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Daptomycin: Drug information

Daptomycin: Drug information
(For additional information see "Daptomycin: Patient drug information" and see "Daptomycin: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Cubicin RF;
  • Cubicin [DSC]
Brand Names: Canada
  • Cubicin RF;
  • Cubicin [DSC]
Pharmacologic Category
  • Antibiotic, Cyclic Lipopeptide
Dosing: Adult

Dosage guidance:

Clinical considerations: Do not use for the treatment of pneumonia due to inactivation of antimicrobial activity by pulmonary surfactant (Ref).

Bloodstream infection

Bloodstream infection:

Empiric or pathogen-directed therapy for methicillin-resistant Staphylococcus aureus : IV: 8 to 10 mg/kg once daily (Ref). For persistent or refractory cases or isolates with reduced susceptibility, use as part of an appropriate combination regimen (Ref). Treat uncomplicated S. aureus bacteremia for ≥14 days from day of first negative blood culture, with longer courses warranted for endocarditis or metastatic sites of infection (Ref).

Empiric or pathogen-directed therapy for methicillin-resistant Staphylococcus epidermidis (alternative agent) (off-label use) : IV: 6 mg/kg once daily (Ref); some experts recommend 8 to 10 mg/kg once daily (Ref). Treat uncomplicated bacteremia for 5 to 7 days from day of first negative blood culture, with longer courses warranted for endocarditis or metastatic sites of infection (Ref).

Empiric or pathogen-directed therapy for vancomycin-resistant enterococci (alternative agent) (off-label use): IV: 8 to 12 mg/kg once daily (Ref). May be used as part of an appropriate combination regimen, especially in critically ill patients or those with a high daptomycin minimum inhibitory concentration (MIC) (eg, 3 to 4 mcg/mL) (Ref). Treat uncomplicated bacteremia for 7 to 14 days from day of first negative blood culture, with longer courses warranted for endocarditis or metastatic sites of infection (Ref). Some experts recommend a duration of 5 to 7 days for uncomplicated infection with rapid blood culture clearance (within 24 hours) and in the absence of metastatic infection (Ref).

Antibiotic lock technique (catheter-salvage strategy) (off-label use): Note: For infections caused by susceptible organisms when the catheter cannot be removed; use in addition to systemic antibiotics. Catheter salvage is not recommended for S. aureus (Ref).

Intracatheter: Prepare lock solution to final concentration of daptomycin 1 to 5 mg/mL; may be combined with heparin (Ref). Instill into each lumen of the catheter access port using a volume sufficient to fill the catheter (2 to 5 mL) with a dwell time of up to 72 hours, depending on frequency of catheter use (Ref). Withdraw lock solution prior to catheter use; replace with fresh daptomycin lock solution after catheter use. Antibiotic lock therapy is given for the same duration as systemic antibiotics (Ref).

Cerebrospinal fluid shunt infection

Cerebrospinal fluid shunt infection (alternative agent) (off-label use):

Pathogen-directed therapy for resistant pathogens (eg, staphylococci [including methicillin-resistant], Cutibacterium acnes, enterococci) or patients intolerant of other antibiotics: IV: 6 to 10 mg/kg once daily for 10 to 14 days; for staphylococci, usually used in combination with rifampin (eg, in the setting of retained hardware) (Ref).

Intraventricular (adjunct to systemic therapy; use a preservative-free preparation): 2 to 5 mg daily (Ref). Additional intraventricular doses have been studied (Ref). When intraventricular daptomycin is administered via a ventricular drain, clamp drain for 15 to 60 minutes after administration (allows solution to equilibrate in cerebrospinal fluid [CSF]) (Ref). Note: Intraventricular administration is generally reserved for use in patients who fail parenteral therapy despite removal of CSF shunt or when CSF shunt cannot be removed (Ref).

Diabetic foot infection, moderate to severe

Diabetic foot infection, moderate to severe (alternative agent) (off-label use):

Empiric or pathogen-directed therapy for methicillin-resistant S. aureus: IV: 4 to 6 mg/kg once daily. For empiric therapy, use as part of an appropriate combination regimen (Ref). If concomitant osteomyelitis is present, higher doses may be required (Ref). Duration (which may include oral step-down therapy) is usually 2 to 4 weeks in the absence of osteomyelitis (Ref).

Endocarditis, treatment

Endocarditis, treatment: Note: Daptomycin should not be used in patients with concomitant pneumonia (Ref).

Pathogen-directed therapy for methicillin-resistant staphylococci (native or prosthetic valve) (alternative agent): Note: Reserve use for patients who cannot receive vancomycin due to intolerance or elevated MIC (Ref).

IV: 8 to 10 mg/kg once daily for ≥6 weeks. For patients with prosthetic valve endocarditis, use as part of an appropriate combination regimen (Ref).

Pathogen-directed therapy for penicillin-, ampicillin-, and vancomycin-resistant enterococci (native or prosthetic valve) (off-label use): IV: 10 to 12 mg/kg once daily as part of an appropriate combination regimen for >6 weeks; may be used as monotherapy for native valve endocarditis (Ref).

Intracranial abscess or spinal epidural abscess

Intracranial abscess (brain abscess, intracranial epidural abscess) or spinal epidural abscess (alternative agent) (off-label use):

Pathogen-directed therapy for staphylococci (including methicillin-resistant): IV: 6 to 10 mg/kg once daily; some experts usually give in combination with rifampin (Ref). Duration usually ranges from 4 to 8 weeks for brain abscess and spinal epidural abscess and 6 to 8 weeks for intracranial epidural abscess (Ref).

Meningitis, bacterial

Meningitis, bacterial (alternative agent) (off-label use):

Pathogen-directed therapy for staphylococci (including methicillin-resistant): IV: 6 to 10 mg/kg once daily for 10 to 14 days; usually used in combination with rifampin (Ref).

Osteomyelitis and/or discitis

Osteomyelitis and/or discitis (alternative agent) (off-label use):

Pathogen-directed therapy for staphylococci (including methicillin-resistant): IV: 6 to 10 mg/kg once daily (Ref). Some experts combine with rifampin in the presence of retained hardware (Ref).

Pathogen-directed therapy for enterococci (penicillin-susceptible or penicillin-resistant): IV: 6 to 10 mg/kg once daily (Ref).

Duration of therapy: Duration is generally ≥6 weeks. Shorter courses are appropriate if the affected bone is completely resected (eg, by amputation) (Ref).

Prosthetic joint infection

Prosthetic joint infection (alternative agent) (off-label use):

Pathogen-directed therapy for staphylococci (including methicillin-resistant): IV: 6 to 10 mg/kg once daily. Duration ranges from 2 to 6 weeks depending on prosthesis management, use of rifampin, and other patient-specific factors (Ref). Note: In select cases (eg, debridement and retention of prosthesis or one-stage arthroplasty), combine with oral rifampin and give oral suppressive antibiotic therapy following completion of IV treatment (Ref).

