DailyMed / TPOXX exact oral and injection label
- Product / population
- TPOXX injection for labeled human smallpox treatment in patients weighing at least 3 kg; not an oral-capsule or mpox treatment protocol.
- Renal measure
- CrCl, mL/min; injection-specific excipient restriction
Selected sections only. Source mirror and underlying label are not independent confirmations.
Renal dosing, restrictions and evidence limits
For IV TPOXX, CrCl below 30 mL/min is a contraindication. Mild (60-89) and moderate (30-59 mL/min) impairment do not require dose adjustment, but the hydroxypropyl-beta-cyclodextrin excipient still warrants caution and renal monitoring. Determine CrCl before IV treatment and monitor as clinically appropriate. Consider conversion to oral treatment once tolerated. Pediatric patients under 2 years have additional excipient/renal-maturity precautions.
Source: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fce826ab-4d6a-4139-a2ee-a304a913a253