Otezla XR

Adult Dosing .

Dosage forms:  ER TAB: 75 mg; 28-DAY INITIATION PACK: 10 mg IR TAB x4, 20 mg IR TAB x4, 30 mg IR TAB x19, and 75 mg ER TAB x14

Special Note

[equivalency or interchangeability info]

Info: apremilast IR and ER products not interchangeable; do not substitute on a mg to mg basis

psoriatic arthritis

[initial dose titration]

Dose: 10 mg IR PO qam x1 day, then 10 mg IR PO bid x1 day, then 10 mg IR PO qam and 20 mg IR PO qpm x1 day, then 20 mg IR PO bid x1 day, then 20 mg IR PO qam and 30 mg IR PO qpm x1 day; Info: do not cut/crush/chew tab

[maintenance tx]

Dose: 75 mg ER PO daily; Start: on day 6 after initial dose titration with apremilast IR tab; Info: do not cut/crush/chew tab

psoriasis, plaque

[initial dose titration]

Dose: 10 mg IR PO qam x1 day, then 10 mg IR PO bid x1 day, then 10 mg IR PO qam and 20 mg IR PO qpm x1 day, then 20 mg IR PO bid x1 day, then 20 mg IR PO qam and 30 mg IR PO qpm x1 day; Info: do not cut/crush/chew tab

[maintenance tx]

Dose: 75 mg ER PO daily; Start: on day 6 after initial dose titration with apremilast IR tab; Info: do not cut/crush/chew tab

oral ulcers, Behcet disease-associated

[initial dose titration]

Dose: 10 mg IR PO qam x1 day, then 10 mg IR PO bid x1 day, then 10 mg IR PO qam and 20 mg IR PO qpm x1 day, then 20 mg IR PO bid x1 day, then 20 mg IR PO qam and 30 mg IR PO qpm x1 day; Info: do not cut/crush/chew tab

[maintenance tx]

Dose: 75 mg ER PO daily; Start: on day 6 after initial dose titration with apremilast IR tab; Info: do not cut/crush/chew tab

renal dosing

[see below]

CrCl >30: not defined; CrCl <30: start 10 mg IR qam x3 days, then 20 mg IR qam x2 days, then 30 mg IR qd; Info: ER tab cannot be cut, use IR tab for dose adjustments

HD/PD: not defined

hepatic dosing

[no adjustment]

Peds Dosing .

Dosage forms:  ER TAB: 75 mg; 28-DAY INITIATION PACK: 10 mg IR TAB x4, 20 mg IR TAB x4, 30 mg IR TAB x19, and 75 mg ER TAB x14

Special Note

[equivalency or interchangeability info]

Info: apremilast IR and ER products not interchangeable; do not substitute on a mg to mg basis

psoriatic arthritis

[6 yo and older, >50 kg, initial dose titration]

Dose: 10 mg IR PO qam x1 day, then 10 mg IR PO bid x1 day, then 10 mg IR PO qam and 20 mg IR PO qpm x1 day, then 20 mg IR PO bid x1 day, then 20 mg IR PO qam and 30 mg IR PO qpm x1 day; Info: do not cut/crush/chew tab

[6 yo and older, >50 kg, maintenance tx]

Dose: 75 mg ER PO daily; Start: on day 6 after initial dose titration with apremilast IR tab; Info: do not cut/crush/chew tab

psoriasis, moderate-severe plaque

[6 yo and older, >50 kg, initial dose titration]

Dose: 10 mg IR PO qam x1 day, then 10 mg IR PO bid x1 day, then 10 mg IR PO qam and 20 mg IR PO qpm x1 day, then 20 mg IR PO bid x1 day, then 20 mg IR PO qam and 30 mg IR PO qpm x1 day; Info: do not cut/crush/chew tab

[6 yo and older, >50 kg, maintenance tx]

Dose: 75 mg ER PO daily; Start: on day 6 after initial dose titration with apremilast IR tab; Info: do not cut/crush/chew tab

renal dosing

[see below]

CrCl >30: not defined; CrCl <30: start 10 mg IR qam x3 days, then 20 mg IR qam x2 days, then 30 mg IR qd; Info: ER tab cannot be cut, use IR tab for dose adjustments

HD/PD: not defined

hepatic dosing

[no adjustment]