Daptomycin 500 mg Injection, Powder, Lyophilized, For Solution, 10 vials
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Lipopeptide Antibacterial class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Daptomycin injection is used to treat certain blood infections or serious skin infections caused by bacteria in adults and children 1 year of age and older. Daptomycin injection is in a class of medications called cyclic lipopeptide antibiotics. It works by killing bacteria. Antibiotics such as daptomycin injection will not work for treating colds, flu, or other viral infections. Using antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.
Read the full MedlinePlus article ↗- Daptomycin only works when given directly into a vein — there's no oral (pill or liquid) form supported for the infections it treats. It's designed for serious infections like bloo...
- Why am I getting this antibiotic instead of a pill?
- The main signs to watch for are new muscle aching, tenderness, or weakness — especially in your arms or legs. Your care team will also check a blood test called CPK (creatine phosp...
- How will I know if daptomycin is causing a muscle problem?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Daptomycin — tap one for details:
Daptomycin may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
300 mg
UNII F7LTH1E20Y
Arginine hydrochloride is an amino acid salt used as a buffer and pH adjuster in medicines. It helps maintain the correct acidity level to keep the drug stable and effective.
-
UNII QTT17582CB
A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
-
UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
3 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $55.37 | — |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Daptomycin 500 mg/10mL 00409-0122-01 | Hospira, | 1 vial | $20.769 | — | FDA listed | — |
| Daptomycin 500 mg 42023-0295-10 | Par | 10 vials | $20.769 | — | FDA listed | — |
| Daptomycin 500 mg/10mL 63323-0371-10 | Fresenius | 1 vial | $20.769 | AP | FDA listed | — |
| Daptomycin 500 mg/10mL 70594-0060-01 | Xellia | 1 vial | $20.769 | — | FDA listed | — |
| Daptomycin 50 mg/mL 16714-0892-01 | NorthStar | 1 vial | $21.846 | AP | Discontinued | — |
| Daptomycin 500 mg/10mL 16729-0435-05 | Accord | 1 vial | $21.846 | AP | Availability likely | — |
| Daptomycin 500 mg/10mL 00143-9444-01 | Hikma | 1 vial | $22.687 | AP | Availability likely | — |
| Daptomycin 500 mg/10mL 00143-9465-01 | Hikma | 1 vial | $22.687 | AP | Availability likely | — |
| daptomycin 50 mg/mL 25021-0174-15 | Sagent | 1 vial | $22.687 | AP | Availability likely | — |
| Daptomycin 500 mg/10mL 31722-0216-01 | Camber | 1 vial | $22.687 | AP | Availability likely | — |
| Daptomycin 500 mg/10mL 43598-0413-11 | Dr.Reddy's | 1 vial | $22.687 | AP | Availability likely | — |
| Daptomycin 500 mg/10mL 55150-0344-01 | Eugia | 1 vial | $22.687 | AP | Availability likely | — |
| Daptomycin 500 mg/10mL 60505-6229-04 | APOTEX | 1 vial | $22.687 | AP | Availability likely | — |
| daptomycin 500 mg/10mL 67457-0813-50 | Mylan | 1 vial | $22.687 | AP | Availability likely | — |
| daptomycin 500 mg/10mL 67457-0941-15 | Mylan | 1 vial | $22.687 | AP | Availability likely | — |
| Daptomycin 500 mg/10mL 68001-0376-68 | BluePoint | 1 vial | $22.687 | AP | Availability likely | — |
| Daptomycin 500 mg/10mL 70377-0093-91 | Biocon | 1 vial | $22.687 | AP | Availability likely | — |
| Daptomycin 500 mg/10mL 70594-0034-01 | Xellia | 1 vial | $22.687 | AP | Availability likely | — |
| Daptomycin 500 mg/10mL 71288-0016-15 | Meitheal | 1 vial | $22.687 | AP | Availability likely | — |
| daptomycin 500 mg/10mL 71839-0107-01 | BE | 1 vial | $22.687 | AP | Availability likely | — |
| Daptomycin 500 mg/10mL 72572-0102-01 | Civica, | 1 vial | $22.687 | AP | Availability likely | — |
| Daptomycin 500 mg/10mL 72603-0152-01 | NorthStar | 1 vial | $22.687 | AP | Availability likely | — |
| Daptomycin 500 mg/10mL 00143-9378-01 | Hikma | 1 vial | — | — | Discontinued | — |
| Daptomycin 500 mg/10mL 00143-9445-01 | Hikma | 1 vial | — | — | FDA listed | — |
| daptomycin 500 mg/20mL 14335-0120-01 | Hainan | 20 ml | — | AP | FDA listed | — |
| Daptomycin 500 mg/10mL 67184-0549-01 | Qilu | 1 vial | — | AP | FDA listed | — |
| daptomycin 500 mg/20mL 70436-0033-80 | Slate | 20 ml | — | AP | FDA listed | — |
| Daptomycin 500 mgthis 70511-0182-84 | MAIA | 10 vials | — | — | FDA listed | — |
| Daptomycin 500 mg/10mL 72572-0158-01 | Civica, | 1 vial | — | — | FDA listed | — |
| daptomycin 500 mg/20mL 83090-0011-01 | Sintetica | 1 vial | — | AP | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.
