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CUBICIN RF (daptomycin for injection) 500mg

CUBICIN (daptomycin for injection) 500mg

Indications and Usage

CrCL=creatinine clearance; HMG-CoA=3-hydroxy-3-methylglutaryl-coenzyme A; ULN=upper limit of normal.

HMG-CoA=3-hydroxy-3-methylglutaryl-coenzyme A; ULN=upper limit of normal.

Indications: CUBICIN and CUBICIN RF are indicated for 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 subspecies equisimilis, and Enterococcus faecalis (vancomycin-susceptible isolates only).

CUBICIN and CUBICIN RF are indicated for the treatment of adult patients with Staphylococcus aureus bloodstream infections (bacteremia), including those with right-sided infective endocarditis, caused by methicillin-susceptible and methicillin-resistant isolates.

CUBICIN and CUBICIN RF are indicated for the treatment of pediatric patients (1 to 17 years of age) with Staphylococcus aureus bloodstream infections (bacteremia).

Limitations of Use: CUBICIN and CUBICIN RF are not indicated for the treatment of pneumonia. CUBICIN and CUBICIN RF are not indicated for the treatment of left-sided infective endocarditis (LIE) due to S. aureus. CUBICIN and CUBICIN RF have not been studied in patients with prosthetic valve endocarditis. CUBICIN and CUBICIN RF are not recommended in pediatric patients younger than 1 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.

Usage: To reduce the development of drug-resistant bacteria and maintain the effectiveness of CUBICIN and CUBICIN RF and other antibacterial drugs, CUBICIN and CUBICIN RF should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information is available, it should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Empiric therapy may be initiated while awaiting test results.

Before prescribing CUBICIN^® (daptomycin for injection), please read the accompanying Prescribing Information.

Before prescribing CUBICIN^® RF (daptomycin for injection), please read the accompanying Prescribing Information.

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%).

Before prescribing CUBICIN^® (daptomycin for injection), please read the accompanying Prescribing Information.

Before prescribing CUBICIN^® RF (daptomycin for injection), please read the accompanying Prescribing Information.

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%).

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Indications and Usage

Selected Important Safety Information

Selected Important Safety Information