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Vibativ

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Vibativ

Vibativ

Vibativ Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Vibativ (telavancin) for Injection is an antibiotic used to treat severe skin infections. Common side effects 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 this medication may need to be slowed or stopped. Metallic/soapy taste, nausea, vomiting, or foamy urine may occur.

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. 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. 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.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Vibativ in Detail - Patient Information: Side Effects

Some people receiving a telavancin injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your doctor right away if you feel itchy or tingly, or have a red rash on your upper body during the injection.

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

Call your doctor at once if you have a serious side effect such as:

  • diarrhea that is watery or bloody;
  • drowsiness, confusion, mood changes, increased thirst, loss of appetite, nausea and vomiting;
  • swelling, weight gain, feeling short of breath; or
  • urinating less than usual or not at all.

Less serious side effects may include:

  • nausea, vomiting, diarrhea, stomach pain, loss of appetite;
  • chills or shivering;
  • headache, dizziness;
  • foamy appearance in your urine;
  • unusual or unpleasant taste in your mouth;
  • vaginal itching or discharge;
  • mild skin rash or itching; or
  • redness or pain around the IV needle.

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) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Vibativ Overview - Patient Information: Side Effects

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

Metallic/soapy taste, nausea, vomiting, or foamy urine may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: change in the amount of urine.

Get medical help right away if any of these rare but serious side effects occur: fast/irregular heartbeat, severe dizziness, fainting.

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have any of the following symptoms because these products may make them worse. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.

Use of this medication for prolonged or repeated periods may result in oral thrush or a new vaginal yeast infection. Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Vibativ (Telavancin for Injection)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Vibativ FDA Prescribing Information: Side Effects
(Adverse Reactions)

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 VIBATIV or Vancomycin Patients Treated in cSSSI Trial 1 and Trial 2

  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%
* Described as a 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). In patients treated with VIBATIV, 69% of the patients were white and 65% were 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 (Kaplan-Meier Estimates) Stratified by Baseline Creatinine Clearance - All-Treated Analysis Population

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
(18.7%)
-8.2
(-15.5, -0.9)
> 50-80 88
(27.4%)
88
(17.7%)
9.7
(-2.7, 22.1)
96
(25.6%)
90
(27.1%)
-1.5
(-14.4, 11.3)
30-50 80
(34.7%)
83
(23.1%)
11.5
(-2.5, 25.5)
62
(27.7%)
68
(23.7%)
4.0
(-11.1, 19.1)
< 30 61
(44.3%)
51
(37.3%)
7.0
(-11.2, 25.2)
38
(61.1%)
41(42.1%) 19.0
(-2.9, 40.8)

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 VIBATIV or Vancomycin Patients Treated in HABP/VABP Trial 1 and Trial 2

  VIBATIV
(N=751)
Vancomycin
(N=752)
Nausea 5% 4%
Vomiting 5% 4%
Renal Failure Acute 5% 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 VIBATIVtreated 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) »

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