Where does this data come from?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 70511-0182-84 You're viewing this | 10 VIAL, SINGLE-DOSE in 1 CARTON (70511-182-84) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (70511-182-15) | 2025-09-08 | Active |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
Why is there no price listed?
Is the NDC printed on the package the same as the 11-digit billing NDC?
What do the three segments of this NDC mean?
Is this package still being marketed?
Who lists this product with the FDA?
Do I need a prescription for this product?
Where does this data come from?
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE 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.
(1.4) • Daptomycin for Injection is not indicated for the treatment of left-sided infective endocarditis due to S. aureus. (1.4) • 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. (1.4) 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.
(1.5)
1.1Complicated Skin and Skin Structure Infections (cSSSI) Daptomycin for Injection is 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 subsp. equisimilis, and Enterococcus faecalis (vancomycin-susceptible isolates only).
1.2Staphylococcus aureus Bloodstream Infections (Bacteremia) in Adult Patients, Including Those with Right-Sided Infective Endocarditis, Caused by Methicillin-Susceptible and Methicillin-Resistant Isolates Daptomycin for Injection is indicated for the treatment of adult patients with Staphylococcus aureus bloodstream infections (bacteremia), including adult patients with right-sided infective endocarditis, caused by methicillin-susceptible and methicillin-resistant isolates.
1.3Staphylococcus aureus Bloodstream Infections (Bacteremia) in Pediatric Patients (1 to 17 Years of Age) Daptomycin for Injection is indicated for the treatment of pediatric patients (1 to 17 years of age) with Staphylococcus aureus bloodstream infections (bacteremia)
1.4Limitations of Use Daptomycin for Injection is not indicated for the treatment of pneumonia. Daptomycin for Injection is not indicated for the treatment of left-sided infective endocarditis due to S. aureus . The clinical trial of Daptomycin for Injection in adult patients with S. aureus bloodstream infections included limited data from patients with left-sided infective endocarditis; outcomes in these patients were poor [see Clinical Studies (14.2)].
Daptomycin for Injection has not been studied in patients with prosthetic valve endocarditis. Daptomycin for Injection is 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 [see Warnings and Precautions (5.7) and Nonclinical Toxicology (13.2)].
1.5Usage Appropriate specimens for microbiological examination should be obtained in order to isolate and identify the causative pathogens and to determine their susceptibility to daptomycin. 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 only to treat or prevent 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 an…
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Adult Patients • Administer to adult patients intravenously, 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 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. aureus bacteremia, based on age (2.5): Age Group Dosage* Duration of therapy 12 to 17 years 7 mg/kg once every 24 hours infused over 30 minutes Up to 42 days 7 to 11 years 9 mg/kg once every 24 hours infused over 30 minutes 1 to 6 years 12 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. • There are other formulations of daptomycin that have differences concerning storage and reconstitution. Carefully follow the reconstitution and storage procedures in labeling. (2.7) • Do not use in conjunction with ReadyMED® elastomeric infusion pumps in adult and pediatric patients.
