Telavancin

Telavancin is an antibacterial drug [ see Clinical Pharmacology ( 12.4 ) ].

• VIBATIV is a lipoglycopeptide antibacterial drug indicated for the treatment of the following infections in adult patients caused by designated susceptible bacteria: Complicated skin and skin structure infections (cSSSI) ( 1.1 ) Hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Staphylococcus aureus . VIBATIV should be reserved for use when alternative treatments are not suitable.ICD-10: J18.9

• Intravenous Unfractionated Heparin Sodium ( 4.1 , 5.5 , 7.1 ) Known hypersensitivity to VIBATIV ( 4.2 , 5.6 , 6.2 ) 4.1 Intravenous Unfractionated Heparin Sodium Use of intravenous unfractionated heparin sodium is contraindicated with VIBATIV administration because the activated partial thromboplastin time (aPTT) test results are expected to be artificially prolonged for 0 to 18 hours after VIBATIV administration [ see Warnings and Precautions ( 5.5 ) and Drug Interactions ( 7.1 ) ]. 4.2 Known Hypersensitivity to VIBATIV VIBATIV is contraindicated in patients with known hypersensitivity to telavancin.contraindicated

Complicated skin and skin structure infections (cSSSI): 10 mg/kg by IV infusion over 60 minutes every 24 hours for 7 to 14 days ( 2.1 ) Dosage adjustment in patients with renal impairment. ( 2.3 ) Hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP): 10 mg/kg by IV infusion over 60 minutes every 24 hours for 7 to 21 days ( 2.2 ) Dosage adjustment in patients with renal impairment. ( 2.3 ) a Calculate using the Cockcroft-Gault formula and ideal body weight (IBW). Use actual body weight if < IBW. ( 12.3 ) Creatinine Clearance a (CrCl) (mL/min) VIBATIV Dosage Regimen >50 10 mg/kg every 24 hours 30-50 7.5 mg/kg every 24 hours 10-<30 10 mg/kg every 48 hours Insufficient data are available to make a dosing recommendation for patients with CrCl <10 mL/min, including patients on hemodialysis. 2.1 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. The duration of therapy should be guided by the severity and site of the infection and the patient's clinical progress. 2.2 Hospital-Acquired Bacterial Pneumonia/Ventilator-Associated Bacterial Pneumonia (HABP/VABP) 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. The duration of therapy should be guided by the severity of the infection and the patient's clinical progress.

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. ( 5.2 ) Coagulation test interference: Telavancin interferes with some laboratory coagulation tests, including prothrombin time, international normalized ratio, and activated partial thromboplastin time. ( 5.5 , 7.1 ) Hypersensitivity reactions: 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. ( 5.6 , 6.2 ) Infusion-related reactions: Administer VIBATIV over at least 60 minutes to minimize infusion-related reactions. ( 5.7 ) Clostridium difficile -Associated Diarrhea: May range from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs. ( 5.8 ) QTc prolongation: Avoid use in patients at risk. Use with caution in patients taking drugs known to prolong the QT interval. ( 5.10 ) 5.1 Increased Mortality in Patients with HABP/VABP and Pre-existing Moderate to Severe Renal Impairment (CrCl ≤50 mL/min) In the analysis of patients (classified by the treatment received) in the two combined HABP/VABP trials with preexisting moderate/severe renal impairment (CrCl ≤50 mL/min), all-cause mortality within 28 days of starting treatment was 95/241 (39%) in the VIBATIV group, compared with 72/243 (30%) in the vancomycin group.