Pathogen-directed therapy for enterococci (penicillin-susceptible or penicillin-resistant): IV: 6 to 10 mg/kg once daily for 4 to 6 weeks (Ref). Note: In select cases (eg, debridement and retention of prosthesis or one-stage arthroplasty), give oral suppressive antibiotic therapy following completion of IV treatment (Ref).

Septic arthritis

Septic arthritis (alternative agent) (off-label use):

Pathogen-directed therapy for staphylococci (including methicillin-resistant): IV: 6 mg/kg once daily (Ref). If concomitant bacteremia is present, higher doses may be required (Ref). Total treatment duration is 3 to 4 weeks (in the absence of osteomyelitis), including oral step-down therapy (Ref); some experts recommend 4 weeks of parenteral therapy for patients with concomitant bacteremia (Ref).

Skin and skin structure infection

Skin and skin structure infection (eg, erysipelas, cellulitis, necrotizing infections) (alternative agent): IV: 4 to 6 mg/kg once daily. Total duration of therapy is usually 5 to 14 days (including oral step-down therapy); for necrotizing infection, continue until further debridement is not necessary, patient has improved clinically, and patient is afebrile for ≥48 hours (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.

Altered kidney function: IV:

CrCl 30 to <130 mL/minute: No dosage adjustment necessary (Ref).

CrCl <30 mL/minute: Administer usual recommended dose every 48 hours (Ref). Note: High doses (>8 mg/kg) have not been well studied (Ref); monitor closely.

Augmented renal clearance (measured urinary CrCl ≥130 mL/minute/1.73 m2): Augmented renal clearance (ARC) is a condition that occurs in certain critically ill patients without organ dysfunction and with normal serum creatinine concentrations. Patients who are young (<55 years of age) admitted post trauma or major surgery are at highest risk for ARC, as well as those with sepsis, burns, or hematologic malignancies. An 8- to 24-hour measured urinary CrCl is necessary to identify these patients (Ref).

IV: 10 mg/kg once daily (Ref); may increase to 12 mg/kg once daily for severe infections (eg, vancomycin-resistant Enterococcus bloodstream infection or endocarditis) (Ref).

Intermittent hemodialysis, thrice weekly: Dialyzable: 51.7% ± 9.2% removed by a standard hemodialysis session (Ref):

Every-48-hour dosing (Ref): IV: Follow dosing recommendations for patients with CrCl <30 mL/minute (administer after hemodialysis on dialysis days).

Three times weekly (post dialysis) dosing: IV: Administer usual recommended dose (ie, 4 or 6 mg/kg) on 48-hour interdialytic days; increase dose by 50% after dialysis on the 72-hour interdialytic day (eg, if the dose is 6 mg/kg for a patient on a Monday, Wednesday, Friday dialysis schedule, administer 6 mg/kg after dialysis on Monday and Wednesday and on Friday administer 9 mg/kg after dialysis) (Ref). Doses ≥6 mg/kg (9 mg/kg on the 72-hour interdialytic day) have not been evaluated.

Note: Although IV administration as a 30-minute infusion or 2-minute IV push post dialysis is preferred (Ref), intradialytic administration (infused during the last hour of a 3.5-hour dialysis session) may be considered (Ref).

Peritoneal dialysis: IV: Follow dosing recommendations for patients with CrCl <30 mL/minute (Ref).

CRRT:

Note: Daptomycin is cleared by CRRT, and its clearance is dependent on the effluent flow rate, filter type, and method of renal replacement (Ref). Recommendations are based on high-flux dialyzers and effluent flow rates of 20 to 25 mL/kg/hour (or ~1,500 to 3,000 mL/hour) unless otherwise noted. Appropriate dosing requires consideration of adequate drug concentrations (eg, site of infection), along with close monitoring for adverse effects (eg, increased CPK).

IV: 6 mg/kg every 24 hours (Ref).

PIRRT (eg, sustained, low-efficiency diafiltration):

Note: Drug clearance is dependent on the effluent flow rate, filter type, and method of renal replacement. Appropriate dosing requires consideration of adequate drug concentrations (eg, site of infection), along with close monitoring for adverse effects (eg, increased CPK).

IV: Daily PIRRT (high-flux dialyzer; blood and dialysate flow rates of 160 mL/minute; duration 8 hours): 6 mg/kg every 24 hours to be given after PIRRT ends (Ref).

Dosing: Hepatic Impairment: Adult

Mild to moderate impairment (Child-Pugh class A or B): No dosage adjustment necessary.

Severe impairment (Child-Pugh class C): There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Dosing: Obesity: Adult

The recommendations for dosing in obese patients are based upon the best available evidence and clinical expertise. Senior Editorial Team: Jeffrey F. Barletta, PharmD, FCCM; Manjunath P. Pai, PharmD, FCP; Jason A. Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC.

Class 1, 2, or 3 obesity (BMI ≥30 kg/m2):

IV: Use adjusted body weight for weight-based dose calculations (Ref).

Rationale for recommendations:

The use of actual body weight for weight-based dosing in patients with obesity is recommended by the manufacturer; however, some clinical data suggest significant increases in AUC and Cmax and a higher incidence of adverse reactions (eg, elevated CPK, myalgias) (Ref). Therefore, actual body weight should not be used in this population (Ref). Some recommend fixed (nonweight-based) dosing based on pharmacokinetic modeling and Monte Carlo simulations to achieve comparable probabilities of achieving therapeutic exposures/concentrations; however, this strategy has not been validated prospectively to determine clinical outcomes (Ref). One retrospective study utilizing a historical cohort suggests no difference in clinical failure rate in patients with BMI ≥30 kg/m2 when using adjusted body weight vs actual body weight (Ref). Although there are methodological issues with this data, use of adjusted body weight may be the safer weight metric until more data become available (Ref).

Higher weight-based dosing (8 to 12 mg/kg) has been recommended in select populations (eg, sepsis and/or bacteremia caused by methicillin-resistant S. aureus, methicillin-resistant Staphylococcus epidermidis, vancomycin-resistant enterococci bacteremia) due to the pharmacokinetic variability observed and potential benefits with higher AUCs (Ref). However, while higher weight-based dosing will result in higher overall AUCs, this may lead to more adverse reactions especially in patients with obesity (eg, elevated CPK, myalgias).

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Daptomycin: Pediatric drug information")

Dosage guidance:

Safety: The manufacturer recommends avoiding use in patients <12 months due to musculoskeletal, neuromuscular, and nervous system adverse effects observed in neonatal canine models. Approved ages and uses for generic products may vary; consult labeling for specific information.

Clinical considerations: Daptomycin should not be used for the treatment of pneumonia due to inactivation of antimicrobial activity by pulmonary surfactant (Ref).

General dosing, susceptible organisms (severe infection): Limited data available:

Infants: Very limited data available; due to insufficient pharmacokinetic data, optimal dosing not established:

Young infants (eg, <2 months of age): IV: 6 mg/kg/dose every 12 hours (Ref); dosing was reported in a case-series including former premature and term neonates (n=3, PNA at treatment: 4 to 12 weeks; weight at treatment: 2 to 4.4 kg); one infant required a dose of 15 mg/kg/dose every 12 hours for endocarditis (Ref).

