Ostedo Tablet 12 mg (Dutetrabenazine)

Adult dose

1. Method of administration The dose of this drug should be determined individually for each patient based on the reduction in symptoms of chorea or tardive dyskinesia and tolerability. For patients who are not switching from tetrabenazine (a VMAT2 inhibitor related to this drug), the recommended starting dose when initiating this drug is 12mg per day (6mg twice daily). Increase the dose of this drug by 6 mg per day at 1-week intervals; the maximum recommended dose is 48 mg per day. If the total daily dose is 12 mg or more, administer it in 2 divided doses. Administer this drug with food. Swallow this drug whole. Do not chew, crush, or split the tablets. 2. Patients switching to this drug from tetrabenazine Discontinue tetrabenazine and start this drug the following day. The recommended initial dosing regimen of this drug for patients switching from tetrabenazine is shown in Table 1. Table 1. Recommended initial dosing regimen when switching from tetrabenazine to this drug Current daily dose of tetrabenazine — Initial dosing regimen of this drug 12.5 mg — 6 mg, once daily 25 mg — 6 mg, twice daily 37.5 mg — 9 mg, twice daily 50 mg — 12 mg, twice daily 62.5 mg — 15 mg, twice daily 75 mg — 18 mg, twice daily 87.5 mg — 21 mg, twice daily 100 mg — 24 mg, twice daily After switching to this drug, the dose may be adjusted at 1-week intervals. 3. Dose adjustment when used concomitantly with strong CYP2D6 inhibitors For patients taking strong CYP2D6 inhibitors (e.g., antidepressants such as paroxetine, fluoxetine, and bupropion, or quinidine), the total daily dose of this drug must not exceed 36 mg (maximum single dose 18 mg) [see Precautions for Use 5. Drug Interactions, item 1)]. 4. Discontinuation and interruption of treatment Treatment with this drug may be discontinued without tapering. If treatment with this drug is resumed after an interruption of more than 1 week, the dose must be titrated again. If treatment has been interrupted for less than 1 week, treatment may be resumed at the previous maintenance dose without dose titration.

This medication may increase the risk of depression and suicidal impulses in patients with Huntington's disease, so the patient's mental state should be carefully evaluated before treatment. Patients and families should be adequately informed about the risk of depression and suicide, and should report any abnormal behavior to healthcare professionals immediately. It should not be administered to patients with suicidal impulses or inadequately treated depression. It should not be used in patients with impaired liver function, and serious side effects may occur when used in combination with certain medications, so consultation with healthcare professionals is necessary. Common side effects during treatment with this medication may include drowsiness, diarrhea, dry mouth, and fatigue, so caution is needed. Activities requiring concentration, such as driving or operating hazardous machinery, should only be undertaken after assessing one's condition after taking this medication. This medication may prolong the QT interval related to heart rate, so special caution is needed for patients with heart disease. Serious neurological side effects such as neuroleptic malignant syndrome may occur, so any unusual symptoms should be reported to healthcare professionals immediately. This medication may cause movement disorders such as akathisia, restlessness, jitteriness, and Parkinsonism, so dose adjustments or discontinuation may be necessary if symptoms occur. Women who are pregnant or breastfeeding should carefully evaluate the potential effects on the fetus or newborn before using this medication. Special caution is needed in pediatric or geriatric patients, as safety and efficacy have not been adequately established. In cases of overdose, symptoms such as severe neurological abnormalities, vomiting, and hypotension may occur, and immediate emergency treatment should be sought. This medication should be kept out of the reach of children and should not be transferred to another container.

• Depression
• suicidal thoughts
• drowsiness
• diarrhea
• dry mouth
• fatigue
• urinary tract infection
• insomnia
• anxiety
• constipation

This medication should be stored in a tightly sealed container to prevent air exposure, and it is best to keep it at room temperature between 1°C and 30°C. Additionally, care should be taken to avoid exposure to light and moisture.

Appearance

Beige colored round film-coated tablet

Package unit

60 tablets/bottle [60 tablets/bottle X 1]