telavancin

telavancin

(tel-a-van-sin) ,

Vibativ

(trade name)

Classification

Therapeutic: anti infectives
Pharmacologic: lipoglycopeptides
Pregnancy Category: C

Indications

Treatment of complicated skin/skin structure infections caused by susceptible bacteria.Hospital-acquired and ventilator-associated bacterial pneumonia caused by Staphylococcus aureus

Action

Inhibits bacterial cell wall synthesis by interfering with the polymerization and cross-linking of peptidoglycan.

Therapeutic effects

Bactericidal action against susceptible organisms.
Active against Staphylococcus aureus (including methicillin-susceptible and -resistant strains), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosus (including S. anginosus, S. intermedius, and S. constellatus), and Enterococcus faecalis (vancomycin-susceptible strains only).

Pharmacokinetics

Absorption: IV administration results in complete bioavailability.
Distribution: Penetrates blister fluid.
Metabolism and Excretion: Metabolism is not known; 76% excreted unchanged in urine <1% in feces.
Half-life: 8 hr.

Time/action profile

ROUTEONSETPEAKDURATION
IVunknownend of infusion24 hr

Contraindications/Precautions

Contraindicated in: HypersensitivityCongenital long QT syndrome, known prolongation of the QT interval, uncompensated HF, or severe left ventricular hypertrophy (risk of fatal arrhythmias); Obstetric: Do not use unless potential maternal benefit outweighs potential risk to fetus.
Use Cautiously in: Renal impairment (efficacy may be ↓; dose ↓ recommended for CCr ≤50 mL/min) (↑ risk of mortality in patients with CCr ≤50 mL/min; use only if benefit outweighs risk) (↑ risk of renal impairment);Diabetes, HF, hypertension (↑ risk of renal impairment) Geriatric: Consider age-related ↓ in renal function, adjust dose accordingly (↑ risk of adverse renal reactions); Lactation: Use cautiously; Pediatric: Safety and effectiveness not established.

Adverse Reactions/Side Effects

Central nervous system

  • dizziness

Cardiovascular

  • QT interval prolongation

Gastrointestinal

  • pseudomembranous colitis (life-threatening)
  • taste disturbance (most frequent)
  • nausea (most frequent)
  • vomiting (most frequent)
  • abdominal pain

Genitourinary

  • foamy urine (most frequent)
  • nephrotoxicity

Miscellaneous

  • anaphylaxis (life-threatening)
  • infusion reactions

Interactions

Drug-Drug interaction

Concurrent use of other medications known to prolong QT interval may ↑ risk of arrhythmias.Concurrent use of NSAIDs, ACE inhibitors, and loop diuretics may ↑ risk of adverse renal effects.

Route/Dosage

Complicated Skin/Skin Structure Infections

Intravenous (Adults) 10 mg/kg ever 24 hr for 7–14 days.

Hospital-Acquired/Ventilator-Associated Bacterial Pneumonia

Intravenous (Adults) 10 mg/kg ever 24 hr for 7–21 days.

Renal Impairment

Intravenous (Adults) CCr 30–50 mL/min—7.5 mg/kg every 24 hr; CCr 10–≤30 mL/min—10 mg/kg every 48 hr.

Availability

Sterile lyophilized powder for IV use (requires reconstitution): 250 mg/vial, 750 mg/vial

Nursing implications

Nursing assessment

  • Assess for infection (vital signs; appearance of wound, sputum, urine, and stool; WBC) at beginning of and throughout therapy.
  • Obtain specimens for culture and sensitivity prior to therapy. First dose may be given before receiving results.
  • Assess women of child bearing age for pregnancy. Women should have a negative serum pregnancy test before starting telavancin.
  • Monitor bowel function. Diarrhea, abdominal cramping, fever, and bloody stools should be reported to health care professional promptly as a sign of pseudomembranous colitis. May begin up to several weeks following cessation of therapy.
  • Monitor for infusion reactions (Red-man syndrome—flushing of upper body, urticaria, pruritus, rash). May resolve with stopping or slowing infusion.
  • Observe patient for signs and symptoms of anaphylaxis (rash, pruritus, laryngeal edema, wheezing). Discontinue drug and notify health care professional immediately if symptoms occur. Keep epinephrine, an antihistamine, and resuscitation equipment close by in case of anaphylactic reaction.
  • Lab Test Considerations: Monitor renal function (serum creatinine. creatinine clearance) prior to, every 48–72 hrs during, and at the end of therapy. May cause nephrotoxicity. If renal function decreases, reassess need for telavancin.
    • May interfere with prothrombin time, INR, aPTT, activated clotting time, and coagulation based factor Xa tests. Collect blood samples for theses tests as close to next dose of telavancin as possible.
    • Interferes with urine qualitative dipstick protein assays and quantitative dye methods; may use microalbumin assays.

