Vibativ
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Vibativ
Vibativ Side Effects Center
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
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 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
The two Phase 3 cSSSI clinical trials (Trial 1 and Trial 2) for VIBATIV (telavancin for injection) included 929 adult patients treated with VIBATIV (telavancin for injection) at 10 mg/kg IV once daily. The mean age of patients treated with VIBATIV (telavancin for injection) was 49 years (range 18-96). There was a slight male predominance (56%) in patients treated with VIBATIV (telavancin for injection) , and patients were predominantly Caucasian (78%).
In the cSSSI clinical trials, < 1% (8/929) patients who received VIBATIV (telavancin for injection) died and < 1% (8/938) patients treated with vancomycin died. Serious adverse events were reported in 7% (69/929) of patients treated with VIBATIV (telavancin for injection) 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 (telavancin for injection) , 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 reactions occurring in 10% of VIBATIV (telavancin for injection) -treated patients observed in the VIBATIV (telavancin for injection) 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 (telavancin for injection) possibly related to the drug (including those reactions known to occur with other glycopeptide antibacterial agents).
Table 4: Incidence of Treatment-emergent Adverse Drug Reactions
Reported in ≥ 2% of VIBATIV (telavancin for injection) or Vancomycin Patients Treated in Trial 1 and
Trial 2
| VIBATIV (N=929) |
Vancomycin (N=938) |
|
| Body as a Whole | ||
| Rigors | 4% | 2% |
| Generalized pruritus | 3% | 6% |
| Digestive System | ||
| Nausea | 27% | 15% |
| Vomiting | 14% | 7% |
| Diarrhea | 7% | 8% |
| Abdominal pain | 2% | 2% |
| Metabolic and Nutritional | ||
| Decreased appetite | 3% | 2% |
| Nervous System | ||
| Taste disturbance1 | 33% | 7% |
| Dizziness | 6% | 6% |
| Renal System | ||
| Foamy urine | 13% | 3% |
| Skin and Appendages | ||
| Pruritus | 6% | 13% |
| Rash | 4% | 5% |
| Other | ||
| Infusion site pain | 4% | 4% |
| Infusion site erythema | 3% | 3% |
| 1Described as a metallic or soapy taste. | ||
Read the entire FDA prescribing information for Vibativ (Telavancin for Injection) »
Additional Vibativ Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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