CUBICIN RF Rx
Generic Name and Formulations:
Daptomycin 500mg/vial; lyophilized pwd for IV inj after reconstitution (with sterile or bacteriostatic water for inj) or IV infusion after reconstitution and dilution; preservative-free; may be stored at room temperature.
Merck & Co., Inc.
Indications for CUBICIN RF:
Susceptible complicated skin and skin structure infections (cSSSI) in adults and pediatrics (1–17yrs). S. aureus bacteremia in adults (including MRSA and MSSA right-sided endocarditis) and in pediatrics (1–17yrs).
Limitations Of use:
Not for treatment of pneumonia or left-sided endocarditis due to S. aureus. Not studied in prosthetic valve endocarditis. Not recommended in pediatrics (<1yr) due to risk of potential effects on muscular, neuromuscular, and/or nervous systems (peripheral and/or central).
Give by IV inj over 2mins or IV infusion over 30mins. cSSSI: 4mg/kg once every 24hrs for 7–14 days. S. aureus bacteremia or endocarditis: 6mg/kg once every 24hrs for 2–6 weeks. Renal impairment (CrCl <30mL/min): decrease dosing interval to once every 48hrs; coincide dose for after dialysis.
<1yr: not recommended. Give by IV infusion over 60mins (1–6yrs) or 30mins (7–17yrs). cSSSI (1–<2yrs): 10mg/kg once every 24hrs; (2–6yrs): 9mg/kg once every 24hrs; (7–11yrs): 7mg/kg once every 24hrs; (12–17yrs): 5mg/kg once every 24hrs. Treat up to 14 days. S. aureus bacteremia (1–6yrs): 12mg/kg once every 24hrs; (7–11yrs): 9mg/kg once every 24hrs; (12–17yrs): 7mg/kg once every 24hrs. Treat up to 42 days. Renal impairment (CrCl <30mL/min): not established.
Monitor for development of muscle pain or weakness (esp. distal extremities). Monitor CPK weekly (more frequently in those with concomitant statin therapy or elevated CPK); discontinue if CPK (≥5xULN) and myopathy occur, or if CPK (≥10xULN) without myopathy occurs. Renal impairment: monitor renal function and CPK more frequently than once weekly. Discontinue immediately if eosinophilic pneumonia develops; treat with systemic steroids. Monitor for neuropathy; consider discontinuation if occurs. Persisting or relapsing S. aureus bacteremia/endocarditis: repeat blood cultures and evaluate. Decreased efficacy observed in adults with moderate baseline renal impairment. Severe hepatic impairment. Pregnancy. Nursing mothers.
Consider suspending agents associated with rhabdomyolysis (eg, statins). May cause false prolongation of PT or elevation of INR when certain recombinant thromboplastin reagents are utilized for the assay.
Diarrhea, headache, dizziness, rash, abnormal LFTs, elevated CPK, UTIs, hypotension, dyspnea, vomiting, abdominal pain, pruritus, pyrexia, sepsis, bacteremia, chest pain, edema, pharyngolarygeal pain, increased sweating, insomnia, hypertension; hypersensitivity reactions, myopathy, rhabdomyolysis, C. difficile-associated diarrhea.
Single-dose vial (10mL)—1