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Vibativ (Telavancin Hydrochloride) - Side Effects and Adverse Reactions

 
 



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 (5.6)]
  • Clostridium difficile-associated diarrhea [see Warnings and Precautions (5.7)]

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)

* Described as a metallic or soapy taste.

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). 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 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 (8.5)].

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 vancomycin-treated 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 (8.5)].

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 (5.5)].



REPORTS OF SUSPECTED VIBATIV SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Vibativ. The information is not vetted and should not be considered as verified clinical evidence.

Possible Vibativ side effects / adverse reactions in 50 year old female

Reported by a physician from United States on 2011-10-04

Patient: 50 year old female

Reactions: Platelet Count Decreased

Suspect drug(s):
Invanz
    Dosage: unk
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-07-29
    End date: 2011-08-17

Vibativ
    Dosage: unk
    Indication: Cellulitis
    Start date: 2011-07-29
    End date: 2011-08-17



Possible Vibativ side effects / adverse reactions in 60 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-14

Patient: 60 year old male weighing 104.0 kg (228.8 pounds)

Reactions: Electrocardiogram QT Prolonged

Suspect drug(s):
Lexapro
    Dosage: oral
    Administration route: Oral

Vibativ
    Dosage: 10 mg/kg total daily dose, intravenous (not otherwise specified)
    Indication: Cellulitis
    Start date: 2011-02-18
    End date: 2011-02-20

Trazodone HCL
    Dosage: oral
    Administration route: Oral

Other drugs received by patient: Metoprolol Tartrate; Fentanyl; Novolin R; Cilostazol; Lisinopril; Imdur; Vitamin D (Colecalciferol); Sitagliptin; Lasix; Hydromorphone HCL; Calcium Citrate; Omeprazole; Reglan; Zolpiderm; Lantus; Oxycodone HCL; Warfarin Sodium; Lipitor



Possible Vibativ side effects / adverse reactions in 65 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-21

Patient: 65 year old female

Reactions: Muscle Spasms

Adverse event resulted in: hospitalization

Suspect drug(s):
Vibativ

Other drugs received by patient: Metoprolol Tartrate; Actos; Anastrozole; Antara (Micronized)



See index of all Vibativ side effect reports >>

Drug label data at the top of this Page last updated: 2014-03-31

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