Telavancin hydrochloride

What is Telavancin hydrochloride?

• Telavancin hydrochloride (VIBATIV) is a lipoglycopeptide antibacterial drug used to treat adults with certain types of germs (bacteria).

What are the uses of this medicine?

This medicine is used alone, or with other medicines, to treat adults with certain types of germs (bacteria) that cause:

• Serious skin infections
• Hospital-Acquired Bacterial Pneumonia (HABP)
• Ventilator-Associated Bacterial Pneumonia (VABP)

How does this medicine work?

• Like vancomycin, telavancin binds tightly to the D-alanyl-D-alanine residue of cell wall precursors, thereby interfering with bacterial cell wall synthesis.
• In addition, the lipophilic moiety of telavancin may interact with the lipid bilayer in the bacterial cell membrane, thereby compromising the integrity of cell membrane and causing cell membrane depolarization.
• This novel mechanism of action may contribute to telavancin's rapid bactericidal activity and its improved activity over vancomycin against some antibiotic resistance gram-positive bacteria.

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• with known hypersensitivity to telavancin

What drug interactions can this medicine cause?

• Telavancin interferes with some laboratory coagulation tests, including prothrombin time, international normalized ratio, and activated partial thromboplastin time.

Is this medicine FDA approved?

• FDA approved this drug in the year of 2013.

How should this medicine be used?

Recommended Dosage: Complicated Skin and Skin Structure Infections:

• The recommended dosing for VIBATIV is 10 mg/kg administered over a 60-minute period in patients ≥18 years of age by intravenous infusion once every 24 hours for 7 to 14 days.

Hospital-Acquired Bacterial Pneumonia/Ventilator-Associated Bacterial Pneumonia (HABP/VABP)ː

• The recommended dosing for VIBATIV is 10 mg/kg administered over a 60-minute period in patients ≥18 years of age by intravenous infusion once every 24 hours for 7 to 21 days.

• Dosage adjustment in patients with renal impairment.

Administration

• VIBATIV is given by your healthcare provider through a needle placed into your vein (IV infusion) slowly over 1 hour, 1 time each day, for 7 to 21 days.
• Do not stop receiving VIBATIV unless your healthcare provider tells you to, even if you feel better.
• Your healthcare provider will do blood tests before you start and while you receive VIBATIV.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Single-use vials containing either 250 or 750 mg telavancin.

This medicine is available in fallowing brand namesː

• VIBATIV

What side effects can this medication cause?

The most common side effects of this medicine include:

• change in your sense of taste
• nausea
• vomiting
• foamy urine
• diarrhea

VIBATIV may cause serious side effects, including:

• Increased risk of death
• New or worsening kidney problems
• VIBATIV may harm your unborn baby
• Serious allergic reactions
• Infusion-related reactions
• Problems with the electrical system of your heart (QTc prolongation)

What special precautions should I follow?

• Decreased efficacy among patients treated for skin and skin structure infections with moderate/severe pre-existing renal impairment. Consider these data when selecting antibacterial therapy for patients with baseline CrCl ≤50 mL/min.
• Serious and potentially fatal hypersensitivity reactions, including anaphylactic reactions, may occur after first or subsequent doses. VIBATIV should be used with caution in patients with known hypersensitivity to vancomycin.
• VIBATIV is a lipoglycopeptide antibacterial agent and should be administered over a period of 60 minutes to reduce the risk of infusion-related reactions. Rapid intravenous infusions of the glycopeptide class of antimicrobial agents can cause “Red-man Syndrome”-like reactions including: flushing of the upper body, urticaria, pruritus, or rash. Stopping or slowing the infusion may result in cessation of these reactions.
• Clostridium difficile-associated diarrhea (CDAD) has been reported with nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis. Prescribing VIBATIV in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
• Caution is warranted when prescribing VIBATIV to patients taking drugs known to prolong the QT interval.
• Telavancin interferes with some laboratory coagulation tests, including prothrombin time, international normalized ratio, and activated partial thromboplastin time.

What to do in case of emergency/overdose?

Management of overdosage:

• In the event of overdosage, VIBATIV should be discontinued and supportive care is advised with maintenance of glomerular filtration and careful monitoring of renal function.
• No information is available on the use of hemodialysis to treat an overdosage.
• The clearance of telavancin by continuous venovenous hemofiltration (CVVH) was evaluated in an in vitro study.
• However, the clearance of telavancin by CVVH has not been evaluated in a clinical study; thus, the clinical significance of this finding and use of CVVH to treat an overdosage is unknown.

Can this medicine be used in pregnancy?

• There are no data on VIBATIV use in pregnant women.
• There is a pregnancy registry that monitors pregnancy outcomes in women exposed to VIBATIV during pregnancy.
• Physicians are encouraged to register pregnant patients, or pregnant women may enroll themselves in the VIBATIV pregnancy registry by calling 1-855-MED-THRX (1-855-633-8479).

Can this medicine be used in children?

• The safety and effectiveness of VIBATIV in pediatric patients has not been studied.

What are the active and inactive ingredients in this medicine?

• Active ingredient: telavancin hydrochloride
• Inactive ingredients: hydroxypropylbetadex, Ph. Eur (hydroxypropyl-beta-cyclodextrin), mannitol, sodium hydroxide and hydrochloric acid

Who manufactures and distributes this medicine?

Manufactured for: Theravance, Inc. South San Francisco

What should I know about storage and disposal of this medication?

• Store original packages at refrigerated temperatures of 2 to 8°C (35 to 46 °F).
• Excursions to ambient temperatures (up to 25 °C (77 °F)) are acceptable.
• Avoid excessive heat.

• Dailymed label info on Telavancin hydrochloride
• FDA Telavancin hydrochloride

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