Vibativ (Telavancin for Injection) Patient Information: Side Effects and Drug Images at RxList

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May 27, 2012

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Vibativ

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VIBATIV
(telavancin) for Injection, for Intravenous Use

WARNING: FETAL RISK

Women of childbearing potential should have a serum pregnancy test prior to administration of VIBATIV (telavancin for injection)
Avoid use of VIBATIV (telavancin for injection) during pregnancy unless the potential benefit to the patient outweighs the potential risk to the fetus
Adverse developmental outcomes observed in 3 animal species at clinically relevant doses raise concerns about potential adverse developmental outcomes in humans [see WARNINGS AND PRECAUTIONS, Use in Specific Populations]

DRUG DESCRIPTION

VIBATIV contains telavancin hydrochloride, a lipoglycopeptide antibacterial that is a synthetic derivative of vancomycin. The chemical name of telavancin hydrochloride is vancomycin,N3”-[2-(decylamino)ethyl]-29-[[(phosphono-methyl)-amino]-methyl]- hydrochloride. Telavancin hydrochloride has the following chemical structure:

Figure 1 : Telavancin Hydrochloride

VIBATIV (telavancin hcl) Structural Formula Illustration

Telavancin hydrochloride is an off-white to slightly colored amorphous powder with the empirical formula C₈₀H₁₀₆C₁₂N₁₁O₂₇P•xHCl (where x = 1 to 3) and a free-base molecular weight of 1755.6. It is highly lipophilic and slightly soluble in water.

VIBATIV (telavancin for injection) is a sterile, preservative-free, white to slightly colored lyophilized powder containing telavancin hydrochloride (equivalent to either 250 mg or 750 mg of telavancin as the free base) for intravenous use. The inactive ingredients are Hydroxypropylbetadex, Ph. Eur (hydroxypropyl-beta-cyclodextrin) (2500 mg per 250 mg telavancin, 7500 mg per 750 mg telavancin), mannitol (312.5 mg per 250 mg telavancin, 937.5 mg per 750 mg telavancin), and sodium hydroxide and hydrochloric acid used in minimal quantities for pH adjustment. When reconstituted, it forms a clear to slightly colored solution with a pH of 4.5 (4.0 to 5.0).

Last reviewed on RxList: 9/17/2009
This monograph has been modified to include the generic and brand name in many instances.