Infants: IV: Reported range: 8 to 10 mg/kg/dose every 24 hours (Ref).

Children ≤6 years: 10 mg/kg/dose every 24 hours (Ref). Note: Higher doses may be necessary depending on indication.

Children ≥7 years and Adolescents: 4 to 6 mg/kg/dose every 24 hours (Ref). Note: Higher doses may be necessary depending on indication.

Bacteremia, due to susceptible Staphylococcus aureus

Bacteremia, due to susceptible Staphylococcus aureus :

Children and Adolescents: Treatment duration variable based on source and clinical response; typically ≥14 days is recommended for S. aureus bacteremia; in trials, total treatment duration (IV and oral step-down therapy) was 5 to 28 days in patients <12 years of age and 5 to 42 days in patients 12 to 17 years of age (Ref).

Children ≤6 years: IV: 12 mg/kg/dose every 24 hours.

Children: 7 to ≤11 years: IV: 9 mg/kg/dose every 24 hours.

Children ≥12 years and Adolescents ≤17 years: IV: 7 mg/kg/dose every 24 hours.

Adolescents ≥18 years: IV: 6 mg/kg/dose every 24 hours.

Endocarditis due to Staphylococcus, treatment

Endocarditis due to Staphylococcus (methicillin-resistant S. aureus [MRSA] or vancomycin resistant/intolerant), treatment (Ref): Note: Based on more recent pharmacokinetic/dynamic experience in pediatric patients (Ref), AHA guideline dosing (Ref) may not be adequate and higher doses necessary in some patients.

Children <6 years: IV: 10 mg/kg/dose every 24 hours.

Children ≥6 years and Adolescents: 6 mg/kg/dose every 24 hours.

Osteomyelitis, acute hematogenous

Osteomyelitis, acute hematogenous (AHO): Limited data available:

Children ≤6 years: IV: 12 mg/kg/dose every 24 hours.

Children 7 to ≤11 years: IV: 9 mg/kg/dose every 24 hours.

Children ≥12 years and Adolescents ≤17 years: IV: 7 mg/kg/dose every 24 hours.

Dosing based on a randomized, controlled, non-inferiority trial (n=146, n=74 received daptomycin; ages: 1.2 to 17.3 years) comparing daptomycin to comparator (chosen based on local antibiogram) for AHO. Pathogens were isolated in 62.2% of patients receiving daptomycin (methicillin-susceptible S. aureus [MSSA]: 84.8%; MRSA: 8.7%). The primary objective of clinical improvement on or before day 5 occurred in 77.5% of patients receiving daptomycin and 82.9% of patients receiving comparator. Adverse events were reported more frequently in comparator (62.5%) compared to daptomycin (45.9%). In the United States, median IV treatment duration for daptomycin was 4 days (range: 1 to 21 days) before transitioning to oral step-down therapy (Ref).

Skin and skin structure infection, complicated due to susceptible S. aureus

Skin and skin structure infection, complicated (cSSSI) due to susceptible S. aureus :

Children: 1 to <2 years: IV: 10 mg/kg/dose every 24 hours.

Children: 2 to ≤6 years: IV: 9 mg/kg dose every 24 hours.

Children: 7 to ≤11 years: IV: 7 mg/kg/dose every 24 hours.

Children ≥12 years and Adolescents ≤17 years: IV: 5 mg/kg/dose every 24 hours.

Adolescents ≥18 years: IV: 4 mg/kg/dose every 24 hours.

Treatment duration: Up to 14 days (Ref); in clinical trials, the median duration of IV therapy was 3 days (range: 1 to 10 days) and the median duration of total therapy (IV plus oral step-down therapy) was 12 days (range: 1 to 35 days) (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Pediatric

Altered kidney function:

There are no pediatric-specific recommendations in the manufacturer's labeling (has not been studied). The following dosage adjustments have been recommended based on physiologically based pharmacokinetic modeling; in patients with kidney impairment, consider monitoring CPK frequently (eg, more than once weekly) (Ref).

Children <2 years: IV:

Daptomycin IV Dosing Adjustments for Kidney Impairment in Children <2 Yearsa

eGFR

Recommended dosing schedule: IV

a Ye 2022.

≥30 mL/minute/1.73 m2

(usual recommended dose)

10 mg/kg/dose every 24 hours

12 mg/kg/dose every 24 hours

15 to <30 mL/minute/1.73 m2

10 mg/kg/dose every 48 hours

12 mg/kg/dose every 48 hours

<15 mL/minute/1.73 m2

6 mg/kg/dose every 48 hours

8 mg/kg/dose every 48 hours

Children 2 to <7 years: IV:

Daptomycin IV Dosing Adjustments for Kidney Impairment in Children 2 to <7 Yearsa

eGFR

Recommended dosing schedule: IV

a Ye 2022.

≥30 mL/minute/1.73 m2

(usual recommended dose)

9 mg/kg/dose every 24 hours

12 mg/kg/dose every 24 hours

15 to <30 mL/minute/1.73 m2

9 mg/kg/dose every 48 hours

12 mg/kg/dose every 48 hours

<15 mL/minute/1.73 m2

7 mg/kg/dose every 48 hours

8 mg/kg/dose every 48 hours

Children 7 to <12 years: IV:

Daptomycin IV Dosing Adjustments for Kidney Impairment in Children 7 to <12 Yearsa

eGFR

Recommended dosing schedule: IV

a Ye 2022.

≥30 mL/minute/1.73 m2

(usual recommended dose)

7 mg/kg/dose every 24 hours

9 mg/kg/dose every 24 hours

<30 mL/minute/1.73 m2

7 mg/kg/dose every 48 hours

9 mg/kg/dose every 48 hours

Children ≥12 years and Adolescents <18 years: IV:

Daptomycin IV Dosing Adjustments for Kidney Impairment in Children 12 to <18 Yearsa

eGFR

Recommended dosing schedule: IV

a Ye 2022.

≥30 mL/minute/1.73 m2

(usual recommended dose)

5 mg/kg/dose every 24 hours

7 mg/kg/dose every 24 hours

<30 mL/minute/1.73 m2

5 mg/kg/dose every 48 hours

7 mg/kg/dose every 48 hours

Hemodialysis, intermittent, 3 times weekly: Note: 51.7% ± 9.2% removed by a 4-hour hemodialysis session in adults (Ref); 22.2% and 24.1% removed by a 3-hour hemodialysis session in two adolescents (Ref).

Children and Adolescents: IV: Based on limited data in adults and a 5-year-old pediatric patient, administer usual recommended dose every 48 hours; on dialysis days, administer after dialysis (Ref). Note: In one study, adolescent patients receiving 3-times-weekly dialysis were administered usual dose on Monday and Wednesday, and given a 50% increased dose on Friday to account for longer interdialytic time (eg, if the dose is 5 mg/kg for a patient who is receiving dialysis on Monday, Wednesday, and Friday, administer 5 mg/kg after dialysis on Monday and Wednesday and on Friday administer 7.5 mg/kg after dialysis) (Ref).