(2.9)
2.1Important Administration Duration Instructions Adults Administer the appropriate volume of the reconstituted Daptomycin for Injection (concentration of 50 mg/mL) to adult patients intravenously either by injection over a two (2) minute period or by intravenous infusion over a thirty (30) minute period [see Dosage and Administration (2.2, 2.4, 2.7)]. Pediatric Patients (1 to 17 Years of Age) Unlike in adults, do NOT administer Daptomycin for Injection by injection over a two (2) minute period to pediatric patients.
Pediatric Patients 7 to 17 years of Age: Administer Daptomycin for Injection intravenously by infusion over a 30-minute period [see Dosage and Administration (2.3, 2.5, 2.7)]. Pediatric Patients 1 to 6 years of Age: Administer Daptomycin for Injection intravenously by infusion over a 60-minute period [see Dosage and Administration (2.3, 2.5, 2.7)].
2.2Dosage in Adults for cSSSI Administer Daptomycin for Injection 4 mg/kg to adult patients intravenously once every 24 hours for 7 to 14 days.
2.3Dosage in Pediatric Patients (1 to 17 Years of Age) for cSSSI The recommended dosage regimens based on age for pediatric patients with cSSSI are shown in Table 1. Administer Daptomycin for Injection intravenously once every 24 hours for up to 14 days. Table 1: Recommended Dosage of Daptomycin for Injection in Pediatric Patients (1 to 17 Years of Age) with cSSSI, Based on Age Age Range Dosage Regimen* 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 onc…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS For Injection: 350 mg or 500 mg daptomycin as a sterile, pale yellow to light brown lyophilized powder for reconstitution in a single-dose vial. • For Injection: 350 mg of daptomycin as a lyophilized powder in a single-dose vial for reconstitution (3) • For Injection: 500 mg of daptomycin as a lyophilized powder in a single-dose vial for reconstitution (3)
⛔ Contraindications ▾
4 CONTRAINDICATIONS Daptomycin for Injection is contraindicated in patients with known hypersensitivity to daptomycin [see Warnings and Precautions (5.1)]. Known hypersensitivity to daptomycin (4)
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • Anaphylaxis/hypersensitivity reactions (including life-threatening): Discontinue Daptomycin for Injection 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 for Injection. (5.2) • Eosinophilic pneumonia: Discontinue Daptomycin for Injection 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 for Injection 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 for Injection 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)
5.1Anaphylaxis/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)].
5.2Myopathy 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. Rhabdomyolysis, with or without acute renal failure, has been reported [see Adverse Reactions (6.2)]. Patients receiving Daptomycin for Injection should be monitored for the development of muscle pain or weakness, particularly of the distal extremities.
In patients who receive Daptomycin for Injection, CPK levels should be monitored weekly, and more frequently in patients who received recent prior or concomitant therapy with an HMG-CoA reductase inhibitor or in whom elevations in CPK occur during treatment with Daptomycin for Injection. In adult patients with renal impairment, both renal function and CPK should be monitored more frequently than once weekly [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)]. In Phase 1 studies and Phase 2 clinical trials in adults, CPK elevations appeared to be more frequent when Daptomycin for Injection was dosed more than once daily.
Therefore, Daptomycin for Injection should not be dosed more frequently than once a day. Daptomycin for Injection should be discontinued in patients with unexplained signs and symptoms of myopathy in conjunction with CPK elevations to levels >1,000 U/L (~5× ULN), and in patients without reported symptoms who have marked elevations in CPK, with levels >2,000 U/L (≥10× ULN). In addition, consideration should be given to suspending agents associated with rhabdomyolysis, such as HMG-CoA reductase inhibitors, temporarily in patients receiving daptomycin [see Drug Interactions (7.1)].
5.3Eosinophilic Pneumonia Eosinophilic pneumonia has been reported in patients receiving daptomycin for injection [see Adverse Reactions (6.2)]. In reported cases associated with daptomycin for injection, patients developed fever, dyspnea with hypoxic respiratory insufficiency, and diffuse pulmonary infiltrates or organizing pneumonia. In general, patients developed eosinophilic pneumonia 2 to 4 weeks after starting daptomycin for injection and improved when daptomycin for injection was discontinued and steroid therapy was initiated.
