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LYBALVI (olanzapine/samidorphan malate)
- Bipolar disorder
- Schizophrenia
10 mg-10 mg tablet
- 1 tablet by oral route once daily
15 mg-10 mg tablet
- 1 tablet by oral route once daily
20 mg-10 mg tablet
- 1 tablet by oral route once daily
5 mg-10 mg tablet
- 1 tablet by oral route once daily
Default screening record
- 1 tablet by oral route once daily
- Abstral
- acetaminophen-codeine
- Actiq
- Alfenta
- alfentanil
- Ascomp With Codeine
- Astramorph-pf
- Avinza
- belladonna alkaloids-opium
- Belladonna-opium
- bromphen-pseudoephed-codeine
- brompheniramine-PE-codeine
- Buprenex
- buprenorphine
- buprenorphine-naloxone
- Butalbital Compound W/codeine
- Butalbital Compound-codeine
- butalbital-acetaminop-caf-cod
- butorphanol tartrate
- Butrans
- Capcof
- Capital With Codeine
- carisoprodol-ASA-codeine
- Cheratussin Ac
- Cheratussin Dac
- chlorcyclizine-codeine
- chlorphen-pseudoephed-codeine
- chlorpheniramine-codeine
- chlorpheniramine-hydrocodone
- chlorpheniramine-PE-codeine
- clrcycliz-pseudoephed-codeine
- codeine sulfate
- codeine-butalbital-ASA-caff
- codeine-guaifenesin
- codeine-pyrilamine
- Conzip
- cpm-pseudoephed-hydrocodone
- Demerol
- Demerol (pf)
- Depodur (pf)
- dexbrompheniramine-PSE-codeine
- dexchlorphen-phenyleph-codeine
- dihydrocodeine-aspirin-caff
- Dilaudid
- Dilaudid (pf)
- Dilaudid-hp (pf)
- diphenoxylate-atropine
- Diskets
- Dolophine
- Duragesic
- Duramorph (pf)
- Endocet
- Endodan
- Exalgo Er
- fentanyl
- fentanyl citrate
- fentanyl citrate (PF)
- Fentora
- Fioricet With Codeine
- Fiorinal-codeine #3
- Guaiatussin Ac
- Guaifenesin Ac
- Guaifenesin Dac
- Guiatuss Ac
- Hycet
- hydrocodone bitartrate
- Hydrocodone Compound
- hydrocodone-acetaminophen
- hydrocodone-homatropine
- hydrocodone-ibuprofen
- Hydromet
- hydromorphone
- hydromorphone (PF)
- Ibudone
- ibuprofen-oxycodone
- Iophen C-nr
- Kadian
- Lazanda
- Lomotil
- Lortab Elixir
- Lortuss Ex
- M-clear Wc
- M-end Max D
- M-end Pe
- Mar-cof Bp
- Mar-cof Cg
- meperidine
- meperidine (PF)
- Meperitab
- methadone
- Methadone Intensol
- Methadose
- metoclopramide HCl
- Metozolv Odt
- morphine
- morphine (PF)
- morphine concentrate
- morphine liposomal (PF)
- Ms Contin
- nalbuphine
- Norco
- Opana
- Opana Er
- opium tincture
- Oxecta
- oxycodone
- oxycodone-acetaminophen
- oxycodone-aspirin
- Oxycontin
- oxymorphone
- paregoric
- pentazocine lactate
- pentazocine-naloxone
- Percocet
- Percodan
- Phenylhistine
- Phenylhistine Dh
- Poly-tussin
- Poly-tussin Ac
- Poly-tussin D
- Primlev
- Pro-clear Ac
- Pro-clear Caps
- Pro-red Ac (w/ Dexchlorphenir)
- Promethazine Vc-codeine
- promethazine-codeine
- promethazine-phenyleph-codeine
- pseudoephedrine-codeine-GG
- pseudoephedrine-hydrocodone
- Reglan
- Relcof C
- remifentanil
- Reprexain
- Rezira
- Roxicet
- Rydex
- Statuss Green (codeine)
- Sublimaze (pf)
- Suboxone
- Subsys
- Sufenta
- sufentanil citrate
- Synalgos-dc
- Synapryn
- Talwin
- tramadol
- tramadol-acetaminophen
- tramadol-glucosamine
- Trymine Cg
- Tusnel C
- Tussicaps
- Tussigon
- Tussionex Pennkinetic Er
- Tylenol-codeine #3
- Tylenol-codeine #4
- Ultiva
- Ultracet
- Ultram
- Ultram Er
- Vicodin
- Vicodin Es
- Vicodin Hp
- Vicoprofen
- Virtussin Ac
- Vituz
- Xartemis Xr
- Xodol 10/300
- Xodol 5/300
- Xodol 7.5/300
- Z-tuss Ac
- Z-tuss E
- Zamicet
- Zodryl Ac 25
- Zodryl Ac 30
- Zodryl Ac 35
- Zodryl Ac 40
- Zodryl Ac 50
- Zodryl Ac 60
- Zodryl Ac 80
- Zodryl Dac 25
- Zodryl Dac 30
- Zodryl Dac 35
- Zodryl Dac 40
- Zodryl Dac 50
- Zodryl Dac 60
- Zodryl Dac 80
- Zodryl Dec 25
- Zodryl Dec 30
- Zodryl Dec 35
- Zodryl Dec 40
- Zodryl Dec 50
- Zodryl Dec 60
- Zodryl Dec 80
- Zohydro Er
- Zubsolv
- Zutripro
Contraindicated
- Apokyn
- apomorphine
- cabergoline
- carbidopa-levodopa
- carbidopa-levodopa-entacapone
- Comtan
- entacapone
- Mirapex
- Mirapex Er
- pramipexole
- Requip
- Requip Xl
- ropinirole
- Sinemet
- Sinemet Cr
- sodium oxybate
- Stalevo 100
- Stalevo 125
- Stalevo 150
- Stalevo 200
- Stalevo 50
- Stalevo 75
- Xyrem
Severe
Moderate
- Aplenzin
- Buproban
- bupropion HBr
- bupropion HCl
- fluvoxamine
- Forfivo Xl
- Luvox Cr
- Wellbutrin
- Wellbutrin Sr
- Wellbutrin Xl
- Zyban
- Neuroleptic malignant syndrome
- Opioid dependence
- Opioid use last 4 hours in narcotic-dependent patient
- Opioid withdrawal symptoms
Contraindicated
