Cubicin Dosage/Direction for Use

Important Administration Duration Instructions: Adults: Administer the appropriate volume of the reconstituted CUBICIN (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 in Adults for cSSSI, 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, and Administration of CUBICIN as follows].
Pediatric Patients (1 to 17 Years of Age): Unlike in adults, do NOT administer CUBICIN by injection over a two (2) minute period to pediatric patients.
Pediatric Patients 7 to 17 years of Age: Administer CUBICIN intravenously by infusion over a 30-minute period [see Dosage in Pediatric Patients (1 to 17 Years of Age) for cSSSI, Dosage in Pediatric Patients (1 to 17 Years of Age) with Staphylococcus aureus Bloodstream Infections (Bacteremia), and Administration of CUBICIN as follows].
Pediatric Patients 1 to 6 years of Age: Administer CUBICIN intravenously by infusion over a 60-minute period [see Dosage in Pediatric Patients (1 to 17 Years of Age) for cSSSI, Dosage in Pediatric Patients (1 to 17 Years of Age) with Staphylococcus aureus Bloodstream Infections (Bacteremia), and Administration of CUBICIN as follows].
Dosage in Adults for cSSSI: Administer CUBICIN 4 mg/kg to adult patients intravenously in 0.9% sodium chloride injection once every 24 hours for 7 to 14 days.
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 10. Administer CUBICIN intravenously in 0.9% sodium chloride injection once every 24 hours for up to 14 days. (See Table 10.)

Click on icon to see table/diagram/image

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 CUBICIN 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 CUBICIN for more than 28 days of therapy. In the Phase 3 trial, there were a total of 14 adult patients who were treated with CUBICIN for more than 28 days.
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 11. Administer CUBICIN intravenously in 0.9% sodium chloride injection once every 24 hours for up to 42 days. (See Table 11.)

Click on icon to see table/diagram/image

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 CUBICIN in adult patients with CL_CR 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 12). When possible, CUBICIN should be administered following the completion of hemodialysis on hemodialysis days [see Myopathy and Rhabdomyolysis, Decreased Efficacy in Patients with Moderate Baseline Renal Impairment, and Patients with Renal Impairment under Precautions; Pharmacology: Pharmacokinetics under Actions]. (See Table 12.)

Click on icon to see table/diagram/image

Pediatric Patients: The dosage regimen for CUBICIN in pediatric patients with renal impairment has not been established.
Administration of CUBICIN: 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 as follows: 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 CUBICIN (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 CUBICIN (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 CUBICIN by injection over a two (2) minute period to pediatric patients [see Important Administration Duration Instructions as previously mentioned].
For Intravenous infusion over a period of 60 minutes in pediatric patients 1 to 6 years of age: The appropriate volume of the reconstituted CUBICIN (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 CUBICIN (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.