daptomycin (Rx)

Brand and Other Names:Cubicin
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injection, lyophilized powder for reconstitution

  • 500mg/vial (Cubicin and Cubicin RF)
  • 350mg/vial
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Staphylococcus Aureus Bacteremia

Indicated for treatment of adults with Staphylococcus aureus bacteremia, including those with right-sided infective endocarditis, caused by methicillin-susceptible and methicillin-resistant isolates

6 mg/kg IV infusion q24hr for at least 2-6 weeks 

Also see Administration for IV dilution and infusion rate instructions

Complicated Skin & Skin Structure Infections

Indicated for treatment of adults with Staphylococcus aureus bacteremia, including those with right-sided infective endocarditis, caused by methicillin-susceptible and methicillin-resistant isolates

4 mg/kg IV q24hr for 7-14 days 

Also see Administration for IV dilution and infusion rate instructions

Susceptible isolates

  • Staphylococcus aureus (including MRSA)
  • Streptococcus pyogenes
  • Streptococcus agalactiae
  • Streptococcus dysgalactiae ssp equisimilis
  • Enterococcus faecalis (vancomycin-susceptible only)

Dosage Modifications

Renal impairment

  • Complicated skin & skin structure infections (cSSSI)
    • CrCl ≥30 mL/min: 4 mg/kg IV q24hr
    • CrCl <30 mL/min: 4 mg/kg IV q48hr
    • Hemodialysis and CAPD: 4 mg/kg IV q48hr administer following hemodialysis on hemodialysis days
  • Staphylococcus aureus bacteremia
    • CrCl ≥30 mL/min: 6 mg/kg IV q24hr
    • CrCl <30 mL/min: 6 mg/kg IV q48hr
    • Hemodialysis and CAPD: 6 mg/kg IV q48hr administer following hemodialysis on hemodialysis days

Dosing Considerations

Monitor creatine phosphokinase (CPK)

Limitations of use

  • Not indicated for the treatment of pneumonia
  • Not indicated for the treatment of left-sided infective endocarditis due to S aureus; the clinical trial in adults with S aureus bacteremia included limited data from patients with left-sided infective endocarditis; outcomes in these patients were poor
  • Has not been studied in patients with prosthetic valve endocarditis
  • Daptomycin for Injection is not recommended in pediatric patients <1 year due to the risk of potential effects on muscular, neuromuscular, and/or nervous systems (either peripheral and/or central) observed in neonatal dog

Dosage Forms & Strengths

injection, lyophilized powder for reconstitution

  • 500mg/vial
more...

Staphylococcus Aureus Bacteremia

Indicated for treatment of children aged 1-17 years with Staphylococcus aureus bacteremia

<1 year: Safety and efficacy not established (see Dosing Considerations)

≥1 year

  • 12-17 years: 7 mg/kg IV q24hr
  • 7-11 years: 9 mg/kg IV q24hr
  • 1-6 years: 12 mg/kg IV q24hr
  • Duration of therapy: Up to 42 days
  • Also see Administration for IV dilution and infusion rate instructions

Complicated Skin & Skin Structure Infections

Indicated for the treatment of adult and pediatric patients (aged 1 to 17 yr) with complicated skin and skin structure infections (cSSSI) caused by susceptible isolates of Gram-positive bacteria

<1 year: Safety and efficacy not established (see Dosing Considerations)

≥1 year

  • 12-17 years: 5 mg/kg IV q24hr
  • 7-11 years: 7 mg/kg IV q24hr
  • 2-6 years: 9 mg/kg IV q24hr
  • 1 to <2 years: 10 mg/kg IV q24hr
  • Duration of therapy: Up to 14 days
  • Also see Administration for IV dilution and infusion rate instructions

Susceptible isolates

  • Staphylococcus aureus (including MRSA)
  • Streptococcus pyogenes
  • Streptococcus agalactiae
  • Streptococcus dysgalactiae ssp equisimilis
  • Enterococcus faecalis (vancomycin-susceptible only)

Dosage Modifications

Renal impairment: Dosage regimen in children with renal impairment has not been established

Dosing Considerations

Limitations of use

  • Not indicated for pneumonia
  • <1 year: Not recommended in children aged <1 yr owing to the risk of potential effects on muscular, neuromuscular, and/or nervous systems (either peripheral and/or central) observed in neonatal dogs
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Interactions

Interaction Checker

and daptomycin

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    Interactions Found

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      Serious - Use Alternative

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            Adverse Effects

            1-10%

            Insomnia (9.0%)

            Pharyngolaryngeal pain (8.0%)

            Chest pain (7.0%)

            Elevated blood creatine phosphokinase (7.0%)

            Edema (7.0%)

            Abdominal pain (6.0%)

            Hypertension (6.0%)

            Pruritus (6.0%)

            Headache (5.4%)

            Diarrhea (5.2%)

