From the FDA Drug Label
8.1 Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of AUSTEDO XR or AUSTEDO in pregnant women.
8.5 Geriatric Use No dosage adjustment is needed for elderly patients
The consideration for alternative doses for elderly patients is that no dosage adjustment is needed. For pregnant women, there are no adequate data on the developmental risk associated with the use of deutetrabenazine, and therefore no conclusion can be drawn regarding alternative doses 1.
From the Research
For elderly patients taking deutetrabenazine, a lower starting dose and slower titration are recommended due to potential increased sensitivity to side effects and age-related changes in drug metabolism, as supported by the most recent study 2 which demonstrated a favorable safety profile of deutetrabenazine. Typically, elderly patients should start at 6 mg per day (3 mg twice daily) and increase gradually based on response and tolerability. For pregnant women, deutetrabenazine is generally not recommended as it falls under FDA Pregnancy Category C, indicating potential risks to the fetus based on animal studies with insufficient human data, as noted in the study 3. If treatment is absolutely necessary during pregnancy, the lowest effective dose should be used after careful risk-benefit assessment. The medication should be taken with food as this increases its bioavailability, as mentioned in the study 3. These dosing considerations reflect the pharmacokinetic changes in elderly patients, including reduced hepatic metabolism and renal clearance, and the precautionary approach needed during pregnancy due to limited safety data. Regular monitoring for adverse effects is essential in both populations, with particular attention to sedation, parkinsonism, and QT prolongation in elderly patients, as highlighted in the study 4. Key points to consider include:
- Starting dose: 6 mg per day (3 mg twice daily) for elderly patients
- Titration: gradual increase based on response and tolerability
- Pregnancy: use lowest effective dose after careful risk-benefit assessment
- Administration: take with food to increase bioavailability
- Monitoring: regular assessment for adverse effects, particularly sedation, parkinsonism, and QT prolongation in elderly patients. The most recent and highest quality study 2 provides the basis for these recommendations, prioritizing morbidity, mortality, and quality of life as the outcome.