DAPTOMYCIN INJECTION 350MG 1 VIAL
Generic: Daptomycin
DAPTOMYCIN INJECTION 350MG 1 VIAL
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Identification
Daptomycin
Daptomycin
Dr. Reddy's Laboratories Inc.,
HUMAN PRESCRIPTION DRUG
Administration
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
INTRAVENOUS
ANDA211403
Active Ingredients
| Ingredient | Strength |
|---|---|
| DAPTOMYCIN | 350 mg/7mL |
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 patients ( 1.1 ) and, Staphylococcus aureus bloodstream infections (bacteremia), in adult patients including those with right-sided infective endocarditis ( 1.2 ) Limitations of Use: Daptomycin for Injection is not indicated for the treatment of pneumonia. ( 1.3 ) Daptomycin for Injection is not indicated for the treatment of left-sided infective endocarditis due to S. aureus . ( 1.3 ) 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 infections that are proven or strongly suspected to be caused by bacteria. ( 1.4 ) 1.1 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). Pediatric use information is approved for Merck & Co., Inc.’s Cubicin (daptomycin for injection). However, due to Merck & Co., Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. 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. Pediatric use information is approved for Merck & Co., Inc.’s Cubicin (daptomycin for injection). However, due to Merck & Co., Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. 1.3 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 Studies ( 14.2 )]. Daptomycin for Injection has not been studied in patients with prosthetic valve endocarditis. 1.4 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 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. 1.1 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). Pediatric use information is approved for Merck & Co., Inc.’s Cubicin (daptomycin for injection). However, due to Merck & Co., Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. 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. Pediatric use information is approved for Merck & Co., Inc.’s Cubicin (daptomycin for injection). However, due to Merck & Co., Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. 1.3 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 Studies ( 14.2 )]. Daptomycin for Injection has not been studied in patients with prosthetic valve endocarditis. 1.4 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 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 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 , 2.5 ) Recommended dosage regimen for adult patients ( 2.2 , 2.3 , 2.4 ): 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. There are other formulations of daptomycin that have differences concerning storage and reconstitution. Carefully follow the reconstitution and storage procedures in labeling. ( 2.5 ) Do not use in conjunction with ReadyMED ® elastomeric infusion pumps in adult patients. ( 2.7 ) 2.1 Important Administration Duration Instructions Adults Administer the appropriate volume of the reconstituted daptomycin (concentration of 50 mg per 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 , 2.5 ) ]. Pediatric use information is approved for Merck & Co., Inc.’s Cubicin (daptomycin for injection). However, due to Merck & Co., Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. 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. Pediatric use information is approved for Merck & Co., Inc.’s Cubicin (daptomycin for injection). However, due to Merck & Co., Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. 2.3 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 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 more than 28 days. Pediatric use information is approved for Merck & Co., Inc.’s Cubicin (daptomycin for injection). However, due to Merck & Co., Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. 2.4 Dosage in Patients with Renal Impairment Adult Patients No dosage adjustment is required in adult patients with creatinine clearance (CL CR ) 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 2). When possible, Daptomycin for Injection should be administered following the completion of hemodialysis on hemodialysis days [ see Warnings and Precautions ( 5.2 , 5.8 ), Use in Specific Populations ( 8.6 ), and Clinical Pharmacology ( 12.3 ) ]. ]. Table 2: Recommended Dosage of Daptomycin for Injection in Adult Patients Creatinine Clearance (CL CR ) Dosage Regimen in Adults cSSSI S. aureus Bloodstream 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. 