Recurrence of eosinophilic pneumonia upon re-exposure has bee…
🤒 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 (5.11) 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 MAIA Pharmaceuticals, Inc. at 1-888-877-9064 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical 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 to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Clinical Trial Experience in Adult Patients Clinical trials enrolled 1,864 adult patients treated with daptomycin for injection and 1,416 treated with comparator. Complicated Skin and Skin Structure Infection Trials in Adults In Phase 3 complicated skin and skin structure infection (cSSSI) trials in adult patients, daptomycin for injection was discontinued in 15/534 (2.8%) patients due to an adverse reaction, while comparator was discontinued in 17/558 (3.0%) patients.
The rates of the most common adverse reactions, organized by body system, observed in adult patients with cSSSI (receiving 4 mg/kg daptomycin for injection) are displayed in Table 7. 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 Trials Adverse Reaction Adult Patients (%) Daptomycin for Injection 4 mg/kg (N=534) Comparator* (N=558) Gastrointestinal disorders Diarrhea 5.2
4.3Nervous system disorders Headache 5.4
5.4Dizziness 2.2
2.0Skin/subcutaneous disorders Rash 4.3
3.8Diagnostic investigations Abnormal liver function tests 3.0
1.6Elevated CPK 2.8
1.8Infections Urinary tract infections 2.4
0.5Vascular disorders Hypotension 2.4
1.4Respiratory disorders Dyspnea 2.1 1.6 * Comparator: vancomycin (1 g IV q12h) or an anti-staphylococcal semi-synthetic penicillin (i.e., nafcillin, oxacillin, cloxacillin, or flucloxacillin; 4 to 12 g/day IV in divided doses). Drug-related adverse reactions (possibly or probably drug-related) that occurred in <1% of adult patients receiving daptomycin for injection in the cSSSI trials are as follows: Body as a Whole: fatigue, weakness, rigors, flushing, hypersensitivity Blood/Lymphatic System: leukocytosi…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS
7.1HMG-CoA Reductase Inhibitors In healthy adult subjects, concomitant administration of daptomycin for injection and simvastatin had no effect on plasma trough concentrations of simvastatin, and there were no reports of skeletal myopathy [see Clinical Pharmacology (12.3)]. However, inhibitors of HMG-CoA reductase may cause myopathy, which is manifested as muscle pain or weakness associated with elevated levels of creatine phosphokinase (CPK). In the adult Phase 3 S. aureus bacteremia/endocarditis trial, some patients who received prior or concomitant treatment with an HMG-CoA reductase inhibitor developed elevated CPK [see Adverse Reactions (6.1)] .
Experience with the coadministration of HMG-CoA reductase inhibitors and daptomycin in patients is limited; therefore, consideration should be given to suspending use of HMG-CoA reductase inhibitors temporarily in patients receiving Daptomycin for Injection.
7.2Drug-Laboratory Test Interactions Clinically relevant plasma concentrations of daptomycin have been observed to cause a significant concentration-dependent false prolongation of prothrombin time (PT) and elevation of International Normalized Ratio (INR) when certain recombinant thromboplastin reagents are utilized for the assay. The possibility of an erroneously elevated PT/INR result due to interaction with a recombinant thromboplastin reagent may be minimized by drawing specimens for PT or INR testing near the time of trough plasma concentrations of daptomycin.
However, sufficient daptomycin concentrations may be present at trough to cause interaction. If confronted with an abnormally high PT/INR result in a patient being treated with Daptomycin for Injection, it is recommended that clinicians: 1. Repeat the assessment of PT/INR, requesting that the specimen be drawn just prior to the next daptomycin dose (i.e., at trough concentration).
If the PT/INR value obtained at trough remains substantially elevated above what would otherwise be expected, consider evaluating PT/INR utilizing an alternative method. 2. Evaluate for other causes of abnormally elevated PT/INR results.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary Limited published data on use of daptomycin for injection 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 6mg/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. Maternal body weight gain and food consumption were decreased at 75 mg/kg/day. No embryo/fetal effects were noted at the highest dose of 75 mg/kg/day, a dose approximately 4-fold higher than in humans at the maximum recommended dose of 6mg/kg (based on body surface area).