The following serious adverse reactions are also discussed elsewhere in the labeling: Nephrotoxicity [ see Warnings and Precautions ( 5.3 ) ] Infusion-related reactions [ see Warnings and Precautions ( 5.7 ) ] Clostridium difficile -associated diarrhea [ see Warnings and Precautions ( 5.8 ) ] Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Most common adverse reaction (≥10% of patients treated with VIBATIV) in the HABP/VABP trials is diarrhea; in the cSSSI trials, the most common adverse reactions (≥10% of patients treated with VIBATIV) include: taste disturbance, nausea, vomiting, and foamy urine. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Cumberland Pharmaceuticals Inc. at 1-877-683-6110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Complicated Skin and Skin Structure Infections The two Phase 3 cSSSI clinical trials (Trial 1 and Trial 2) for VIBATIV included 929 adult patients treated with VIBATIV at 10 mg/kg IV once daily. The mean age of patients treated with VIBATIV was 49 years (range 18-96). There was a slight male predominance (56%) in patients treated with VIBATIV, and patients were predominantly Caucasian (78%). In the cSSSI clinical trials, <1% (8/929) patients who received VIBATIV died and <1% (8/938) patients treated with vancomycin died.

Pediatric patients: Safety and efficacy have not been established. ( 8.4 ) 8.1 Pregnancy Risk Summary Based on findings in animal reproduction studies, VIBATIV may cause fetal harm. There are no available data on VIBATIV use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In embryo-fetal development studies in rats, rabbits, and minipigs, telavancin demonstrated the potential to cause limb and skeletal malformations when given intravenously during the period of organogenesis at doses providing approximately 1- to 2-fold the human exposure at the maximum recommended clinical dose (see Data). Advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data In embryo-fetal development studies in rats, rabbits, and minipigs, telavancin demonstrated the potential to cause limb and skeletal malformations when given intravenously during the period of organogenesis at doses up to 150, 45, or 75 mg/kg/day, respectively.

Metabolism

The mean pharmacokinetic parameters of telavancin (10 mg/kg) after a single and multiple 60-minute intravenous infusions (10 mg/kg every 24 hours) are summarized in Table 8 . Table 8: Pharmacokinetic Parameters of Telavancin in Healthy Adults, 10 mg/kg C max = maximum plasma concentration; AUC = area under concentration-time course; t 1/2 = terminal elimination half-life; Cl = clearance; V ss = apparent volume of distribution at steady state; -- 1 Data not available Single Dose (n=42) Multiple Dose (n=36) C max (mcg/mL) 93.6 ± 14.2 108 ± 26 AUC 0-∞ (mcg⋅hr/mL) 747 ± 129 -- 1 AUC 0-24h (mcg⋅hr/…

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. Following administration of a single dose of VIBATIV 7.5 mg/kg to subjects with end-stage renal disease, approximately 5.9% of the administered dose of telavancin was recovered in the dialysate following 4 hours of hemodialysis. However, no information is available on the use of hemodialysis to treat an overdosage [ see Clinical Pharmacology ( 12.3 ) ]. The clearance of telavancin by continuous venovenous hemofiltration (CVVH) was evaluated in an in vitro study [ see Nonclinical Toxicology ( 13.2 ) ]. Telavancin was cleared by CVVH and the clearance of telavancin increased with increasing ultrafiltration rate. 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.

• Sep 11, 2009NDANDA022110Cumberland

1. 1Off Label Use1916%
2. 2Renal Failure Acute1513%
3. 3Blood Creatinine Increased1210%
4. 4Nausea1210%
5. 5Chills97.6%
6. 6Thrombocytopenia75.9%
7. 7Diarrhoea65.1%
8. 8Dyspnoea65.1%
9. 9Leukopenia65.1%
10. 10Renal Failure65.1%
11. 11Vomiting65.1%
12. 12Rash54.2%
13. 13Renal Impairment54.2%
14. 14Tubulointerstitial Nephritis54.2%
15. 15Alanine Aminotransferase Increased43.4%

