Tembexa

Black Box Warnings .

Adult Dosing .

Dosage forms:  TAB: 100 mg; SUSPENSION: 10 mg per mL

Restricted Distribution in US

[distributed directly to CDC and US Department of Defense]

smallpox

[>48 kg]

Dose: 200 mg PO qwk x2 doses; Info: give tab on empty stomach or with low fat meal; give suspension on empty stomach; do not cut/crush/chew tab; avoid direct contact with crushed or broken tab or suspension

mpox (off-label)

[>48 kg]

Dose: 200 mg PO qwk x2 doses; Info: not 1st-line agent; give with tecovirimat; may extend duration based on clinical response; give tab on empty stomach or with low fat meal; give suspension on empty stomach; do not cut/crush/chew tab; avoid direct contact with crushed or broken tab or suspension

renal dosing

[no adjustment]

renal impairment: no adjustment

HD/PD: no adjustment; no supplement

hepatic dosing

[no adjustment]

Peds Dosing .

Dosage forms:  TAB: 100 mg; SUSPENSION: 10 mg per mL

Restricted Distribution in US

[distributed directly to CDC and US Department of Defense]

smallpox

[<10 kg]

Dose: 6 mg/kg/dose suspension PO qwk x2 doses; Info: give on empty stomach; avoid direct contact with suspension

[10-47 kg]

Dose: 4 mg/kg/dose suspension PO qwk x2 doses; Info: give on empty stomach; avoid direct contact with suspension

[>48 kg]

Dose: 200 mg PO qwk x2 doses; Info: give tab on empty stomach or with low fat meal; give suspension on empty stomach; do not cut/crush/chew tab; avoid direct contact with crushed or broken tab or suspension

mpox (off-label)

[<10 kg]

Dose: 6 mg/kg/dose suspension PO qwk x2 doses; Info: not 1st-line agent; give with tecovirimat; may extend duration based on clinical response; give on empty stomach; avoid direct contact with suspension

[10-47 kg]

Dose: 4 mg/kg/dose suspension PO qwk x2 doses; Info: not 1st-line agent; give with tecovirimat; may extend duration based on clinical response; give on empty stomach; avoid direct contact with suspension

[>48 kg]

Dose: 200 mg PO qwk x2 doses; Info: not 1st-line agent; give with tecovirimat; may extend duration based on clinical response; give tab on empty stomach or with low fat meal; give suspension on empty stomach; do not cut/crush/chew tab; avoid direct contact with crushed or broken tab or suspension

renal dosing

[no adjustment]

renal impairment: no adjustment

HD/PD: no adjustment; no supplement

hepatic dosing

[no adjustment]