In a combined fertility and pre/postnatal development study, daptomycin was administered intravenously to female rats at doses of 2, 25, 75 mg/kg/day from 14-days pre-mating through lactation/postpartum day 20). No effects on pre/postnatal development were observed up to the highest dose of 75 mg/kg/day, a dose approximately 2-fold higher than the maximum recommended human dose of 6 mg/kg (based on body surface area) 1 .
8.2Lactation Risk Summary Limited published data report that daptomycin is present in human milk at infant doses of 0.1% of the maternal dose (see Data) 2,3,4 . There is no information on the effects of daptomycin on the breastfed infant or the effects of daptomycin on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Daptomycin for Injection and any potential adverse effects on the breastfed infant from Daptomycin for Injection or from the underlying maternal condition.
8.4Pediatric Use The safety and effectiveness of daptomycin for injection in the treatment of cSSSI and S. aureus bloodstream infections (bacteremia) have been established in the age groups 1 to 17 years of age. Use of daptomycin for injection in these age groups is supported by evidence from adequate and well-controlled studies in adults, with additional data from pharmacokinetic studies in pediatric patients, and from safety, efficacy and PK studies in pediatric patients with cSSSI and S. aureus bloodstream infections [see Adverse Reactions (6.1), Clinical Pharmacology (12.3), and Clinical Studies (14.1, 14.2)].
Safety and effectiveness in pediatric patients below the age of one year have not been established. Avoid use of Daptomycin for Injection 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 [see Warnings and Precautions (5.7) and Nonclinical Toxicology (13.2)]. Daptomycin for Injection is not indicated in pediatric patients with renal impairment because dosage has not been established in these patients.
Daptomycin for Injection has not been studied in pediatric patients with other bacterial infections.
8.5 Geriatric Use Of the 534 adult patients treate…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Limited published data on use of daptomycin for injection 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 6mg/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. Maternal body weight gain and food consumption were decreased at 75 mg/kg/day. No embryo/fetal effects were noted at the highest dose of 75 mg/kg/day, a dose approximately 4-fold higher than in humans at the maximum recommended dose of 6mg/kg (based on body surface area).
In a combined fertility and pre/postnatal development study, daptomycin was administered intravenously to female rats at doses of 2, 25, 75 mg/kg/day from 14-days pre-mating through lactation/postpartum day 20). No effects on pre/postnatal development were observed up to the highest dose of 75 mg/kg/day, a dose approximately 2-fold higher than the maximum recommended human dose of 6 mg/kg (based on body surface area) 1 .
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of daptomycin for injection in the treatment of cSSSI and S. aureus bloodstream infections (bacteremia) have been established in the age groups 1 to 17 years of age. Use of daptomycin for injection in these age groups is supported by evidence from adequate and well-controlled studies in adults, with additional data from pharmacokinetic studies in pediatric patients, and from safety, efficacy and PK studies in pediatric patients with cSSSI and S. aureus bloodstream infections [see Adverse Reactions (6.1), Clinical Pharmacology (12.3), and Clinical Studies (14.1, 14.2)].
Safety and effectiveness in pediatric patients below the age of one year have not been established. Avoid use of Daptomycin for Injection 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 [see Warnings and Precautions (5.7) and Nonclinical Toxicology (13.2)]. Daptomycin for Injection is not indicated in pediatric patients with renal impairment because dosage has not been established in these patients.
Daptomycin for Injection has not been studied in pediatric patients with other bacterial infections.
🧓 Geriatric Use ▾
8.5Geriatric Use Of the 534 adult patients treated with daptomycin for injection in Phase 3 controlled clinical trials of complicated skin and skin structure infections (cSSSI), 27% were 65 years of age or older and 12% were 75 years of age or older. Of the 120 adult patients treated with daptomycin in the Phase 3 controlled clinical trial of S. aureus bacteremia/endocarditis, 25% were 65 years of age or older and 16% were 75 years of age or older. In Phase 3 adult clinical trials of cSSSI and S. aureus bacteremia/endocarditis, clinical success rates were lower in patients ≥65 years of age than in patients <65 years of age.
