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warnings and cautions
5 WARNINGS AND PRECAUTIONS • Anaphylaxis/hypersensitivity reactions (including life-threatening): Discontinue DAPZURA RT and treat signs/symptoms. ( 5.1 ) • Myopathy and rhabdomyolysis: Monitor CPK levels and follow muscle pain or weakness; if elevated CPK or myopathy occurs, consider discontinuation of DAPZURA RT. ( 5.2 ) • Eosinophilic pneumonia: Discontinue DAPZURA RT and consider treatment with systemic steroids. ( 5.3 ) • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): Discontinue DAPZURA RT and institute appropriate treatment. ( 5.4 ) • Tubulointerstitial Nephritis (TIN): Discontinue DAPZURA RT and institute appropriate treatment. ( 5.5 ) • Peripheral neuropathy: Monitor for neuropathy and consider discontinuation. ( 5.6 ) • Potential nervous system and/or muscular system effects in pediatric patients younger than 12 months: Avoid use of DAPZURA RT in this age group. ( 5.7 ) • Clostridioides difficile– associated diarrhea: Evaluate patients if diarrhea occurs. ( 5.8 ) • Persisting or relapsing S. aureus bacteremia/endocarditis: Perform susceptibility testing and rule out sequestered foci of infection. ( 5.9 ) • Decreased efficacy was observed in adult patients with moderate baseline renal impairment. ( 5.10 ) • Hereditary Fructose Intolerance (HFI): DAPZURA RT contains sorbitol. Risk of metabolic crisis with life-threatening hypoglycemia, hypophosphatemia, lactic acidosis, and hepatic failure. Obtain history of HFI symptoms in pediatric patients before DAPZURA RT administration ( 5.11 , 8.4 ) 5.1 Anaphylaxis/Hypersensitivity Reactions Anaphylaxis/hypersensitivity reactions have been reported with the use of antibacterial agents, including daptomycin for injection, and may be life-threatening. If an allergic reaction to DAPZURA RT occurs, discontinue the drug and institute appropriate therapy [see Adverse Reactions (6.2) ]. 5.2 Myopathy and Rhabdomyolysis 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 daptomycin for injection. Rhabdomyolysis, with or without acute renal failure, has been reported [see Adverse Reactions (6.2) ] . Patients receiving DAPZURA RT should be monitored for the development of muscle pain or weakness, particularly of the distal extremities. In pat...
warnings and cautions table
Table 5. Clinical Success Rates by Renal Function and Treatment Group in Phase 3 cSSSI Trials in Adult Patients (Population: ITT)CLCRSuccess Rate n/N (%)Daptomycin for Injection 4 mg/kg every 24hComparator50- 70 mL/min25/38 (66%)30/48 (63%)30-<50 mL/min7/15 (47%)20/35 (57%)
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adverse reactions
6 ADVERSE REACTIONS The following adverse reactions are described, or described in greater detail, in other sections: • Anaphylaxis/Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] • Myopathy and Rhabdomyolysis [see Warnings and Precautions (5.2) ] • Eosinophilic Pneumonia [see Warnings and Precautions (5.3) ] • Drug Reaction with Eosinophilia and Systemic Symptoms [see Warnings and Precautions (5.4) ] • Tubulointerstitial Nephritis [see Warnings and Precautions (5.5) ] • Peripheral Neuropathy [see Warnings and Precautions (5.6) ] • Increased International Normalized Ratio (INR)/Prolonged Prothrombin Time [see Warnings and Precautions (5.12) and Drug Interactions (7.2) ] • 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 ) • Pediatric cSSSI Patients: The most common adverse reactions that occurred in ≥2% of pediatric patients receiving daptomycin for injection were diarrhea, vomiting, abdominal pain, pruritus, pyrexia, elevated CPK, and headache. ( 6.1 ) • 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 ) • Pediatric S. aureus bacteremia Patients: The most common adverse reactions that occurred in ≥5% of pediatric patients receiving daptomycin for injection were vomiting and elevated CPK. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare Corporation at 1-866-888-2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. Clinical Trial Experience in Adult Patients Clinical trials enrolled 1,864 adult patients treated with daptomycin for injection and 1,416 treated with...
adverse reactions table
Table 7. Incidence of Adverse Reactions that Occurred in ≥2% of Adult Patients in the Daptomycin for Injection Treatment Group and ≥ the Comparator Treatment Group in Phase 3 cSSSI TrialsAdverse ReactionAdult Patients (%)Daptomycin for Injection 4 mg/kg (N=534)ComparatorComparator: vancomycin (1 g IV every 12h) or an anti-staphylococcal semi-synthetic penicillin (i.e., nafcillin, oxacillin, cloxacillin, or flucloxacillin; 4 to 12 g/day IV in divided doses). (N=558)Gastrointestinal disorders Diarrhea 5.2 4.3 Nervous system disorders Headache 5.4 5.4 Dizziness 2.2 2.0 Skin/subcutaneous disorders Rash 4.3 3.8 Diagnostic investigations Abnormal liver function tests 3.0 1.6 Elevated CPK 2.8 1.8 Infections Urinary tract infections 2.4 0.5 Vascular disorders Hypotension 2.4 1.4 Respiratory disorders Dyspnea 2.1 1.6