DAPTOMYCIN 500MG SINGLE VIAL
Generic: Daptomycin
DAPTOMYCIN 500MG SINGLE VIAL
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Identification
Daptomycin
Daptomycin
Dr.Reddy's Laboratories Inc.,
HUMAN PRESCRIPTION DRUG
Administration
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
INTRAVENOUS
ANDA208375
Active Ingredients
| Ingredient | Strength |
|---|---|
| DAPTOMYCIN | 500 mg/10mL |
Pharmacological Class
Data sourced from openFDA / DailyMed. For full prescribing information, consult the drug label.
Wholesale compliance resources
Drug Resources
Clinical Drug Information
Indications & 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 ) 1.1 Complicated 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) Daptomycin for injection is indicated for the treatment of adult patients 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). 1.2 Staphylococcus 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. 1.3 Staphylococcus 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). 1.4 Limitations 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 Trials ( 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 )]. 1.5 Usage 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 antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Empiric therapy may be initiated while awaiting test results.
Dosage & 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 (CLCR) 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 two 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 ). 2.1 Important 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 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)]. 2.2 Dosage in Adults for cSSSI Administer daptomycin for injection 4 mg/kg to adult patients intravenously in 0.9% sodium chloride injection once every 24 hours for 7 to 14 days. 2.3 Dosage 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 intravenously in 0.9% sodium chloride injection 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 once every 24 hours infused over 60 minutes *Recommended dosage regimen 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. 2.4 Dosage in Adult Patients with Staphylococcus aureus Bloodstream Infections (Bacteremia), Including Those with Right-Sided Infective Endocarditis, Caused by Methicillin-Susceptible and Methicillin-Resistant Isolates Administer daptomycin for injection 6 mg/kg to adult patients intravenously in 0.9% sodium chloride injection once every 24 hours for 2 to 6 weeks.There are limited safety data for the use of daptomycin for injection for more than 28 days of therapy. In the Phase 3 trial, there were a total of 14 adult patients who were treated with daptomycin for injection for more than 28 days. 2.5 Dosage in Pediatric Patients (1 to 17 Years of Age) with Staphylococcus aureus Bloodstream Infections (Bacteremia) The recommended dosage regimens based on age for pediatric patients with S. aureus bloodstream infections (bacteremia) are shown in Table 2. Administer daptomycin for injection intravenously in 0.9% sodium chloride injection once every 24 hours for up to 42 days. Table 2: Recommended Dosage of Daptomycin for Injection in Pediatric Patients (1 to 17 Years of Age) with S. aureus Bacteremia, Based on Age 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. 2.6 Dosage in Patients with Renal Impairment Adult Patients : No dosage adjustment is required in adult patients with creatinine clearance (CLCR) greater than or equal to 30 mL/min. The recommended dosage regimen for daptomycin for injection in adult patients with CLCR less than 30 mL/min, including adult patients on hemodialysis or continuous ambulatory peritoneal dialysis (CAPD), is 4 mg/kg (cSSSI) or 6 mg/kg ( S. aureus bloodstream infections) once every 48 hours (Table 3). When possible, daptomycin for injection should be administered following the completion of hemodialysis on hemodialysis days [see Warnings and Precautions ( 5.2 , 5.10 ), Use in Specific Populations ( 8.6 ), and Clinical Pharmacology ( 12.3 )]. Table 3: Recommended Dosage of Daptomycin for Injection in Adult Patients Creatinin e Clearance(CL CR ) Dosage Regimen in Adults cSSSI S. aureus Bloods tream Infections Greater than or equal to 30 mL/min 4 mg/kg once every 24 hours 6 mg/kg once every 24 hours Less than 30 mL/min, including hemodialysis and CAPD 4 mg/kg once every 48 hours* 6 mg/kg once every 48 hours* * When possible, administer daptomycin for injection following the completion of hemodialysis on hemodialysis days. Pediatric Patients : The dosage regimen for daptomycin for injection in pediatric patients with renal impairment has not been established. 2.7 Preparation and Administration of Daptomycin for Injection There are other formulations of daptomycin that have differences concerning reconstitution and storage. Carefully follow the reconstitution and storage procedures described in this labeling. Reconstitution of Daptomycin for Injection Vial Daptomycin for injection is supplied in single-dose vials, each containing 500 mg daptomycin as a sterile, lyophilized cake or powder. The contents of a daptomycin for injection vial should be reconstituted with 0.9 % sodium chloride injection, using aseptic technique, to 50 mg/mL as follows: 1. To minimize foaming, AVOID vigorous agitation or shaking of the vial during or after reconstitution. 