CUBICIN RF

Clinical safety rating: caution

Comprehensive clinical and safety monograph for CUBICIN RF (CUBICIN RF).

How it works

Daptomycin is a cyclic lipopeptide antibiotic that binds to bacterial cell membranes, causing rapid depolarization and disruption of membrane potential, leading to cell death.

What the body does with it

Metabolism	Largely excreted unchanged via kidneys; minimal hepatic metabolism (oxidative metabolites)
Excretion	Renal excretion: approximately 80% of the dose as unchanged drug; biliary/fecal elimination: minor (<5%).
Half-life	Terminal elimination half-life: approximately 8-9 hours in patients with normal renal function; prolonged in renal impairment.
Protein binding	90-93% bound to human plasma proteins, primarily albumin.
Volume of Distribution	Volume of distribution (Vd): 0.1-0.2 L/kg, indicating limited tissue distribution; predominantly in extracellular fluid.
Bioavailability	Intravenous: 100% (only route of administration); no oral formulation available.
Onset of Action	Intravenous: rapid, within minutes; complete bactericidal activity achieved within 1-2 hours post-infusion.
Duration of Action	Duration of bactericidal activity: approximately 24 hours, supporting once-daily dosing; post-antibiotic effect (PAE) of 3-6 hours.

Classification & Brands

Dosing & administration

Adults: 6 mg/kg IV over 30-60 minutes every 24 hours. For deep-seated infections (e.g., endocarditis, osteomyelitis), consider 10 mg/kg IV every 24 hours.

Dosage form	POWDER
Renal impairment	CrCl ≥30 mL/min: no adjustment; CrCl <30 mL/min: 6 mg/kg IV every 48 hours. For deep-seated infections in CrCl <30 mL/min, consider 10 mg/kg every 48 hours. Administer after hemodialysis on dialysis days.
Liver impairment	No dose adjustment required for mild to moderate hepatic impairment (Child-Pugh A or B). Not studied in severe hepatic impairment (Child-Pugh C); use with caution.
Pediatric use	Children 1-17 years: 6 mg/kg IV over 30-60 minutes every 24 hours (off-label for most indications; safety and efficacy not established for all uses). Infants and neonates: not recommended due to lack of data and potential for higher mortality in neonates.
Geriatric use	No specific dose adjustment based on age alone. Monitor renal function closely; use creatinine clearance to determine dosing interval as per renal adjustment guidelines.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for CUBICIN RF (CUBICIN RF).

Breastfeeding	It is not known whether daptomycin is excreted in human milk. The M/P ratio has not been determined. Caution is advised when administered to a nursing woman because many drugs are excreted in human milk.
Teratogenic Risk	Cubicin RF (daptomycin) is classified as pregnancy category B. Animal studies have not demonstrated fetal risk, but there are no adequate and well-controlled studies in pregnant women. Daptomycin should be used during pregnancy only if clearly needed. First trimester: No known teratogenic effects; second and third trimesters: No known fetal harm, but limited human data.

Warnings & precautions

■ FDA Black Box Warning

Eosinophilic pneumonia and anaphylaxis/hypersensitivity reactions have been reported. Daptomycin is not indicated for the treatment of pneumonia.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Known hypersensitivity to daptomycin or any component of the formulation","Use in patients with pre-existing myopathy or high CPK levels without careful monitoring"]

Clinical Precautions

Precautions

["Eosinophilic pneumonia (monitor for cough, fever, dyspnea, pulmonary infiltrates)","Peripheral neuropathy","Skeletal muscle effects: monitor CPK levels weekly due to risk of myopathy and rhabdomyolysis","Hypersensitivity reactions including anaphylaxis","Reduced efficacy in patients with moderate to severe renal impairment"]

Clinical Tips & Counseling

Drug interactions

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CUBICIN RF

Clinical safety rating: caution

Comprehensive clinical and safety monograph for CUBICIN RF (CUBICIN RF).

How it works

Daptomycin is a cyclic lipopeptide antibiotic that binds to bacterial cell membranes, causing rapid depolarization and disruption of membrane potential, leading to cell death.

What the body does with it

Metabolism	Largely excreted unchanged via kidneys; minimal hepatic metabolism (oxidative metabolites)
Excretion	Renal excretion: approximately 80% of the dose as unchanged drug; biliary/fecal elimination: minor (<5%).
Half-life	Terminal elimination half-life: approximately 8-9 hours in patients with normal renal function; prolonged in renal impairment.
Protein binding	90-93% bound to human plasma proteins, primarily albumin.
Volume of Distribution	Volume of distribution (Vd): 0.1-0.2 L/kg, indicating limited tissue distribution; predominantly in extracellular fluid.
Bioavailability	Intravenous: 100% (only route of administration); no oral formulation available.
Onset of Action	Intravenous: rapid, within minutes; complete bactericidal activity achieved within 1-2 hours post-infusion.
Duration of Action	Duration of bactericidal activity: approximately 24 hours, supporting once-daily dosing; post-antibiotic effect (PAE) of 3-6 hours.

Classification & Brands

Dosing & administration

Adults: 6 mg/kg IV over 30-60 minutes every 24 hours. For deep-seated infections (e.g., endocarditis, osteomyelitis), consider 10 mg/kg IV every 24 hours.

Dosage form	POWDER
Renal impairment	CrCl ≥30 mL/min: no adjustment; CrCl <30 mL/min: 6 mg/kg IV every 48 hours. For deep-seated infections in CrCl <30 mL/min, consider 10 mg/kg every 48 hours. Administer after hemodialysis on dialysis days.
Liver impairment	No dose adjustment required for mild to moderate hepatic impairment (Child-Pugh A or B). Not studied in severe hepatic impairment (Child-Pugh C); use with caution.
Pediatric use	Children 1-17 years: 6 mg/kg IV over 30-60 minutes every 24 hours (off-label for most indications; safety and efficacy not established for all uses). Infants and neonates: not recommended due to lack of data and potential for higher mortality in neonates.
Geriatric use	No specific dose adjustment based on age alone. Monitor renal function closely; use creatinine clearance to determine dosing interval as per renal adjustment guidelines.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for CUBICIN RF (CUBICIN RF).

Breastfeeding	It is not known whether daptomycin is excreted in human milk. The M/P ratio has not been determined. Caution is advised when administered to a nursing woman because many drugs are excreted in human milk.
Teratogenic Risk	Cubicin RF (daptomycin) is classified as pregnancy category B. Animal studies have not demonstrated fetal risk, but there are no adequate and well-controlled studies in pregnant women. Daptomycin should be used during pregnancy only if clearly needed. First trimester: No known teratogenic effects; second and third trimesters: No known fetal harm, but limited human data.

Warnings & precautions

■ FDA Black Box Warning

Eosinophilic pneumonia and anaphylaxis/hypersensitivity reactions have been reported. Daptomycin is not indicated for the treatment of pneumonia.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Known hypersensitivity to daptomycin or any component of the formulation","Use in patients with pre-existing myopathy or high CPK levels without careful monitoring"]