CUBICIN
Clinical safety rating: caution
Comprehensive clinical and safety monograph for CUBICIN (CUBICIN).
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.
| 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. |
| Molecular Weight | 1620.69 |
| Action Class | Cell membrane active agent |
| Brand Substitutes | EMARSA 350 MG INJECTION, Daptobio 350mg Injection, Ivdapt 350mg Injection, Daptocure 350mg Injection, Daptojub 350mg Injection |
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. |
| 1st trimester | No adequate human studies; animal studies show fetal harm at high doses. Use only if potential benefit justifies risk. |
| 2nd trimester | No adequate human studies; animal studies show fetal harm at high doses. Use only if potential benefit justifies risk. |
| 3rd trimester | No adequate human studies; animal studies show fetal harm at high doses. Use only if potential benefit justifies risk. |
Clinical note
Comprehensive clinical and safety monograph for CUBICIN (CUBICIN).
| Placental transfer | Minimal transfer in animal studies; human data lacking but expected low due to high protein binding. |
| Breastfeeding | Not known if daptomycin is excreted in human milk; caution advised. Monitor infant for diarrhea or rash. |
| Lactation Rating |
■ 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.
| Serious Effects |
Hypersensitivity to daptomycin
| 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 |
| Food/Dietary | No clinically significant food interactions. Grapefruit juice does not affect daptomycin. Can be taken with or without food. |
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| L3 (Moderately Safe) |
| 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. |
| Fetal Monitoring | Monitor maternal renal function (serum creatinine, BUN), liver function tests (ALT, AST, alkaline phosphatase, bilirubin), creatine phosphokinase (CPK) levels, and complete blood count. Assess for signs of myopathy or neuropathy. Fetal monitoring via ultrasound if prolonged use. |
| Fertility Effects | No significant adverse effects on fertility reported in animal studies. Human data insufficient; theoretically may affect spermatogenesis due to potential testicular effects observed in some animal studies. |
| Clinical Pearls |
| CUBICIN (daptomycin) is a lipopeptide antibiotic with concentration-dependent bactericidal activity against gram-positive organisms, including MRSA and VRE. It is inactivated by pulmonary surfactant, so it must not be used for pneumonia. Monitor CPK levels weekly due to risk of myopathy; discontinue if CPK >5x ULN or with symptoms. Dose adjustment required for CrCl <30 mL/min. Avoid use with HMG-CoA reductase inhibitors (statins) if possible due to increased myopathy risk. |
| Patient Advice | Report any new muscle pain, weakness, or tenderness immediately. · Complete the full course of therapy even if you feel better. · This medication is given intravenously, typically once daily. · Inform your doctor about all other medications, especially statins or other cholesterol-lowering drugs. |