Tetrabenazine
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]
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Black Box Warning
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WARNING: DEPRESSION AND SUICIDALITY
See full prescribing information for complete Boxed Warning.
* XENAZINE can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington's disease. Anyone considering the use of XENAZINE must balance the risks of depression and suicidality with the clinical need for control of choreiform movements. Close observation of patients for the emergence or worsening of depression, suicidality, or unusual changes in behavior should accompany therapy. 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.
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Overview
Tetrabenazine is a central nervous system agent that is FDA approved for the treatment of chorea associated with Huntington's disease. There is a Black Box Warning for this drug as shown here. Common adverse reactions include Sedation,somnolence, fatigue, insomnia, depression, akathisia, anxiety, nausea.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Indications
- Treatment of chorea associated with Huntington's disease.
Dosage
General Dosing Considerations
The chronic daily dose of XENAZINE used to treat chorea associated with Huntington's disease (HD) is determined individually for each patient. When first prescribed, XENAZINE therapy should be titrated slowly over several weeks to identify a dose of XENAXINE that reduces chorea and is tolerated. XENAZINE can be administered without regard to food.
Individualization of Dose
The dose of XENAZINE should be individualized.
'Dosing Recommendations Up to 50 mg per day'
The starting dose should be 12.5 mg per day given once in the morning. After one week, the dose should be increased to 25 mg per day given as 12.5 mg twice a day. XENAZINE should be titrated up slowly at weekly intervals by 12.5 mg daily, to allow the identification of a tolerated dose that reduces chorea. If a dose of 37.5 to 50 mg per day is needed, it should be given in a three times a day regimen. The maximum recommended single dose is 25 mg. If adverse events such as akathisia, restlessness, parkinsonism, depression, insomnia, anxiety or sedation occur, titration should be stopped and the dose should be reduced. If the adverse event does not resolve, consideration should be given to withdrawing XENAZINE treatment or initiating other specific treatment (e.g., antidepressants) [see ADVERSE REACTIONS (6.1)].
'Dosing Recommendations Above 50 mg per day'
Patients who require doses of XENAZINE greater than 50 mg per day should be first tested and genotyped to determine if they are poor metabolizers (PMs) or extensive metabolizers (EMs) by their ability to express the drug metabolizing enzyme, CYP2D6. The dose of XENAZINE should then be individualized accordingly to their status as PMs or EMs.
'Extensive and Intermediate CYP2D6 Metabolizers'
Genotyped patients who are identified as extensive (EMs) or intermediate metabolizers (IMs) of CYP2D6, who need doses of XENAZINE above 50 mg per day, should be titrated up slowly at weekly intervals by 12.5 mg daily, to allow the identification of a tolerated dose that reduces chorea. Doses above 50 mg per day should be given in a three times a day regimen. The maximum recommended daily dose is 100 mg and the maximum recommended single dose is 37.5 mg. If adverse events such as akathisia, parkinsonism, depression, insomnia, anxiety or sedation occur, titration should be stopped and the dose should be reduced. If the adverse event does not resolve, consideration should be given to withdrawing XENAZINE treatment or initiating other specific treatment (e.g., antidepressants).
'Poor CYP2D6 Metabolizers'
In PMs, the initial dose and titration is similar to EMs except that the recommended maximum single dose is 25 mg, and the recommended daily dose should not exceed a maximum of 50 mg.
CYP2D6 Inhibitors
'Strong CYP2D6 Inhibitors'
Medications that are strong CYP2D6 inhibitors such as quinidine or antidepressants (e.g., fluoxetine, paroxetine) significantly increase the exposure to α-HTBZ and β-HTBZ, therefore, the total dose of XENAZINE should not exceed a maximum of 50 mg and the maximum single dose should not exceed 25 mg [see WARNINGS AND PRECAUTIONS (5.3), DRUG INTERACTIONS (7.1), USE IN SPECIFIC POPULATIONS (8.8), and CLINICAL PHARMACOLOGY (12.3)].
2.4 Patients with Hepatic Impairment Because the safety and efficacy of the increased exposure to XENAZINE and other circulating metabolites are unknown, it is not possible to adjust the dosage of XENAZINE in hepatic impairment to ensure safe use. Therefore, XENAZINE is contraindicated in patients with hepatic impairment [see CONTRAINDICATIONS (4), WARNINGS AND PRECAUTIONS (5.16), USE IN SPECIFIC POPULATIONS (8.6), and CLINICAL PHARMACOLOGY (12.3)].
2.5 Discontinuation of Treatment Treatment with XENAZINE can be discontinued without tapering. Re-emergence of chorea may occur within 12 to 18 hours after the last dose of XENAZINE [see DRUG ABUSE AND DEPENDENCE (9.2)].
2.6 Resumption of Treatment Following treatment interruption of greater than five (5) days, XENAZINE therapy should be re-titrated when resumed. For short-term treatment interruption of less than five (5) days, treatment can be resumed at the previous maintenance dose without titration.
Off-Label Use and Dosage (Adult)
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding FDA-Labeled Use of Tetrabenazine in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Tetrabenazine in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Tetrabenazine in pediatric patients.
Contraindications
There is limited information regarding Tetrabenazine Contraindications in the drug label.
Warnings
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WARNING: DEPRESSION AND SUICIDALITY
See full prescribing information for complete Boxed Warning.
* XENAZINE can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington's disease. Anyone considering the use of XENAZINE must balance the risks of depression and suicidality with the clinical need for control of choreiform movements. Close observation of patients for the emergence or worsening of depression, suicidality, or unusual changes in behavior should accompany therapy. 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.
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There is limited information regarding Tetrabenazine Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Tetrabenazine in the drug label.
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Tetrabenazine in the drug label.
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Drug Interactions
There is limited information regarding Tetrabenazine Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Tetrabenazine in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Tetrabenazine in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Tetrabenazine during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Tetrabenazine with respect to nursing mothers.
Pediatric Use
There is no FDA guidance on the use of Tetrabenazine with respect to pediatric patients.
Geriatic Use
There is no FDA guidance on the use of Tetrabenazine with respect to geriatric patients.
Gender
There is no FDA guidance on the use of Tetrabenazine with respect to specific gender populations.
Race
There is no FDA guidance on the use of Tetrabenazine with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Tetrabenazine in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Tetrabenazine in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Tetrabenazine in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Tetrabenazine in patients who are immunocompromised.
Administration and Monitoring
Administration
- Oral
Monitoring
There is limited information regarding Monitoring of Tetrabenazine in the drug label.
IV Compatibility
There is limited information regarding IV Compatibility of Tetrabenazine in the drug label.
Overdosage
There is limited information regarding Chronic Overdose of Tetrabenazine in the drug label.
Pharmacology
There is limited information regarding Tetrabenazine Pharmacology in the drug label.
Mechanism of Action
Structure
There is limited information regarding Tetrabenazine Structure in the drug label.
Pharmacodynamics
There is limited information regarding Pharmacodynamics of Tetrabenazine in the drug label.
Pharmacokinetics
There is limited information regarding Pharmacokinetics of Tetrabenazine in the drug label.
Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Tetrabenazine in the drug label.
Clinical Studies
There is limited information regarding Clinical Studies of Tetrabenazine in the drug label.
How Supplied
Storage
There is limited information regarding Tetrabenazine Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Patient Counseling Information of Tetrabenazine in the drug label.
Precautions with Alcohol
- Alcohol-Tetrabenazine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Tetrabenazine Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Tetrabenazine Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
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