disregard [10%:7 days, retitrate when resuming. Dosing: Geriatric Refer to adult dosing; use with caution. Dosing: Renal Impairment There are no dosage adjustments provided in the manufacturer s labeling (has not been studied). Dosing: Hepatic Impairment Use is contraindicated. Dosing: Adjustment for Toxicity For toxicity/adverse reaction, including agitation, akathisia, anxiety, cognitive decline, depression, restlessness, parkinsonism, sedation (intolerable), somnolence, suicidality: Decrease or discontinue deutetrabenazine. Administration Oral: Administer with food. Swallow tablets whole and do not chew, crush, or break. Dietary Considerations Administer with food. Storage Store at 25ºC (77ºF); excursions permitted between 15 C and 30ºC (59 F and 86ºF). Protect from light and moisture. Drug Interactions Abiraterone Acetate: May increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Management: Avoid concurrent use of abiraterone with CYP2D6 substrates that have a narrow therapeutic index whenever possible. When concurrent use is not avoidable, monitor patients closely for signs/symptoms of toxicity. Consider therapy modification Alcohol (Ethyl): CNS Depressants may enhance the CNS depressant effect of Alcohol (Ethyl). Monitor therapy Amifampridine: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Highest Risk). Avoid combination Antipsychotic Agents: Deutetrabenazine may enhance the adverse/toxic effect of Antipsychotic Agents. Specifically, the risk for akathisia, parkinsonism, or neuroleptic malignant syndrome may be increased. Monitor therapy Asunaprevir: May increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Consider therapy modification Azelastine (Nasal): CNS Depressants may enhance the CNS depressant effect of Azelastine (Nasal). Avoid combination Bilastine: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Highest Risk). Monitor therapy Blonanserin: CNS Depressants may enhance the CNS depressant effect of Blonanserin. Consider therapy modification Brimonidine (Topical): May enhance the CNS depressant effect of CNS Depressants. Monitor therapy Buprenorphine: CNS Depressants may enhance the CNS depressant effect of Buprenorphine. Management: Consider reduced doses of other CNS depressants, and avoiding such drugs in patients at high risk of buprenorphine overuse/self-injection. Initiate buprenorphine patches (Butrans brand) at 5 mcg/hr in adults when used with other CNS depressants. Consider therapy modification Cannabis: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy Chlormethiazole: May enhance the CNS depressant effect of CNS Depressants. Management: Monitor closely for evidence of excessive CNS depression. The chlormethiazole labeling states that an appropriately reduced dose should be used if such a combination must be used. Consider therapy modification Chlorphenesin Carbamate: May enhance the adverse/toxic effect of CNS Depressants. Monitor therapy CNS Depressants: May enhance the adverse/toxic effect of other CNS Depressants. Monitor therapy Cobicistat: May increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Monitor therapy CYP2D6 Inhibitors (Moderate): May decrease the metabolism of CYP2D6 Substrates (High risk with Inhibitors). Monitor therapy CYP2D6 Inhibitors (Strong): May increase the serum concentration of Deutetrabenazine. Management: The total daily dose of deutetrabenazine should not exceed 36 mg, and the maximum single dose of deutetrabenazine should not exceed 18 mg with concurrent use of a strong CYP2D6 inhibitor. Consider therapy modification Darunavir: May increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Monitor therapy Dimethindene (Topical): May enhance the CNS depressant effect of CNS Depressants. Monitor therapy Doxylamine: May enhance the CNS depressant effect of CNS Depressants. Management: The manufacturer of Diclegis (doxylamine/pyridoxine), intended for use in pregnancy, specifically states that use with other CNS depressants is not recommended. Monitor therapy Dronabinol: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy Flunitrazepam: CNS Depressants may enhance the CNS depressant effect of Flunitrazepam. Consider therapy modification HYDROcodone: CNS Depressants may enhance the CNS depressant effect of HYDROcodone. Management: Avoid concomitant use of hydrocodone and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Consider therapy modification Hydroxychloroquine: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Highest Risk). Avoid combination Imatinib: May increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Monitor therapy Indapamide: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Highest Risk). Consider therapy modification Kava Kava: May enhance the adverse/toxic effect of CNS Depressants. Monitor therapy Magnesium Sulfate: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy Methotrimeprazine: CNS Depressants may enhance the CNS depressant effect of Methotrimeprazine. Methotrimeprazine may enhance the CNS depressant effect of CNS Depressants. Management: Reduce adult dose of CNS depressant agents by 50% with initiation of concomitant methotrimeprazine therapy. Further CNS depressant dosage adjustments should be initiated only after clinically effective methotrimeprazine dose is established. Consider therapy modification Metoclopramide: Deutetrabenazine may enhance the adverse/toxic effect of Metoclopramide. Specifically, the risk for akathisia, parkinsonism, or neuroleptic malignant syndrome may be increased. Monitor therapy MetyroSINE: CNS Depressants may enhance the sedative effect of MetyroSINE. Monitor therapy MiFEPRIStone: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Highest Risk). Avoid combination Minocycline: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy Mizolastine: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Highest Risk). Avoid combination Monoamine Oxidase Inhibitors: May enhance the adverse/toxic