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Valbenazine

Also known as: Ingrezza, Ingrezza Sprinkle

Route: Oral

5 interactions on record⛔ Black Box Warning

Valbenazine has 5 known drug interactions based on U.S. FDA drug labeling data. Of these, 3 are contraindicated combinations that should be avoided entirely. 2 are classified as major interactions requiring close medical supervision. Notable interactions include combinations with Deutetrabenazine, Monoamine Oxidase Inhibitors (Maois), Tetrabenazine. Patients taking Valbenazine should inform their healthcare provider of all current medications — including over-the-counter drugs and supplements — to avoid potentially harmful combinations. Data sourced from OpenFDA and the NIH National Library of Medicine.

Total: 5
Contraindicated: 3
Major: 2

Contraindicated (3)

Valbenazine + Deutetrabenazine— Contraindicated in patients currently taking valbenazine.
Valbenazine + Monoamine Oxidase Inhibitors (Maois)— Concomitant use may increase monoamine neurotransmitter concentration in synapses, potentially leading to serotonin synd…
Valbenazine + Tetrabenazine— Concurrent use is contraindicated.

Major (2)

Valbenazine + Cyp3a Inducers— Decreased exposure to valbenazine and active metabolite, potentially reducing efficacy. Concomitant use is not recommend…
Valbenazine + Mao Inhibitors— Increased exposure to valbenazine and active metabolite, raising risk of exposure-related adverse reactions. Dose reduct…

Valbenazine + Deutetrabenazine⛔Contraindicated

Contraindicated in patients currently taking valbenazine.

Valbenazine + Monoamine Oxidase Inhibitors (Maois)⛔Contraindicated

Concomitant use may increase monoamine neurotransmitter concentration in synapses, potentially leading to serotonin syndrome or attenuated treatment effect. Avoid use or within 14 days of discontinuing MAOI therapy.

Valbenazine + Tetrabenazine⛔Contraindicated

Concurrent use is contraindicated.

Valbenazine + Cyp3a Inducers⚠️Major

Decreased exposure to valbenazine and active metabolite, potentially reducing efficacy. Concomitant use is not recommended.

Valbenazine + Mao Inhibitors⚠️Major

Increased exposure to valbenazine and active metabolite, raising risk of exposure-related adverse reactions. Dose reduction to 40 mg once daily recommended.

⛔ FDA Black Box Warning

WARNING: DEPRESSION AND SUICIDAL IDEATION AND BEHAVIOR IN PATIENTS WITH HUNTINGTON’S DISEASE VMAT2 inhibitors, including INGREZZA and INGREZZA SPRINKLE, can increase the risk of depression and suicidal thoughts and behavior in patients with Huntington’s disease. Anyone considering the use of INGREZZA or INGREZZA SPRINKLE must balance the risks of depression and suicidal ideation and behavior with the clinical need for treatment of chorea. Closely monitor patients for the emergence or worsening of depression, suicidal ideation, or unusual changes in behavior. Inform patients, their caregivers, and families of the risk of depression and suicidal ideation and behavior and instruct them 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 patients with Huntington’s disease [see Warnings and Precautions ( 5.1 )]. WARNING: DEPRESSION AND SUICIDAL IDEATION AND BEHAVIOR IN PATIENTS WITH HUNTINGTON’S DISEASE See full prescribing information for complete boxed warning. • Increases the risk of depression and suicidal thoughts and behavior in patients with Huntington’s disease ( 5.1 ) • Balance risks of depression, and suicidal ideation and behavior with the clinical need for treatment of chorea when considering the use of INGREZZA or INGREZZA SPRINKLE ( 5.1 ) • Monitor patients for the emergence or worsening of depression, suicidal ideation, or unusual changes in behavior ( 5.1 ) • Inform patients, caregivers, and families of the risk of depression and suicidal ideation and behavior and instruct them 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 )

Contraindications

4 CONTRAINDICATIONS INGREZZA and INGREZZA SPRINKLE are contraindicated in patients with a history of hypersensitivity to valbenazine or any components of INGREZZA or INGREZZA SPRINKLE. Rash, urticaria, and reactions consistent with angioedema (e.g., swelling of the face, lips, and mouth) have been reported with use of INGREZZA [see Warnings and Precautions ( 5.2 ) and Adverse Reactions ( 6.2 )]. Known hypersensitivity to valbenazine or any components of INGREZZA or INGREZZA SPRINKLE. ( 4 )

Pregnancy & Breastfeeding

8.1 Pregnancy Risk Summary The limited available data on INGREZZA or INGREZZA SPRINKLE use in pregnant women are insufficient to inform a drug-associated risk. In animal reproductive studies, no malformations were observed when valbenazine was administered orally to rats and rabbits during the period of organogenesis at doses up to 1.8 or 24 times, respectively, the maximum recommended human dose (MRHD) of 80 mg/day based on mg/m 2 body surface area. However, administration of valbenazine to pregnant rats during organogenesis through lactation produced an increase in the number of stillborn pups and postnatal pup mortalities at doses <1 times the MRHD based on mg/m 2 [see Data ]. Advise a pregnant woman of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The background risk of major birth defects and miscarriage in the U.S. general population is 2 to 4% and 15 to 20% of clinically recognized pregnancies, respectively. Data Animal Data Valbenazine was administered orally to pregnant rats during the period of organogenesis at 1, 5, and 15 mg/kg/day, which are approximately 0.1, 0.6, and 2 times the MRHD of 80 mg/day based on mg/m 2 body surface area. Valbenazine produced a significant decrease in maternal body weight gain at 0.6 and 2 times the MRHD of 80 mg/day based on mg/m 2 . No adverse embryo fetal effects were produced when valbenazine was administered at doses up to 2 times the MRHD of 80 mg/day based on mg/m 2 . Valbenazine was administered orally to pregnant rabbits during the period of organogenesis at 20, 50, and 100 mg/kg/day, which are approximately 5, 12, and 24 times the MRHD of 80 mg/day based on mg/m 2 . No malformations were observed at doses up to 24 times the MRHD of 80 mg/day based on mg/m 2 . However, valbenazine produced a delay in fetal development (decreased fetal w

Data sourced from U.S. FDA drug labeling via openFDA and the NIH National Library of Medicine, supplemented with a small number of well-established interactions from curated clinical references. For informational purposes only. Always consult your pharmacist or physician.