In addition, treatment-emergent adverse events were more common in patients ≥65 years of age than in patients <65 years of age. The exposure of daptomycin was higher in healthy elderly subjects than in healthy young adult subjects. However, no adjustment of Daptomycin for Injection dosage is warranted for elderly patients with creatinine clearance (CL CR ) ≥30 mL/min [see Dosage and Administration (2.6) and Clinical Pharmacology (12.3)].
🆘 Overdosage ▾
10 OVERDOSAGE 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.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Daptomycin is an antibacterial drug [see Clinical Pharmacology (12.4)].
12.2Pharmacodynamics Based on animal models of infection, the antimicrobial activity of daptomycin for injection appears to correlate with the AUC/MIC (area under the concentration-time curve/minimum inhibitory concentration) ratio for certain pathogens, including S. aureus . The principal pharmacokinetic/pharmacodynamic parameter best associated with clinical and microbiological cure has not been elucidated in clinical trials with daptomycin for injection.
12.3Pharmacokinetics 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 for injection over a 30-minute period at 4 to 12 mg/kg every 24h to healthy young adults are summarized in Table 12. Table 12: Mean (SD) Daptomycin Pharmacokinetic Parameters in Healthy Adult Volunteers at Steady-State Dose*† (mg/kg) Pharmacokinetic Parameters ‡ AUC 0-24 (mcg∙h/mL) t 1/2 (h) V SS (L/kg) CL T (mL/h/kg) C max (mcg/mL) 4 (N=6) 494 (75) 8.1 (1.0) 0.096 (0.009) 8.3 (1.3) 57.8 (3.0) 6 (N=6) 632 (78) 7.9 (1.0) 0.101 (0.007) 9.1 (1.5) 93.9 (6.0) 8 (N=6) 858 (213) 8.3 (2.2) 0.101 (0.013) 9.0 (3.0) 123.3 (16.0) 10 (N=9) 1039 (178) 7.9 (0.6) 0.098 (0.017) 8.8 (2.2) 141.1 (24.0) 12 (N=9) 1277 (253) 7.7 (1.1) 0.097 (0.018) 9.0 (2.8) 183.7 (25.0) * Daptomycin for injection was administered by IV infusion over a 30-minute period. † Doses of daptomycin for injection in excess of 6 mg/kg have not been approved. ‡ AUC 0-24 , area under the concentration-time curve from 0 to 24 hours; t 1/2 , elimination half-life; V SS , volume of distribution at steady-state; CL T , total plasma clearance; C max , maximum plasma concentration.
Daptomycin pharmacokinetics were generally linear and time-independent at daptomycin doses of 4 to 12 mg/kg every 24h administered by IV infusion over a 30-minute period for up to 14 days. Steady-state trough concentrations were achieved by the third daily dose. The mean (SD) steady-state trough concentrations attained following the administration of 4, 6, 8, 10, and 12 mg/kg every 24h were 5.9 (1.6), 6.7 (1.6), 10.3 (5.5), 12.9 (2.9), and 13.7 (5.2) mcg/mL, respectively.
Daptomycin for Injection Administered over a 2-Minute Period in Adults Following IV administration of daptomycin for injection over a 2-minute period to healthy adult volunteers at doses of 4 mg/kg (N=8) and 6 mg/kg (N=12), the mean (SD) steady-state systemic exposure (AUC) values were 475 (71) and 701 (82) mcg∙h/mL, respectively. Values for maximum plasma concentration (C max ) at the end of the 2-minute period could not be determined adequately in this study. However, using pharmacokinetic parameters from 14 healthy adult volunteers who received a single dose of daptomycin 6 mg/kg IV administered over a 30-minute period in a separate study, steady-state C max values were simulated for daptomycin 4 and 6 mg/kg IV administered over a 2-minute period.
The simulated mean (SD) steady-state C max values were 77.7 (8.1) and 116.6 (12.2) mcg/mL, respectively. Distribution Daptomycin is reversibly bound to human plasma proteins, primarily to serum albumin, in a concentration-independent manner. The overall mean binding ranges from 90 to 93%.