effect of Deutetrabenazine. Avoid combination Nabilone: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy Opioid Analgesics: CNS Depressants may enhance the CNS depressant effect of Opioid Analgesics. Management: Avoid concomitant use of opioid analgesics and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Consider therapy modification Orphenadrine: CNS Depressants may enhance the CNS depressant effect of Orphenadrine. Avoid combination Oxomemazine: May enhance the CNS depressant effect of CNS Depressants. Avoid combination OxyCODONE: CNS Depressants may enhance the CNS depressant effect of OxyCODONE. Management: Avoid concomitant use of oxycodone and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Consider therapy modification Paraldehyde: CNS Depressants may enhance the CNS depressant effect of Paraldehyde. Avoid combination Peginterferon Alfa-2b: May decrease the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Peginterferon Alfa-2b may increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Monitor therapy Perampanel: May enhance the CNS depressant effect of CNS Depressants. Management: Patients taking perampanel with any other drug that has CNS depressant activities should avoid complex and high-risk activities, particularly those such as driving that require alertness and coordination, until they have experience using the combination. Consider therapy modification Perhexiline: CYP2D6 Substrates (High risk with Inhibitors) may increase the serum concentration of Perhexiline. Perhexiline may increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Monitor therapy Piribedil: CNS Depressants may enhance the CNS depressant effect of Piribedil. Monitor therapy Pramipexole: CNS Depressants may enhance the sedative effect of Pramipexole. Monitor therapy Probucol: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Highest Risk). Avoid combination Promazine: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Highest Risk). Avoid combination QTc-Prolonging Agents (Highest Risk): May enhance the QTc-prolonging effect of other QTc-Prolonging Agents (Highest Risk). Avoid combination QTc-Prolonging Agents (Indeterminate Risk and Risk Modifying): May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Highest Risk). Management: Avoid such combinations when possible. Use should be accompanied by close monitoring for evidence of QT prolongation or other alterations of cardiac rhythm. Consider therapy modification QTc-Prolonging Agents (Moderate Risk): May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Highest Risk). Avoid combination Reserpine: May enhance the adverse/toxic effect of Deutetrabenazine. Avoid combination ROPINIRole: CNS Depressants may enhance the sedative effect of ROPINIRole. Monitor therapy Rotigotine: CNS Depressants may enhance the sedative effect of Rotigotine. Monitor therapy Rufinamide: May enhance the adverse/toxic effect of CNS Depressants. Specifically, sleepiness and dizziness may be enhanced. Monitor therapy Selective Serotonin Reuptake Inhibitors: CNS Depressants may enhance the adverse/toxic effect of Selective Serotonin Reuptake Inhibitors. Specifically, the risk of psychomotor impairment may be enhanced. Monitor therapy Sodium Oxybate: May enhance the CNS depressant effect of CNS Depressants. Management: Consider alternatives to combined use. When combined use is needed, consider minimizing doses of one or more drugs. Use of sodium oxybate with alcohol or sedative hypnotics is contraindicated. Consider therapy modification Suvorexant: CNS Depressants may enhance the CNS depressant effect of Suvorexant. Management: Dose reduction of suvorexant and/or any other CNS depressant may be necessary. Use of suvorexant with alcohol is not recommended, and the use of suvorexant with any other drug to treat insomnia is not recommended. Consider therapy modification Tapentadol: May enhance the CNS depressant effect of CNS Depressants. Management: Avoid concomitant use of tapentadol and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Consider therapy modification Teneligliptin: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Highest Risk). Monitor therapy Tetrabenazine: Deutetrabenazine may enhance the adverse/toxic effect of Tetrabenazine. Avoid combination Tetrahydrocannabinol: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy Thalidomide: CNS Depressants may enhance the CNS depressant effect of Thalidomide. Avoid combination Trimeprazine: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy Valbenazine: Deutetrabenazine may enhance the adverse/toxic effect of Valbenazine. Avoid combination Vinflunine: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Highest Risk). Avoid combination Xipamide: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Highest Risk). Monitor therapy Zolpidem: CNS Depressants may enhance the CNS depressant effect of Zolpidem. Management: Reduce the Intermezzo brand sublingual zolpidem adult dose to 1.75 mg for men who are also receiving other CNS depressants. No such dose change is recommended for women. Avoid use with other CNS depressants at bedtime; avoid use with alcohol. Consider therapy modification Adverse Reactions >10%: Central nervous system: Drowsiness (11%) 1% to 10%: Central nervous system: Fatigue (9%), insomnia (4% to 7%), anxiety (4%), depression ( 4%), agitation ( 4%), akathisia ( 4%), restlessness ( 4%), suicidal ideation (2%) Gastrointestinal: Diarrhea (9%), xerostomia (9%), constipation (4%) Genitourinary: Urinary tract infection (7%) Hematologic & oncologic: Bruise (4%) Respiratory: Nasopharyngitis (4%) Frequency not defined: Central nervous system: Sedation ALERT: U.S. Boxed Warning Depression and suicidality in patients with Huntington disease: Deutetrabenazine can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington disease. Anyone considering the use of deutetrabenazine must balance the risks of depression and suicidality