Peritoneal dialysis:

Children ≥12 years and Adolescents: IV: Based on limited data in adults and pediatric patients 12 to 15 years of age, consider administering usual recommended dose every 48 hours (Ref).

Dosing: Hepatic Impairment: Pediatric

Children and Adolescents:

Mild to moderate impairment: No dosage adjustment necessary.

Severe impairment: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Adverse Reactions (Significant): Considerations
Clostridioides difficile infection

Antibiotics, including daptomycin, have been associated with Clostridioides difficile infection (CDI), including Clostridioides difficile associated diarrhea and Clostridioides difficile colitis; however, daptomycin is associated with a lower risk for CDI compared to other high-risk antibiotics (Ref). In addition, some data has suggested efficacy of daptomycin against C. difficile in vitro (Ref).

Mechanism: Non–dose-related; antibiotics disrupt the indigenous gut microbiota which promotes C. difficile spore germination, growth, and toxin production, leading to epithelial damage and colitis (Ref).

Onset: Varied; in general, antibiotic-associated CDI may start on the first day of antibiotic therapy or up to 3 months postantibiotic (Ref).

Risk factors: Antibiotics in general:

Antibiotic exposure (highest risk factor); antibiotics most frequently associated with C. difficile include clindamycin, fluoroquinolones, third-/fourth-generation cephalosporins, and carbapenems (Ref)

Long durations in a hospital or other health care setting (recent or current) (Ref)

Older age (Ref)

Immunocompromised conditions or serious underlying conditions (Ref)

GI surgery/manipulation (Ref)

Antiulcer medications, such as proton pump inhibitors and H2 blockers (suggested risk factor) (Ref)

Chemotherapy (suggested risk factor) (Ref)

Eosinophilic pneumonia

Daptomycin-induced eosinophilic pneumonitis (or eosinophilic interstitial pneumonia) has been reported. It is characterized by new-onset dyspnea, fever, bilateral infiltrates, and/or >25% eosinophils in bronchoalveolar lavage. Peripheral eosinophilia and fine crackles have also been commonly observed in case reports. Most cases reported improvement after daptomycin discontinuation; however, some patients developed chronic pneumonitis and required long-term corticosteroid treatment. However, literature does support a temporal association between daptomycin exposure and the development of eosinophilic pneumonia. Recurrence upon rechallenge has also been observed (Ref).

Mechanism: There have been several mechanisms suggested for daptomycin eosinophilic pneumonia with one centered on daptomycin accumulating and binding to pulmonary surfactant. This has been thought to cause direct or indirect damage to the pulmonary epithelium with resulting inflammation. Of note, one study found an association with development of eosinophilic pneumonia and cumulative dose or duration, while another study did not find this association. An allergic mechanism has also been suggested that attributes the pathophysiology to an antigen-mediated process in which alveolar macrophages and T-helper 2 (Th2) lymphocyte cells are activated, which then cause the subsequent release of interleukin-5, leading to an influx of eosinophils to the lungs (Ref).

Onset: Intermediate; usually 10 days to 4 weeks after initiation of therapy (Ref).

Risk factors: Note: Risk factors for this condition have not been well established (Ref)

• Males (potential risk factor) (Ref)

• Older age (potential risk factor) (Ref)

Hypersensitivity reactions (immediate and delayed)

Immediate hypersensitivity reactions (urticaria, angioedema, anaphylaxis) have been reported (Ref). Delayed hypersensitivity reactions have also been reported, including skin rash, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) (Ref).

Mechanism: Non–dose-related; immunologic. Immediate hypersensitivity reactions (eg, anaphylaxis, angioedema, urticaria) are IgE-mediated. Delayed hypersensitivity reactions, including AGEP, are T-cell mediated (Ref).

Onset: Immediate hypersensitivity reactions: Rapid; generally occurs within 1 hour of administration, but may occur 6 hours after exposure (Ref). Delayed hypersensitivity reactions: Varied; rashes usually begin 6 to 10 days after initiation. Severe cutaneous adverse reactions, including DRESS and AGEP, occur days to 8 weeks after drug exposure (Ref).

Myopathy and rhabdomyolysis

Daptomycin may cause symptomatic or asymptomatic increased creatine phosphokinase in blood specimen (CPK) (or creatine kinase) in pediatrics and adults. Use is also associated with significant CPK elevations (>10 times the upper limit of normal [ULN]) and skeletal muscle toxicities, such as myopathy and rhabdomyolysis (including cases of acute renal failure and/or liver injury secondary to the rhabdomyolysis). Case reports of daptomycin-induced rhabdomyolysis have occurred in the setting of monotherapy and with concomitant use of another medication, particularly an HMG CoA-reductase inhibitor (ie, a statin) (Ref). Daptomycin-induced CPK elevation is reversible upon discontinuation (Ref). Therapy discontinuation is warranted in patients with significant CPK elevations, which the prescribing information defines as an increase in CPK >5 times ULN (or 1,000 units/L) in patients with signs/symptoms of myopathy OR an increase in CPK ≥10 times ULN (or >2,000 units/L) in asymptomatic patients.

Mechanism: Exact mechanism is unknown, but it is believed that similar to daptomycin’s mechanism of action in bacterial cells that causes release of intracellular ions, it may also affect myocytes in skeletal muscles resulting in leakage of intracellular CPK (Ref).

Onset: Varied; in a case control study, the mean onset of CPK elevation was 16.7 days (range: 1 to 58 days), the mean onset for myopathy was 25 days (range: 3 to 176 days), and the mean onset for rhabdomyolysis was 13 days (range: 1 to 24 days) (Ref).

Risk factors: Note: A number of risk factors have been suggested, but overall data regarding risk factors are limited, unclear, and conflicting.

• Concomitant statin therapy (potential risk factor suggested by some observational studies (Ref); however, other observational studies have failed to find a significant association) (Ref)

• Obesity (BMI >25 kg/m2) (potential risk factor) (Ref) Note: Patients with obesity have lower daptomycin clearance potentially resulting in greater exposure (Ref)

• Critically ill patients/hypoxic conditions, such as severe sepsis (potential risk factor) (Ref)

• Daptomycin exposure:

- Dosing intervals more frequent than the recommended once-daily regimen (suggested by earlier phase, dose-finding human and animal studies where daptomycin was administered more frequently than once daily) (Ref)

- Trough levels ≥24.3 mg/L has been suggested as a potential risk factor increasing the risk of CPK elevations (Ref); however, other data have not found a significant association (Ref)

• Severe renal impairment (potential risk factor; conflicting evidence exists) (Ref)

Peripheral neuropathy

Cases of peripheral neuropathy have been reported. There is also a single published case report of external popliteal sciatic nerve paralysis with daptomycin therapy (Ref). In addition, in a clinical trial evaluating daptomycin for bacteremia and endocarditis due to Staphylococcus aureus, an increased incidence of adverse events related to the peripheral nervous system (eg, paresthesia, dysesthesias, and peripheral neuropathies) were observed in patients receiving daptomycin compared to those receiving standard therapy; however, the authors described these events as mild to moderate, mostly short-lived, and resolving with continued treatment (Ref).