            Sweating (5.0%)

            Bacteremia (5.0%)

            Sepsis (5.0%)

            Rash (4.3%)

            Abnormal LFTs (3.0%)

            UTI (2.4%)

            Hypotension (2.4%)

            Dizziness (2.2%)

            Dyspnea (2.1%)

            Postmarketing Reports

            Immune system disorders: Anaphylaxis; hypersensitivity reactions, including angioedema, drug rash with eosinophilia and systemic symptoms (DRESS), pruritus, hives, shortness of breath, difficulty swallowing, truncal erythema, and pulmonary eosinophilia; consider treatment with systemic steroids

            Infections and infestations: Clostridium difficile–associated diarrhea

            Musculoskeletal disorders: myoglobin increased; rhabdomyolysis;

            Respiratory, thoracic, and mediastinal disorders: Cough, eosinophilic pneumonia, organizing pneumonia

            Nervous system disorders: Peripheral neuropathy

            Skin and subcutaneous tissue disorders: Serious skin reactions, including Stevens-Johnson syndrome and vesiculobullous rash

            Gastrointestinal disorders: Nausea, vomiting

            Special senses: Visual disturbances

            Blood and lymphatic system disorders: Anemia

            General and administration site conditions: Pyrexia

            Renal and urinary disorders: Acute kidney injury, renal insufficiency, and renal failure

            Skin and Subcutaneous Tissue Disorders: Acute generalized exanthematous pustulosis

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            Warnings

            Contraindications

            Hypersensitivity

            Cautions

            Anaphylaxis/hypersensitivity reactions have been reported and may be life-threatening; discontinue the drug and institute appropriate therapy if allergic reaction occurs

            May cause eosinophilic pneumonia characterized by fever, cough, shortness of breath, and difficulty breathing; may result in progressive respiratory failure and is potentially fatal; prompt medical evaluation, and treatment should be discontinued immediately if signs/symptoms develop; treatment with systemic steroids is recommended

            Prolonged use may result in fungal or bacterial superinfection Perform susceptibility testing and rule out sequestered foci of infection if persisting or relapsing S. aureus bacteremia/endocarditis occurs

            Avoid use in pediatric patients <12 months; potential nervous system or muscular system effects

            Decreased efficacy reported in patients with moderate baseline renal impairment

            Fever, dyspnea with hypoxic respiratory insufficiency, and diffuse pulmonary infiltrates or organizing pneumonia

            Cases of peripheral neuropathy have been reported during the daptomycin postmarketing experience; monitor and consider discontinuation

            Clostridium difficile-associated diarrhea (CDAD)

            • CDAD has been reported and may range in severity from mild diarrhea to fatal; CDAD must be considered in all patients who present with diarrhea following antibacterial use
            • Careful medical history is necessary because CDAD has been reported to occur more than 2 months after the administration of antibacterial agents
            • If CDAD is suspected/confirmed, ongoing antibacterial use not directed against C. difficile may need to be discontinued
            • Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated

            Myopathy and rhabdomyolysis

            • Use cautiously in patients with peripheral neuropathies and myopathy; monitor for neuropathy and consider discontinuation
            • Discontinue with symptoms of myopathy and CPK >1000 U/L (>5x ULN), or no symptoms and CPK >2000 U/L (>10x ULN)
            • CPK elevations more prevalent if dosed more frequently than q24hr
            • Consider suspending statins during daptomycin therapy; theoretical risk of additive myopathy
            • Renal function and CPK should be monitored more frequently than once weekly in adult patients with renal impairment
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            Pregnancy & Lactation

            Pregnancy

            Limited published data on use in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage; no evidence of adverse developmental outcomes observed in animal reproduction studies

            Lactation

            Limited published data report that daptomycin is present in human milk at infant doses of 0.1% of maternal dose; there is no information on effects of daptomycin on breastfed infant or effects of daptomycin on milk production; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from therapy or from the underlying maternal condition

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Cyclic lipopeptide: Binds to bacterial membranes and causes rapid depolarization of membrane potential; causes inhibition of protein, DNA, RNA synthesis, and bacterial cell death

            Absorption

            Peak plasma time

            • 0.5-0.8 hr

            Peak plasma concentration

            • 4 mg/kg dose: 58 mcg/mL
            • 6 mg/kg dose: 94 mcg/mL

            AUC

            • 4 mg/kg dose: 494 mcg•hr/mL
            • 6 mg/kg dose: 632 mcg•hr/mL

            Distribution

            Protein bound: 92%

            Vd: 0.1 L/kg

            Elimination

            Half-life: 8 hr

            Dialyzable: 11-15% of dose removed by continuous ambulatory peritoneal dialysis/hemodialysis

            Renal clearance: 3.7-4.8 mL/hr/kg

            Total body clearance: 8-9 mL/hr/kg

            Excretion: Urine (78%)

