pharmacopeia
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/api/v1/drug/daptomycin

Mechanism of action

Sourced from openFDA

Daptomycin is an antibacterial drug [see Clinical Pharmacology ( 12.4 )] .

Indications

Sourced from openFDA
  • Daptomycin for injection is a lipopeptide antibacterial indicated for the treatment of: • Complicated skin and skin structure infections (cSSSI) in adult and pediatric patients (1 to 17 years of age) ( 1.1 ) and, • Staphylococcus aureus bloodstream infections (bacteremia), in adult patients including those with right-sided infective endocarditis, ( 1.2 ) • Staphylococcus aureus bloodstream infections (bacteremia) in pediatric patients (1 to 17 years of age). ( 1.3 ) Limitations of Use : • Daptomycin for injection is not indicated for the treatment of pneumonia.ICD-10: J18.9

Contraindications

Sourced from openFDA
  • Daptomycin for injection is contraindicated in patients with known hypersensitivity to daptomycin. [see Warnings and Precautions ( 5.1 )].contraindicated

Dosage & administration

Sourced from openFDA

Adult 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 , 2.7 ) · Recommended dosage regimen for adult patients ( 2.2 , 2.4 , 2.6 ): Creatinine Clearance (CL CR ) 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* *Administered following hemodialysis on hemodialysis days. Pediatric Patients • Unlike in adults, do NOT administer by injection over a two (2) minute period to pediatric patients . ( 2.1 , 2.7 ) • Administer to pediatric patients intravenously in 0.9% sodium chloride, by infusion over a 30-or 60-minute period, based on age. ( 2.1 , 2.7 ) • Recommended dosage regimen for pediatric patients (1 to 17 years of age) with cSSSI, based on age ( 2.3 ): Age group Dosage* Duration of therapy 12 to 17 years 5 mg/kg once every 24 hours infused over 30 minutes Up to 14 days 7 to 11 years 7 mg/kg once every 24 hours infused over 30 minutes 2 to 6 years 9 mg/kg once every 24 hours infused over 60 minutes 1 to less than 2 years 10 mg/kg once every 24 hours infused over 60 minutes *Recommended dosage is for pediatric patients (1 to 17 years of age) with normal renal function. Dosage adjustment for pediatric patients with renal impairment has not been established. Recommended dosage regimen for pediatric patients (1 to 17 years of age) with S.

Warnings & precautions

Sourced from openFDA

• Anaphylaxis/hypersensitivity reactions (including life-threatening): Discontinue daptomycin 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 daptomycin. ( 5.2 ) • Eosinophilic pneumonia: Discontinue daptomycin and consider treatment with systemic steroids. ( 5.3 ) • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): Discontinue daptomycin and institute appropriate treatment. ( 5.4 ) • Tubulointerstitial Nephritis (TIN): Discontinue daptomycin 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 daptomycin 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 ) 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 daptomycin for injection occurs, discontinue the drug and institute appropriate therapy [see Adverse Reactions ( 6.2 )].

Adverse reactions

Sourced from openFDA

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 ( 5.11 ) and Drug Interactions ( 7.2 )] • Adult cSSSI Patients : The most common adverse reactions that occurred in ≥2% of adult cSSSI patients receiving daptomycin 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 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 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.

Use in specific populations

Sourced from openFDA

8.1 Pregnancy Risk Summary Limited published data on use of daptomycin in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. In animal reproduction studies performed in rats and rabbits daptomycin was administered intravenously during organogenesis at doses 2 and 4-times, respectively, the recommended 6 mg/kg human dose (on a body surface area basis). No evidence of adverse developmental outcomes was observed. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data In pregnant rats, daptomycin was administered intravenously at doses of 5, 20, or 75 mg/kg/day during the gestation days 6 to 18. Maternal body weight gain was decreased at 75 mg/kg/day. No embryo/fetal effects were noted at the highest dose of 75 mg/kg/day, a dose approximately 2-fold higher than in humans at the recommended maximum dose of 6 mg/kg (based on body surface area). In pregnant rabbits, daptomycin was administered intravenously at doses of 5, 20, or 75 mg/kg/day during the gestation days 6 to 15.