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults and pediatric patients unless otherwise specified.

>10%: Gastrointestinal: Vomiting (children and adolescents: 3% to 11%)

1% to 10%:

Cardiovascular: Chest pain (adults: 7%), edema (adults: 7%), hypertension (adults: 6%), hypotension (adults: 2%)

Dermatologic: Diaphoresis (adults: 5%), pruritus (3% to 6%), skin rash (adults: 4%) (table 1)

Daptomycin: Adverse Reaction: Skin Rash

Drug (Daptomycin)

Comparator (Vancomycin or an Anti-Staphylococcal Semi-Synthetic Penicillin)

Population

Dose

Indication

Number of Patients (Daptomycin)

Number of Patients (Vancomycin or an Anti-Staphylococcal Semi-Synthetic Penicillin)

4%

4%

Adults

4 mg/kg

Complicated skin and skin structure infections

534

558

Gastrointestinal: Abdominal pain (adults: 6%; children and adolescents: 2%), diarrhea (5% to 7%)

Genitourinary: Urinary tract infection (adults: 2%)

Hepatic: Abnormal hepatic function tests (adults: 3%)

Infection: Bacteremia (adults: 5%), gram-negative organism infection (adults: 8%), sepsis (adults: 5%)

Nervous system: Dizziness (adults: 2%), headache (3% to 5%), insomnia (adults: 9%)

Neuromuscular & skeletal: Increased creatine phosphokinase in blood specimen (3% to 9%) (table 2)

Daptomycin: Adverse Reaction: Increased Creatine Phosphokinase in Blood Specimen

Drug (Daptomycin)

Comparator (Vancomycin, Clindamycin, Cefazolin, or an Anti-Staphylococcal Semi-Synthetic Penicillin)

Population

Dose

Indication

Number of Patients (Daptomycin)

Number of Patients (Comparator)

7%

0%

Children and Adolescents

Age specific dosing (7 mg/kg to 12 mg/kg)

S. aureus bacteremia

55

26

6%

5%

Children and Adolescents

Age specific dosing (5 mg/kg to 10 mg/kg)

Complicated skin and skin structure infections

256

133

7%

1%

Adults

6 mg/kg

S. aureus bacteremia/endocarditis

120

116

3%

2%

Adults

4 mg/kg

Complicated skin and skin structure infections

534

558

Respiratory: Dyspnea (adults: 2%), pharyngolaryngeal pain (adults: 8%)

Miscellaneous: Fever (children and adolescents: 4%)

<1%:

Cardiovascular: Flushing, supraventricular cardiac arrhythmia

Dermatologic: Eczema

Endocrine & metabolic: Electrolyte disturbance, hypomagnesemia, increased lactate dehydrogenase, increased serum bicarbonate

Gastrointestinal: Abdominal distension, dysgeusia, stomatitis

Hematologic & oncologic: Eosinophilia, increased INR, leukocytosis, thrombocythemia, thrombocytopenia

Hepatic: Jaundice

Hypersensitivity: Hypersensitivity reaction

Nervous system: Fatigue, mental status changes, myasthenia, paresthesia, rigors, vertigo

Neuromuscular & skeletal: Arthralgia, asthenia, muscle cramps, myalgia

Ophthalmic: Eye irritation

Frequency not defined:

Cardiovascular: Atrial fibrillation, atrial flutter

Dermatologic: Vesicular eruption

Endocrine & metabolic: Increased serum phosphate

Gastrointestinal: Decreased appetite, epigastric distress, gingival pain, oral candidiasis, xerostomia

Genitourinary: Fungal urinary tract infection, proteinuria, vulvovaginal candidiasis

Hematologic & oncologic: Lymphadenopathy, prolonged prothrombin time

Hepatic: Increased serum alanine aminotransferase, increased serum alkaline phosphatase, increased serum aspartate aminotransferase

Infection: Candidiasis, fungal septicemia

Nervous system: Hallucination, hypoesthesia (oral)

Neuromuscular & skeletal: Dyskinesia

Ophthalmic: Blurred vision

Otic: Tinnitus

Renal: Renal insufficiency

Postmarketing:

Dermatologic: Acute generalized exanthematous pustulosis (Gordon Spratt 2014), erythema of skin (Caulder 2014), Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria (Metz 2008), vesiculobullous dermatitis

Endocrine & metabolic: Hyperkalemia (Budovich 2014)

Gastrointestinal: Clostridioides difficile associated diarrhea (Webb 2020), dysphagia, nausea

Hematologic & oncologic: Anemia, myoglobin increased, neutropenia (Knoll 2013)

Hepatic: Hepatotoxicity (Abraham 2008)

Hypersensitivity: Anaphylaxis, angioedema (Gisler 2016)

Immunologic: Drug reaction with eosinophilia and systemic symptoms

Nervous system: Peripheral neuropathy (Villaverde Piñeiro 2018)

Neuromuscular & skeletal: Myopathy (Hagiya 2015), rhabdomyolysis (King 2014)

Ophthalmic: Visual disturbance

Renal: Acute interstitial nephritis (Bosak 2016), acute kidney injury (Abraham 2008)

Respiratory: Bronchiolitis obliterans organizing pneumonia, cough, eosinophilic pneumonitis (Higashi 2018)

Contraindications

Hypersensitivity to daptomycin or any component of the formulation

Warnings/Precautions

Concerns related to adverse effects:

• Superinfection: Prolonged use may result in fungal or bacterial superinfection.

• Interstitial nephritis, acute: Interstitial nephritis has been reported. Evaluate patients with new or worsening renal impairment; discontinue and institute appropriate treatment if suspected.

Disease-related concerns:

• Persisting or relapsing S. aureus bacteremia or endocarditis: Repeat blood cultures in patients with persisting or relapsing S. aureus bacteremia/endocarditis or poor clinical response. If culture is positive for S. aureus, perform minimum inhibitory concentration (MIC) susceptibility testing of the isolate and diagnostic evaluation of the patient to rule out sequestered foci of infection. Appropriate surgical intervention (eg, debridement, removal of prosthetic devices, valve replacement surgery) and/or consideration of a change in antibacterial therapy may be necessary.

• Renal impairment: Use with caution in patients with renal impairment; dosage adjustment required in severe renal impairment (CrCl <30 mL/minute). Limited data (eg, subgroup analysis) from cSSSI and endocarditis trials suggest possibly reduced clinical efficacy (relative to comparators) in patients with baseline moderate to severe renal impairment (<50 mL/minute).

Special populations:

• Pediatric: Avoid use in pediatric patients <12 months due to risk of potential muscular, neuromuscular, and/or nervous systems effects observed in neonatal canines.

Dosage form specific issues:

• Latex: Some products may contain latex.

