Vibativ

Last updated on RxList: 7/20/2020
Vibativ Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Vibativ?

Vibativ (telavancin) for Injection is an antibiotic used to treat severe skin infections.

What Are Side Effects of Vibativ?

Common side effects of Vibativ include:

  • flushing of the upper body if this medication is injected too fast ("red man syndrome")
Tell your doctor immediately if this occurs. The infusion of Vibativ may need to be slowed or stopped.

Other side effects of Vibativ include:

Tell your doctor if you have serious side effects of Vibativ including:

  • diarrhea that is watery or bloody,
  • drowsiness,
  • confusion,
  • mood changes,
  • increased thirst,
  • swelling,
  • weight gain,
  • shortness of breath, or
  • urinating less than usual or not at all.

Dosage for Vibativ

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

What Drugs, Substances, or Supplements Interact with Vibativ?

Vibativ may interact with chemotherapy, medicines to treat a bowel disorder, medication to prevent organ transplant rejection, antiviral medications, pain or arthritis medicines, diuretics, other injected antibiotics, arsenic trioxide, droperidol, antibiotics, antidepressants, anti-malaria medications, heart rhythm medicines, medicine to prevent or treat nausea and vomiting, medicines to treat psychiatric disorders, migraine headache medicines, or narcotics.

Vibativ During Pregnancy and Breastfeeding

Tell your doctor all medications and supplements you use. Vibativ is not recommended for use during pregnancy. It may harm a fetus. It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Vibativ (telavancin) for Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Vibativ Consumer Information

Some side effects may occur during the injection. Tell your caregiver if you feel itchy or tingly, or have a red rash during the injection.

Get emergency medical help if you have signs of an allergic reaction: hives; rapid heartbeats; difficult breathing, fainting; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • severe stomach pain, diarrhea that is watery or bloody (even if it occurs months after your last dose);
  • fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out); or
  • signs of kidney problems--little or no urinating, swelling in your ankles or feet, weight gain, or urine that looks foamy.

Common side effects may include:

  • foamy urine;
  • nausea, vomiting;
  • diarrhea; or
  • changes in your sense of taste.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Vibativ (Telavancin for Injection)

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Vibativ Professional Information

SIDE EFFECTS

The following serious adverse reactions are also discussed elsewhere in the labeling:

  • Nephrotoxicity [see WARNINGS AND PRECAUTIONS]
  • Infusion-related reactions [see WARNINGS AND PRECAUTIONS]
  • Clostridium difficile-associated diarrhea [see WARNINGS AND PRECAUTIONS]

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.

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. 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

VIBATIV (N=929)Vancomycin (N=938)
Body as a Whole
  Rigors4%2%
Digestive System
  Nausea27%15%
  Vomiting14%7%
  Diarrhea7%8%
Metabolic and Nutritional
  Decreased appetite3%2%
Nervous System
  Taste disturbance*33%7%
Renal System
  Foamy urine13%3%
*Described as metallic or soapy taste.

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

CrCl (mL/min)Trial 1Trial 2
VIBATIV N (%)Vancomycin N (%)Difference (95% CI)VIBATIV N (%)Vancomycin N (%)Difference (95% CI)
>80143 (12.2%)152 (14.1%)-1.8
(-9.6, 6.0)
181 (10.5%)181 (18.7%)-8.2
(-15.5, -0.9)
>50-8088 (27.4%)88 (17.7%)9.7
(-2.7, 22.1)
96 (25.6%)90 (27.1%)-1.5
(-14.4, 11.3)
30-5080 (34.7%)83 (23.1%)11.5
(-2.5, 25.5)
62 (27.7%)68 (23.7%)4.0
(-11.1, 19.1)
<3061 (44.3%)51 (37.3%)7.0
(-11.2, 25.2)
38 (61.1%)41 (42.1%)19.0
(-2.9, 40.8)
*(Kaplan-Meier Estimates)

Serious adverse events were reported in 31% of patients treated with VIBATIV and 26% of patients who received vancomycin. Treatment discontinuations due to adverse events occurred in 8% (60/751) of patients who received VIBATIV, the most common events being acute renal failure and electrocardiogram QTc interval prolonged (~1% each). Treatment discontinuations due to adverse events occurred in 5% (40/752) of vancomycin-patients, the most common events being septic shock and multi-organ failure (<1%).

Table 6 displays the incidence of treatment-emergent adverse drug reactions reported in ≥ 5% of HABP/VABP patients treated with VIBATIV possibly related to the drug.

"Table 6: Incidence of Treatment Emergent Adverse Drug Reactions Reported in ≥5% of Patients Treated in HABP/VABP Trial 1 and Trial 2

VIBATIV (N=751)Vancomycin (N=752)
Nausea5%4%
Vomiting5%4%
Renal Failure Acute5%4%

Nephrotoxicity

Complicated Skin and Skin Structure Infections

In cSSSI trials, the incidence of renal adverse events indicative of renal impairment (increased serum creatinine, renal impairment, renal insufficiency, and/or renal failure) was 30/929 (3%) of VIBATIV-treated patients compared with 10/938 (1%) of vancomycin-treated patients. In 17 of the 30 VIBATIV-treated patients, these adverse events had not completely resolved by the end of the trials, compared with 6 of the 10 vancomycin-treated patients. Serious adverse events indicative of renal impairment occurred in 11/929 (1%) of VIBATIV-treated patients compared with 3/938 (0.3%) of vancomycin-treated patients. Twelve patients treated with VIBATIV discontinued treatment due to adverse events indicative of renal impairment compared with 2 patients treated with vancomycin.

Increases in serum creatinine to 1.5 times baseline occurred more frequently among VIBATIV-treated patients with normal baseline serum creatinine (15%) compared with vancomycin-treated patients with normal baseline serum creatinine (7%).

Fifteen of 174 (9%) VIBATIV-treated patients ≥65 years of age had adverse events indicative of renal impairment compared with 16 of 755 patients (2%) <65 years of age [see Use In Specific Populations].

Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia

In the HABP/VABP trials, the incidence of renal adverse events (increased serum creatinine, renal impairment, renal insufficiency, and/or renal failure) was 10% for VIBATIV vs. 8% for vancomycin. Of the patients who had at least one renal adverse event, 54% in each treatment group recovered completely, recovered with sequelae, or were improving from the renal AE at the last visit. Three percent of VIBATIV-treated patients and 2% of vancomycintreated patients experienced at least one serious renal adverse event. Renal adverse events resulted in discontinuation of study medication in 14 VIBATIV-treated patients (2%) and 7 vancomycin-treated patients (1%).

Increases in serum creatinine to 1.5 times baseline occurred more frequently among VIBATIV-treated patients (16%) compared with vancomycin-treated patients (10%).

Forty-four of 399 (11.0%) VIBATIV-treated patients ≥65 years of age had adverse events indicative of renal impairment compared with 30 of 352 patients (8%) <65 years of age [see Use In Specific Populations].

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of VIBATIV. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Serious hypersensitivity reactions have been reported after first or subsequent doses of VIBATIV, including anaphylactic reactions. It is unknown if patients with hypersensitivity reactions to vancomycin will experience cross-reactivity to telavancin. [see Hypersensitivity Reactions]

Read the entire FDA prescribing information for Vibativ (Telavancin for Injection)

© Vibativ Patient Information is supplied by Cerner Multum, Inc. and Vibativ Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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