2. Remove the polypropylene flip-off cap from the daptomycin for injection vial to expose the central portion of the rubber stopper. 3. Wipe the top of the rubber stopper with an alcohol swab or other antiseptic solution and allow to dry. After cleaning, do not touch the rubber stopper or allow it to touch any other surface. 4. Slowly transfer 10 mL of 0.9% sodium chloride injection through the center of the rubber stopper into the daptomycin for injection vial, pointing the transfer needle toward the wall of the vial. It is recommended that a beveled sterile transfer needle that is 21 gauge or smaller in diameter, or a needleless device is used, pointing the transfer needle toward the wall of the vial. 5. Ensure that all of the daptomycin for injection powder is wetted by gently rotating the vial. 1. Allow the wetted product to stand undisturbed for 10 minutes. 2. Gently rotate or swirl the vial contents for a few minutes, as needed, to obtain a completely reconstituted solution. Administration Instructions Parenteral drug products should be inspected visually for particulate matter prior to administration. Slowly remove reconstituted liquid (50 mg daptomycin/mL) from the vial using a beveled sterile needle that is 21 gauge or smaller in diameter. Administer as an intravenous injection or infusion as described below: Adults Intravenous Injection over a period of 2 minutes For intravenous (IV) injection over a period of 2 minutes in adult patients only : Administer the appropriate volume of the reconstituted daptomycin for injection (concentration of 50 mg/mL). Intravenous Infusion over a period of 30 minutes For IV infusion over a period of 30 minutes in adult patients: The appropriate volume of the reconstituted daptomycin for injection (concentration of 50 mg/mL) should be further diluted, using aseptic technique, into a 50 mL IV infusion bag containing 0.9% sodium chloride injection. Pediatric Patients (1 to 17 Years of Age) Intravenous Infusion over a period of 30 or 60 minutes Unlike in Adults, do NOT administer daptomycin by injection over a two (2) minute period to pediatric patients [see Dosage and Administration (2.1)]. For Intravenous infusion over a period of 60 minutes in pediatric patients 1 to 6 years of age: The appropriate volume of the reconstituted daptomycin for injection (concentration of 50 mg/mL) should be further diluted, using aseptic technique, into an intravenous infusion bag containing 25 mL of 0.9% sodium chloride injection. The infusion rate should be maintained at 0.42 mL/minute over the 60-minute period. For Intravenous infusion over a period of 30 minutes in pediatric patients 7 to 17 years of age: The appropriate volume of the reconstituted daptomycin for injection (concentration of 50 mg/mL) should be further diluted, using aseptic technique, into a 50 mL IV infusion bag containing 0.9% sodium chloride injection. The infusion rate should be maintained at 1.67 mL/minute over the 30-minute period. No preservative or bacteriostatic agent is present in this product. Aseptic technique must be used in the preparation of final IV solution. Do not exceed the In-Use storage conditions of the reconstituted and diluted solutions of daptomycin for injection described below. Discard unused portions of daptomycin for injection. In-Use Storage Conditions for Daptomycin for Injection Once Reconstituted in Acceptable Intravenous Diluents Stability studies have shown that the reconstituted solution is stable in the vial for 12 hours at room temperature and up to 48 hours if stored under refrigeration at 2°C to 8°C (36°F to 46°F). The diluted solution is stable in the infusion bag for 12 hours at room temperature and 48 hours if stored under refrigeration. The combined storage time (reconstituted solution in vial and diluted solution in infusion bag) should not exceed 12 hours at room temperature or 48 hours under refrigeration. 2.8 Compatible Intravenous Solution for Reconstitution and Dilution Daptomycin for injection is compatible with 0.9% sodium chloride injection for reconstitution. Reconstituted Daptomycin injection can only be diluted with 0.9% sodium chloride injection. 2.9 Incompatibilities Daptomycin for injection is not compatible with dextrose-containing diluents. Daptomycin for injection should not be used in conjunction with ReadyMED ® elastomeric infusion pumps. Stability studies of daptomycin for injection solutions stored in ReadyMED ® elastomeric infusion pumps identified an impurity (2-mercaptobenzothiazole) leaching from this pump system into the daptomycin for injection solution. Because only limited data are available on the compatibility of daptomycin for injection with other IV substances, additives and other medications should not be added to daptomycin for injection single-dose vials or infusion bags, or infused simultaneously with daptomycin for injection through the same IV line. If the same IV line is used for sequential infusion of different drugs, the line should be flushed with a compatible intravenous solution before and after infusion with daptomycin for injection.