Warnings: Additional Pediatric Considerations

Avoiding use in neonatal and pediatric patients <12 months is recommended in product labeling; neonatal animal models (canine) have shown reversible musculoskeletal, neuromuscular, and nervous system adverse effects including twitching, muscle rigidity of the limbs, and impaired use of the limbs; adverse effects were observed at lower serum concentrations than older canine models (approximately threefold less than juvenile models and ninefold less than adult models) and resolved within 28 days of discontinuation. The neuromuscular/skeletal adverse events occurred with canine doses and drug exposure levels that were higher than the standard adult human dose (6 mg/kg) and corresponding daptomycin exposure levels. Nervous system adverse effects are most associated with high peak serum concentrations; to mitigate this risk and lower patient's exposure, longer infusion times are used in pediatric patients (ie, age ≤6 years: Infuse over 60 minutes; >6 years of age: Infuse over 30 minutes vs adolescents ≥18 years: Bolus over 2 minutes) (Arrieta 2018). Evaluate risk vs benefit when considering use in neonates and infants.

Product Availability

Dapzura RT: FDA approved January 2022; anticipated availability currently unknown. Information pertaining to this product within the monograph is pending revision. Dapzura RT contains sorbitol. Consult the prescribing information for additional information.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution, Intravenous [preservative free]:

Generic: 1000 mg (100 mL); 350 mg (50 mL); 500 mg (50 mL); 700 mg (100 mL)

Solution Reconstituted, Intravenous:

Generic: 350 mg (1 ea); 500 mg (1 ea)

Solution Reconstituted, Intravenous [preservative free]:

Cubicin: 500 mg (1 ea [DSC])

Cubicin RF: 500 mg (1 ea)

Generic: 350 mg (1 ea); 500 mg (1 ea)

Generic Equivalent Available: US

Yes

Pricing: US

Solution (DAPTOmycin-Sodium Chloride Intravenous)

350 mg/50 mL 0.9% (per mL): $0.79

500 mg/50 mL 0.9% (per mL): $0.94

700 mg/100 mL 0.9% (per mL): $0.68

1000 mg/100 mL 0.9% (per mL): $0.79

Solution (reconstituted) (Cubicin RF Intravenous)

500 mg (per each): $534.59

Solution (reconstituted) (DAPTOmycin Intravenous)

350 mg (per each): $16.36 - $332.40

500 mg (per each): $22.31 - $534.58

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution Reconstituted, Intravenous:

Cubicin: 500 mg ([DSC])

Cubicin RF: 500 mg (1 ea)

Generic: 500 mg (1 ea)

Administration: Adult

IV: Administer as an IV infusion over 30 minutes. May also administer IV push over 2 minutes. Do not use in conjunction with ReadyMED elastomeric infusion pumps (Cardinal Health, Inc) due to an impurity (2-mercaptobenzothiazole) leaching from the pump system into the daptomycin solution.

Intraventricular (off-label route): Use preservative-free preparations only. When administered through a ventricular drain, clamp drain for 15 to 60 minutes before opening the drain to allow daptomycin solution to equilibrate in the cerebrospinal fluid (Ref).

Administration: Pediatric

IV: Intermittent IV infusion:

Neonates: Infusion over 60 minutes has been reported in trials (Ref).

Infants <3 months: Infusion over 30 or 60 minutes has been reported in trials with every 12-hour dosing (Ref).

Infants ≥3 months: Infusion over 30 minutes has been reported in trials; a longer infusion time of 60 minutes may be considered to minimize exposure to high peak serum concentration (Ref).

Children 1 to 6 years: Infuse over 60 minutes.

Children ≥7 years and Adolescents: Infuse over 30 minutes.

Do not use in conjunction with ReadyMED elastomeric infusion pumps (Cardinal Health, Inc) due to an impurity (2-mercaptobenzothiazole) which leaches from the pump system into the daptomycin solution.

Use: Labeled Indications

Bloodstream infection: Treatment of bloodstream infection caused by Staphylococcus aureus (methicillin-susceptible and methicillin-resistant isolates) in adults, including those with right-sided infective endocarditis; treatment of bloodstream infection due to S. aureus in pediatric patients 1 to 17 years of age.

Skin and skin structure infections, complicated: Treatment of complicated skin and skin structure infections caused by S. aureus (including methicillin-resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae subspecies equisimilis, and Enterococcus faecalis (vancomycin-susceptible isolates only) in adult and pediatric patients 1 to 17 years of age.

Limitations of use: Not indicated for the treatment of pneumonia.

Use: Off-Label: Adult

Cerebrospinal fluid shunt infection; Diabetic foot infections; Endocarditis, treatment; Intracranial abscess (brain abscess, intracranial epidural abscess) or spinal epidural abscess; Meningitis, bacterial; Osteomyelitis and/or discitis; Prosthetic joint infection; Septic arthritis

Medication Safety Issues
Sound-alike/look-alike issues:

Cubicin may be confused with Cleocin, Cubicin RF

Cubicin RF may be confused with Cubicin

DAPTOmycin may be confused with DACTINomycin

Other safety concerns:

Storage and preparations errors have occurred when Cubicin has been confused with Cubicin RF (ISMP 2016)

Pediatric patients: High-risk medication:

KIDs List: Daptomycin, when used in neonates and infants <1 year of age, is identified on the Key Potentially Inappropriate Drugs in Pediatrics (KIDs) list and should be used with caution due to risk of neuromuscular and skeletal adverse events (weak recommendation; very low quality of evidence) (PPA [Meyers 2020]).

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Bacillus clausii: Antibiotics may diminish the therapeutic effect of Bacillus clausii. Management: Bacillus clausii should be taken in between antibiotic doses during concomitant therapy. Risk D: Consider therapy modification

BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination

BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Risk C: Monitor therapy

Cholera Vaccine: Antibiotics may diminish the therapeutic effect of Cholera Vaccine. Management: Avoid cholera vaccine in patients receiving systemic antibiotics, and within 14 days following the use of oral or parenteral antibiotics. Risk X: Avoid combination

Fecal Microbiota (Live) (Oral): May diminish the therapeutic effect of Antibiotics. Risk X: Avoid combination

Fecal Microbiota (Live) (Rectal): Antibiotics may diminish the therapeutic effect of Fecal Microbiota (Live) (Rectal). Risk X: Avoid combination

HMG-CoA Reductase Inhibitors (Statins): May enhance the adverse/toxic effect of DAPTOmycin. Specifically, the risk of skeletal muscle toxicity may be increased. Management: Consider temporarily stopping statin (HMG-CoA reductase inhibitor) therapy prior to daptomycin. If daptomycin is used with a statin, creatine phosphokinase (CPK) monitoring could be considered. Risk D: Consider therapy modification

Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies): Antibiotics may diminish the therapeutic effect of Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies). Risk C: Monitor therapy

Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Risk C: Monitor therapy

Methadone: May decrease the serum concentration of DAPTOmycin. Risk C: Monitor therapy

Simvastatin: May enhance the adverse/toxic effect of DAPTOmycin. Risk X: Avoid combination

Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Risk D: Consider therapy modification

Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Avoid use of live attenuated typhoid vaccine (Ty21a) in patients being treated with systemic antibacterial agents. Postpone vaccination until 3 days after cessation of antibiotics and avoid starting antibiotics within 3 days of last vaccine dose. Risk D: Consider therapy modification

Pregnancy Considerations

Adverse events were not observed in animal reproduction studies. Successful use of daptomycin during the second and third trimesters of pregnancy has been described; however, only limited information is available from case reports.

