Daptomycin

Daptomycin for Injection is a lipopeptide antibacterial indicated for the treatment of: Complicated skin and skin structure infections (cSSSI) in adult and pediatric patients (1 to 17 years of age) and, Staphylococcus aureus bloodstream infections (bacteremia), in adult patients including those with right-sided infective endocarditis,. Staphylococcus aureus bloodstream infections (bacteremia) in pediatric patients (1 to 17 years of age). Limitations of Use: Daptomycin for Injection is not indicated for the treatment of pneumonia. Daptomycin for Injection is not indicated for the treatment of left-sided infective endocarditis due to S. aureus. Daptomycin for Injection is not recommended in pediatric patients younger than one year of age due to the risk of potential effects on muscular, neuromuscular, and/or nervous systems (either peripheral and/or central) observed in neonatal dogs.

Daptomycin is an antibacterial drug.

Adult Patients Administer to adult patients intravenously in 0.9% sodium chloride, either by injection over a 2-minute period or by infusion over a 30-minute period. Recommended dosage regimen for adult patients: Creatinine Clearance (CL CR ) Dosage Regimen cSSSI For 7 to 14 days S. aureus Bacteremia For 2 to 6 weeks ≥30 mL/min 4 mg/kg once every 24 hours 6 mg/kg once every 24 hours <30 mL/min, including hemodialysis and CAPD 4 mg/kg once every 48 hours* 6 mg/kg once every 48 hours* *Administered following hemodialysis on hemodialysis days. Pediatric Patients Unlike in adults, do NOT administer by injection over a two minute period to pediatric patients. Administer to pediatric patients intravenously in 0.9% sodium chloride, by infusion over a 30- or 60-minute period, based on age.

Daptomycin for injection is contraindicated in patients with known hypersensitivity to daptomycin. Known hypersensitivity to daptomycin

Anaphylaxis/hypersensitivity reactions (including life-threatening): Discontinue daptomycin and treat signs/symptoms. Myopathy and rhabdomyolysis: Monitor CPK levels and follow muscle pain or weakness, if elevated CPK or myopathy occurs, consider discontinuation of daptomycin. Eosinophilic pneumonia: Discontinue daptomycin and consider treatment with systemic steroids. Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): Discontinue daptomycin and institute appropriate treatment. Tubulointerstitial Nephritis (TIN): Discontinue daptomycin and institute appropriate treatment. Peripheral neuropathy: Monitor for neuropathy and consider discontinuation. Potential nervous system and/or muscular system effects in pediatric patients younger than 12 months: Avoid use of daptomycin in this age group. Clostridioides difficile –associated diarrhea: Evaluate patients if diarrhea occurs.

The following adverse reactions are described, or described in greater detail, in other sections: Anaphylaxis/Hypersensitivity Reactions Myopathy and Rhabdomyolysis Eosinophilic Pneumonia Drug Reaction with Eosinophilia and Systemic Symptoms Tubulointerstitial Nephritis Peripheral Neuropathy Increased International Normalized Ratio (INR)/Prolonged Prothrombin Time Adult cSSSI Patients: The most common adverse reactions that occurred in ≥2% of adult cSSSI patients receiving daptomycin 4 mg/kg were diarrhea, headache, dizziness, rash, abnormal liver function tests, elevated creatine phosphokinase (CPK), urinary tract infections, hypotension, and dyspnea. Pediatric cSSSI Patients: The most common adverse reactions that occurred in ≥2% of pediatric patients receiving daptomycin were diarrhea, vomiting, abdominal pain, pruritus, pyrexia, elevated CPK, and headache.

HMG-CoA Reductase Inhibitors In healthy adult subjects, concomitant administration of daptomycin and simvastatin had no effect on plasma trough concentrations of simvastatin, and there were no reports of skeletal myopathy. However, inhibitors of HMG-CoA reductase may cause myopathy, which is manifested as muscle pain or weakness associated with elevated levels of creatine phosphokinase (CPK). In the adult Phase 3 S. aureus bacteremia/endocarditis trial, some patients who received prior or concomitant treatment with an HMG-CoA reductase inhibitor developed elevated CPK. Experience with the coadministration of HMG-CoA reductase inhibitors and daptomycin in patients is limited, therefore, consideration should be given to suspending use of HMG-CoA reductase inhibitors temporarily in patients receiving daptomycin.

Store refrigerated between 2°C and 8°C (36°F and 46° F), avoid excessive heat. Storage conditions for the reconstituted and diluted solutions are described in another section of the prescribing information.