during clinical trials and from spontaneous reports worldwide, outcomes were available from 23 prospectively collected, olanzapine-exposed pregnancies.
Spontaneous abortion occurred in 13% of these pregnancies, stillbirth in 5%, major malformations in 0%, and prematurity in 5%; these rates were all within the range of normal historical control rates. In 11 retrospectively collected, olanzapine-exposed pregnancies, there was one case of dysplastic kidney, one case of Down's syndrome, and one case of heart murmur and sudden infant death syndrome at 2 months of age. In another study, the majority of women with schizophrenia receiving atypical antipsychotic agents were found to be overweight and to have reduced folate intake and low serum folate concentrations, which may increase the potential risk of neural tube defects.
In a prospective, comparative trial assessing pregnancy outcome in women receiving atypical antipsychotic agents (olanzapine, clozapine, risperidone, and quetiapine) during pregnancy, atypical antipsychotics did not appear to be associated with an increased risk of major congenital malformations. In addition, several case reports have described healthy infants born to women without complications despite prenatal exposure to olanzapine. Neonates exposed to antipsychotic agents, including olanzapine, during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery.
There have been reports of agitation, hypertonia, hypotonia, tardive dyskinetic-like symptoms, tremor, somnolence, respiratory distress, and feeding disorder in these neonates. The majority of cases were also confounded by other factors, including concomitant use of other drugs known to be associated with withdrawal symptoms, prematurity, congenital malformations, and obstetrical and perinatal complications; however, some cases suggested that neonatal extrapyramidal and withdrawal symptoms may occur with exposure to antipsychotic agents alone. Some of the cases described time of symptom onset, which ranged from birth to one month after birth.
Any neonate exhibiting extrapyramidal or withdrawal symptoms following in utero exposure to antipsychotic agents should be monitored. Symptoms were self-limiting in some neonates but varied in severity; some infants required intensive care unit support and prolonged hospitalization. For further information on extrapyramidal and withdrawal symptoms in neonates, see Cautions: Pregnancy, Fertility, and Lactation, in the Phenothiazines General Statement 28:16.08.24.
The manufacturer and some clinicians state that there are no adequate and well-controlled studies to date using olanzapine in pregnant women, and the drug should be used during pregnancy only when the potential benefits justify the potential risks to the fetus. Women should be advised to notify their clinician if they become pregnant or plan to become pregnant during therapy with the drug. In addition, clinicians should advise women of childbearing potential about the benefits and risks of using antipsychotic agents during pregnancy.
Patients should also be advised not to stop taking their antipsychotic agent if they become pregnant without first consulting with their clinician, since abruptly discontinuing the drugs can cause clinically important complications. Parturition in rats was not affected by olanzapine. The effect of olanzapine on labor and delivery is unknown.
In oral reproduction studies in rats receiving dosages of up to 18 mg/kg daily and in rabbits at dosages of up to 30 mg/kg daily (equivalent to 9 and 30 times the maximum recommended human daily oral dosage on a mg/m2 basis, 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 dosage of 18 mg/kg daily (9 times the maximum recommended human daily oral dosage on a mg/m2 basis), and gestation was prolonged at a dosage of 10 mg/kg daily (equivalent to 5 times the maximum recommended human daily oral dosage on a mg/m2 basis). In an oral rabbit teratology study, fetal toxicity, which was manifested as increased resorptions and decreased fetal weight, occurred at a maternally toxic dosage of 30 mg/kg daily (equivalent to 30 times the maximum recommended human daily oral dosage on a mg/m2 basis).
Spontaneous abortion occurred in 13% of these pregnancies, stillbirth in 5%, major malformations in 0%, and prematurity in 5%; these rates were all within the range of normal historical control rates. In 11 retrospectively collected, olanzapine-exposed pregnancies, there was one case of dysplastic kidney, one case of Down's syndrome, and one case of heart murmur and sudden infant death syndrome at 2 months of age. In another study, the majority of women with schizophrenia receiving atypical antipsychotic agents were found to be overweight and to have reduced folate intake and low serum folate concentrations, which may increase the potential risk of neural tube defects.
In a prospective, comparative trial assessing pregnancy outcome in women receiving atypical antipsychotic agents (olanzapine, clozapine, risperidone, and quetiapine) during pregnancy, atypical antipsychotics did not appear to be associated with an increased risk of major congenital malformations. In addition, several case reports have described healthy infants born to women without complications despite prenatal exposure to olanzapine. Neonates exposed to antipsychotic agents, including olanzapine, during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery.
There have been reports of agitation, hypertonia, hypotonia, tardive dyskinetic-like symptoms, tremor, somnolence, respiratory distress, and feeding disorder in these neonates. The majority of cases were also confounded by other factors, including concomitant use of other drugs known to be associated with withdrawal symptoms, prematurity, congenital malformations, and obstetrical and perinatal complications; however, some cases suggested that neonatal extrapyramidal and withdrawal symptoms may occur with exposure to antipsychotic agents alone. Some of the cases described time of symptom onset, which ranged from birth to one month after birth.
Any neonate exhibiting extrapyramidal or withdrawal symptoms following in utero exposure to antipsychotic agents should be monitored. Symptoms were self-limiting in some neonates but varied in severity; some infants required intensive care unit support and prolonged hospitalization. For further information on extrapyramidal and withdrawal symptoms in neonates, see Cautions: Pregnancy, Fertility, and Lactation, in the Phenothiazines General Statement 28:16.08.24.
