VIBATIV telavancin hydrochloride 15 mg/mL Injection, Powder, Lyophilized, For Solution
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Lipoglycopeptide Antibacterial class.
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🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Telavancin injection is used alone or with other medications to treat serious skin infections caused by certain types of bacteria. It is also used alone or with other medications to treat certain types of pneumonia caused by bacteria when there are no other treatment options available. Telavancin injection is in a class of medications called lipoglycopeptide antibiotics. It works by killing bacteria that cause infection. Antibiotics such as telavancin injection will not work for colds, flu, or other viral infections. Using antibiotics when they are not needed increases your risk of getting an...
Read the full MedlinePlus article ↗- Vibativ only comes as an intravenous infusion — there's no pill or tablet form. It needs to go directly into your bloodstream to reach the high levels needed to fight a serious bac...
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- The most common side effects include an altered or metallic taste, nausea, vomiting, foamy urine, and diarrhea. These are worth mentioning to your care team but aren't usually dang...
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Patient education
Supplement & herbal interactions
Telavancin may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII QTT17582CB
A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
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UNII 1I96OHX6EK
A cyclic carbohydrate derived from plant starch that acts as a solubilizer and stabilizer. It helps dissolve poorly water-soluble drugs and protects active ingredients from degradation in the formulation.
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UNII 3OWL53L36A
A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
4 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $548.10 | $27,405.10 / 50 ml |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Vibativ 15 mg/mLthis 66220-0315-11 | Cumberland | 1 vial | — | — | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.
Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.
🛈 What do these terms mean?
- Patent
- Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
- Substance patent
- Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
- Formulation (product) patent
- Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
- Method-of-use patent
- A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
- Skinny label
- A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
- Exclusivity
- FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
- Paragraph IV
- A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
- RLD / RS
- Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
- TE / AB rating
- FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
- LOE (loss of exclusivity)
- The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.
Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.
| Patent | Type | Use code | Expires |
|---|---|---|---|
| US 7531623 ↗ | Drug substance | — | Jan 1, 2027 |
| US 7531623 ↗ | Drug substance | — | Jan 1, 2027 |
Is there a generic version of VIBATIV 750 MG VIAL?
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🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 66220-0315-11 You're viewing this | 1 VIAL, SINGLE-DOSE in 1 CARTON (66220-315-11) / 50 mL in 1 VIAL, SINGLE-DOSE | 2021-01-01 | Active |
| 66220-0315-22 | 12 VIAL, SINGLE-DOSE in 1 CARTON (66220-315-22) / 50 mL in 1 VIAL, SINGLE-DOSE | 2021-01-01 | Active |
| 66220-0315-44 | 4 VIAL, SINGLE-DOSE in 1 CARTON (66220-315-44) / 50 mL in 1 VIAL, SINGLE-DOSE | 2023-12-15 | Active |
This pack accounts for about 21% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓
Pack size FAQ
What quantity is in NDC 66220-0315-11?
What NDC number is used to bill for this package of VIBATIV telavancin hydrochloride 15 mg/mL Injection, Powder, Lyophilized, For Solution?
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | ✓ Available |
Questions about this listing
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📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: 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 ( 5.1 , 8.4 )].
Nephrotoxicity: New onset or worsening renal impairment has occurred. Monitor renal function in all patients [see Warnings and Precautions ( 5.3 )] . Embryofetal Toxicity: VIBATIV may cause fetal harm.
In animal reproduction studies, adverse developmental outcomes were observed in 3 animal species at clinically relevant doses. Verify pregnancy status in females of reproductive potential prior to initiating VIBATIV. Advise pregnant women of the potential risk to a fetus.
Advise females of reproductive potential to use effective contraception during treatment with VIBATIV and for 2 days after the final dose [see Warnings and Precautions ( 5.1 ), and Use in Specific Populations ( 8.1 , 8.3 )]. WARNING: INCREASED MORTALITY IN HABP/VABP PATIENTS WITH PRE-EXISTING MODERATE OR SEVERE RENAL IMPAIRMENT, NEPHROTOXICITY, and EMBRYO-FETAL TOXICITY See full prescribing information for the complete boxed warning 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 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. ( 5.1 , 8.4 ) Nephrotoxicity: New onset or worsening renal impairment has occurred. Monitor renal function in all patients.