In clinical studies, mean serum protein binding in adult subjects with creatinine clearance (CL CR ) ≥30 mL/min was comparable to that observed in healthy adult subjects with normal renal function. However, there was a trend toward decreasing serum protein binding among subjects with CL CR <30 mL/min (88%), including those receiving hemodialysis (86%) and continuous ambulatory peritoneal dialysis (CAPD) (84%). The protein binding of daptomycin in adult subjects with moderate hepatic impairment (Child-Pugh Class B) was similar to that in healthy adult subjects.
The volume of distribution at steady-state (V S…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Daptomycin is an antibacterial drug [see Clinical Pharmacology (12.4)].
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Daptomycin for Injection is supplied as a sterile pale yellow to light brown lyophilized powder in single-dose vials containing 350 mg or 500 mg of daptomycin: 350 mg/vial - Package of 1 vial (NDC 70511-181-10) 350 mg/vial - Package of 10 vials (NDC 70511-181-84) 500 mg/vial - Package of 1 vial (NDC 70511-182-15) 500 mg/vial - Package of 10 vials (NDC 70511-182-84) Store original packages at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
Storage conditions for the reconstituted and diluted solutions are described in another section of the prescribing information [see Dosage and Administration (2.7)].
📋 Description ▾
11 DESCRIPTION Daptomycin for Injection contains daptomycin, a cyclic lipopeptide antibacterial agent derived from the fermentation of Streptomyces roseosporus . The chemical name is N-decanoyl-L-tryptophyl-D-asparaginyl-L-aspartyl-L-threonylglycyl-L-ornithyl-L- aspartyl-D-alanyl-L-aspartylglycyl-D-seryl-threo-3-methyl-L-glutamyl-3-anthraniloyl-L- alanine ε 1 -lactone. The empirical formula is C 72 H 101 N 17 O 26 ; the molecular weight is 1620.67.
The chemical structure is: Daptomycin for Injection is supplied in a single-dose vial as a sterile, preservative-free, pale yellow to light brown lyophilized powder containing 350 mg or 500 mg of daptomycin for intravenous (IV) use following reconstitution with Sterile Water for Injection [see Dosage and Administration (2.7)] . Freshly reconstituted solutions of Daptomycin for Injection range in color from pale yellow to light brown. Daptomycin for Injection 350 mg per vial, contains 350 mg daptomycin and 210 mg arginine hydrochloride.
Hydrochloric acid and/or sodium hydroxide is used to adjust the pH. Daptomycin for Injection 500 mg per vial contains 500 mg daptomycin, and 300 mg arginine hydrochloride. Hydrochloric acid and/or sodium hydroxide is used to adjust the pH. daptomycin-spl-structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Allergic Reactions Advise patients that allergic reactions, including serious skin, kidney, lung, or other organ reactions, could occur and that these serious reactions require immediate treatment. Patients should report any previous allergic reactions to daptomycin [see Warnings and Precautions (5.1, 5.4, 5.5)]. Muscle Pain or Weakness (Myopathy and Rhabdomyolysis, Peripheral Neuropathy) Advise patients to report muscle pain or weakness, especially in the forearms and lower legs, as well as tingling or numbness [see Warnings and Precautions (5.2, 5.6)].
Cough, Breathlessness, or Fever (Eosinophilic Pneumonia) Advise patients to report any symptoms of cough, breathlessness, or fever [see Warnings and Precautions (5.3)]. C. difficile -Associated Diarrhea (CDAD) Advise patients that diarrhea is a common problem caused by antibacterials including Daptomycin for Injection, that usually ends when the antibacterial is discontinued. Sometimes after starting treatment with antibacterials, including Daptomycin for Injection, patients can develop watery and bloody stools (with or without stomach cramps and fever), even as late as 2 or more months after having received the last dose of the antibacterial.
If this occurs, patients should contact their physician as soon as possible [see Warnings and Precautions (5.8)]. Antibacterial Resistance Patients should be counseled that antibacterial drugs, including Daptomycin for Injection, should be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold).
When Daptomycin for Injection is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be administered exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Daptomycin for Injection or other antibacterial drugs in the future.
Manufactured for: MAIA Pharmaceuticals, Inc. 707 State Road, Suite 104 Princeton, NJ 08540 Manufactured in India