2.5 Preparation and Administration of Daptomycin for Injection There are different formulations of daptomycin that have differences concerning storage and reconstitution. Carefully follow the reconstitution and storage procedures in labeling. Reconstitution of Daptomycin for Injection Vial Daptomycin for Injection is supplied in single-dose vials, each containing 350 mg daptomycin as a sterile, lyophilized powder. The contents of a Daptomycin for Injection vial should be reconstituted, using aseptic technique, to 50 mg per 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 7 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 per 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 per mL). Intravenous Infusion over a period of 30 minutes For intravenous (IV) infusion over a period of 30 minutes in adult patients: The appropriate volume of the reconstituted daptomycin for injection (concentration of 50 mg per mL) should be further diluted, using aseptic technique, into a 50 mL IV infusion bag containing 0.9% sodium chloride injection. 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 between 2° and 8°C (36° and 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. Pediatric use information is approved for Merck & Co., Inc.’s Cubicin (daptomycin for injection). However, due to Merck & Co., Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. 2.6 Compatible Intravenous Solutions Daptomycin for Injection is compatible with 0.9% sodium chloride injection and lactated Ringer’s injection. 2.7 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. 2.1 Important Administration Duration Instructions Adults Administer the appropriate volume of the reconstituted daptomycin (concentration of 50 mg per 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 , 2.5 ) ]. Pediatric use information is approved for Merck & Co., Inc.’s Cubicin (daptomycin for injection). However, due to Merck & Co., Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. 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. Pediatric use information is approved for Merck & Co., Inc.’s Cubicin (daptomycin for injection). However, due to Merck & Co., Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. 2.3 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 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 more than 28 days. Pediatric use information is approved for Merck & Co., Inc.’s Cubicin (daptomycin for injection). However, due to Merck & Co., Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. 2.4 Dosage in Patients with Renal Impairment Adult Patients No dosage adjustment is required in adult patients with creatinine clearance (CL CR ) 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 2). When possible, Daptomycin for Injection should be administered following the completion of hemodialysis on hemodialysis days [ see Warnings and Precautions ( 5.2 , 5.8 ), Use in Specific Populations ( 8.6 ), and Clinical Pharmacology ( 12.3 ) ]. ]. Table 2: Recommended Dosage of Daptomycin for Injection in Adult Patients Creatinine Clearance (CL CR ) Dosage Regimen in Adults cSSSI S. aureus Bloodstream 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. 2.5 Preparation and Administration of Daptomycin for Injection There are different formulations of daptomycin that have differences concerning storage and reconstitution. Carefully follow the reconstitution and storage procedures in labeling. Reconstitution of Daptomycin for Injection Vial Daptomycin for Injection is supplied in single-dose vials, each containing 350 mg daptomycin as a sterile, lyophilized powder. The contents of a Daptomycin for Injection vial should be reconstituted, using aseptic technique, to 50 mg per 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 7 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 per 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 per mL). Intravenous Infusion over a period of 30 minutes For intravenous (IV) infusion over a period of 30 minutes in adult patients: The appropriate volume of the reconstituted daptomycin for injection (concentration of 50 mg per mL) should be further diluted, using aseptic technique, into a 50 mL IV infusion bag containing 0.9% sodium chloride injection. 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 between 2° and 8°C (36° and 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. Pediatric use information is approved for Merck & Co., Inc.’s Cubicin (daptomycin for injection). However, due to Merck & Co., Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. 2.6 Compatible Intravenous Solutions Daptomycin for Injection is compatible with 0.9% sodium chloride injection and lactated Ringer’s injection. 2.7 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 ) ] Peripheral neuropathy [ see Warnings and Precautions ( 5.4 )] Increased International Normalized Ratio (INR)/prolonged prothrombin time [ see Warnings and Precautions ( 5.9 ) 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 ) 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 ) 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. Pediatric use information is approved for Merck & Co., Inc.’s Cubicin (daptomycin for injection). However, due to Merck & Co., Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. 