Daurismo

Risk of embryo-fetal death or severe birth defects in pregnant women. Verify pregnancy status within 7 days prior to initiating therapy. Advise females of reproductive potential to use effective contraception during therapy and for ≥30 days after the last dose; male patients should use condoms (even after a vasectomy) during and for ≥30 days after the last dose. Advise patients not to donate blood or blood products during therapy and for ≥30 days after the last dose. Advise male patients not to donate semen during and for ≥30 days after the last dose. Assess CBCs, electrolytes, renal, and hepatic function prior to initiation and at least once weekly for the first month; then monitor electrolytes and renal function once monthly during therapy. Obtain CPK levels prior to initiation and clinically thereafter. Obtain CPK and serum creatinine levels at least weekly (in patients with musculoskeletal adverse reactions with concurrent CPK elevation >2.5xULN) until resolution of signs/symptoms. Monitor ECGs prior to initiation, approx. 1 week after, then once monthly for the next 2 months; in those with congenital long QT syndrome, CHF, electrolyte abnormalities, monitor more frequently. Interrupt if QTc interval >500ms; permanently discontinue if QTc interval prolongation with life-threatening arrhythmia develops. Premature fusion of the epiphyses may occur in pediatrics if exposed. Severe renal impairment (eGFR 15–29mL/min): monitor for increased risk of adverse reactions (eg, QT prolongation). Pregnancy, nursing mothers: not recommended (during and for ≥30 days after the last dose).