The 10 most recently updated of 17 ClinicalTrials.gov registrations naming Telavancin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Telavancin Blood and Cerebrospinal Fluid Concentrations in Patients With External Ventricular Drainage
  Recruiting · Phase 4 · Interventional · 20 enrolled · Aaron Cook
  NCT06119061updated 2025-12-26
• Telavancin Pediatric PK Study (Ages >12 Months to 17 Years)
  Terminated · Phase 1 · Interventional · 22 enrolled · Cumberland Pharmaceuticals
  NCT02013141updated 2024-06-24
• VIBATIV Pregnancy Registry
  Withdrawn · Observational · 0 enrolled · Cumberland Pharmaceuticals
  NCT01130324updated 2020-10-19
• A Phase 3 Telavancin Staphylococcus Aureus (S. Aureus) Bacteremia Trial
  Terminated · Phase 3 · Interventional · 121 enrolled · Cumberland Pharmaceuticals
  NCT02208063updated 2020-02-17
• Study to Evaluate the Safety and Efficacy of Telavancin in the Treatment of Gram Positive Bloodstream Infections in Cancer Patients
  Completed · Phase 2 · Interventional · 40 enrolled · M.D. Anderson Cancer Center
  NCT01321879updated 2019-12-27
• Telavancin Pharmacokinetics in Cystic Fibrosis Patients
  Completed · Phase 4 · Interventional · 18 enrolled · Joseph L. Kuti, PharmD
  NCT03172793updated 2019-10-24
• Comparison of Telavancin and Vancomycin for Complicated Skin and Skin Structure Infections With a Focus on Methicillin-resistant Staphylococcus Aureus
  Completed · Phase 3 · Interventional · 862 enrolled · Cumberland Pharmaceuticals
  NCT00091819updated 2019-01-16
• Telavancin for Treatment of Uncomplicated Staphylococcus Aureus Bacteremia
  Completed · Phase 2 · Interventional · 60 enrolled · Cumberland Pharmaceuticals
  NCT00062647updated 2019-01-16
• Phase 2 Trial of TD-6424 (Telavancin) Versus Standard Therapy for Complicated Gram Positive Skin and Skin Structure Infections (Gram Positive cSSSI)
  Completed · Phase 2 · Interventional · 201 enrolled · Cumberland Pharmaceuticals
  NCT00077675updated 2019-01-16
• Comparison of Telavancin and Vancomycin for Complicated Skin and Skin Structure Infections With a Focus on Methicillin-resistant Staphylococcus Aureus
  Completed · Phase 3 · Interventional · 1,035 enrolled · Cumberland Pharmaceuticals
  NCT00107978updated 2019-01-16

Frequently asked questions

How does Telavancin work?

Telavancin is an antibacterial drug [ see Clinical Pharmacology ( 12.4 ) ].

What is Telavancin used for?

According to FDA labeling, Telavancin carries indications including: VIBATIV is a lipoglycopeptide antibacterial drug indicated for the treatment of the following infections in adult patients caused by designated susceptible bacteria: Complicated skin and skin structure infections (cSSSI) ( 1.1 ) Hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Staphylococcus aureus . VIBATIV should be reserved for use when alternative treatments are not suitable.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Telavancin?

Telavancin is classified as Glycopeptide antibacterials, Lipoglycopeptide Antibacterial, Decreased Cell Membrane Integrity, Decreased Cell Wall Synthesis & Repair.

What are the brand names for Telavancin?

Telavancin is marketed under brand names including Vibativ.

What are the contraindications for Telavancin?

Telavancin labeling lists contraindications including: Intravenous Unfractionated Heparin Sodium ( 4.1 , 5.5 , 7.1 ) Known hypersensitivity to VIBATIV ( 4.2 , 5.6 , 6.2 ) 4.1 Intravenous Unfractionated Heparin Sodium Use of intravenous unfractionated heparin sodium is contraindicated with VIBATIV administration because the activated partial thromboplastin time (aPTT) test results are expected to be artificially prolonged for 0 to 18 hours after VIBATIV administration [ see Warnings and Precautions ( 5.5 ) and Drug Interactions ( 7.1 ) ]. 4.2 Known Hypersensitivity to VIBATIV VIBATIV is contraindicated in patients with known hypersensitivity to telavancin.. Always consult the full prescribing information and a clinician.