( 5.3 ) Embryo-Fetal Toxicity: VIBATIV may cause fetal harm. In animal reproduction studies, adverse developmental outcomes were observed in 3 animal species at clinically relevant doses. Verify pregnancy status prior to initiating treatment and advise females of reproductive potential to use effective contraception ( 5.4 , 8.1 , 8.3 ).
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE 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. ( 1.2 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of VIBATIV and other antibacterial drugs VIBATIV should only be used to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
1.1Complicated Skin and Skin Structure Infections VIBATIV is indicated for the treatment of adult patients with complicated skin and skin structure infections (cSSSI) caused by susceptible isolates of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible and -resistant isolates), Streptococcus pyogenes , Streptococcus agalactiae , Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus) , or Enterococcus faecalis (vancomycinsusceptible isolates only).
1.2HABP/VABP VIBATIV is indicated for the treatment of adult patients with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP), caused by susceptible isolates of Staphylococcus aureus (both methicillin-susceptible and -resistant isolates). VIBATIV should be reserved for use when alternative treatments are not suitable.
1.3Usage Combination therapy may be clinically indicated if the documented or presumed pathogens include Gram-negative organisms. Appropriate specimens for bacteriological examination should be obtained in order to isolate and identify the causative pathogens and to determine their susceptibility to telavancin. VIBATIV may be initiated as empiric therapy before results of these tests are known.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of VIBATIV and other antibacterial drugs, VIBATIV should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION 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.
2.1Complicated 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.
2.2Hospital-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.
2.3Patients with Renal Impairment Because telavancin is eliminated primarily by the kidney, a dosage adjustment is required for patients whose creatinine clearance is ≤50 mL/min, as listed in Table 1 [ see Clinical Pharmacology ( 12.3 ) ]. Table 1: Dosage Adjustment in Adult Patients with Renal Impairment a Calculate using the Cockcroft-Gault formula and ideal body weight (IBW). Use actual body weight if it is less than 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 There is insufficient information to make specific dosage adjustment recommendations for patients with end-stage renal disease (CrCl <10 mL/min), including patients undergoing hemodialysis.
2.4Preparation and Administration 750 mg vial : Reconstitute the contents of a VIBATIV 750 mg vial with 45 mL of 5% Dextrose Injection, USP; Sterile Water for Injection, USP; or 0.9% Sodium Chloride Injection, USP. The resultant solution has a concentration of 15 mg/mL (total volume of approximately 50.0 mL). To minimize foaming during product reconstitution, allow the vacuum of the vial to pull the diluent from the syringe into the vial.
Do not forcefully inject the diluent into the vial. Do not forcefully shake the vial and do not shake final infusion solution. The following formula can be used to calculate the volume of reconstituted VIBATIV solution required to prepare a dose: Telavancin dose (mg) = 10 mg/kg or 7.5 mg/kg x patient weight (in kg) (see Table 1 ) Volume of reconstituted solution (mL) = Telavancin dose (mg) 15 mg/mL For doses of 150 to 800 mg, the appropriate volume of reconstituted solution must be further diluted in 100 to 250 mL prior to infusion.
Doses less than 150 mg or greater than 800 mg should be further diluted in a volume resulting in a final concentration of 0.6 to 8 mg/mL. Appropriate infusion solutions include: 5% Dextrose Injection, USP; 0.9% Sodium Chloride Injection, USP; or Lactated Ringer's Injection, USP. The dosing solution should be administered by intravenous infusion over a period of 60 minutes.
Reconstitution time is generally under 2 minutes, but can sometimes take up to 20 minutes. Mix thoroughly to reconstitute and check to see if the contents have dissolved completely. Parenteral drug products should be inspected visually for particulate matter prior to administration.
D…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS VIBATIV is supplied in single-dose vials containing 750 mg telavancin as a sterile, lyophilized powder. Single-dose vials containing 750 mg telavancin. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Intravenous Unfractionated Heparin Sodium ( 4.1 , 5.5 , 7.1 ) Known hypersensitivity to VIBATIV ( 4.2 , 5.6 , 6.2 )
4.1Intravenous 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 ) ].
