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What is AUSTEDO?
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Clinical Data: Safety
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For the treatment of chorea associated with Huntington’s disease (HD) in adults

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Indication and Usage

AUSTEDO is indicated for the treatment of chorea associated with Huntington’s disease.

Important Safety Information

WARNING: DEPRESSION AND SUICIDALITY

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 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 is contraindicated in patients who are suicidal, and in patients with untreated or inadequately treated depression.

Contraindications: AUSTEDO is contraindicated in patients:

  • Who are suicidal, or in patients with untreated or inadequately treated depression.
  • With hepatic impairment.
  • Taking monoamine oxidase inhibitors (MAOIs). AUSTEDO should not be used in combination with an MAOI, or within 14 days of discontinuing therapy with an MAOI.
  • Taking reserpine. At least 20 days should elapse after stopping reserpine before starting AUSTEDO.
  • Taking tetrabenazine (XENAZINE®).

Clinical Worsening and Adverse Events: VMAT2 inhibitors, including AUSTEDO, may cause a worsening in mood, cognition, rigidity, and functional capacity. Prescribers should periodically re-evaluate the need for AUSTEDO in their patients by assessing the effect on chorea and possible adverse effects.

Neuroleptic Malignant Syndrome (NMS), a potentially fatal symptom complex, has been observed in patients receiving tetrabenazine. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability. Additional signs may include elevated creatinine phosphokinase, myoglobinuria, rhabdomyolysis, and acute renal failure. The management of NMS should include immediate discontinuation of AUSTEDO; intensive symptomatic treatment and medical monitoring; and treatment of any concomitant serious medical problems.

Akathisia, Agitation, and Restlessness: AUSTEDO may increase the risk of akathisia, agitation, and restlessness in patients with Huntington’s disease. Monitor patients for signs and symptoms of restlessness and agitation. If a patient develops akathisia during treatment with AUSTEDO, the AUSTEDO dose should be reduced; some patients may require discontinuation of therapy.

Parkinsonism: AUSTEDO may cause parkinsonism in patients with Huntington’s disease. If a patient develops parkinsonism during treatment with AUSTEDO, the AUSTEDO dose should be reduced; some patients may require discontinuation of therapy.

Sedation and Somnolence: Sedation is a common dose-limiting adverse reaction of AUSTEDO. Patients should not perform activities requiring mental alertness to maintain the safety of themselves or others, such as operating a motor vehicle or operating hazardous machinery, until they are on a maintenance dose of AUSTEDO and know how the drug affects them.

QTc Prolongation: Tetrabenazine causes an increase (about 8 msec) in the corrected QT (QTc) interval. A clinically relevant QT prolongation may occur in some patients treated with AUSTEDO who are CYP2D6 poor metabolizers or are co-administered a strong CYP2D6 inhibitor. The use of AUSTEDO should be avoided in combination with other drugs that are known to prolong QTc. AUSTEDO should also be avoided in patients with congenital long QT syndrome and in patients with a history of cardiac arrhythmias.

Hyperprolactinemia: Serum prolactin levels were not evaluated in the AUSTEDO development program. Tetrabenazine elevates serum prolactin concentrations in humans. If there is a clinical suspicion of symptomatic hyperprolactinemia, appropriate laboratory testing should be done and consideration should be given to discontinuation of AUSTEDO.

Binding to Melanin-Containing Tissues: Since deutetrabenazine or its metabolites bind to melanin-containing tissues, it could accumulate in these tissues over time. This raises the possibility that AUSTEDO may cause toxicity in these tissues after extended use. Although there are no specific recommendations for periodic ophthalmologic monitoring, prescribers should be aware of the possibility of long-term ophthalmologic effects.

Common Adverse Reactions: The most common adverse reactions (> 8% and greater than placebo) in a controlled clinical study were somnolence, diarrhea, dry mouth, and fatigue.

Drug Interactions: See Contraindications. The daily dosage of AUSTEDO should not exceed 36 mg (maximum single dose of 18 mg) in patients taking strong CYP2D6 inhibitors. The risk for parkinsonism, NMS, and akathisia may be increased by concomitant use of AUSTEDO and dopamine antagonists or antipsychotics. Concomitant use of alcohol or other sedating drugs may have additive effects and worsen sedation and somnolence.

Poor CYP2D6 Metabolizers: In patients who are CYP2D6 poor metabolizers, the daily dosage of AUSTEDO should not exceed 36 mg (maximum single dose of 18 mg).

