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Tetrabenazine (Tetrabenazine)

Trade Name : Tetrabenazine

Hikma Pharmaceuticals USA Inc.

TABLET

Strength 12.5 mg/1

TETRABENAZINE Vesicular Monoamine Transporter 2 Inhibitor [EPC],Vesicular Monoamine Transporter 2 Inhibitors [MoA]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Tetrabenazine (Tetrabenazine) which is also known as Tetrabenazine and Manufactured by Hikma Pharmaceuticals USA Inc.. It is available in strength of 12.5 mg/1 per ml. Read more

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • No data
  • -removal
  • Tetrabenazine can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntingtonu2019s disease. Anyone considering the use of tetrabenazine must balance the risks of depression and suicidality with the clinical need for control of chorea. 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.
  • 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 Huntingtonu2019s disease. Tetrabenazine is contraindicated in patients who are actively suicidal, and in patients with untreated or inadequately treated depression n
  • WARNING: DEPRESSION AND SUICIDALITY
  • See full prescribing information for complete boxed warning.
  • Increases the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntingtonu2019s disease ()
  • Balance risks of depression and suicidality with the clinical need for control of chorea when considering the use of tetrabenazine ()
  • Monitor patients for the emergence or worsening of depression, suicidality, or unusual changes in behavior ()
  • Inform patients, caregivers and families of the risk of depression and suicidality and instruct to report behaviors of concern promptly to the treating physician ()
  • Exercise caution when treating patients with a history of depression or prior suicide attempts or ideation ()
  • Tetrabenazine is contraindicated in patients who are actively suicidal, and in patients with untreated or inadequately treated depression (, )
  • Tetrabenazine tablets are indicated for the treatment of chorea associated with Huntingtonu2019s disease.
  • Tetrabenazine tabletsare a vesicular monoamine transporter 2 (VMAT) inhibitor indicated for the treatment of chorea associated with Huntingtonu2019s disease ().
  • No data
  • stn- nd
  • 2.1n- 2.2
  • 2.2n- 5.3
  • Tetrabenazine Tablets are available in the following strengths and packages:
  • The 12.5 mg tablets are supplied as a white to off white, round biconvex tablet, debossed with u201c54u201d [above] u201c347u201d on one side and plain on the other.
  • The 25 mg tablets are supplied as a light tan to tan, speckled, round biconvex tablet, debossed with u201c54u201d [above] u201c254u201d on one side and a functional score on the other.
  • Tablets: 12.5 mg non-scored and 25 mg functionally scored ()
  • Tetrabenazine is contraindicated in patients:
  • 4n- 5.1
  • 4n- 8.6n- 12.3
  • 4n- 7.2n- 7.3
  • 4n- 7.7
  • No data
  • 5.3n- 7.1
  • 5.4n- 7.6
  • 5.5n- 5.6
  • The following serious adverse reactions are described below and elsewhere in the labeling:
  • Most common adverse reactions (>10% and at least 5% greater than placebo) were: Sedation/somnolence, fatigue, insomnia, depression, akathisia, anxiety/anxiety aggravated, nausea ()
  • No data
  • Pregnancy: Based on animal data, may cause fetal harm ()
  • No data
  • Three episodes of overdose occurred in the open-label trials performed in support of registration. Eight cases of overdose with tetrabenazine have been reported in the literature. The dose of tetrabenazine in these patients ranged from 100 mg to 1u00a0gram. Adverse reactions associated with tetrabenazine overdose include acute dystonia, oculogyric crisis, nausea and vomiting, sweating, sedation, hypotension, confusion, diarrhea, hallucinations, rubor, and tremor.
  • Treatment should consist of those general measures employed in the management of overdosage with any CNS-active drug. General supportive and symptomatic measures are recommended. Cardiac rhythm and vital signs should be monitored. In managing overdosage, the possibility of multiple drug involvement should always be considered. The physician should consider contacting a poison control center on the treatment of any overdose.
  • Tetrabenazine is a monoamine depletor for oral administration. The molecular weight of tetrabenazine is 317.42; the pKa is 6.51. Tetrabenazine is a hexahydro-dimethoxy-benzoquinolizine derivative and has the following chemical name: cis rac u20131,3,4,6,7,11b-hexahydro-9,10-dimethoxy-3-(2-methylpropyl)-2H-benzo[a]quinolizin-2-one.
  • The molecular formula CHNO is represented by the following structural formula:
  • Tetrabenazine is a white to slightly yellow powder that is sparingly soluble in water and soluble in ethanol.
  • Tetrabenazine Tablets are available for oral administration containing either 12.5 mg or 25 mg of tetrabenazine. Each tablet contains the following inactive ingredients: crospovidone, lactose monohydrate, microcrystalline cellulose and sodium stearyl fumarate. In addition, the 25 mg tablet also contains ferric oxide [iron oxide (yellow 10)].
  • No data
  • Carcinogenesis
  • No increase in tumors was observed in p53 transgenic mice treated orally with tetrabenazine (5, 15, and 30 mg/kg/day) for 26 weeks. No increase in tumors was observed in Tg.rasH2 transgenic mice treated orally with a major human metabolite, 9-desmethyl-u03b2-DHTBZ (20, 100, and 200 mg/kg/day), for 26 weeks.