4.2Known Hypersensitivity to VIBATIV VIBATIV is contraindicated in patients with known hypersensitivity to telavancin.
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS 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 )
5.1Increased 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. Allcause mortality at 28 days in patients without pre-existing moderate/severe renal impairment (CrCl >50 mL/min) was 86/510 (17%) in the VIBATIV group and 92/510 (18%) in the vancomycin group.
Therefore, VIBATIV use in patients with baseline CrCl ≤50 mL/min should be considered only when the anticipated benefit to the patient outweighs the potential risk [ see Adverse Reactions ( 6.1 ), Use in Specific Populations ( 8.4 ) and Clinical Studies ( 14.2 ) ].
5.2Decreased Clinical Response in Patients with cSSSI and Pre-existing Moderate/Severe Renal Impairment (CrCl ≤50 mL/min) In a subgroup analysis of the combined cSSSI trials, clinical cure rates in the VIBATIV-treated patients were lower in patients with baseline CrCl ≤50 mL/min compared with those with CrCl >50 mL/min ( Table 2 ). A decrease of this magnitude was not observed in vancomycin-treated patients. Consider these data when selecting antibacterial therapy for use in patients with cSSSI and with baseline moderate/severe renal impairment.
Table 2: Clinical Cure by Pre-existing Renal Impairment – Clinically Evaluable Population VIBATIV % (n/N) Vancomycin % (n/N) cSSSI Trials CrCl >50 mL/min 87.0% (520/598) 85.9% (524/610) CrCl ≤50 mL/min 67.4% (58/86) 82.7% (67/81)
5.3Nephrotoxicity In both the HABP/VABP trials and the cSSSI trials, renal adverse events were more likely to occur in patients with baseline comorbidities known to predispose patients to kidney dysfunction (pre-existing renal disease, diabetes mellitus, congestive heart failure, or hypertension). The renal adverse event rates were also higher in patients who received concomitant medications known to affect kidney function (e.g., non-steroidal anti-inflammatory drugs, ACE inhibitors, and loop diuretics). Monitor renal function (i.e., serum creatinine, creatinine clearance) in all patients receiving VIBATIV.
Values should be obtained prior to initiation of treatment, during treatment (at 48- to 72-hour intervals or more frequently, if clinically indicated), and at the end of therapy. If renal function decreases, the benefit of continuing VIBATIV versus discontinuing and initiating therapy with an alternative agent should be assessed [ see Dosage and Administration ( 2 ), Adverse Reactions ( 6 ), and Clinical Pharmacology ( 12.3 ) ]. In patients with renal dysfunction, accumulation of the solubilizer hydroxypropyl-beta-cyclodextrin can occur [ see Patients with Renal…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS 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.
6.1Clinical 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. Serious adverse events were reported in 7% (69/929) of patients treated with VIBATIV and most commonly included renal, respiratory, or cardiac events. Serious adverse events were reported in 5% (43/938) of vancomycin-treated patients, and most commonly included cardiac, respiratory, or infectious events.
Treatment discontinuations due to adverse events occurred in 8% (72/929) of patients treated with VIBATIV, the most common events being nausea and rash (~1% each). Treatment discontinuations due to adverse events occurred in 6% (53/938) of vancomycin-treated patients, the most common events being rash and pruritus (~1% each). The most common adverse events occurring in ≥10% of VIBATIV-treated patients observed in the VIBATIV Phase 3 cSSSI trials were taste disturbance, nausea, vomiting, and foamy urine.
Table 4 displays the incidence of treatment-emergent adverse drug reactions reported in ≥2% of patients treated with VIBATIV possibly related to the drug. Table 4: Incidence of Treatment-Emergent Adverse Drug Reactions Reported in ≥2% of Patients Treated in cSSSI Trial 1 and Trial 2 *Described as metallic or soapy taste. VIBATIV (N=929) Vancomycin (N=938) Body as a Whole Rigors 4% 2% Digestive System Nausea 27% 15% Vomiting 14% 7% Diarrhea 7% 8% Metabolic and Nutritional Decreased appetite 3% 2% Nervous System Taste disturbance * 33% 7% Renal System Foamy urine 13% 3% HABP/VABP Two randomized, double-blind Phase 3 trials (Trial 1 and Trial 2) for VIBATIV included 1,503 adult patients treated with VIBATIV at 10 mg/kg IV once daily or vancomycin at 1 g IV twice daily.