- Acute myocardial infarction
- Angle-closure glaucoma
- Benign prostatic hyperplasia with lower urinary tract sx
- Carcinoma of breast
- Cardiac arrhythmia
- Cerebrovascular accident
- Cerebrovascular disorder
- Chronic heart failure
- Dehydration
- Diabetes mellitus
- Esophageal dysmotility
- Hypercholesterolemia
- Hyperlipidemia
- Hypertriglyceridemia
- Hypotension
- Hypovolemia
- Leukopenia
- Lower seizure threshold
- Myocardial ischemia
- Neutropenic disorder
- Orthostatic hypotension
- Paralytic ileus
- Parkinsonism
- Predisposition to aspiration
- Seizure disorder
- Senile dementia
- Severe hepatic disease
- Suicidal ideation
- Tardive dyskinesia
- Transient cerebral ischemia
Severe
Moderate
- Abnormal hepatic function tests
- Bradycardia
- Hyperprolactinemia
- Obesity
- Sinus tachycardia
- Tobacco smoker
- Weight gain
LYBALVI (olanzapine/samidorphan malate)
- Bipolar disorder
- Schizophrenia
- Akathisia
- Parkinsonism
- Personality disorders
- Amblyopia
- Back pain
- Constipation
- Disturbance of attention
- Dizziness
- Drowsy
- Fatigue
- General weakness
- Headache disorder
- Hyperprolactinemia
- Hypertriglyceridemia
- Increased appetite
- Orthostatic hypotension
- Rhinitis
- Sedation
- Tremor
- Weight gain
- Xerostomia
More Frequent
Severe
Less Severe
- Altered mental status
- Chest pain
- Euphoria
- Extrapyramidal disease
- Fever
- Memory impairment
- Peripheral edema
- Tardive dyskinesia
- 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
Less Frequent
Severe
Less Severe
Rare / Very Rare
Severe
- 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
Less Severe
- Acute confusion
- Alopecia
- Epistaxis
- Galactorrhea not associated with childbirth
- Gynecomastia
- Increased urinary frequency
- Libido changes
- Mastalgia
- Pruritus of skin
- Restless leg syndrome
- Skin photosensitivity
- Stuttering
- Urticaria
- Vasodilation of blood vessels
Contraindicated
None
Severe Precaution
None
Management or Monitoring Precaution
Olanzapine-Samidorphan
Safety and effectiveness of combination product not established in pediatric patients. Increased risk of weight gain, hyperlipidemia, hyperglycemia seen with olanzapine.
- 1 Day – 18 Years
- Safety and effectiveness of combination product not established in pediatric patients. Increased risk of weight gain, hyperlipidemia, hyperglycemia seen with olanzapine.
Olanzapine
- Severity Level:
2
- Additional Notes: Non-teratogenic complications (resp, gi,cns) with exposure during 3rd trimester
Samidorphan
- Severity Level:
2
- Additional Notes: Insufficient human data available on developmental toxicity risk.
Contraindicated
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Precaution Exists
Olanzapine
Limited data suggest low levels excreted resulting in infant sedation
Insufficient human data available
| General | Excretion Potential | Effect on Infant | Notes |
| Evaluate use carefully | Excreted | Drug shown to have adverse effect | Limited data suggest low levels excreted resulting in infant sedation |
Samidorphan
Limited data suggest low levels excreted resulting in infant sedation
Insufficient human data available
| General | Excretion Potential | Effect on Infant | Notes |
| Evaluate use carefully | Unknown | Not known; no or inclusive data | Insufficient human data available |
No Known Risk
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Contraindicated
None
Precaution Exists
Olanzapine
Neuro/Psych-Higher risk of tardive dyskinesia. CNS effects; sedation, cognit impair and inc fall risk. Avoid use for behav probs of dementia or delirium unless fail nonpharm options. Inc risk of stroke, cognitive decline, and death when used w/senile dementia.Max 7.5mg/day. Endocrine-May exacerbate or cause SIADH or hyponatremia. Cardiovascular-May cause orthostatic hypotens, bradycardia. Gastrointestinal-Monitor for constipation. Genitourinary-Avoid in patients w/urinary retention.
| Organ / System | HEP | REN | CARD | ENDO | NEURO / PSYCH | PULM |
| Increased Risk / Adverse Effects | N | N | Y | Y | N | Y |
BEERS: Y HEDIS: Y STOPP: Y
No Known Risk
None
- 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.
| 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 |
| 0-9 | A-Z |
|---|---|
| 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 |
| 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 |
Formulary Reference Tool