Ajuben 12 mg

INDICATIONS

Deutetrabenazine is a vesicular monoamine transporter 2 (VMAT2) inhibitor indicated for the treatment of-

Chorea associated with Huntington's disease
Tardive dyskinesia in adults.

PHARMACOLOGY

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 and β-dihydrotetrabenazine) 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.

DOSAGE & ADMINISTRATION

Patients not presently receiving Tetrabenazine:Chorea associated with Huntington’s disease-

Initial dose: 6 mg/day
Maintenance dose: 6 mg-48 mg/day
Maximum dose: 48 mg/day

Tardive dyskinesia-

Initial dose: 12 mg/day
Maintenance dose: 12 mg-48 mg/day
Maximum dose: 48 mg/day

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. The recommended initial dosing regimen of deutetrabenazine in patients switching from tetrabenazine to deutetrabenazine is shown in below chert:
 


Current Tetrabenazine daily dosage
Initial regimen of Deutetrabenazine


12.5 mg
6 mg once daily


25 mg
6 mg once daily


37.5 mg
9 mg once daily


50 mg
12 mg once daily


62.5 mg
15 mg once daily


75 mg
18 mg once daily


87.5 mg
21 mg once daily


100 mg
24 mg once daily



After patients are switched to deutetrabenazine, the dose may be adjusted at weekly intervals.

INTERACTION

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

SIDE EFFECTS

Most common adverse reactions (>8%) of deutetrabenzine’s are somnolence, diarrhea, dry mouth, and fatigue.

PREGNANCY & LACTATION

There are no adequate data on the developmental risk associated with the use of deutetrabenazine in pregnant women. 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.

PRECAUTIONS & WARNINGS

Patients may experience Neuroleptic Malignant Syndrome (discontinue deutetrabenazine if this occurs), Akathisia, agitation, restlessness, and Parkinsonism (reduce the daily dose of deutetrabenazine or discontinue if this occurs) and Sedation/somnolence.

USE IN SPECIAL POPULATIONS

Use in Children: Safety & effectiveness of deutetrabenzine in infants & children have not been established.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 mg twice daily)

STORAGE CONDITIONS

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