Telavancin

Serious hypersensitivity reactions, including anaphylaxis, have been reported after first or subsequent doses; some have been fatal. Discontinue if hypersensitivity or rash occurs. Telavancin is a semisynthetic derivative of vancomycin; cross-reactivity rates are unknown. Use with caution in patients with known vancomycin hypersensitivity.

May prolong QTc interval; avoid use in patients with congenital long QT syndrome, known QTc prolongation, uncompensated heart failure, or severe left ventricular hypertrophy (were excluded from studies); use with caution in patients with concurrent administration of other medications known to prolong the QT interval. Clinical studies indicate mean maximal QTc prolongation of 12 to 15 msec at the end of 10 mg/kg infusion.

Rapid IV administration may result in flushing, rash, urticaria, and/or pruritus; slowing or stopping the infusion may alleviate these symptoms.

New onset or worsening renal impairment has occurred. Monitor renal function prior to, during (at least every 48 to 72 hours; more frequently if indicated), and following therapy in all patients. Usual risk factors include concomitant nephrotoxic medications or baseline comorbidities associated with decreased renal function (eg baseline renal dysfunction, diabetes, hypertension, or heart failure). Contains solubilizer cyclodextrin (hydroxypropyl-beta-cyclodextrin) which may accumulate in patients with renal dysfunction, although the clinical significance of this finding is uncertain (Luke, 2010).

Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment. Disease-related concerns:

In clinical studies, patients with pre-existing moderate-to-severe renal impairment (CrCl ≤50 mL/minute) treated for hospital-acquired/ventilator-associated bacterial pneumonia (HABP/VABP) had increased (all cause) mortality versus vancomycin. Use in HABP/VABP only when benefit outweighs risk. In patients with complicated skin and skin structure infections, efficacy may be reduced in patients with a baseline CrCl ≤50 mL/minute. Concurrent drug therapy issues:

Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information. Special populations:

Lower doses are often required secondary to age-related decreases in renal function.

Based on animal data, adverse developmental outcomes have been observed. Prior to use, women of childbearing potential should have a serum pregnancy test. Use of telavancin is not recommended during pregnancy unless the potential benefit outweighs the risk to the fetus. Other warnings/precautions:

May interfere with tests used to monitor coagulation (eg, prothrombin time, INR, activated partial thromboplastin time, activated clotting time, coagulation based factor Xa tests) when samples drawn ≤18 hours after drug administration. Blood samples should be collected as close to the next dose of telavancin as possible or a non-phospholipid dependent coagulation test (eg, bleeding time, factor Xa [chromogenic assay], platelet aggregation study, thrombin time) should be used. Consider selecting an alternative anticoagulant not requiring aPTT monitoring; concomitant use of telavancin with IV unfractionated heparin is contraindicated.