Selected Important Safety Information

• Anaphylaxis/hypersensitivity reactions, which may be life-threatening, have been reported with CUBICIN use. If an allergic reaction occurs, discontinue CUBICIN or CUBICIN RF and treat appropriately.
• Myopathy and rhabdomyolysis have been reported with CUBICIN use. Monitor for muscle pain or weakness, particularly of the distal extremities. Monitor creatine phosphokinase (CPK) levels weekly and more frequently in patients with CPK elevations while on CUBICIN or CUBICIN RF treatment and in those who received recent prior or concomitant HMG-CoA reductase inhibitors. In patients with renal impairment, monitor renal function and CPK levels more than once weekly. Discontinue CUBICIN or CUBICIN RF in patients with unexplained signs and symptoms of myopathy with CPK levels >1,000 U/L (~5× ULN), and in patients without symptoms and CPK levels >2,000 U/L (≥10× ULN). In addition, consider temporarily suspending agents associated with rhabdomyolysis, such as HMG-CoA reductase inhibitors.
• Eosinophilic pneumonia has been reported with CUBICIN use. Promptly evaluate patients who develop fever, dyspnea with hypoxic respiratory insufficiency, and diffuse pulmonary infiltrates or organizing pneumonia and discontinue CUBICIN or CUBICIN RF immediately. Treatment with systemic steroids is recommended. Recurrence of eosinophilic pneumonia upon re-exposure has been reported.
• Peripheral neuropathy has been reported with CUBICIN use. Monitor for signs and symptoms of peripheral neuropathy and consider discontinuation.
• Potential nervous and/or muscular system effects in patients younger than 12 months: Avoid use of CUBICIN and CUBICIN RF in patients younger than 12 months due to the risk of potential effects on muscular, neuromuscular, and/or nervous systems (either peripheral and/or central) observed in neonatal dogs.
• Clostridium difficile–associated diarrhea (CDAD), ranging from mild diarrhea to fatal colitis, has been reported with nearly all systemic antibacterial agents, including CUBICIN. Evaluate all patients who present with diarrhea following antibacterial use. Careful medical history is necessary because CDAD has been reported to occur more than two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, antibacterial use not directed against C. difficile should be discontinued, if possible.
• Patients with persisting or relapsing S. aureus bacteremia/endocarditis, possibly due to reduced daptomycin susceptibility, or poor clinical response should have repeat blood cultures. Appropriate surgical intervention and/or change in antibacterial regimen may be required. Failure of treatment due to persisting or relapsing S. aureus bacteremia/endocarditis may be due to reduced daptomycin susceptibility.
• In the cSSSI and S. aureus bacteremia/endocarditis trials, decreased efficacy was observed in CUBICIN-treated adult patients with moderate baseline renal impairment (CrCL <50 mL/min).
• Adverse Reactions:

  Adult cSSSI Patients: The common adverse reactions that occurred in ≥2% of adult cSSSI patients receiving CUBICIN 4 mg/kg were diarrhea (5.2%), headache (5.4%), dizziness (2.2%), rash (4.3%), abnormal liver function tests (3.0%), elevated creatinine phosphokinase (CPK) (2.8%), urinary tract infections (2.4%), hypotension (2.4%), and dyspnea (2.1%).

  Adult S. aureus bacteremia/endocarditis Patients: The most common adverse reactions that occurred in ≥5% of S. aureus bacteremia/endocarditis patients receiving CUBICIN 6 mg/kg were sepsis (5%), bacteremia (5%), abdominal pain (6%), chest pain (7%), edema (7%), pharyngolaryngeal pain (8%), pruritus (6%), increased sweating (5%), insomnia (9%), elevated CPK (7%), and hypertension (6%).

  Pediatric cSSSI Patients: The most common adverse reactions that occurred in ≥2% of pediatric patients receiving CUBICIN were diarrhea (7.0%), vomiting (2.7%), abdominal pain (2.0%), pruritus (3.1%), pyrexia (3.9%), elevated CPK (5.5%), and headache (2.7%).

  Pediatric S. aureus bacteremia Patients: The most common adverse reactions that occurred in ≥5% of pediatric patients receiving CUBICIN were vomiting (10.9%) and elevated CPK (7.3%).