telavancin

(redirected from Vibativ)

telavancin

Vibativ

Pharmacologic class: Lipoglyco-peptide

Therapeutic class: Anti-infective

Pregnancy risk category C

GI: nausea, vomiting, diarrhea, abdominal pain, taste disturbance, Clostridium difficile-associated diarrhea

FDA Box Warning

Women of childbearing age should have serum pregnancy test before receiving telavancin.

Avoid using telavancin during pregnancy unless potential benefit to patient outweighs potential risk to fetus.

Adverse developmental outcomes observed in three animal species at clinically relevant doses raise concerns about potential adverse developmental outcomes in humans.

Action

Binds to bacterial membrane and disrupts membrane barrier function

Availability

Injection: 250 mg, 750 mg in single-use vials

Indications and dosages

Complicated skin and skin-structure infections caused by susceptible gram-positive bacteria

Adults: 10 mg/kg I.V infusion over 60 minutes q 24 hours for 7 to 14 days

Dosage adjustment

• Renal impairment

Contraindications

None

Precautions

Use cautiously in:

• renal impairment

• concurrent use of drugs known to prolong QT interval

• history of congenital long QT syndrome, known prolongation of QTc interval, uncompensated heart failure, severe left ventricular hypertrophy (avoid use)

• elderly patients

• pregnant or breastfeeding patients

• children (safety and efficacy not established).

Administration

• Obtain renal function studies before starting therapy.

• Administer slowly (over 60 minutes) to reduce risk of infusion-related reactions.

• Although drug doesn't interfere with coagulation, it does, shortly after completion of infusion, interfere with certain tests used to monitor coagulation, such as prothrombin time (PT), International Normalized Ratio (INR), activated partial thromboplastin time (aPTT), activated clotting time, and coagulation-based factor Xa tests. Don't collect blood samples for such assays immediately or shortly after infusion completion because such effects dissipate as telavancin concentration decreases.

Adverse reactions

CNS: dizziness

CV: cardiac events

GI: nausea, vomiting, diarrhea, abdominal pain, taste disturbance, Clostridium difficile-associated diarrhea

GU: foamy urine, renal events, nephrotoxicity

Respiratory: respiratory events

Skin: rash, pruritus, infusion-site erythema

Other: rigors, decreased appetite, infectious events, superinfection, infusion-site pain, infusion reactions

Interactions

Drug-diagnostic tests. Activated clotting time, aPTT, coagulation-based factor Xa tests, INR, PT; urine qualitative protein assays: interference with results

Patient monitoring

Be aware that new-onset or worsening renal impairment has occurred in patients taking telavancin. Monitor renal function at 48- and 72-hour intervals during treatment, or more frequently if clinically indicated, and at end of therapy.

Watch for C. difficile-associated diarrhea, which may range in severity from mild diarrhea to fatal colitis; consider discontinuing drug if C. difficile-associated diarrhea occurs.

• Watch for "red-man" syndrome, which can result from rapid infusion. Signs and symptoms include flushing of upper body, hypotension, pruritus, and maculopapular rash on face, neck, trunk, and limbs.

Patient teaching

Instruct patient to tell prescriber if severe diarrhea occurs.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the tests mentioned above.

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 ?
Increased sales team and national territories to improve support for acute-care key brands Caldolor, Vibativ and Vaprisol
Hegde has participated in the discovery of several New Chemical Entities, including now-marketed products Yuperli and Vibativ as well as clinical candidates currently in Phase 2 and Phase 3 development.
Following the company's acquisition of Vibativ in late 2018, its commercial portfolio now includes eight FDA-approved brands.
(NASDAQ: CPIX) has agreed to acquire Vibativ from Theravance Biopharma, located in the Cayman Islands, the company said.
M2 EQUITYBITES-November 9, 2018-Cumberland Pharmaceuticals to Acquire Vibativ from Theravance Biopharma
Under his leadership, the company nominated more than 30 development candidates in 17 years, created three approved products (Breo, Anoro, Vibativ), as well as a pipeline containing 11 development-stage compounds and two additional assets that have successfully completed Phase 3 studies.
An antibacterial, telavancin (Vibativ), indicated for skin infections is being studied by the Vibativ Pregnancy Registry (888-658-4228 / www.clinicaltrial.gov).
This has resulted in the discovery, development and regulatory approval of Vibativ (telavancin) and a pipeline of small-molecule product candidates across several therapeutic areas, as well as major late-stage respiratory programs in partnership with GSK.
Telavancin (brand name Vibativ, manufactured by Astellas) was approved by the Food and Drug Administration about 2 years ago for the treatment of gram-positive complicated SSSIs in adults.
One of those new agents is telavancin, a lipoglycopeptide from Theravance that was approved in September 2009 for complicated skin and skin-structure infections and is currently marketed under the brand name Vibativ. Two other lipoglycopeptides, dalbavancin and oritavancin, are not currently available and continue to be studied.
Theravance Biopharma will reduce its overall headcount by approximately 50 individuals, with affected employees primarily focused on early research or the infrastructure in support of VIBATIV. VIBATIV is a marketed antibiotic recently sold by the company to Cumberland Pharmaceuticals (CPIX).
M2 EQUITYBITES-November 7, 2018-Cumberland Pharmaceuticals signs definitive agreement to acquire VIBATIV from Theravance Biopharma