Xenazine 25 mg/1

tetrabenazine · TABLET · Lundbeck Pharmaceuticals LLC

No Recall History

Plain English

Xenazine is a tablet containing tetrabenazine at 25 mg/1, taken oral. Manufactured by Lundbeck Pharmaceuticals LLC.

Key Facts

Brand Name: Xenazine
Generic Name: tetrabenazine
NDC Code (Product): 67386-422
Manufacturer: Lundbeck Pharmaceuticals LLC
Strength: 25 mg/1
Dosage Form: TABLET
Route: ORAL
Marketing Status
Application #: NDA021894
Drug Class: Vesicular Monoamine Transporter 2 Inhibitor [EPC]
Marketing Start: 11/24/2008

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

death1,215 reports

off label use1,126 reports

drug ineffective701 reports

depression474 reports

somnolence451 reports

fatigue361 reports

fall315 reports

hospitalisation297 reports

insomnia276 reports

intentional product use issue274 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE XENAZINE is indicated for the treatment of chorea associated with Huntington’s disease. XENAZINE is a vesicular monoamine transporter 2 (VMAT) inhibitor indicated for the treatment of chorea associated with Huntington’s disease. ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Individualization of dose with careful weekly titration is required. The 1 st week’s starting dose is 12.5 mg daily; 2 nd week, 25 mg (12.5 mg twice daily); then slowly titrate at weekly intervals by 12.5 mg to a tolerated dose that reduces chorea. ( 2.1 , 2.2 ) Doses of 37.5 mg and up to 50 mg/day should be administered in three divided doses per day with a maximum recommended single dose not to exceed 25 mg. ( 2.2 ) Patients requiring doses above 50 mg/day should be genotyped for the drug metabolizing enzyme CYP2D6 to determine if the patient is a poor metabolizer (PM) or an extensive metabolizer (EM). ( 2.2 , 5.3) Maximum daily dose in PMs: 50 mg with a maximum single dose of 25 mg ( 2.2 ) Maximum daily dose in EMs and intermediate metabolizers (IMs): 100 mg with a maximum single dose of 37.5 mg ( 2.2 ) If serious adverse reactions occur, titration should be stopped and the dose should be reduced. If the adverse reaction(s) do not resolve, consider withdrawal of XENAZINE. ( 2.2 ) 2.1 General Dosing Considerations The chronic daily dose of XENAZINE used to treat chorea associated with Huntington’s disease (HD) is determined individually for each patien…

Contraindications

4 CONTRAINDICATIONS XENAZINE is contraindicated in patients: Who are actively suicidal, or in patients with 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 monoamine oxidase inhibitors (MAOIs). XENAZINE should not be used in combination with an MAOI, or within a minimum of 14 days of discontinuing therapy with an MAOI [see Drug Interactions (7.3) ]. Taking reserpine. At least 20 days should elapse after stopping reserpine before starting XENAZINE [see Drug Interactions ( 7.2 )]. Taking deutetrabenazine or valbenazine [see Drug Interactions ( 7.7 )]. Actively suicidal, or who have depression which is untreated or undertreated ( 4 , 5.1 ) Hepatic impairment ( 4 , 8.6 , 12.3 ) Taking monoamine oxidase inhibitors (MAOIs) or reserpine ( 4 , 7.2 , 7.3 ) Taking deutetrabenazine or valbenazine ( 4 , 7.7 )

Drug Interactions

7 DRUG INTERACTIONS 7.1 Strong CYP2D6 Inhibitors In vitro studies indicate that α-HTBZ and β-HTBZ are substrates for CYP2D6. Strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, quinidine) markedly increase exposure to these metabolites. A reduction in XENAZINE dose may be necessary when adding a strong CYP2D6 inhibitor (e.g., fluoxetine, paroxetine, quinidine) in patients maintained on a stable dose of XENAZINE. The daily dose of XENAZINE should not exceed 50 mg/day and the maximum single dose of XENAZINE should not exceed 25 mg in patients taking strong CYP2D6 inhibitors [see Dosage and Administration (2.3) , Warnings and Precautions (5.3) , Use in Specific Populations (8.7), Clinical Pharmacology (12.3) ]. 7.2 Reserpine Reserpine binds irreversibly to VMAT2, and the duration of its effect is several days. Prescribers should wait for chorea to re-emerge before administering XENAZINE to avoid overdosage and major depletion of serotonin and norepinephrine in the CNS. At least 20 days should elapse after stopping reserpine before starting XENAZINE. XENAZINE and reserpine should not be used concomitantly [see Contraindications (4) ]. 7.3 Monoamine Oxidase Inhibitors (MAOIs) XENAZI…

Adverse Reactions

6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in the labeling: Depression and Suicidality [see Warnings and Precautions (5.1) ] Neuroleptic Malignant Syndrome (NMS) [see Warnings and Precautions (5.4) ] Akathisia, Restlessness, and Agitation [see Warnings and Precautions (5.5) ] Parkinsonism [see Warnings and Precautions (5.6) ] Sedation and Somnolence [see Warnings and Precautions (5.7) ] QTc Prolongation [see Warnings and Precautions (5.8) ] Hypotension and Orthostatic Hypotension [see Warnings and Precautions (5.9) ] Hyperprolactinemia [see Warnings and Precautions (5.10) ] Binding to Melanin-Containing Tissues [see Warnings and Precautions (5.11) ] Most common adverse reactions (greater than 10% and at least 5% greater than placebo) were: sedation/somnolence, fatigue, insomnia, depression, akathisia, anxiety/anxiety aggravated, nausea. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Lundbeck’s XENAZINE Information Center at 1-888-882-6013 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the…

Frequently Asked Questions

What is Xenazine used for?

Xenazine contains tetrabenazine. It is a tablet taken oral. Consult your doctor for specific uses.

Is Xenazine a controlled substance?

Xenazine is not classified as a controlled substance by the DEA.

What is the generic name for Xenazine?

The generic name for Xenazine is tetrabenazine. There are 11 other brand versions of tetrabenazine.

What is the NDC code for Xenazine 25 mg/1?

The NDC (National Drug Code) for Xenazine 25 mg/1 is 67386-422, listed by Lundbeck Pharmaceuticals LLC.

Product NDC

67386-422

Package NDC

67386-422-01

Other Tetrabenazine Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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