"The U.S. Food and Drug Administration today approved Orbactiv (oritavancin), a new antibacterial drug to treat adults with skin infections.
Orbactiv is approved to treat patients with acute bacterial skin and skin structure infections (ABSS"...
(telavancin) Lyophilized Powder for Intravenous Use
INCREASED MORTALITY IN HABP/VABP PATIENTS WITH PRE-EXISTING MODERATE OR SEVERE RENAL IMPAIRMENT, NEPHROTOXICITY, POTENTIAL ADVERSE DEVELOPMENTAL OUTCOMES
- Patients with pre-existing moderate/severe renal impairment (CrCl ≤ 50 mL/min) who were treated with VIBATIV for hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia (HABP/VABP) had increased mortality observed versus vancomycin. Use of VIBATIV in patients with pre-existing moderate/severe renal impairment (CrCl ≤ 50 mL/min) should be considered only when the anticipated benefit to the patient outweighs the potential risk [see WARNINGS AND PRECAUTIONS].
- Nephrotoxicity: New onset or worsening renal impairment has occurred. Monitor renal function in all patients [see WARNINGS AND PRECAUTIONS].
- Women of childbearing potential should have a serum pregnancy test prior to administration of VIBATIV [see WARNINGS AND PRECAUTIONS, Use in Specific Populations].
- Avoid use of VIBATIV during pregnancy unless the potential benefit to the patient outweighs the potential risk to the fetus [see WARNINGS AND PRECAUTIONS, Use in Specific Populations].
- 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]
VIBATIV contains telavancin hydrochloride (Figure 1), 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
Telavancin hydrochloride is an off-white to slightly colored amorphous powder with the empirical formula C80H106 Cl2N11O27 P•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 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).
What are the possible side effects of telavancin (Vibativ)?
Some people receiving a telavancin injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your doctor right away if you feel itchy or tingly, or have a red rash on your upper body during the injection.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
- diarrhea that is watery or bloody;
- drowsiness, confusion, mood changes, increased...
What are the precautions when taking telavancin for injection (Vibativ)?
See also Warning section.
Before using telavancin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history.
Telavancin may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.
The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT...
Last reviewed on RxList: 5/19/2016
This monograph has been modified to include the generic and brand name in many instances.
Additional Vibativ Information
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