CUBICIN

Clinical safety rating: caution

Comprehensive clinical and safety monograph for CUBICIN (CUBICIN).

How it works

Cubicin is a lipopeptide antibiotic that binds to bacterial cell membranes, causing rapid depolarization and inhibition of protein, DNA, and RNA synthesis, leading to bacterial cell death.

What the body does with it

Metabolism	Daptomycin is minimally metabolized; it is primarily excreted unchanged in the urine. Metabolism is thought to occur via renal and possibly hepatic pathways, but specific enzymes have not been identified.
Excretion	Renal excretion of unchanged drug accounts for approximately 80% of the administered dose; minor fecal excretion (<5%) via biliary elimination.
Half-life	Terminal elimination half-life is about 8-9 hours (mean 8.1 hours) in patients with normal renal function; prolonged to 27-35 hours in severe renal impairment (CrCl <30 mL/min).
Protein binding	Reversible binding to human plasma proteins, primarily albumin, at approximately 90-93% (concentration-dependent; decreases at higher drug levels).
Volume of Distribution	Steady-state volume of distribution (Vdss) is approximately 0.2-0.3 L/kg (mean 0.24 L/kg), indicating distribution primarily in extracellular fluid and low tissue penetration.
Bioavailability	Not applicable; only available as intravenous formulation; oral bioavailability is negligible (0% due to lack of oral formulation).
Onset of Action	Intravenous administration: onset occurs within minutes; bactericidal effect measurable within 1-2 hours post-infusion.
Duration of Action	Duration of action approximately 12-24 hours based on post-antibiotic effect (PAE) against gram-positive bacteria; clinical dosing interval is every 24 hours.

Classification & Brands

Action Class	Cell membrane active agent
Brand Substitutes	EMARSA 350 MG INJECTION, Daptobio 350mg Injection, Ivdapt 350mg Injection, Daptocure 350mg Injection, Daptojub 350mg Injection

Dosing & administration

4-6 mg/kg IV once daily for complicated skin infections; 6 mg/kg IV once daily for Staphylococcus aureus bloodstream infections (including right-sided endocarditis); infuse over 2 minutes or 30 minutes.

Dosage form	POWDER
Renal impairment	CrCl >=30 mL/min: no adjustment; CrCl <30 mL/min, including hemodialysis: 6 mg/kg IV every 48 hours.
Liver impairment	No dose adjustment recommended for mild-to-moderate hepatic impairment (Child-Pugh A or B); insufficient data for Child-Pugh C; use with caution.
Pediatric use	Approved for children 1-17 years: 6 mg/kg IV every 24 hours (up to 12 mg/kg in some guidelines for complicated infections); safety in neonates not established.
Geriatric use	No specific dose adjustment based solely on age; monitor renal function and adjust based on CrCl; increased risk of adverse events due to age-related renal decline.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for CUBICIN (CUBICIN).

Breastfeeding	Excretion into human milk unknown; M/P ratio not determined. Caution advised due to potential adverse effects in nursing infant (e.g., gastrointestinal disturbances). Decision to discontinue breastfeeding or drug should consider importance of drug to mother.
Teratogenic Risk	CUBICIN (daptomycin) is classified as Pregnancy Category B. Animal studies have not demonstrated fetal risk, but no adequate and well-controlled studies in pregnant women. Use only if clearly needed. First trimester: No known teratogenic effects; however, caution advised. Second and third trimesters: Use only if potential benefit justifies potential risk to the fetus.

Warnings & precautions

■ FDA Black Box Warning

Cubicin is not indicated for the treatment of pneumonia. In clinical trials, higher mortality was observed in patients with community-acquired pneumonia (CAP) treated with Cubicin compared to comparator.

Side Effect Profile

Serious Effects

Absolute Contraindications

Hypersensitivity to daptomycin or any component of the formulation

Clinical Precautions

Precautions

["Skeletal muscle effects: Monitor creatine phosphokinase (CPK) levels weekly; discontinue if myopathy occurs","Eosinophilic pneumonia: Discontinue if symptoms develop","Peripheral neuropathy","Clostridioides difficile-associated diarrhea","Hypersensitivity reactions"]

Clinical Tips & Counseling

Drug interactions

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CUBICIN

Clinical safety rating: caution

Comprehensive clinical and safety monograph for CUBICIN (CUBICIN).

How it works

Cubicin is a lipopeptide antibiotic that binds to bacterial cell membranes, causing rapid depolarization and inhibition of protein, DNA, and RNA synthesis, leading to bacterial cell death.

What the body does with it

Metabolism	Daptomycin is minimally metabolized; it is primarily excreted unchanged in the urine. Metabolism is thought to occur via renal and possibly hepatic pathways, but specific enzymes have not been identified.
Excretion	Renal excretion of unchanged drug accounts for approximately 80% of the administered dose; minor fecal excretion (<5%) via biliary elimination.
Half-life	Terminal elimination half-life is about 8-9 hours (mean 8.1 hours) in patients with normal renal function; prolonged to 27-35 hours in severe renal impairment (CrCl <30 mL/min).
Protein binding	Reversible binding to human plasma proteins, primarily albumin, at approximately 90-93% (concentration-dependent; decreases at higher drug levels).
Volume of Distribution	Steady-state volume of distribution (Vdss) is approximately 0.2-0.3 L/kg (mean 0.24 L/kg), indicating distribution primarily in extracellular fluid and low tissue penetration.
Bioavailability	Not applicable; only available as intravenous formulation; oral bioavailability is negligible (0% due to lack of oral formulation).
Onset of Action	Intravenous administration: onset occurs within minutes; bactericidal effect measurable within 1-2 hours post-infusion.
Duration of Action	Duration of action approximately 12-24 hours based on post-antibiotic effect (PAE) against gram-positive bacteria; clinical dosing interval is every 24 hours.

Classification & Brands

Action Class	Cell membrane active agent
Brand Substitutes	EMARSA 350 MG INJECTION, Daptobio 350mg Injection, Ivdapt 350mg Injection, Daptocure 350mg Injection, Daptojub 350mg Injection

Dosing & administration

Dosage form	POWDER
Renal impairment	CrCl >=30 mL/min: no adjustment; CrCl <30 mL/min, including hemodialysis: 6 mg/kg IV every 48 hours.
Liver impairment	No dose adjustment recommended for mild-to-moderate hepatic impairment (Child-Pugh A or B); insufficient data for Child-Pugh C; use with caution.
Pediatric use	Approved for children 1-17 years: 6 mg/kg IV every 24 hours (up to 12 mg/kg in some guidelines for complicated infections); safety in neonates not established.
Geriatric use	No specific dose adjustment based solely on age; monitor renal function and adjust based on CrCl; increased risk of adverse events due to age-related renal decline.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for CUBICIN (CUBICIN).

Breastfeeding	Excretion into human milk unknown; M/P ratio not determined. Caution advised due to potential adverse effects in nursing infant (e.g., gastrointestinal disturbances). Decision to discontinue breastfeeding or drug should consider importance of drug to mother.
Teratogenic Risk	CUBICIN (daptomycin) is classified as Pregnancy Category B. Animal studies have not demonstrated fetal risk, but no adequate and well-controlled studies in pregnant women. Use only if clearly needed. First trimester: No known teratogenic effects; however, caution advised. Second and third trimesters: Use only if potential benefit justifies potential risk to the fetus.

Warnings & precautions

■ FDA Black Box Warning

Side Effect Profile

Serious Effects

Absolute Contraindications

Hypersensitivity to daptomycin or any component of the formulation

Clinical Precautions

Precautions

Clinical Tips & Counseling

Drug interactions

Loading safety data…