Deutetrabenazine + Monoamine Oxidase Inhibitors (Maois)Contraindicated
Contraindicated; deutetrabenazine should not be used with MAOIs or within 14 days of discontinuing MAOI therapy.
Source: NLP:deutetrabenazine
Deutetrabenazine Interactions
Brand names: Austedo, Austedo, Austedo Xr
Route: Oral
FDA Black Box Warning
WARNING: DEPRESSION AND SUICIDALITY IN PATIENTS WITH HUNTINGTON’S DISEASE AUSTEDO XR and AUSTEDO can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease. Anyone considering the use of AUSTEDO XR or AUSTEDO 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’s disease. AUSTEDO XR and AUSTEDO are contraindicated in patients who are suicidal, and in patients with untreated or inadequately treated depression [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 )]. WARNING: DEPRESSION AND SUICIDALITY IN PATIENTS WITH HUNTINGTON’S DISEASE See full prescribing information for complete boxed warning. Increases the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease ( 5.1 ) Balance risks of depression and suicidality with the clinical need for treatment of chorea when considering the use of AUSTEDO XR or AUSTEDO ( 5.1 ) Monitor patients for the emergence or worsening of depression, suicidality, or unusual changes in behavior ( 5.1 ) Inform patients, caregivers, and families of the risk of depression and suicidality and instruct to report behaviors of concern promptly to the treating physician ( 5.1 ) Exercise caution when treating patients with a history of depression or prior suicide attempts or ideation ( 5.1 ) AUSTEDO XR and AUSTEDO are contraindicated in patients who are suicidal, and in patients with untreated or ina
Contraindications
4 CONTRAINDICATIONS AUSTEDO XR and AUSTEDO are contraindicated in patients: With Huntington’s disease who are suicidal, or have untreated or inadequately treated depression [see Warnings and Precautions ( 5.1 )] . With hepatic impairment [see Use in Specific Populations ( 8.6 ), Clinical Pharmacology ( 12.3 )] . Taking reserpine. At least 20 days should elapse after stopping reserpine before starting AUSTEDO XR or AUSTEDO [see Drug Interactions ( 7.2 )] . Taking monoamine oxidase inhibitors (MAOIs). AUSTEDO XR and AUSTEDO should not be used in combination with an MAOI, or within 14 days of discontinuing therapy with an MAOI [see Drug Interactions ( 7.3 )] . Taking tetrabenazine or valbenazine [see Drug Interactions ( 7.6 )] . Suicidal, or untreated/inadequately treated depression in patients with Huntington’s disease ( 4 , 5.1 ) Hepatic impairment ( 4 , 8.6 , 12.3 ) Taking reserpine, MAOIs, tetrabenazine, or valbenazine ( 4 , 7.2 , 7.3 , 7.6 )
Pregnancy & Breastfeeding
8.1 Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of AUSTEDO XR or AUSTEDO in pregnant women. Administration of deutetrabenazine to rats during organogenesis produced no clear adverse effect on embryofetal development. However, administration of tetrabenazine to rats throughout pregnancy and lactation resulted in an increase in stillbirths and postnatal offspring mortality [see Data]. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown. Data Animal Data Oral administration of deutetrabenazine (5, 10, or 30 mg/kg/day) or tetrabenazine (30 mg/kg/day) to pregnant rats during organogenesis had no clear effect on embryofetal development. The highest dose tested was 6 times the maximum recommended human dose of 48 mg/day, on a body surface area (mg/m 2 ) basis. The effects of deutetrabenazine when administered during organogenesis to rabbits or during pregnancy and lactation to rats have not been assessed. Tetrabenazine had no effects on embryofetal development when administered to pregnant rabbits during the period of organogenesis at oral doses up to 60 mg/kg/day. When tetrabenazine was administered to female rats (doses of 5, 15, and 30 mg/kg/day) from the beginning of organogenesis through the lactation period, an increase in stillbirths and offspring postnatal mortality was observed at 15 and 30 mg/kg/day, and delayed pup maturation was observed at all doses.
10 interactions on record
Deutetrabenazine + ReserpineContraindicated
Contraindicated; concomitant use risks major depletion of serotonin and norepinephrine. At least 20 days must elapse after stopping reserpine before starting deutetrabenazine.
Source: NLP:deutetrabenazine
Deutetrabenazine + TetrabenazineContraindicated
Contraindicated in patients currently taking tetrabenazine. Deutetrabenazine may be initiated the day following discontinuation of tetrabenazine.
Source: NLP:deutetrabenazine
Deutetrabenazine + ValbenazineContraindicated
Contraindicated in patients currently taking valbenazine.
Source: NLP:deutetrabenazine
Strong CYP2D6 inhibitor that increases systemic exposure to active dihydro-metabolites of deutetrabenazine by approximately 3-fold. Maximum recommended dose should not exceed 36 mg per day.
Source: NLP:deutetrabenazine
Concomitant use may increase risk of parkinsonism, neuroleptic malignant syndrome, and akathisia.
Source: NLP:deutetrabenazine
Strong CYP2D6 inhibitor that increases systemic exposure to active dihydro-metabolites of deutetrabenazine by approximately 3-fold. Maximum recommended dose should not exceed 36 mg per day.
Source: NLP:deutetrabenazine
Strong CYP2D6 inhibitor that increases systemic exposure to active dihydro-metabolites of deutetrabenazine by approximately 3-fold. Maximum recommended dose should not exceed 36 mg per day.
Source: NLP:deutetrabenazine
Strong CYP2D6 inhibitor that increases systemic exposure to active dihydro-metabolites of deutetrabenazine by approximately 3-fold. Maximum recommended dose should not exceed 36 mg per day.
Source: NLP:deutetrabenazine
Deutetrabenazine + AlcoholModerate
Concomitant use may have additive effects and worsen sedation and somnolence.
Source: NLP:deutetrabenazine