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 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. aureus bacteremia Patients: The most common adverse reactions that occurred in ≥5% of pediatric patients receiving daptomycin were vomiting and elevated CPK. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Dr.Reddy's Laboratories Inc., at 1-888-375-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. Clinical Trial Experience in Adult Patients Clinical trials enrolled 1,864 adult patients treated with daptomycin for injection and 1,416 treated with 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%) 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 6. Table 6. 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 4.3 Nervous system disorders Headache 5.4 5.4 Dizziness 2.2 2.0 Skin/subcutaneous disorders Rash 4.3 3.8 Diagnostic investigations Abnormal liver function tests 3.0 1.6 Elevated CPK 2.8 1.8 Infections Urinary tract infections 2.4 0.5 Vascular disorders Hypotension 2.4 1.4 Respiratory disorders Dyspnea 2.1 1.6 * 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× ULN † 9.3 40 8.9 41 8.8 33 8.9 35 >2× ULN 4.9 21 4.8 22 3.7 14 3.1 12 >4× ULN 1.4 6 1.5 7 1.1 4 1 4 >5× ULN 1.4 6 0.4 2 1.1 4 0 0 >10× ULN 0.5 2 0.2 1 0.2 1 0 0 Note: Elevations in CPK observed in adult patients treated with daptomycin for injection or comparator were not clinically or statistically significantly different. * 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). † ULN (Upper Limit of Normal) is defined as 200 U/L. S. aureus Bacteremia/Endocarditis Trial in Adults In the S. aureus bacteremia/endocarditis trial in adult patients, at a dose of 6 mg/kg, 11/120 (9.2%) daptomycin for injection- treated patients, including two patients with baseline CPK levels >500 U/L, had CPK elevations to levels >500 U/L, compared with 1/116 (0.9%) comparator-treated patients. Of the 11 daptomycin for injection-treated patients, 4 had prior or concomitant treatment with an HMG-CoA reductase inhibitor. Three of these 11 daptomycin for injection-treated patients discontinued therapy due to CPK elevation, while the one comparator-treated patient did not discontinue therapy [see Warnings and Precautions ( 5.2 )]. Clinical Trial Experience in Pediatric Patients Complicated Skin and Skin Structure Infection Trial in Pediatric Patients The safety of daptomycin was evaluated in one clinical trial (in cSSSI), which included 256 pediatric patients (1 to 17 years of age) treated with intravenous daptomycin and 133 patients treated with comparator agents. Patients were given age-dependent doses once daily for a treatment period of up to 14 days (median treatment period was 3 days). The doses given by age group were as follows: 10mg/kg for 1 to < 2 years, 9 mg/kg for 2 to 6 years, 7mg/kg for 7 to 11 years and 5 mg/kg for 12 to 17 years of age [see Clinical Studies (14)]. Patients treated with daptomycin were (51%) male, (49%) female and (46%) Caucasian and (32%) Asian. Adverse Reactions Leading to Discontinuation In the cSSSI study, daptomycin was discontinued in 7/256 (2.7%) patients due to an adverse reaction, while comparator was discontinued in 7/133 (5.3%) patients. Most Common Adverse Reactions The rates of the most common adverse reactions, organized by body system, observed in these pediatric patients with cSSSI are displayed in Table 9. Table 9: Adverse Reactions that Occurred in ≥2% of Pediatric Patients in the Daptomycin Treatment-Arm and Greater Than or Equal to the Comparator Treatment-Arm in the cSSSI Pediatric Trial Adverse Reaction Daptomycin (N = 256) Comparator* (N = 133) n (%) n (%) Gastrointestinal disorders Diarrhea 18 (7.0) 7 (5.3) Vomiting 7 (2.7) 1 (0.8) Abdominal Pain 5 (2.0) 0 Skin and subcutaneous tissue disorders Pruritus 8 (3.1) 2 (1.5) General disorders and administration site conditions Pyrexia 10 (3.9) 4 (3.0) Investigations Blood CPK increased 14 (5.5) 7 (5.3) Nervous system disorders Headache 7 (2.7) 3 (2.3) *Comparators included intravenous therapy with either vancomycin, clindamycin, or an