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            Administration

            IV Incompatibilities

            Solution: Dextrose-containing diluents

            Do not admix with other drugs

            IV Compatibilities

            Solution: 0.9% NaCl, LR

            IV Preparation

            There are 3 formulations of daptomycin that have differences concerning storage and reconstitution; carefully follow the reconstitution and storage procedures in labeling

            Reconstitution

            • Cubicin
              • To minimize foaming, avoid vigorous agitation or shaking of the vial during or after reconstitution
              • Slowly transfer 10 mL of 0.9% NaCl through the center of the rubber stopper into vial, pointing the transfer needle toward the wall of the vial
              • A beveled sterile transfer needle that is 21-gauge or smaller in diameter is recommended, or a needleless device is used, pointing the transfer needle toward the wall of the vial
              • Ensure that all of the lyophilized powder is wetted by gently rotating the vial
              • Allow wetted product to stand undisturbed for 10 minutes
              • Gently rotate or swirl the vial contents for a few minutes, as needed, to obtain a completely reconstituted solution
            • Cubicin RF
              • Must be reconstituted within the vial only with either sterile water for injection or bacteriostatic water for injection
              • Do not use 0.9% NaCl (saline) based diluents for the reconstitution in the vial because this will result in a hyperosmotic solution that may result in infusion site reactions if the reconstituted product is administered as an IV injection over a period of 2 minutes (adults)
              • Transfer 10 mL of sterile water for injection or bacteriostatic water for injection through the center of the rubber stopper into the vial
              • Use a beveled sterile transfer needle that is 21-gauge or smaller in diameter, pointing the transfer needle toward the wall of the vial
              • Rotate or swirl the vial contents for a few minutes, as needed, to obtain a completely reconstituted solution
            • Daptomycin 350 mg vial
              • Carefully follow the reconstitution and storage procedures in labeling
              • Do not use in conjunction with ReadyMED elastomeric infusion pumps in adult patients
              • Avoid vigorous agitation or shaking of the vial during or after reconstitution
              • Slowly transfer 7 mL of 0.9% NaCl through the center of the rubber stopper (concentration of 50 mg/mL)
              • Use a beveled sterile transfer needle that is 21-gauge or smaller in diameter, pointing the transfer needle toward the wall of the vial
              • Allow the wetted product to stand undisturbed for 10 minutes
              • Rotate or swirl the vial contents for a few minutes, as needed, to obtain a completely reconstituted solution

            Further dilute for IV infusion

            • Adults and children aged 7-17 years: Add calculated dose from reconstituted vial to IV bag containing 50 mL 0.9% NaCl
            • Children aged 1-6 years: Add calculated dose from reconstituted vial to IV bag containing 25 mL 0.9% NaCl

            IV Administration

            Adults

            • On hemodialysis days, administer after hemodialysis
            • IV push: Administer reconstituted solution IV over 2 min (in adults only)
            • IV infusion: Infuse diluted solution IV over 30 min

            Pediatrics

            • See section on IV preparation for appropriate concentrations of dilution for each age group
            • 1-6 years: Infuse diluted IV solution at rate of 0.42 mL/min over a 60-min period
            • 7-17 years: Infuse diluted IV solution at rate of 1.67 mL/min over a 30-min period
            • Do not administer Cubicin RF by injection over a two (2) minute period to 1-17 years

            Storage

            Unopened vials

            • Cubicin: Refrigerate in original packages at 2-8°C (36-46°F)
            • Cubicin RF: Store in original packages at controlled room temperature of 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F)
            • Daptomycin 350 mg vials: Store in original packages at refrigerated temperatures at 2-8°C (36-46°F); avoid excessive heat

            Reconstituted or diluted solution (Cubicin)

            • Store in room temperature at 20-25°C (68-77°F) for up to 12 hr
            • Store in refrigerator at 2-8°C (36-46°F) for up to 48 hr

            Reconstituted solution (Cubicin RF)

            • Sterile water diluent
              • Vial or polypropylene syringe: 1 day (controlled room temperature) or 3 days (refrigerated at 2-8°C [36-46°F])
            • Bacteriostatic water for injection diluent
              • Vial: 2 days (controlled room temperature) or 3 days (refrigerated at 2-8°C [36-46°F])
              • Polypropylene syringe: 2 days (controlled room temperature) or 5 days (refrigerated at 2-8°C [36-46°F])

            Diluted solution in IV bag (Cubicin RF)

            • Reconstituted and immediately diluted further with 0.9% NaCl
            • Reconstituted with sterile water for injection: 19 hr (room temperature) or 3 days (refrigerated)
            • Reconstituted with bacteriostatic water for injection: 2 days (room temperature) or 5 days (refrigerated)
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            Formulary

            FormularyPatient Discounts

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            • View the formulary and any restrictions for each plan.
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            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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