Indicated for:

Complicated Skin and Skin Structure Infections (cSSSI):

• The treatment of adult and pediatric patients (1 to 17 years of age) with complicated skin and skin structure infections (cSSSI) caused by susceptible isolates of the following Gram-positive bacteria: Staphylococcus aureus (including methicillin-resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae subsp. equisimilis, and Enterococcus faecalis (vancomycin-susceptible isolates only).

Staphylococcus aureus Bloodstream Infections (Bacteremia) in Adult Patients, Including Those with Right-Sided Infective Endocarditis, Caused by Methicillin Susceptible and Methicillin-Resistant Isolates:

• The treatment of adult patients with Staphylococcus aureus bloodstream infections (bacteremia), including adult patients with right-sided infective endocarditis, caused by methicillin–susceptible and methicillin-resistant isolates.

Staphylococcus aureus Bloodstream Infections (Bacteremia) in Pediatric Patients (1 to 17 Years of Age):

• The treatment of pediatric patients (1 to 17 years of age) with Staphylococcus aureus bloodstream infections (bacteremia).

Unlike in adults, do NOT administer CUBICIN by injection over a two (2) minute period to pediatric patients.

The dosage regimen for CUBICIN in pediatric patients with renal impairment has not been established.

CUBICIN is not indicated for the treatment of pneumonia.

CUBICIN is not indicated for the treatment of left-sided infective endocarditis due to S. aureus. The clinical trial of CUBICIN in patients with S. aureus bloodstream infections included limited data from patients with left-sided infective endocarditis; outcomes in these patients were poor.

CUBICIN has not been studied in patients with prosthetic valve endocarditis.

CUBICIN is not compatible with dextrose-containing diluents. CUBICIN should not be used in conjunction with ReadyMED elastomeric infusion pumps.

Stability studies of CUBICIN solutions stored in ReadyMED elastomeric infusion pumps identified an impurity (2 mercaptobenzothiazole) leaching from this pump system into the CUBICIN solution. Because only limited data are available on the compatibility of CUBICIN with other IV substances, additives and other medications should not be added to CUBICIN single-dose vials or infusion bags, or infused simultaneously with CUBICIN through the same IV line.

Clostridium difficile–associated diarrhea (CDAD) has been reported with the use of nearly all systemic antibacterial agents, including CUBICIN, and may range in severity from mild diarrhea to fatal colitis.

Anaphylaxis/hypersensitivity reactions have been reported with the use of antibacterial agents, including CUBICIN, and may be life-threatening.

DRESS has been reported in post-marketing experience with CUBICIN.

Tubulointerstitial nephritis (TIN) has been reported in post-marketing experience with CUBICIN.

Myopathy, defined as muscle aching or muscle weakness in conjunction with increases in creatine phosphokinase (CPK) values to greater than 10 times the upper limit of normal (ULN), has been reported with the use of CUBICIN. Rhabdomyolysis, with or without acute renal failure, has been reported.

Eosinophilic pneumonia has been reported in patients receiving CUBICIN. In reported cases associated with CUBICIN, patients developed fever, dyspnea with hypoxic respiratory insufficiency, and diffuse pulmonary infiltrates or organizing pneumonia.

Cases of peripheral neuropathy have been reported during the CUBICIN postmarketing experience.

Patients with persisting or relapsing S. aureus bacteremia/endocarditis or poor clinical response should have repeat blood cultures. Failure of treatment due to persisting or relapsing S. aureus bacteremia/endocarditis may be due to reduced daptomycin susceptibility.

Clinically relevant plasma concentrations of daptomycin have been observed to cause a significant concentration-dependent false prolongation of prothrombin time (PT) and elevation of International Normalized Ratio (INR) when certain recombinant thromboplastin reagents are utilized for the assay.

Limited published data on use of CUBICIN RF in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. Animal studies: decreased body weight.

Limited published data report that daptomycin is present in human milk at infant doses of 0.1% of the maternal dose.

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• Use in patients under 1 year of age. GoToSource

• Use with rifampicin for gram-positive osteoarticular infections. GoToSource

• Urinary tract infections. GoToSource

• Use in cardiac surgery. GoToSource

Acute renal and hepatic toxicity (kidney and liver damage). GoToSource

Thrombocytopenia (low blood platelet count). GoToSource

Eosinophilic pneumonia (elevated eosinophils in the lungs). GoToSource

Peripheral eosinophilia (elevated eosinophils in the blood). GoToSource

Aphthous stomatitis (inflammation of mouth mucosa) and rhabdomyolysis (breakdown of muscle tissue). GoToSource 

Upper respiratory infection, urinary tract infections, diarrhea and arthralgia. GoToSource

Angioedema (swelling, shortness of breath, rash and drug rash with eosinophilia and systemic symptoms. GoToSource

Lawsuits filed for eosinophilic pneumonia.