Please see full Prescribing Information, including Boxed Warning, for AUSTEDO.

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Indication and Usage

AUSTEDO is indicated for the treatment of chorea associated with Huntington’s disease.

Important Safety Information

WARNING: DEPRESSION AND SUICIDALITY

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 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 is contraindicated in patients who are suicidal, and in patients with untreated or inadequately treated depression.

Contraindications: AUSTEDO is contraindicated in patients:

  • Who are suicidal, or in patients with untreated or inadequately treated depression.
  • With hepatic impairment.
  • Taking monoamine oxidase inhibitors (MAOIs). AUSTEDO should not be used in combination with an MAOI, or within 14 days of discontinuing therapy with an MAOI.
  • Taking reserpine. At least 20 days should elapse after stopping reserpine before starting AUSTEDO.
  • Taking tetrabenazine (XENAZINE®).

Clinical Worsening and Adverse Events: VMAT2 inhibitors, including AUSTEDO, may cause a worsening in mood, cognition, rigidity, and functional capacity. Prescribers should periodically re-evaluate the need for AUSTEDO in their patients by assessing the effect on chorea and possible adverse effects.

Neuroleptic Malignant Syndrome (NMS), a potentially fatal symptom complex, has been observed in patients receiving tetrabenazine. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability. Additional signs may include elevated creatinine phosphokinase, myoglobinuria, rhabdomyolysis, and acute renal failure. The management of NMS should include immediate discontinuation of AUSTEDO; intensive symptomatic treatment and medical monitoring; and treatment of any concomitant serious medical problems.

Akathisia, Agitation, and Restlessness: AUSTEDO may increase the risk of akathisia, agitation, and restlessness in patients with Huntington’s disease. Monitor patients for signs and symptoms of restlessness and agitation. If a patient develops akathisia during treatment with AUSTEDO, the AUSTEDO dose should be reduced; some patients may require discontinuation of therapy.

Parkinsonism: AUSTEDO may cause parkinsonism in patients with Huntington’s disease. If a patient develops parkinsonism during treatment with AUSTEDO, the AUSTEDO dose should be reduced; some patients may require discontinuation of therapy.

Sedation and Somnolence: Sedation is a common dose-limiting adverse reaction of AUSTEDO. Patients should not perform activities requiring mental alertness to maintain the safety of themselves or others, such as operating a motor vehicle or operating hazardous machinery, until they are on a maintenance dose of AUSTEDO and know how the drug affects them.

QTc Prolongation: Tetrabenazine causes an increase (about 8 msec) in the corrected QT (QTc) interval. A clinically relevant QT prolongation may occur in some patients treated with AUSTEDO who are CYP2D6 poor metabolizers or are co-administered a strong CYP2D6 inhibitor. The use of AUSTEDO should be avoided in combination with other drugs that are known to prolong QTc. AUSTEDO should also be avoided in patients with congenital long QT syndrome and in patients with a history of cardiac arrhythmias.

Hyperprolactinemia: Serum prolactin levels were not evaluated in the AUSTEDO development program. Tetrabenazine elevates serum prolactin concentrations in humans. If there is a clinical suspicion of symptomatic hyperprolactinemia, appropriate laboratory testing should be done and consideration should be given to discontinuation of AUSTEDO.

Binding to Melanin-Containing Tissues: Since deutetrabenazine or its metabolites bind to melanin-containing tissues, it could accumulate in these tissues over time. This raises the possibility that AUSTEDO may cause toxicity in these tissues after extended use. Although there are no specific recommendations for periodic ophthalmologic monitoring, prescribers should be aware of the possibility of long-term ophthalmologic effects.

Common Adverse Reactions: The most common adverse reactions (> 8% and greater than placebo) in a controlled clinical study were somnolence, diarrhea, dry mouth, and fatigue.

Drug Interactions: See Contraindications. The daily dosage of AUSTEDO should not exceed 36 mg (maximum single dose of 18 mg) in patients taking strong CYP2D6 inhibitors. The risk for parkinsonism, NMS, and akathisia may be increased by concomitant use of AUSTEDO and dopamine antagonists or antipsychotics. Concomitant use of alcohol or other sedating drugs may have additive effects and worsen sedation and somnolence.

Poor CYP2D6 Metabolizers: In patients who are CYP2D6 poor metabolizers, the daily dosage of AUSTEDO should not exceed 36 mg (maximum single dose of 18 mg).

Please see full Prescribing Information, including Boxed Warning, for AUSTEDO.