  • Mutagenesis
  • Tetrabenazine and metabolites u03b1-HTBZ, u03b2-HTBZ, and 9-desmethyl-u03b2-DHTBZ were negative in an bacterial reverse mutation assay. Tetrabenazine was clastogenic in an chromosomal aberration assay in Chinese hamster ovary cells in the presence of metabolic activation. u03b1-HTBZ and u03b2-HTBZ were clastogenic in an chromosome aberration assay in Chinese hamster lung cells in the presence and absence of metabolic activation. 9-desmethyl-u03b2-DHTBZ was not clastogenic in an chromosomal aberration assay in human peripheral blood mononuclear cells in the presence or absence of metabolic activation. micronucleus assays were conducted in male and female rats and male mice. Tetrabenazine was negative in male mice and rats but produced an equivocal response in female rats.
  • Impairment of Fertility
  • Oral administration of tetrabenazine (5, 15, or 30 mg/kg/day) to female rats prior to and throughout mating, and continuing through day 7 of gestation resulted in disrupted estrous cyclicity at doses greater than 5 mg/kg/day (less than the MRHD on a mg/m basis).
  • No effects on mating and fertility indices or sperm parameters (motility, count, density) were observed when males were treated orally with tetrabenazine (5, 15, or 30 mg/kg/day; up to 3 times the MRHD on a mg/m basis) prior to and throughout mating with untreated females.
  • Because rats dosed with tetrabenazine do not produce 9-desmethyl-beta-DHTBZ, a major human metabolite, these studies may not have adequately assessed the potential of tetrabenazine to impair fertility in humans.
  • Study 1
  • The efficacy of tetrabenazine as a treatment for the chorea of Huntingtonu2019s disease was established primarily in a randomized, double-blind, placebo-controlled multi-center trial (Study 1) conducted in ambulatory patients with a diagnosis of HD. The diagnosis of HD was based on family history, neurological exam, and genetic testing. Treatment duration was 12 weeks, including a 7-week dose titration period and a 5-week maintenance period followed by a 1-week washout. Tetrabenazine was started at a dose of 12.5 mg per day, followed by upward titration at weekly intervals, in 12.5 mg increments until satisfactory control of chorea was achieved, intolerable side effects occurred, or until a maximal dose of 100 mg per day was reached.
  • The primary efficacy endpoint was the Total Chorea Score, an item of the Unified Huntingtonu2019s Disease Rating Scale (UHDRS). On this scale, chorea is rated from 0 to 4 (with 0 representing no chorea) for 7 different parts of the body. The total score ranges from 0 to 28.
  • As shown in Figure 1, Total Chorea Scores for patients in the drug group declined by an estimated 5.0 units during maintenance therapy (average of Week 9 and Week 12 scores versus baseline), compared to an estimated 1.5 units in the placebo group. The treatment effect of 3.5 units was statistically significant. At the Week 13 follow-up in Study 1 (1 week after discontinuation of the study medication), the Total Chorea Scores of patients receiving tetrabenazine returned to baseline.
  • Figure 1: Mean u00b1 s.e.m. Changes from Baseline in Total Chorea Score in 84 HD Patients Treated with Tetrabenazine (n=54) or Placebo (n=30)
  • (error bars are u00b1 s.e.m.)
  • *p<0.05
  • Figure 2 illustrates the cumulative percentages of patients from the tetrabenazine and placebo treatment groups who achieved the level of reduction in the Total Chorea Score shown on the X axis. The left-ward shift of the curve (toward greater improvement) for the tetrabenazine-treated patients indicates that these patients were more likely to have any given degree of improvement in chorea score. For example, about 7% of placebo patients had a 6-point or greater improvement compared to 50% of tetrabenazine-treated patients. The percentage of patients achieving reductions of at least 10, 6, and 3 points from baseline to Week 12 are shown in the inset table.
  • Figure 2: Cumulative Percentage of Patients with Specified Changes from Baseline in Total Chorea Score. The Percentages of Randomized Patients within each treatment group who completed Study 1 were: Placebo 97%, Tetrabenazine 91%.
  • A Physician-rated Clinical Global Impression (CGI) favored tetrabenazine statistically. In general, measures of functional capacity and cognition showed no difference between tetrabenazine and placebo. However, one functional measure (Part 4 of the UHDRS), a 25-item scale assessing the capacity for patients to perform certain activities of daily living, showed a decrement for patients treated with tetrabenazine compared to placebo, a difference that was nominally statistically significant. A 3-item cognitive battery specifically developed to assess cognitive function in patients with HD (Part 2 of the UHDRS) also showed a decrement for patients treated with tetrabenazine compared to placebo, but the difference was not statistically significant.
  • Study 2
  • A second controlled study was performed in patients who had been treated with open-label tetrabenazine for at least 2 months (mean duration of treatment was 2 years). They were randomized to continuation of tetrabenazine at the same dose (n=12) or to placebo (n=6) for three days, at which time their chorea scores were compared. Although the comparison did not reach statistical significance (p=0.1), the estimate of the treatment effect was similar to that seen in Study 1 (about 3.5 units).