anti-staphylococcal semi-synthetic penicillin (nafcillin, oxacillin or cloxacillin) The safety profile in the clinical trial of cSSSI pediatric patients was similar to that observed in the cSSSI adult patients. S. aureus Bacteremia Trial in Pediatric Patients The safety of daptomycin was evaluated in one clinical trial (in S. aureus bacteremia), which treated 55 pediatric patients with intravenous daptomycin and 26 patients with comparator agents. Patients were given age-dependent doses once daily for a treatment period of up to 42 days (mean duration of IV treatment was 12 days). The doses by age group were as follows: 12 mg/kg for 1 to <6 years, 9 mg/kg for 7 to 11 years and 7 mg/kg for 12 to 17 years of age [see Clinical Studies (14)]. Patients treated with daptomycin were (69%) male and (31%) female. No patients 1 to <2 years of age were enrolled. Adverse Reactions Leading to Discontinuation In the bacteremia study, daptomycin was discontinued in 3/55 (5.5%) patients due to an adverse reaction, while comparator was discontinued in 2/26 (7.7%) patients. Most Common Adverse Reactions The rates of the most common adverse reactions, organized by body system, observed in these pediatric patients with bacteremia are displayed in Table 10. Table 10: Incidence of Adverse Reactions that Occurred in ≥5% of Pediatric Patients in the Daptomycin Treatment-Arm and Greater Than or Equal to the Comparator Treatment-Arm in the Pediatric Bacteremia Trial Adverse Reaction Daptomycin (N = 55) Comparator (N = 26) n (%) n (%) Gastrointestinal disorders Vomiting 6 (10.9) 2 (7.7) Investigations Blood CPK increased 4 (7.3) 0 *Comparators included intravenous therapy with either vancomycin, cefazolin, or an anti-staphylococcal semi-synthetic penicillin (nafcillin, oxacillin or cloxacillin) 6.2 Post-Marketing Experience The following adverse reactions have been identified during post-approval use of daptomycin for injection. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Blood and lymphatic system disorders: anemia, thrombocytopenia General and administration site conditions: pyrexia Immune System Disorders: anaphylaxis; hypersensitivity reactions, including angioedema, pruritus, hives, shortness of breath, difficulty swallowing, truncal, erythema, and pulmonary eosinophilia [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 )] Infections and Infestations: Clostridioides difficile– associated diarrhea [see Warnings and Precautions ( 5.8 )] Laboratory Investigations: platelet count decreased Musculoskeletal Disorders: myoglobin increased; rhabdomyolysis (some reports involved patients treated concurrently with daptomycin for injection and HMG-CoA reductase inhibitors) [see Warnings and Precautions ( 5.2 ), Drug Interactions ( 7.1 ), and Clinical Pharmacology ( 12.3 )] Respiratory, Thoracic, and Mediastinal Disorders: cough, eosinophilic pneumonia, organizing pneumonia. [see Warnings and Precautions ( 5.3 )] Nervous System Disorders : peripheral neuropathy [see Warnings and Precautions ( 5.6 )] Skin and Subcutaneous Tissue Disorders: serious skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), vesiculobullous rash (with or without mucous membrane involvement, including Stevens-Johnson syndrome [SJS] and toxic epidermal necrolysis [TEN]), and acute generalized exanthematous pustulosis [see Warnings and Precautions ( 5.4 )] Gastrointestinal Disorders: nausea, vomiting Metabolic and Nutritional Disorders : hyperkalemia Renal and urinary disorders: acute kidney injury, renal insufficiency, renal failure , and tubulointerstitial nephritis (TIN) [see Warnings and Precautions ( 5.5 )] Special Senses: visual disturbances
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 that usually ends when the antibacterials including daptomycin for injection, 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. Rx Only Distributor: Dr. Reddy’s Laboratories Inc., Princeton, NJ 08540 Made in India Issued: 05/2025
Clinical data sourced from openFDA drug labeling. For complete prescribing information, consult the full drug label.