The mean age of patients treated with VIBATIV was 62 years (range 18-100) with 69% of the patients white and 65% male. In the combined VIBATIV group, 29% were VAP and 71% were HAP patients. Table 5 summarizes deaths using Kaplan-Meier estimates at Day 28 as stratified by baseline creatinine clearance categorized into four groups.
Patients with pre-existing moderate/severe renal impairment (CrCl ≤ 50 mL/min) who were treated with VIBATIV for HABP/VABP had increased mortality observed versus vancomycin in both the trials. Table 5: 28-Day Mortality* Stratified by Baseline Creatinine Clearance- All-Treated Analysis Population *(Kaplan-Meier Estimates) CrCl (mL/min) Trial 1 Trial 2 VIBATIV N (%) Vancomycin N (%) Difference (95% CI) VIBATIV N (%) Vancomycin N (%) Difference (95% CI) >80 143 (12.2%) 152 (14.1%) -1.8 (-9.6, 6.0) 181 (10.5%) 181 (18.…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS
7.1Drug-Laboratory Test Interactions Effects of Telavancin on Coagulation Test Parameters Telavancin binds to the artificial phospholipid surfaces added to common anticoagulation tests, thereby interfering with the ability of the coagulation complexes to assemble on the surface of the phospholipids and promote clotting in vitro . These effects appear to depend on the type of reagents used in commercially available assays. Thus, when measured shortly after completion of an infusion of VIBATIV, increases in the PT, INR, aPTT, and ACT have been observed.
These effects dissipate over time, as plasma concentrations of telavancin decrease. Urine Protein Tests Telavancin interferes with urine qualitative dipstick protein assays, as well as quantitative dye methods (e.g., pyrogallol red-molybdate). However, microalbumin assays are not affected and can be used to monitor urinary protein excretion during VIBATIV treatment.
🔄 Drug / Laboratory Test Interactions ▾
7.1Drug-Laboratory Test Interactions Effects of Telavancin on Coagulation Test Parameters Telavancin binds to the artificial phospholipid surfaces added to common anticoagulation tests, thereby interfering with the ability of the coagulation complexes to assemble on the surface of the phospholipids and promote clotting in vitro . These effects appear to depend on the type of reagents used in commercially available assays. Thus, when measured shortly after completion of an infusion of VIBATIV, increases in the PT, INR, aPTT, and ACT have been observed.
These effects dissipate over time, as plasma concentrations of telavancin decrease. Urine Protein Tests Telavancin interferes with urine qualitative dipstick protein assays, as well as quantitative dye methods (e.g., pyrogallol red-molybdate). However, microalbumin assays are not affected and can be used to monitor urinary protein excretion during VIBATIV treatment.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Pediatric patients: Safety and efficacy have not been established. ( 8.4 )
8.1Pregnancy 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. These doses resulted in exposure levels approximately 1- to 2-fold the human exposure (AUC) at the maximum recommended clinical dose.
Malformations observed at <1% (but absent or at lower rates in historical or concurrent controls), included brachymelia (rats and rabbits), syndactyly (rats, minipigs), adactyly (rabbits), and polydactyly (minipigs). Additional findings in rabbits included flexed front paw and absent ulna, and in the minipigs included misshapen digits and deformed front leg. Fetal body weights were decreased in rats.
In a prenatal/perinatal development study, pregnant rats received intravenous telavancin at up to 150 mg/kg/day (approximately the same AUC as observed at the maximum clinical dose) from the start of organogenesis through lactation. Offspring showed decreases in fetal body weight and an increase in the number of stillborn pups. Brachymelia was also observed.
Developmental milestones and fertility of the pups were unaffected.
8.2Lactation Risk Summary There are no data on the presence of telavancin in human milk, the effects on the breastfed child, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for VIBATIV and any potential adverse effects on the breastfed child from VIBATIV or from the underlying maternal conditions.
8.3Females and Males of Reproductive Potential Pregnancy Testing Verify pregnancy status in females of reproductive potential prior to initiating VIBATIV. Contraception Females VIBATIV may cause fetal harm when administered to a pregnant woman [see Use in Specific Populations ( 8.1 )]. Advise females of reproductive potential to use effective contraception during treatment and for 2 days after the final dose.