with the clinical need for treatment of chorea. Closely monitor patients for the emergence or worsening of depression, suicidality, or unusual changes in behavior. Patients, their caregivers, and families should be informed of the risk of depression and suicidality and should be instructed to report behaviors of concern promptly to the treating physician. Particular caution should be exercised in treating patients with a history of depression or prior suicide attempts or ideation, which are increased in frequency in Huntington disease. Deutetrabenazine is contraindicated in patients who are suicidal, and in patients with untreated or inadequately treated depression. Warnings/Precautions Concerns related to adverse effects: Akathisia: Use has been associated with akathisia; monitor for signs and symptoms of restlessness and agitation. Dosage reduction or discontinuation may be necessary. CNS depression: May cause CNS depression, which may impair physical or mental abilities; patients must be cautioned about performing tasks that require mental alertness (eg, operating machinery or driving). Depression/suicidal ideation: [US Boxed Warning]: Use can increase risk for depression and suicidal thoughts and behavior in patients with Huntington disease; closely monitor for emergence or worsening of depression, suicidality, or unusual behavior changes. Use caution in patients with a history of depression or prior suicide attempts or ideation. Use is contraindicated in patients with Huntington disease who are suicidal or have untreated or inadequately treated depression. Consider discontinuing use if depression/suicidal ideation does not resolve. Hyperprolactinemia: May increase prolactin levels; clinical significance of hyperprolactinemia in patients with breast cancer or other prolactin-dependent tumors is unknown. Neuroleptic malignant syndrome (NMS): Use may be associated with NMS; monitor for mental status changes, fever, muscle rigidity and/or autonomic instability. Discontinue with confirmed NMS; may recur with reintroduction of treatment; monitor carefully. Ophthalmic effects: Binds to melanin-containing tissues in animal studies; may result in accumulation and toxicity with extended use and long-term ophthalmic effects. Clinical relevance and monitoring recommendations are unknown. Parkinsonism: May cause parkinsonism symptoms (ie, bradykinesia, hypertonia, rigidity) in patients with Huntington disease, which can be difficult to differentiate from progression of the underlying disease. Dose reduction or discontinuation of therapy may be necessary. QTc prolongation: QTc prolongation may occur in patients who are CYP2D6 poor metabolizers or are coadministered a strong CYP2D6 inhibitor. Avoid use in patients with congenital QT prolongation, a history of cardiac arrhythmias, or concomitant drugs known to cause QT prolongation. For patients at risk for QT prolongation, assess the QT interval before and after increasing total dose above 24 mg/day. Concurrent drug therapy issues: Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information. Special populations: CYP2D6 poor metabolizers: CYP2D6 poor metabolizers have increased levels of primary drug metabolites; maximum dosage should not exceed 36 mg/day in poor metabolizers. Huntington disease: May worsen mood, cognition, rigidity, and functional capacity in patients with Huntington disease, which can be difficult to differentiate from progression of the underlying disease. Underlying chorea may improve over time in some patients, thereby decreasing the need for therapy. Re-evaluate patients' need for treatment by periodically assessing the effect on chorea and possible adverse effects. Dose reduction or discontinuation of therapy may be necessary. Monitoring Parameters Electrolytes; EKG (QT interval before and after dose is increased to >24 mg/day in patients with increased risk for QTc prolongation); signs/symptoms of depression or suicidal ideation; signs and/or symptoms of NMS, restlessness and agitation. Pregnancy Considerations Adverse events were not observed in available animal reproduction studies. Although not evaluated in preclinical studies, deutetrabenazine may increase serum prolactin concentrations which may lead to amenorrhea, galactorrhea, gynecomastia, or impotence. Patient Education Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?) Patient may experience fatigue, loss of strength and energy, diarrhea, dry mouth, insomnia, rhinitis, or pharyngitis. Have patient report immediately to prescriber signs of depression (suicidal ideation, anxiety, emotional instability, or confusion), agitation, irritability, panic attacks, mood changes, signs of a urinary tract infection (hematuria, burning or painful urination, polyuria, fever, lower abdominal pain, or pelvic pain), abnormal movements, change in balance, tremors, muscle rigidity, severe fatigue, restlessness, confusion, vision changes, tachycardia, abnormal heartbeat, dizziness, passing out, nipple discharge, enlarged breasts, sexual dysfunction, amenorrhea, or signs of neuroleptic malignant syndrome (fever, muscle cramps or stiffness, dizziness, severe headache, confusion, change in thinking, tachycardia, abnormal heartbeat, or sweating a lot). (HCAHPS). Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions. Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients. Print this page]} Recently Approved Lonhala Magnair Lonhala Magnair (glycopyrrolate) is a long-acting muscarinic antagonist (LAMA) bronchodilator for... Ozempic Ozempic (semaglutide) is a glucagon-like peptide-1 (GLP-1) analog administered once-weekly for the... Ogivri Ogivri (trastuzumab-dkst) is a HER2 / neu receptor antagonist biosimilar to Herceptin indicated for... Sublocade Sublocade (buprenorphine) is a once-monthly injectable partial opioid agonist formulation for the... More} } obligations
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