Ajuben Tablet

Ajuben is a vesicular monoamine transporter 2 (VMAT2) inhibitor indicated for the treatment of Chorea associated with Huntington’s disease & Tardive dyskinesia in adults.

The precise mechanism by which deutetrabenazine exerts its anti-chorea effects is unknown but is believed to be related to its effect as a reversible depletor of monoamines (such as dopamine, serotonin, norepinephrine, and histamine) from nerve terminals. The major circulating metabolites (α-dihydrotetrabenazine [HTBZ] and β-HTBZ) of deutetrabenazine, are reversible inhibitors of VMAT2, resulting in decreased uptake of monoamines into synaptic vesicles and depletion of monoamine stores

Patients not presently receiving Tetrabenazine: Titrate up at weekly intervals by 6 mg per day to a tolerated dose that reduces chorea, up to a maximum recommended daily dosage of 48 mg (24 mg twice daily). Administer total daily dosages of 12 mg or above in two divided doses and administer with foods.

Patients receiving Tetrabenazine: If switching patients from tetrabenazine, discontinue tetrabenazine and initiate deutetrabenazine the following day. After patients are switched to deutetrabenazine, the dose may be adjusted at weekly intervals.

Patients with Hepatic & Renal Impairment: No clinical studies have been conducted to assess the effect of renal & hepatic impairment on the pharmacokinetics of deutetrabenazine.

Patients with poor CYP2D6 metabolizers: Maximum recommended dosage of deutetrabenazine in poor CYP2D6 metabolizers is 36 mg per day (i.e., 18 mThe precise mechanism by which deutetrabenazine exerts its anti-chorea effects is unknown but is believed to be related to its effect as a reversible depletor of monoamines (such as dopamine, serotonin, norepinephrine, and histamine) from nerve terminals. The major circulating metabolites (α-dihydrotetrabenazine and βdihydrotetrabenazine) of deutetrabenazine, are reversible inhibitors of vesicular monoamine transporter 2 (VMAT2), resulting in decreased uptake of monoamines into synaptic vesicles and depletion of monoamine stores.g twice daily).

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

Concomitant use of strong CYP2D6 inhibitors: Maximum recommended dose of Ajuben is 36 mg per day (18 mg twice daily).
Alcohol or other sedating drugs: May have additive sedation and somnolence.

Deutetrabenazine is contraindicated in patients:

• Who are suicidal, or in patients with untreated or inadequately treated depression.
• With hepatic impairment.
• Taking monoamine oxidase inhibitors (MAOIs). Deutetrabenazine 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

The most common side effects of Ajuben include:

• sleepiness (sedation)
• tiredness
• diarrhea
• dry mouth

Pregnancy: There are no adequate data on the developmental risk associated with the use of Deutetrabenazine in pregnant women. Administration of deutetrabenazine to rats during organogenesis produced no clear adverse effect on embryofetal development. However, administration of tetrabenazine to rats throughout pregnancy and lactation resulted in an increase in stillbirths and postnatal offspring mortality.

Lactation: There are no data on the presence of deutetrabenazine or its metabolites in human milk, the effects on the breastfed infant, or the effects of the drug on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Deutetrabenazine and any potential adverse effects on the breastfed infant from Deutetrabenazine or from the underlying maternal condition.

• Increases the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease
• Balance risks of depression and suicidality with the clinical need for treatment of chorea when considering the use of Ajuben
• 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
• Ajuben is contraindicated in patients who are suicidal, and in patients with untreated or inadequately treated depression

Overdoses ranging from 100 mg to 1 g have been reported in the literature with tetrabenazine, a closely related VMAT2 inhibitor. The following adverse reactions occurred with overdosing: 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 central nervous system-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.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.