  • No data
  • Advise the patient to read the FDA-approved patient labeling (Medication Guide).
  • Risk of Suicidality
  • Inform patients and their families that tetrabenazine may increase the risk of suicidal thinking and behaviors. Counsel patients and their families to remain alert to the emergence of suicidal ideation and to report it immediately to the patientu2019s physician .
  • Risk of Depression
  • Inform patients and their families that tetrabenazine may cause depression or may worsen pre-existing depression. Encourage patients and their families to be alert to the emergence of sadness, worsening of depression, withdrawal, insomnia, irritability, hostility (aggressiveness), akathisia (psychomotor restlessness), anxiety, agitation, or panic attacks and to report such symptoms promptly to the patientu2019s physician .
  • Dosing of Tetrabenazine
  • Inform patients and their families that the dose of tetrabenazine will be increased slowly to the dose that is best for each patient. Sedation, akathisia, parkinsonism, depression, and difficulty swallowing may occur. Such symptoms should be promptly reported to the physician, and the tetrabenazine dose may need to be reduced or discontinued .
  • Risk of Sedation and Somnolence
  • Inform patients that tetrabenazine may induce sedation and somnolence and may impair the ability to perform tasks that require complex motor and mental skills. Advise patients that until they learn how they respond to tetrabenazine, they should be careful doing activities that require them to be alert, such as driving a car or operating machinery .
  • Interaction with Alcohol
  • Advise patients and their families that alcohol may potentiate the sedation induced by tetrabenazine .
  • Usage in Pregnancy
  • Advise patients and their families to notify the physician if the patient becomes pregnant or intends to become pregnant during tetrabenazine therapy, or is breast-feeding or intending to breast-feed an infant during therapy .
  • Distr. by: Eatontown, NJ 07724
  • 10009084/01
  • Revised February 2019
  • Tetrabenazine Tabletsn
  • Rx only
  • Read the Medication Guide that comes with tetrabenazine before you start taking it and each time you refill the prescription. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment. You should share this information with your family members and caregivers.
  • What is the most important information I should know about tetrabenazine?
  • Call the doctor right away if you become depressed or have any of the following symptoms, especially if they are new, worse, or worry you:
  • What is tetrabenazine?
  • Tetrabenazine is a medicine that is used to treat the involuntary movements (chorea) of Huntingtonu2019s disease. Tetrabenazine does not cure the cause of the involuntary movements, and it does not treat other symptoms of Huntingtonu2019s disease, such as problems with thinking or emotions.
  • It is not known whether tetrabenazine is safe and effective in children.
  • Who should not take tetrabenazine?
  • Do not take tetrabenazinen- if you:
  • What should I tell my doctor before taking tetrabenazine?
  • Tell your doctor about all your medical conditions, including if you:
  • Tell your doctor about all the medicines you taken- . Do not start new medicines while taking tetrabenazine without talking to your doctor first.
  • How should I take tetrabenazine?
  • What should I avoid while taking tetrabenazine?
  • Sleepiness (sedation) is a common side effect of tetrabenazine. While taking tetrabenazine. Drinking alcohol and taking other drugs that may also cause sleepiness while you are taking tetrabenazine may increase any sleepiness caused by tetrabenazine.
  • What are the possible side effects of tetrabenazine?
  • Tetrabenazine can cause serious side effects, including:
  • Common side effects with tetrabenazine include:
  • Tell your doctor if you have any side effects. Do not stop taking tetrabenazine without talking to your doctor first.
  • Call your doctor for medical advice about side effects. You may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088.
  • General information about tetrabenazine
  • Tetrabenazine tablets are available for oral administration containing either 12.5 mg or 25 mg of tetrabenazine. Each tablet contains the following inactive ingredients: crospovidone, lactose monohydrate, microcrystalline cellulose and sodium stearyl fumarate. In addition, the 25 mg tablet also contains ferric oxide [iron oxide (yellow 10)].
  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use tetrabenazine for a condition for which it was not prescribed. Do not give tetrabenazine to other people, even if they have the same symptoms that you have. It may harm them. Keep tetrabenazine out of the reach of children.
  • This Medication Guide summarizes the most important information about tetrabenazine. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about tetrabenazine that is written for healthcare professionals. You can also call Hikma Pharmaceuticals USA Inc. at 1-800-962-8364.
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • The brands listed are registered trademarks of their respective owners.
  • Distr. by: Eatontown, NJ 07724
  • 10009084/01
  • Revised February 2019
  • Rx only
  • Rx only

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