HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use DAPTOMYCIN FOR INJECTION safely and effectively. See full prescribing information for DAPTOMYCIN FOR INJECTION.
DAPTOMYCIN for injection, for intravenous use
Initial U.S. Approval: 2003 INDICATIONS AND USAGEDaptomycin for Injection is a lipopeptide antibacterial indicated for the treatment of: - •
- Complicated skin and skin structure infections (cSSSI) in adult patients (1.1) and,
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- Staphylococcus aureus bloodstream infections (bacteremia), in adult patients including those with right-sided infective endocarditis, (1.2)
Limitations of Use: - •
- This Daptomycin for Injection product is not approved for use in pediatric patients. (1.3)
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- Daptomycin for Injection is not indicated for the treatment of pneumonia. (1.3)
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- Daptomycin for Injection is not indicated for the treatment of left-sided infective endocarditis due to S. aureus. (1.3)
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- 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. (1.3)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Daptomycin for Injection and other antibacterial drugs, Daptomycin for Injection should be used to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1.4) DOSAGE AND ADMINISTRATIONAdult 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. (2.1, 2.5)
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- Recommended dosage regimen for adult patients (2.2, 2.3, 2.4):
| Creatinine Clearance (CrCl) | 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* |
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- There are other formulations of daptomycin that have differences concerning storage and reconstitution. Carefully follow the reconstitution and storage procedures described in this labeling. (2.5)
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- Do not use in conjunction with ReadyMED® elastomeric infusion pumps in adult patients. (2.5)
DOSAGE FORMS AND STRENGTHS- •
- 350 mg lyophilized powder for reconstitution in a single-dose vial (3)
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- 500 mg lyophilized powder for reconstitution in a single-dose vial (3)
CONTRAINDICATIONSKnown hypersensitivity to daptomycin (4) WARNINGS AND PRECAUTIONS- •
- Anaphylaxis/hypersensitivity reactions (including life-threatening): Discontinue Daptomycin for Injection and treat sign/symptoms. (5.1)
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- Myopathy and rhabdomyolysis: Monitor CPK levels and follow muscle pain or weakness; if elevated CPK or myopathy occurs, consider discontinuation of Daptomycin for Injection. (5.2)
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- Eosinophilic pneumonia: Discontinue Daptomycin for Injection and consider treatment with systemic steroids. (5.3)
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- Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): Discontinue Daptomycin for Injection and institute appropriate treatment. (5.4)
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- Tubulointerstitial Nephritis (TIN): Discontinue Daptomycin for Injection and institute appropriate treatment. (5.5)
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- Peripheral neuropathy: Monitor for neuropathy and consider discontinuation. (5.6)
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- Potential nervous system and/or muscular system effects in pediatric patients younger than 12 months: Avoid use of Daptomycin for Injection in this age group. (5.7)
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- Clostridioides difficile–associated diarrhea: Evaluate patients if diarrhea occurs. (5.8)
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- Persisting or relapsing S. aureus bacteremia/endocarditis: Perform susceptibility testing and rule out sequestered foci of infection. (5.9)
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- Decreased efficacy was observed in adult patients with moderate baseline renal impairment. (5.10)
ADVERSE REACTIONS- •
- Adult cSSSI Patients: The most common adverse reactions that occurred in ≥2% of adult cSSSI patients receiving daptomycin for injection 4 mg/kg were diarrhea, headache, dizziness, rash, abnormal liver function tests, elevated creatine phosphokinase (CPK), urinary tract infections hypotension, and dyspnea. (6.1)
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- Adult S. aureus bacteremia/endocarditis Patients: The most common adverse reactions that occurred in ≥5% of S. aureus bacteremia/endocarditis patients receiving daptomycin for injection 6 mg/kg were sepsis, bacteremia, abdominal pain, chest pain, edema, pharyngolaryngeal pain, pruritus, increased sweating, insomnia, elevated CPK, and hypertension. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Hospira at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. See 17 for PATIENT COUNSELING INFORMATION. Revised: 2/2025 |