Infertility Males Based on findings in rats, VIBATIV may impair male fertility [see Nonclinical Toxicology ( 13.1 )]. The effect on fertility was reversible in rats.
8.4Pediatric Use The safety and effectiveness of VIBATIV have not been established in pediatric patients. In particular, there is a concern for poor clinical outcomes in pediatric patients less than one year of age due to immature renal function. Increased mortality in adult patients with HABP/VABP and renal impairment and decreased clinical response in adults with cSSSI and renal impairment were observed [see Boxed Warning and Warnings and Precautions ( 5.1 , 5.2 )] .
8.5Geriatric Use Of the 929 patients treated with VIBATIV at a dose of 10 mg/kg once daily in clinical trials of cSSSI, 174 (19%) were ≥65 years of age…
🤰 Pregnancy ▾
8.1Pregnancy 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. These doses resulted in exposure levels approximately 1- to 2-fold the human exposure (AUC) at the maximum recommended clinical dose.
Malformations observed at <1% (but absent or at lower rates in historical or concurrent controls), included brachymelia (rats and rabbits), syndactyly (rats, minipigs), adactyly (rabbits), and polydactyly (minipigs). Additional findings in rabbits included flexed front paw and absent ulna, and in the minipigs included misshapen digits and deformed front leg. Fetal body weights were decreased in rats.
In a prenatal/perinatal development study, pregnant rats received intravenous telavancin at up to 150 mg/kg/day (approximately the same AUC as observed at the maximum clinical dose) from the start of organogenesis through lactation. Offspring showed decreases in fetal body weight and an increase in the number of stillborn pups. Brachymelia was also observed.
Developmental milestones and fertility of the pups were unaffected.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of VIBATIV have not been established in pediatric patients. In particular, there is a concern for poor clinical outcomes in pediatric patients less than one year of age due to immature renal function. Increased mortality in adult patients with HABP/VABP and renal impairment and decreased clinical response in adults with cSSSI and renal impairment were observed [see Boxed Warning and Warnings and Precautions ( 5.1 , 5.2 )] .
🧓 Geriatric Use ▾
8.5Geriatric Use Of the 929 patients treated with VIBATIV at a dose of 10 mg/kg once daily in clinical trials of cSSSI, 174 (19%) were ≥65 years of age and 87 (9%) were ≥75 years of age. In the cSSSI trials, lower clinical cure rates were observed in patients ≥65 years of age compared with those <65 years of age. Overall, treatment-emergent adverse events occurred with similar frequencies in patients ≥65 (75% of patients) and <65 years of age (83% of patients).
Fifteen of 174 (9%) patients ≥65 years of age treated with VIBATIV had adverse events indicative of renal impairment compared with 16 of 755 (2%) patients <65 years of age [ see Warnings and Precautions ( 5.3 ), Clinical Trials ( 14.1 ) ]. Of the 749 HABP/VABP patients treated with VIBATIV at a dose of 10 mg/kg once daily in clinical trials of HABP/VABP, 397 (53%) were ≥65 years of age and 230 (31%) were ≥75 years of age. Treatment-emergent adverse events as well as deaths and other serious adverse events occurred more often in patients ≥ 65 years of age than in those <65 years of age in both treatment groups.
Telavancin is substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection in this age group. The mean plasma AUC values of telavancin were similar in healthy young and elderly subjects.
Dosage adjustment for elderly patients should be based on renal function [ see Dosage and Administration ( 2 ), Clinical Pharmacology ( 12.3 ) ].
🆘 Overdosage ▾
10 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. 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.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Telavancin is an antibacterial drug [ see Clinical Pharmacology ( 12.4 ) ].
12.2Pharmacodynamics The antimicrobial activity of telavancin appears to best correlate with the ratio of area under the concentration-time curve to minimum inhibitory concentration (AUC/MIC) for S taphylococcus aureus based on animal models of infection. Exposure-response analyses of the clinical trials support the dose of 10 mg/kg every 24 hours. Cardiac Electrophysiology The effect of telavancin on cardiac repolarization was assessed in a randomized, double-blind, multiple-dose, positive-controlled, and placebo-controlled, parallel study (n=160).
