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Cubicin (Daptomycin) - Drug Interactions, Contraindications, Overdosage, etc

 
 



DRUG INTERACTIONS

Warfarin

Concomitant administration of CUBICIN (6 mg/kg q24h for 5 days) and warfarin (25 mg single oral dose) had no significant effect on the pharmacokinetics of either drug, and the INR was not significantly altered.  As experience with the concomitant administration of CUBICIN and warfarin is limited, anticoagulant activity in patients receiving CUBICIN and warfarin should be monitored for the first several days after initiating therapy with CUBICIN (see CLINICAL PHARMACOLOGY, Drug-Drug Interactions).

HMG-CoA Reductase Inhibitors

Inhibitors of HMG-CoA reductase may cause myopathy, which is manifested as muscle pain or weakness associated with elevated levels of CPK.  There were no reports of skeletal myopathy in a placebo-controlled Phase 1 trial in which 10 healthy subjects on stable simvastatin therapy were treated concurrently with CUBICIN (4 mg/kg q24h) for 14 days.  In the Phase 3 S. aureus bacteremia/endocarditis trial, 5/22 CUBICIN-treated patients who received prior or concomitant therapy with an HMG-CoA reductase inhibitor developed CPK elevations >500 U/L.  Experience with coadministration of HMG-CoA reductase inhibitors and CUBICIN in patients is limited; therefore, consideration should be given to temporarily suspending use of HMG-CoA reductase inhibitors in patients receiving CUBICIN (see ADVERSE REACTIONS, Post-Marketing Experience).

OVERDOSAGE

In the event of overdosage, supportive care is advised with maintenance of glomerular filtration.  Daptomycin is slowly cleared from the body by hemodialysis (approximately 15% recovered over 4 hours) or peritoneal dialysis (approximately 11% recovered over 48 hours).  The use of high-flux dialysis membranes during 4 hours of hemodialysis may increase the percentage of dose removed compared with low-flux membranes.

CONTRAINDICATIONS

CUBICIN is contraindicated in patients with known hypersensitivity to daptomycin.

REFERENCES

  1. Clinical and Laboratory Standards Institute (CLSI).  Methods for dilution antimicrobial susceptibility tests for bacteria that grow aerobically; approved standard—seventh edition.  CLSI Document M7-A7; Wayne, PA.  2006 January.

  2. Clinical and Laboratory Standards Institute (CLSI).  Performance standards for antimicrobial susceptibility testing; sixteenth informational supplement.  CLSI Document M100-S16; Wayne, PA.  2006 January.

  3. Clinical and Laboratory Standards Institute (CLSI).  Performance standards for antimicrobial disk susceptibility tests; approved standard—ninth edition.  CLSI Document M2-A9; Wayne, PA.  2006 January.

  4. Li JS, Sexton DJ, Mick N, Nettles R, Fowler VG Jr, Ryan T, Bashore T, Corey GR.  Proposed modifications to the Duke criteria for the diagnosis of infective endocarditis.  Clin Infect Dis 2000;30:633–638.

Rx only

CUBICIN is a registered trademark of Cubist Pharmaceuticals, Inc.  All other trademarks are property of their respective owners.

Manufactured for:

Cubist Pharmaceuticals, Inc.
Lexington, MA 02421 USA

For all medical inquiries call: (866) 793-2786

August 2008 (1004-8)

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