Potential Nursing Diagnoses

Risk for infection (Indications)
Diarrhea (Adverse Reactions)

Implementation

  • Intravenous Administration
  • Intermittent Infusion: Reconstitute the 250 mg vial with 15 mL and the 750 mg vial with 45 mL of D5W, sterile water for injection, or 0.9% NaCl for concentrations of 15 mg/mL. Reconstitution time is usually under 2 min but may require up to 20 min. Mix thoroughly with contents dissolved completely. Do not administer solution that is discolored or contains particulate matter. Discard vial if vacuum did not pull diluent into vial. Time in vial plus time in bag should not exceed 4 hr at room temperature or 72 hr if refrigerated. Diluent: For doses of 150–800 mg dilute further with 100–250 mL of D5W, 0.9% NaCl, or LR.Concentration: For doses <150 mg or >800 mg dilute for a final concentration of 0.6–8 mg/mL.
  • Rate: Administer over at least 60 min to minimize infusion reactions.
  • Y-Site Incompatibility: Do not mix or administer with other medications. Flush line with D5W, 0.9% NaCl, or LR before and after administration.
  • Y-Site Compatibility: amphotericin B lipid complex, ampicillin/sulbactam, azithromycin, calcium gluconate, caspofungin, cefepime, ceftazidime, ceftriaxone, ciprofloxacin, dexamethasone, diltiazem, dobutamine, dopamine, doripenem, doxycycline, ertapenem, famotidine, fluconazole, gentamicin, hydrocortisone, labetalol, magnesium sulfate, mannitol, meropenem, metoclopramide, milrinone, norepinephrine, ondansetron, pantoprazole, phenylephrine, piperacillin/tazobactam, potassium chloride, potassium phosphates, ranitidine, sodium bicarbonate, sodium phosphates, tigecycline, tobramycin, vasopressin
  • Y-Site Incompatibility: amphotericin B colloidal, amphotericin B liposome, digoxin, esomeprazole, furosemide, levofloxacin, micafungin

Patient/Family Teaching

  • Instruct patient to notify health care professional immediately if diarrhea, abdominal cramping, fever, or bloody stools occur and not to treat with antidiarrheals without consulting health care professionals.
  • Inform patient that common side effects include taste disturbance, nausea, vomiting, headache and foamy urine. Notify health care professional if signs of infusion reaction occur.
  • Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.
  • Advise female patients to use effective contraception during therapy and to notify health care professional if pregnancy is suspected. Encourage pregnant patients to enroll in the VIBATIV pregnancy registry by calling 1-888-658-4228.
  • Instruct the patient to notify health care professional if symptoms do not improve.

Evaluation/Desired Outcomes

  • Resolution of the signs and symptoms of infection. Length of time for complete resolution depends on the organism and site of infection.
References in periodicals archive ?
An antibacterial, telavancin (Vibativ), indicated for skin infections is being studied by the Vibativ Pregnancy Registry (888-658-4228 / www.
Telavancin demonstrates a low potential for in vitro selection of resistance among key target Gram-positive species.
Telavancin, approved by the FDA to treat MRSA, represents only the fourth new class of antibiotic approved since 1998
Quality control ranges added and/ or revised for M100-S24 include aztreonam-avibactam, biapenem, ceftolozanetazobactam, eravacycline, surotomycin, and telavancin.
CHICAGO - In obese patients, the antibiotic telavancin may offer an alternative to vancomycin for treating complicated skin and skin structure infections, according to a post hoc analysis.
Dalbavancin, iclaprim, oritavancin, and telavancin have all done well in trials, with success rates similar to those of the comparator.
Therapeutic use: Telavancin (40, 41), a lipoglycopeptide antibiotic, is indicated for the treatment of adult patients with complicated skin and skin structure infections caused by susceptible gram-positive bacteria.
Newer (but not necessarily better) therapies include daptomycin, linezolid, tigecycline, and the newly licensed telavancin.
The company announced that the FDA sent it a letter indicating that its response to the agency's questions about telavancin for the treatment of nosocomial pneumonia (NP) is incomplete and that the review clock will not start until the FDA receives a "complete response.
Astellas Pharma Inc was also one of a scant handful of shares in positive territory after a key antibiotic drug, telavancin, had won marketing approval from U.
Drugs that are in the development phase include: ceftobiprole, dalbavancin, oritavancin, and telavancin.
The antibiotic pipeline today * Novel Compound Class MOA Dalbavancin Lipoglycopeptide No ([dagger]) Iclaprim Diaminopyrimidine No Oritavancin Glycopeptide No Telavancin Lipoglycopeptide Yes ([double dagger]) Ceftobiprole Cephalosporin ([section]) No Cethromycin Ketolide No Doripenem Carbapenem No Faropenem Penem No Prulifloxacin Quinolone No Compound Formulation Status Dalbavancin IV Filed Iclaprim IV Phase 3 Oritavancin IV Phase 3 Telavancin IV Phase 3 Ceftobiprole IV Filed Cethromycin Oral Phase 3 Doripenem IV Approved Faropenem Oral Filed ([paragraph]) Prulifloxacin Oral Phase 3 * Adapted from ref.