Healthy subjects received VIBATIV 7.5 mg/kg, VIBATIV 15 mg/kg, positive control, or placebo infused over 60 minutes once daily for 3 days. Based on interpolation of the data from VIBATIV 7.5 mg/kg and 15 mg/kg, the mean maximum baseline-corrected, placebocorrected QTc prolongation at the end of infusion was estimated to be 12-15 msec for VIBATIV 10 mg/kg and 22 msec for the positive control ( Table 7 ). By 1 hour after infusion the maximum QTc prolongation was 6-9 msec for VIBATIV and 15 msec for the positive control.
Table 7: Mean and Maximum QTcF Changes from Baseline Relative to Placebo 1 Fridericia corrected; 2 Upper Confidence Limit (CL) from a 2-sided 90% Confidence Interval (CI) on difference from placebo (msec) QTcF 1 Change from Baseline Mean (Upper 90% Confidence Limit 2 ) msec Maximum (Upper 90% Confidence Limit) msec VIBATIV 7.5 mg/kg 4.1 (7) 11.6 (16) VIBATIV 15 mg/kg 4.6 (8) 15.1 (20) Positive Control 9.5 (13) 21.6 (26) ECGs were performed prior to and during the treatment period in patients receiving VIBATIV 10 mg/kg in 3 cSSSI studies to monitor QTc intervals.
In these trials, 214 of 1029 (21%) patients allocated to treatment with VIBATIV and 164 of 1033 (16%) allocated to vancomycin received concomitant medications known to prolong the QTc interval and known to be associated with definite or possible risk of torsades de pointes. The incidence of QTc prolongation >60 msec was 1.5% (15 patients) in the VIBATIV group and 0.6% (6 patients) in the vancomycin group. Nine of the 15 VIBATIV patients received concomitant medications known to prolong the QTc interval and definitely or possibly associated with a risk of torsades de pointes, compared with 1 of the 6 patients who received vancomycin.
A similar number of patients in each treatment group (<1%) who did not receive a concomitant medication known to prolong the QTc interval experienced a prolongation >60 msec from baseline. In a separate analysis, 1 patient in the VIBATIV group and 2 patients in the vancomycin group experienced QTc >500 msec. No cardiac adverse events were ascribed to prolongation of the QTc interval.
In the Phase 3 HABP/VABP studies, the incidence of QTc prolongation >60 msec or mean value >500 msec was 8% (52 patients) in the telavancin group and 7% (48 patients) in the vancomycin group.
12.3Pharmacokinetics 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/mL) 666 ± 107 780 ± 125 t 1/2 (hr) 8.0 ± 1.5 8.1 ±
1.5Cl (mL/hr/kg) 13.9 ± 2.9 13.1 ±
2.0V ss (mL/kg) 145 ± 23 133 ± 24 In healthy young adults, the pharmacokinetics of telavancin administered intravenously were linear following single doses from 5 to 12.5 mg/kg and multiple doses from 7.5 to 15 mg/kg administered once daily for up to 7 days. Steadystate concentrations were ach…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Telavancin is an antibacterial drug [ see Clinical Pharmacology ( 12.4 ) ].
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Individual cartons of 750 mg single-dose vials (NDC 66220-315-11) Cartons of 12 individually packaged 750 mg single-dose vials (NDC 66220-315-22); cartons of 4 individually packaged 750 mg single-dose vials (NDC 66220-315-44) Store original packages at refrigerated temperatures of 2°C to 8°C (35°F to 46°F). Excursions to ambient temperatures (up to 25°C (77°F) are acceptable. Avoid excessive heat.
📋 Description ▾
11 DESCRIPTION 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[[(phosphonomethyl)-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 C 80 H 106 Cl 2 N 11 O 27 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 750 mg of telavancin as the free base) for intravenous use. The inactive ingredients are Hydroxypropylbetadex, (hydroxypropyl-beta-cyclodextrin) (7500 mg per 750 mg telavancin), mannitol (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). Figure 1
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Medication Guide ). Embryo-Fetal Toxicity Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions ( 5.4 ) and Use in Specific Populations ( 8.1 , 8.3 )].
