REMS
Spectrum:
Absorption: IV administration results in complete bioavailability.
Distribution: Minimal distribution to tissues.
Half-Life: 8 hr.
Contraindicated in:
Pregnancy
.Use Cautiously in:
Renal impairment (↓ dose if CCr ≤50 mL/min) (efficacy may be ↓ in patients with complicated skin/skin structure infections and CCr ≤50 mL/min) (↑ risk of mortality in patients with hospital-acquired or ventilator-associated pneumonia and CCr ≤50 mL/min; use only if benefit outweighs risk)
;Diabetes, HF, or hypertension (↑ risk of renal impairment)
;CV: QT interval prolongation
GI: nausea, taste disturbance, vomiting, abdominal pain, CLOSTRIDIOIDES DIFFICILE-ASSOCIATED DIARRHEA (CDAD)
GU: foamy urine, nephrotoxicity
Neuro: dizziness
Misc: ANAPHYLAXIS, infusion reactions
Drug-drug:
NSAIDs, ACE inhibitors, and loop diuretics may ↑ risk of nephrotoxicity.
Complicated Skin/Skin Structure Infections
Renal Impairment
Hospital-Acquired/Ventilator-Associated Bacterial Pneumonia
Renal Impairment
Lab Test Considerations:
Verify negative pregnancy test before starting therapy.
Monitor renal function (serum creatinine, CCr) prior to, every 4872 hr during, and at the end of therapy. May cause nephrotoxicity. If ↓ renal function, reassess need for telavancin.
IV Administration:
May cause fetal harm. Advise women of reproductive potential to use effective contraception during therapy and for 2 days after last dose and to notify health care provider if pregnancy is suspected. Inform patient of pregnancy exposure registry that monitors pregnancy outcomes in women exposed to telavancin during pregnancy. Encourage pregnant patients to enroll in the VIBATIV pregnancy registry by calling 1-877-484-2700. May impair fertility in men.