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Adempas
riociguat
Black Box Warnings .
Appropriate Use
restricted distribution program (Adempas REMS) for all female pts to minimize fetal exposure; prescribers, pharmacies, and female pts must enroll at 1-855-4-ADEMPAS or www.adempasrems.com
Embryo-Fetal Toxicity
contraindicated in pregnancy; exclude pregnancy in females of reproductive potential prior to tx start, then qmo during tx and x1mo after D/C; use acceptable methods of contraception during tx and x1mo after D/C
Adult Dosing .
Dosage forms: TAB: 0.5 mg, 1 mg, 1.5 mg, 2 mg, 2.5 mg
Restricted Distribution in US
- [1-855-423-3672 or www.adempasrems.com for more info]
- Info: female pts may only receive tx through Adempas REMS program
chronic thromboembolic pulmonary HTN
- [0.5-2.5 mg PO tid]
- Start: 1 mg PO tid, may adjust by 0.5 mg PO tid no more frequently than q2wk; Max: 2.5 mg PO tid; Info: for persistent or recurrent dz; may start 0.5 mg PO tid if hypotension risk; may consider higher doses in smokers; retitrate dose if tx interrupted >3 days
pulmonary arterial HTN
- [0.5-2.5 mg PO tid]
- Start: 1 mg PO tid, may adjust by 0.5 mg PO tid no more frequently than q2wk; Max: 2.5 mg PO tid; Info: may start 0.5 mg PO tid if hypotension risk; may consider higher doses in smokers; retitrate dose if tx interrupted >3 days
renal dosing
- [see below]
- CrCl >15: no adjustment; CrCl <15: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- Child-Pugh Class A or B: no adjustment; Child-Pugh Class C: not defined
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.