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 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 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) are displayed in Table 5. Table 5: Incidence of Adverse Reactions that Occurred in ≥2% of Adult Patients in the Daptomycin Treatment Group and ≥ the Comparator Treat ment Group in Phase 3 cSSSI Trials Adult Patients (%) Daptomycin 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 1.0 4 >5× ULN 1.4 6 0.4 2 1.1 4 0.0 0 >10× ULN 0.5 2 0.2 1 0.2 1 0.0 0 Note: Elevations in CPK observed in adult patients treated with daptomycin 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-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-treated patients, 4 had prior or concomitant treatment with an HMG-CoA reductase inhibitor. Three of these 11 daptomycin-treated patients discontinued therapy due to CPK elevation, while the one comparator-treated patient did not discontinue therapy [see Warnings and Precautions ( 5.2 )]. 6.2 Post-Marketing Experience The following adverse reactions have been identified during post-approval use of daptomycin. 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, drug rash with eosinophilia and systemic symptoms (DRESS), pruritus, hives, shortness of breath, difficulty swallowing, truncal erythema, and pulmonary eosinophilia [s ee Contraindications (4 ), Warnings and Precautions ( 5.1 ) ] Infections and Infestations: Clostridium difficile–associated diarrhea [ see Warnings and Precautions ( 5.6 ) ] Laboratory Investigations: platelet count decreased Musculoskeletal Disorders: myoglobin increased; rhabdomyolysis (some reports involved patients treated concurrently with daptomycin 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 ( 5.4 ) ] Skin and Subcutaneous Tissue Disorders : serious skin reactions, including Stevens-Johnson syndrome and vesiculobullous rash (with or without mucous membrane involvement), acute generalized exanthematous pustulosis Gastrointestinal Disorders: nausea, vomiting Renal and Urinary Disorders: acute kidney injury, renal insufficiency, and renal failure Special Senses : visual disturbances 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 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 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) are displayed in Table 5. Table 5: Incidence of Adverse Reactions that Occurred in ≥2% of Adult Patients in the Daptomycin Treatment Group and ≥ the Comparator Treat ment Group in Phase 3 cSSSI Trials Adult Patients (%) Daptomycin 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 1.0 4 >5× ULN 1.4 6 0.4 2 1.1 4 0.0 0 >10× ULN 0.5 2 0.2 1 0.2 1 0.0 0 Note: Elevations in CPK observed in adult patients treated with daptomycin 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-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-treated patients, 4 had prior or concomitant treatment with an HMG-CoA reductase inhibitor. Three of these 11 daptomycin-treated patients discontinued therapy due to CPK elevation, while the one comparator-treated patient did not discontinue therapy [see Warnings and Precautions ( 5.2 )]. 6.2 Post-Marketing Experience The following adverse reactions have been identified during post-approval use of daptomycin. 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, drug rash with eosinophilia and systemic symptoms (DRESS), pruritus, hives, shortness of breath, difficulty swallowing, truncal erythema, and pulmonary eosinophilia [s ee Contraindications (4 ), Warnings and Precautions ( 5.1 ) ] Infections and Infestations: Clostridium difficile–associated diarrhea [ see Warnings and Precautions ( 5.6 ) ] Laboratory Investigations: platelet count decreased Musculoskeletal Disorders: myoglobin increased; rhabdomyolysis (some reports involved patients treated concurrently with daptomycin 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 ( 5.4 ) ] Skin and Subcutaneous Tissue Disorders : serious skin reactions, including Stevens-Johnson syndrome and vesiculobullous rash (with or without mucous membrane involvement), acute generalized exanthematous pustulosis Gastrointestinal Disorders: nausea, vomiting Renal and Urinary Disorders: acute kidney injury, renal insufficiency, and renal failure Special Senses : visual disturbances
Information for Patients
17 PATIENT COUNSELING INFORMATION Advise patients that allergic reactions, including serious allergic reactions, could occur and that serious reactions require immediate treatment. Patients should report any previous allergic reactions to daptomycin. [ See Warnings and Precautions ( 5.1 ) .] 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, 5.4 ) .] Advise patients to report any symptoms of cough, breathlessness, or fever. [ See Warnings and Precautions ( 5.3 ). ] Advise patients that diarrhea is a common problem caused by antibacterials that usually ends when the antibacterial is discontinued. Sometimes after starting treatment with antibacterials, 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 ( 5.6 ). ] Counsel patients 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. Brands listed are the trademarks of their respective owners Rx Only Distributor: Dr. Reddy’s Laboratories Inc., Princeton, NJ 08540 Made in India Issued: 0420
Clinical data sourced from openFDA drug labeling. For complete prescribing information, consult the full drug label.