Pharmacokinetics

Sourced from openFDA
Metabolism
Daptomycin Administered over a 30-Minute Period in Adults The mean and standard deviation (SD) pharmacokinetic parameters of daptomycin at steady-state following intravenous (IV) administration of daptomycin over a 30-minute period at 4 to 12 mg/kg every 24h to healthy young adults are summarized in Table 11.

Overdosage

Sourced from openFDA

In the event of overdosage, supportive care is advised with maintenance of glomerular filtration. Daptomycin is cleared slowly from the body by hemodialysis (approximately 15% of the administered dose is removed over 4 hours) and by peritoneal dialysis (approximately 11% of the administered dose is removed over 48 hours). The use of high-flux dialysis membranes during 4 hours of hemodialysis may increase the percentage of dose removed compared with that removed by low-flux membranes.

Approval history

Sourced from openFDA
  • Jun 15, 2016ANDAANDA206005Xellia Pharms Aps
  • Sep 12, 2017NDANDA208385Sagent Pharms Inc
  • Oct 20, 2017NDANDA209949Hikma
  • Apr 11, 2018ANDAANDA206077Fresenius Kabi Usa
  • Jun 21, 2021NDANDA210282Hospira
  • Jan 25, 2022NDANDA213645Baxter Hlthcare Corp
  • Jan 30, 2023NDANDA217415Hikma
  • Nov 21, 2024NDANDA217630Maia Pharms Inc

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
8,818 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective7268.2%
  2. 2Off Label Use6737.6%
  3. 3Acute Kidney Injury5586.3%
  4. 4Pyrexia4675.3%
  5. 5Eosinophilic Pneumonia4495.1%
  6. 6Eosinophilia3534.0%
  7. 7Rhabdomyolysis3473.9%
  8. 8Blood Creatine Phosphokinase Increased3313.8%
  9. 9Drug Reaction With Eosinophilia And Systemic Symptoms3293.7%
  10. 10Neutropenia2833.2%
  11. 11Product Use In Unapproved Indication2803.2%
  12. 12Thrombocytopenia2643.0%
  13. 13Rash2623.0%
  14. 14Interstitial Lung Disease2512.8%
  15. 15Pneumonitis2472.8%

Literature

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Recent PubMed references pinned to Daptomycin as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 122 ClinicalTrials.gov registrations naming Daptomycin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Daptomycin work?
Daptomycin is an antibacterial drug [see Clinical Pharmacology ( 12.4 )] .
What is Daptomycin used for?
According to FDA labeling, Daptomycin carries indications including: Daptomycin for injection is a lipopeptide antibacterial indicated for the treatment of: • Complicated skin and skin structure infections (cSSSI) in adult and pediatric patients (1 to 17 years of age) ( 1.1 ) and, • Staphylococcus aureus bloodstream infections (bacteremia), in adult patients including those with right-sided infective endocarditis, ( 1.2 ) • Staphylococcus aureus bloodstream infections (bacteremia) in pediatric patients (1 to 17 years of age). ( 1.3 ) Limitations of Use : • Daptomycin for injection is not indicated for the treatment of pneumonia.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Daptomycin?
Daptomycin is classified as Other antibacterials, Lipopeptide Antibacterial, Cellular Synthetic Activity Alteration, Decreased Cell Membrane Integrity.
What are the brand names for Daptomycin?
Daptomycin is marketed under brand names including Cubicin, Dapzura.
What are the contraindications for Daptomycin?
Daptomycin labeling lists contraindications including: Daptomycin for injection is contraindicated in patients with known hypersensitivity to daptomycin. [see Warnings and Precautions ( 5.1 )].. Always consult the full prescribing information and a clinician.
Note. Data for daptomycin is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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