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Myqorzo
aficamten
Black Box Warnings .
Appropriate Use
available only through restricted distribution program (Myqorzo REMS) due to heart failure risk from systolic dysfunction; prescribers, patients, and pharmacies must enroll at 1-844-285-7367 or www.MYQORZOREMS.com
Heart Failure Risk
LVEF decr. may cause heart failure from systolic dysfunction; echocardiogram required before tx initiation and during tx; avoid tx initiation or up-titration in patients with LVEF <55%; decr. dose if LVEF is 40-49%; interrupt tx if LVEF <40%, heart failure signs/symptoms, or worsening clinical status
Adult Dosing .
Dosage forms: TAB: 5 mg, 10 mg, 15 mg, 20 mg
Restricted Distribution in US
- [1-844-285-7367 or www.MYQORZOREMS.com for more info]
obstructive hypertrophic cardiomyopathy
- [5-20 mg PO qd]
- Start: 5 mg PO qd, adjust dose by 5 mg/day PO q2-8wk based on Valsalva LVOT gradient and LVEF; Max: 20 mg/day; Info: see pkg insert for dose adjustment, maintenance, and interruption details; restart tx at 5 mg PO qd if LVEF at least 55% after tx interrupted for 7 days or more; consider dose adjustment or interruption if serious illness, new arrhythmia, or other conditions that may impair systolic function
renal dosing
- [see below]
- eGFR >30: no adjustment; eGFR <30: 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.