Breastfeeding Considerations

Low concentrations of daptomycin have been detected in breast milk; however, daptomycin is poorly absorbed orally. According to the manufacturer, the decision to continue or discontinue breastfeeding during therapy should take into account the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother. In general, antibiotics that are present in breast milk may cause non-dose-related modification of bowel flora. Monitor infants for GI disturbances (WHO 2002).

Monitoring Parameters

Monitor signs and symptoms of infection. CPK should be monitored at least weekly during therapy; more frequent monitoring if current or prior statin therapy, unexplained CPK increases, and/or renal impairment. Monitor for muscle pain or weakness, especially if noted in distal extremities. Monitor for new onset or worsening peripheral neuropathy. Monitor for signs/symptoms of eosinophilic pneumonia (eg, new-onset or worsening fever, dyspnea, difficulty breathing, new infiltrates on chest imaging studies, and/or >25% eosinophils present in bronchoalveolar lavage). Monitor for signs/symptoms of hypersensitivity reactions, including DRESS (eg, fever, peripheral eosinophilia, rash, systemic organ impairment [eg, hepatic, pulmonary, renal]).

Reference Range

Trough concentrations at steady-state:

4 mg/kg once daily: 5.9 ± 1.6 mcg/mL

6 mg/kg once daily: 6.7 ± 1.6 mcg/mL

Note: Routine trough monitoring is not recommended. Trough concentrations are not predictive of efficacy. Drug exhibits concentration-dependent bactericidal activity, so Cmax:MIC ratios may be a more useful parameter for efficacy.

Mechanism of Action

Daptomycin binds to components of the cell membrane of susceptible organisms and causes rapid depolarization, inhibiting intracellular synthesis of DNA, RNA, and protein. Daptomycin is bactericidal in a concentration-dependent manner.

Pharmacokinetics (Adult Data Unless Noted)

Distribution:

Vss:

Neonates and Infants <3 months of age: Median: 0.21 L/kg (range: 0.11 to 0.34 L/kg) (Cohen-Wolkowiez 2012).

Children 2 to 6 years of age: 0.14 L/kg (Abdel-Rahman 2008; Abdel-Rahman 2011).

Children 7 to 17 years of age: 0.11 ± 0.02 L/kg (Abdel-Rahman 2008).

Adults: 0.1 L/kg; Critically-ill patients: Vss: 0.23 ± 0.14 L/kg (Vilay 2011).

Bone (cancellous): fCmax (plasma)/fCmax (tissue) ratio, steady state: 75%; fAUCtissue/fAUCplasma ratio, steady state: 117% (Traunmüller 2010); bone/plasma ratio, single dose, ~7 hours postdose: ~8% to 10% (Montange 2014).

CSF:plasma ratio: AUC24 0.45%; Cmax 0.24% (Piva 2019).

Synovial fluid, single dose, ~7 hours postdose:plasma ratio ~54% (Montange 2014).

Protein binding: 90% to 93%; 84% to 88% in patients with CrCl <30 mL/minute.

Metabolism: Minor amounts of oxidative metabolites have been detected.

Half-life elimination:

Neonates and infants <3 months of age: Median: 6.2 hours (range: 3.7 to 9 hours) (Cohen-Wolkowiez 2012).

Children 2 to 6 years of age: Mean range: 5.3 to 5.7 hours (Abdel-Rahman 2008; Abdel-Rahman 2011).

Children 7 to 11 years of age: 5.6 ± 2.2 hours (Abdel-Rahman 2008).

Children 12 to 17 years of age: 6.7 ± 2.2 hours (Abdel-Rahman 2008).

Adults: 8 to 9 hours (up to 28 hours in renal impairment).

Excretion: Urine (78%; primarily as unchanged drug); feces (5.7%).

Clearance:

Neonates and infants <3 months of age: Median: 21 mL/hour/kg (range: 16 to 34 mL/hour/kg) (Cohen-Wolkowiez 2012).

Children 2 to 6 years of age: 19 to 20 mL/hour/kg (Abdel-Rahman 2008; Abdel-Rahman 2011).

Children 7 to 11 years of age: 17 mL/hour/kg (Abdel-Rahman 2008).

Children: 12 to 17 years of age: 11 mL/hour/kg (Abdel-Rahman 2008).

Adults: 8.3 to 9 mL/hour/kg.

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Altered kidney function: Mean total plasma clearance was 9%, 22%, and 46% lower in patients with mild (CrCl 50 to 80 mL/minute), moderate (CrCl 30 to <50 mL/minute), and severe (CrCl <30 mL/minute) renal impairment, respectively, compared with those with healthy renal function. Mean AUC, half-life, and Vd at steady state increased with decreasing renal function.

Pediatric: In neonates and pediatric patients <12 years of age, clearance and volume of distribution are higher than older populations; these patients require higher mg/kg doses or more frequent dosing to achieve adequate serum concentrations and systemic exposure (Principi 2015)

Older adult: Mean total clearance is reduced ~35% and AUC is increased ~58% in elderly patients compared with younger healthy subjects.

Obesity: Plasma clearance was 15% and 23% lower and AUC increased by 30% and 31% in moderately obese patients and extremely obese patients, respectively, compared with nonobese controls.

Anti-infective considerations:

Parameters associated with efficacy:

Gram-positive infection: Concentration dependent, associated with AUC24/minimum inhibitory concentration (MIC), goal: >400 (bacteriostatic), ≥666 (reduced mortality) (Falcone 2013a), >800 (bactericidal) (Di Paolo 2013), and fCmax (peak)/MIC, goal: 2.5 to 7 (bacteriostatic); 7 to 25 (2-log kill) (Safdar 2004).

Pathogen specific:

E. faecalis: fAUC24/MIC ≥7.2 (bacteriostatic) (Kidd 2018).

Enterococcus faecium: Cmax/MIC ≥0.14 to 0.25 (bacteriostatic); AUC24/MIC ≥0.94 to 1.67 (bacteriostatic) (Safdar 2004); fAUC24/MIC ≥0.85 (bacteriostatic); ≥12.9 (1-log kill) (Kidd 2018).

S. aureus: Cmax/MIC ≥59 to 94 (bacteriostatic); AUC24/MIC ≥388 to 537 (bacteriostatic) (Safdar 2004); fAUC24/MIC ≥42 to 43 (stasis) (Louie 2001; Safdar 2004).

Streptococcus pneumoniae: Cmax/MIC ≥12 to 36 (bacteriostatic); AUC24/MIC ≥75 to 237 (bacteriostatic) (Safdar 2004).

Expected drug exposure in patients with normal renal function:

AUC24:

Pediatric patients with bacteremia:

Children 2 to 6 years: 12 mg/kg once daily: 620 ± 109 mg•hour/L.

Children 7 to 11 years: 9 mg/kg once daily: 579 ± 116 mg•hour/L.