Advise female patients of reproductive potential to use effective contraception during treatment with VIBATIV and for 2 days after the final dose [see Use in Specific Populations ( 8.3 )] Diarrhea Diarrhea is a common problem caused by antibiotics that usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as 2 or more months after having received the last dose of the antibiotic.
If this occurs, patients should contact their physician as soon as possible. Antibacterial Resistance Patients should be counseled that antibacterial drugs including VIBATIV should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold).
When VIBATIV is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may: (1) decrease the effectiveness of immediate treatment, and (2) increase the likelihood that the bacteria will develop resistance and will not be treatable by VIBATIV or other antibacterial drugs in the future. Common Adverse Effects Patients should be informed about the common adverse effects of VIBATIV including diarrhea, taste disturbance, nausea, vomiting, headache, and foamy urine.
Patients should be instructed to inform their healthcare provider if they develop any unusual symptom, or if any known symptom persists or worsens. Patients should be instructed to inform their healthcare provider of any other medications they are currently taking with VIBATIV, including over-thecounter medications. Manufactured for: Cumberland Pharmaceuticals Inc.
Nashville, TN 37203 US Patent Nos. 6,635,618 B2; 6,858,584 B2; 6,872,701 B2; 7,008,923 B2; 7,208,471 B2; 7,351,691 B2; 7,531,623 B2; 7,544,364 B2; 7,700,550 B2; 8,101,575 B2; 8,158,580 B2. VIBATIV ® and the VIBATIV ® logo are a registered trademark of Cumberland Pharmaceuticals Inc.
💬 Medication Guide ▾
This Medication Guide has been approved by the U.S. Food and Drug Administration Revised: 01/2021 MEDICATION GUIDE VIBATIV ® (vy-'ba-tiv) (telavancin) for injection, for intravenous use Read this Medication Guide before you receive VIBATIV. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.
What is the most important information I should know about VIBATIV? VIBATIV can cause serious side effects, including: Increased risk of death. VIBATIV was associated with an increased risk of death compared to vancomycin in people who already had kidney problems and were treated for bacterial pneumonia that you can get when you are in the hospital.
New or worsening kidney problems. Your healthcare provider should do a blood test to check your kidneys before you start, while you receive, and after you stop receiving VIBATIV. VIBATIV may harm your unborn baby.
If you are a woman who can become pregnant, your healthcare provider should do a pregnancy test before you start receiving VIBATIV. Talk to your healthcare provider if you are pregnant or plan to become pregnant. Your healthcare provider will decide if VIBATIV is the right medicine for you.
Women who can become pregnant should use effective birth control (contraception) while receiving VIBATIV and for 2 days after the last dose of VIBATIV. Talk to your healthcare provider if you have questions about birth control. What is VIBATIV?
VIBATIV is a prescription antibacterial medicine 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) It is not known if VIBATIV is safe or effective in children. Who should not receive VIBATIV? Do not receive VIBATIV if you: are allergic to telavancin or any of the ingredients in VIBATIV.
See the end of this Medication Guide for a complete list of ingredients in VIBATIV. What should I tell my healthcare provider before receiving VIBATIV? Before you receive VIBATIV, tell your healthcare provider about all of your medical conditions, including if you: have had a serious allergic reaction to VIBATIV or vancomycin. have kidney problems. have diabetes. have, have had or have a family history of heart problems, including QTc prolongation. have high blood pressure. are pregnant or plan to become pregnant.
See “ What is the most important information I should know about VIBATIV? ” are breastfeeding or plan to breastfeed. It is not known if VIBATIV passes into breast milk. You and your healthcare provider should decide if you will breastfeed while receiving VIBATIV.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. VIBATIV and other medicines can affect each other causing side effects. Especially tell your healthcare provider if you take : a Non-Steroidal Anti-Inflammatory Drug (NSAID) certain blood pressure medicines called Angiotensin-Converting Enzyme (ACE) Inhibitors or Angiotensin Receptor Blockers (ARBs) water pills (diuretics) a blood thinner medicine to control your heart rate or rhythm (antiarrhythmics) Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure.
Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine. How will I receive VIBATIV?
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 possible side effects of VIBATIV? VIBATIV may cause serious side effects, including: See “ What is t…