Cubicin Rf (daptomycin)

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Daptomycin is administered by IV injection (adults only) or IV infusion (adults and pediatric patients 1-17 years of age).

Daptomycin is commercially available for IV use as 2 different formulations: a lyophilized powder for solution that does not contain sucrose and a lyophilized powder for solution that contains 713 mg of sucrose per vial. Instructions for storage, reconstitution, and dilution differ for the 2 daptomycin formulations and recommendations for the specific formulation used should be followed.

Additives and other drugs should not be added to daptomycin solutions or infused simultaneously 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 infusion solution before and after infusion of daptomycin. Daptomycin is not compatible with dextrose-containing diluents (e.g., 5% dextrose injection).

Daptomycin should not be used in conjunction with ReadyMed(R) elastomeric infusion pumps since stability studies identified an impurity (i.e., 2-mercaptobenzothiazole) leaching from this pump system into the daptomycin solution.

Strict aseptic technique must be observed in preparing daptomycin solutions since the drug contains no preservative. Daptomycin solutions should be inspected visually for particulate matter prior to administration.

Daptomycin for injection (formulation not containing sucrose): The lyophilized powder should be stored at 2-8degreesC. The reconstituted daptomycin solution (in the original vial) and reconstituted and further diluted solutions (in an IV infusion bag) are stable for 12 hours at room temperature or up to 48 hours when refrigerated at 2-8degreesC; the combined storage time (reconstituted vial and diluted infusion bag) at room temperature or under refrigeration should not exceed 12 or 48 hours, respectively.

Daptomycin for injection (formulation containing sucrose): The lyophilized powder should be stored at 20-25degreesC, but may be exposed to 15-30degreesC. The stability of reconstituted daptomycin solution and reconstituted and further diluted solutions varies based on the specific diluent and container used. (See Table 1.)

Table 1: Stability of Daptomycin (formulation containing sucrose) After Reconstitution

Container Diluent Stability at Stability at 20-25degreesC 2-8degreesC Vial Sterile water for 1 day 3 days injection Bacteriostatic 2 days 3 days water for injection Syringe Sterile water for 1 day 3 days injection Bacteriostatic 2 days 5 days water for injection Infusion bag Reconstituted 19 hours 3 days with sterile water for injection and immediate dilution in 0.9% sodium chloride injection Reconstituted 2 days 5 days with bacteriostatic water for injection and immediate dilution in 0.9% sodium chloride injection

Polypropylene syringe with elastomeric plunger stopper.

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There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*Known hypersensitivity to daptomycin.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

Adverse effects occurring in >=2% of adult patients receiving daptomycin for the treatment of complicated skin and skin structure infections in clinical trials include diarrhea, nervous system effects (headache, dizziness), rash, abnormal liver function test results, elevated serum creatine kinase (CK, creatine phosphokinase, CPK) concentrations, urinary tract infections, hypotension, and dyspnea.

Adverse effects occurring in >=2% of pediatric patients receiving daptomycin for the treatment of complicated skin and skin structure infections in a clinical trial include diarrhea, vomiting, abdominal pain, pruritus, pyrexia, elevated CK concentrations, and headache.

Adverse effects occurring in >=5% of adult patients receiving daptomycin for the treatment of bacteremia/endocarditis in a clinical trial include abdominal pain, insomnia, pharyngolaryngeal pain, infections (sepsis, bacteremia), chest pain, edema, pruritus, increased sweating, elevated CK concentrations, and hypertension.

Adverse effects occurring in >=5% of pediatric patients receiving daptomycin for the treatment of bacteremia in a clinical trial include vomiting and elevated CK concentrations.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

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Safety and efficacy of daptomycin have not been established in pediatric patients <1 year of age.

Use of daptomycin should be avoided in children younger than 12 months of age because of the potential risk of adverse muscular, neuromuscular, peripheral nervous system, and CNS effects; such adverse effects have been observed in neonatal dogs receiving IV daptomycin.

The safety and efficacy of daptomycin for the treatment of complicated skin and skin structure infections and S. aureus bacteremia have been established in the pediatric patients 1-17 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 pharmacokinetic studies in pediatric patients with complicated skin and skin structure infections and S. aureus bacteremia.

Daptomycin has not been studied in pediatric patients with other bacterial infections. Daptomycin is not indicated in pediatric patients with renal impairment because dosage of the drug has not been established in these patients.

Data on the use of daptomycin in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. No evidence of adverse developmental outcomes was observed in animal reproduction studies performed in rats and rabbits administered IV daptomycin during organogenesis at doses 2 and 4 times, respectively, the recommended 6-mg/kg human dose (on a body surface area basis).

According to limited published data, daptomycin is distributed into human milk at infant doses of 0.1% of the maternal dose. The effects of daptomycin on the breast-fed infant or on milk production are unknown. Consider the developmental and health benefits of breast-feeding along with the mother's clinical need for daptomycin and any potential adverse effects on the breast-fed infant from the drug or the underlying maternal condition.

Dosage adjustments based solely on age are not necessary when daptomycin is used in geriatric patients, but dosage adjustments are indicated in those with renal impairment.

Among the total number of adult patients studied in phase 3 clinical trials of daptomycin for the treatment of complicated skin and skin structure infections, 27% were >=65 years of age and 12% were >=75 years of age. In a phase 3 clinical trial of daptomycin for the treatment of bacteremia and endocarditis in adults, 25% of patients were >=65 years of age and 16% were >=75 years of age. There was some evidence from these studies that clinical success rates were lower and treatment-emergent adverse effects were more common in geriatric patients >=65 years of age compared with younger adults.

Although daptomycin exposures are higher in healthy geriatric adults than in healthy young adults, adjustment of daptomycin dosage is not necessary in geriatric patients based solely on age. However, age-related decreases in renal function should be considered when selecting dosage in geriatric patients.