Children and Adolescents 12 to 17 years: 7 mg/kg once daily: 656 ± 334 mg•hour/L.

Adults (healthy):

6 mg/kg once daily: 632 ± 78 mg•hour/L.

8 mg/kg once daily: 858 ± 213 mg•hour/L.

10 mg/kg once daily: 1,039 ± 178 mg•hour/L.

12 mg/kg once daily: 1,277 ± 254 mg•hour/L.

Cmax (peak):

Pediatric patients with bacteremia:

Children 2 to 6 years: 12 mg/kg once daily: 106 ± 12.8 mg/L.

Children 7 to 11 years: 9 mg/kg once daily: 104 ± 14.5 mg/L.

Children and Adolescents 12 to 17 years: 7 mg/kg once daily: 104 ± 35.5 mg/L.

Adults (healthy):

6 mg/kg once daily: 93.9 ± 6 mg/L.

8 mg/kg once daily: 123.3 ± 16 mg/L.

10 mg/kg once daily: 141.1 ± 24 mg/L.

12 mg/kg once daily: 183.7 ± 25 mg/L.

Postantibiotic effect: Bacterial killing continues after daptomycin concentration falls below the MIC of targeted pathogen and varies based on the organism:

E. faecalis: 0.6 to 6.7 hours, dose dependent (Hanberger 1991).

S. aureus: 1 to 6.3 hours (Hanberger 1991; Pankuch 2003; Safdar 2004).

Methicillin-susceptible S. aureus: Mean: 2.4 hours (Pankuch 2003).

Methicillin-resistant S. aureus: Mean: 4.1 hours (Pankuch 2003).

S. pneumoniae: 1 to 2.5 hours (mean: 1.7 hours) (Pankuch 2003); postantibiotic effect of up to 10.8 hours has been observed at a dose of 10 mg/kg (Safdar 2004).

Parameters associated with toxicity: Cmin (trough) (steady state) ≥24.3 mg/L associated with increased risk of CPK elevation (Abdul-Aziz 2020; Bhavnani 2010).

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Cubicin | Cubicin rf;
  • (AR) Argentina: Cubicin | Cubicin rt;
  • (AT) Austria: Cubicin | Daptomycin accordpharma | Daptomycin betapharm | Daptomycin norameda;
  • (AU) Australia: Cubicin | Daptomycin accord | Daptomycin dr.reddys | Daptomycin juno | Pfizer daptomycin;
  • (BG) Bulgaria: Cubicin;
  • (BR) Brazil: Cubicin | Daptomicina | Daptomicina accord farma | Dopcym | Exfuno | Trisk;
  • (CH) Switzerland: Cubicin | Daptomycin accord | Daptomycin labatec;
  • (CL) Chile: Cubicin;
  • (CO) Colombia: Cubicin | Daptomicina | Daptomred | Databin;
  • (CZ) Czech Republic: Daptomycin accordpharma;
  • (DE) Germany: Cubicin | Daptomycin accord | Daptomycin beta | Daptomycin cipla | Daptomycin Hikma | Daptomycin noridem | Daptomycin panpharma | Daptomycin ratiopharm;
  • (EE) Estonia: Cubicin | Daptomycin norameda;
  • (ES) Spain: Cubicin | Daptomicina accord | Daptomicina aristo | Daptomicina cipla | Daptomicina dr reddys | Daptomicina normon | Daptomicina sala | Daptomicina tillomed | Daptomicina xellia;
  • (FI) Finland: Daptomycin accordpharma | Daptomycin norameda;
  • (FR) France: Cubicin | Daptomycine Accord | Daptomycine hikma | Daptomycine hospira | Daptomycine medac | Daptomycine noridem | Daptomycine Reddy | Daptomycine xellia;
  • (GB) United Kingdom: Cubicin;
  • (GR) Greece: Cubicin | Daptomycin/accordpharma | Daptomycin/demo | Zepraxen;
  • (HK) Hong Kong: Cubicin;
  • (HU) Hungary: Cubicin | Daptomycin anfarm | Daptomycin hameln | Daptomycin hospira;
  • (IE) Ireland: Cubicin | Daptomycin accordpharma;
  • (IN) India: Cubicin | Daptobio | Daptovan | Ivdapt;
  • (IT) Italy: Cubicin | Daptomicina accord | Daptomicina Dr. Reddy's | Daptomicina Teva Generics | Daptomicina tillomed;
  • (JO) Jordan: Xeracine;
  • (JP) Japan: Cubicin;
  • (KR) Korea, Republic of: Boryung daptomycin | Daptocin;
  • (KW) Kuwait: Cubicin;
  • (LB) Lebanon: Cubicin rf;
  • (MX) Mexico: Cubicine;
  • (MY) Malaysia: Cubicin;
  • (NL) Netherlands: Cubicin | Daptomycin Hikma | Daptomycine eureco pharma;
  • (NO) Norway: Daptomycin accordpharma;
  • (NZ) New Zealand: Cubicin;
  • (PH) Philippines: Cubicin;
  • (PL) Poland: Cubicin;
  • (PR) Puerto Rico: Cubicin | Cubicin rf;
  • (PT) Portugal: Cubicin | Daptomicina accord | Daptomicina normon;
  • (QA) Qatar: Cubicin | Cubicin RF | Xeracine;
  • (RO) Romania: Cubicin;
  • (RU) Russian Federation: Cubicin | Daptomycin psk;
  • (SA) Saudi Arabia: Daci | Docine;
  • (SE) Sweden: Cubicin | Daptomycin accordpharma | Daptomycin stada;
  • (SG) Singapore: Cubicin;
  • (SI) Slovenia: Cubicin;
  • (SK) Slovakia: Cubicin;
  • (TH) Thailand: Cubicin;
  • (TR) Turkey: Cubicin | Daptocin | Daptomax | Dupcin;
  • (TW) Taiwan: Cubicin;
  • (UA) Ukraine: Cubicin | Daptomycin vista;
  • (VE) Venezuela, Bolivarian Republic of: Cubicin;
  • (ZA) South Africa: Cubicin | Cusyn | Drymred
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  2. Abdel-Rahman SM, Chandorkar G, Akins RL, et al. Single-dose pharmacokinetics and tolerability of daptomycin 8 to 10 mg/kg in children aged 2 to 6 years with suspected or proved gram-positive infections. Pediatr Infect Dis J. 2011;30(8):712-714. [PubMed 21317681]
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  8. Ando M, Nishioka H, Nakasako S, et al. Observational retrospective single-centre study in Japan to assess the clinical significance of serum daptomycin levels in creatinine phosphokinase elevation. J Clin Pharm Ther. 2020;45(2):290-297. doi:10.1111/jcpt.13061 [PubMed 31696963]
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  12. Avery LM, Kuti JL, Weisser M, et al. Pharmacodynamics of daptomycin in combination with other antibiotics for the treatment of enterococcal bacteraemia. Int J Antimicrob Agents. 2019;54(3):346-350. doi:10.1016/j.ijantimicag.2019.07.002 [PubMed 31284042]
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