The manufacturer and some clinicians state that there are no adequate and well-controlled studies to date using olanzapine in pregnant women, and the drug should be used during pregnancy only when the potential benefits justify the potential risks to the fetus. Women should be advised to notify their clinician if they become pregnant or plan to become pregnant during therapy with the drug. In addition, clinicians should advise women of childbearing potential about the benefits and risks of using antipsychotic agents during pregnancy.
Patients should also be advised not to stop taking their antipsychotic agent if they become pregnant without first consulting with their clinician, since abruptly discontinuing the drugs can cause clinically important complications. Parturition in rats was not affected by olanzapine. The effect of olanzapine on labor and delivery is unknown.
In oral reproduction studies in rats receiving dosages of up to 18 mg/kg daily and in rabbits at dosages of up to 30 mg/kg daily (equivalent to 9 and 30 times the maximum recommended human daily oral dosage on a mg/m2 basis, 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 dosage of 18 mg/kg daily (9 times the maximum recommended human daily oral dosage on a mg/m2 basis), and gestation was prolonged at a dosage of 10 mg/kg daily (equivalent to 5 times the maximum recommended human daily oral dosage on a mg/m2 basis). In an oral rabbit teratology study, fetal toxicity, which was manifested as increased resorptions and decreased fetal weight, occurred at a maternally toxic dosage of 30 mg/kg daily (equivalent to 30 times the maximum recommended human daily oral dosage on a mg/m2 basis).
Olanzapine is distributed into milk. The mean dosage received by an infant at steady state is estimated to be about 1.8% of the maternal dosage. The manufacturer recommends that women receiving olanzapine not breast-feed.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for LYBALVI (olanzapine/samidorphan malate):
WARNING: There may be a slightly increased risk of serious, possibly fatal side effects (such as stroke, heart failure, fast/irregular heartbeat, pneumonia) when this product is used by older adults with dementia. This product is not approved for the treatment of dementia-related behavior problems. Discuss the risks and benefits of this product, as well as other effective and possibly safer treatments for dementia-related behavior problems, with the doctor.
WARNING: There may be a slightly increased risk of serious, possibly fatal side effects (such as stroke, heart failure, fast/irregular heartbeat, pneumonia) when this product is used by older adults with dementia. This product is not approved for the treatment of dementia-related behavior problems. Discuss the risks and benefits of this product, as well as other effective and possibly safer treatments for dementia-related behavior problems, with the doctor.
The following icd codes are available for LYBALVI (olanzapine/samidorphan malate)'s list of indications:
| Bipolar disorder | |
| F31 | Bipolar disorder |
| F31.0 | Bipolar disorder, current episode hypomanic |
| F31.1 | Bipolar disorder, current episode manic without psychotic features |
| F31.10 | Bipolar disorder, current episode manic without psychotic features, unspecified |
| F31.11 | Bipolar disorder, current episode manic without psychotic features, mild |
| F31.12 | Bipolar disorder, current episode manic without psychotic features, moderate |
| F31.13 | Bipolar disorder, current episode manic without psychotic features, severe |
| F31.2 | Bipolar disorder, current episode manic severe with psychotic features |
| F31.3 | Bipolar disorder, current episode depressed, mild or moderate severity |
| F31.30 | Bipolar disorder, current episode depressed, mild or moderate severity, unspecified |
| F31.31 | Bipolar disorder, current episode depressed, mild |
| F31.32 | Bipolar disorder, current episode depressed, moderate |
| F31.4 | Bipolar disorder, current episode depressed, severe, without psychotic features |
| F31.5 | Bipolar disorder, current episode depressed, severe, with psychotic features |
| F31.6 | Bipolar disorder, current episode mixed |
| F31.60 | Bipolar disorder, current episode mixed, unspecified |
| F31.61 | Bipolar disorder, current episode mixed, mild |
| F31.62 | Bipolar disorder, current episode mixed, moderate |
| F31.63 | Bipolar disorder, current episode mixed, severe, without psychotic features |
| F31.64 | Bipolar disorder, current episode mixed, severe, with psychotic features |
| F31.7 | Bipolar disorder, currently in remission |
| F31.70 | Bipolar disorder, currently in remission, most recent episode unspecified |
| F31.71 | Bipolar disorder, in partial remission, most recent episode hypomanic |
| F31.72 | Bipolar disorder, in full remission, most recent episode hypomanic |
| F31.73 | Bipolar disorder, in partial remission, most recent episode manic |
| F31.74 | Bipolar disorder, in full remission, most recent episode manic |
| F31.75 | Bipolar disorder, in partial remission, most recent episode depressed |
| F31.76 | Bipolar disorder, in full remission, most recent episode depressed |
| F31.77 | Bipolar disorder, in partial remission, most recent episode mixed |
| F31.78 | Bipolar disorder, in full remission, most recent episode mixed |
| F31.8 | Other bipolar disorders |
| F31.81 | Bipolar II disorder |
| F31.89 | Other bipolar disorder |
| F31.9 | Bipolar disorder, unspecified |
| Schizophrenia | |
| F20 | Schizophrenia |
| F20.0 | Paranoid schizophrenia |
| F20.1 | Disorganized schizophrenia |
| F20.2 | Catatonic schizophrenia |
| F20.3 | Undifferentiated schizophrenia |
| F20.5 | Residual schizophrenia |
| F20.8 | Other schizophrenia |
| F20.81 | Schizophreniform disorder |
| F20.89 | Other schizophrenia |
| F20.9 | Schizophrenia, unspecified |
Formulary Reference Tool