VIBATIV is indicated for the treatment of adults with nosocomial pneumonia (NP) including ventilator associated pneumonia, known or suspected to be caused by methicillin-resistant Staphylococcus aureus (MRSA)

VIBATIV should be used only in situations where it is known or suspected that other alternatives are not suitable.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Dosage and usage

IV Icon

VIBATIV 750 mg powder for concentrate for solution for infusion
Each vial contains 750 mg telavancin (as hydrochloride).

After reconstitution, each ml contains 15 mg of telavancin.

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Risk Information

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Patients with severe renal impairment, i.e. creatinine clearance (CrCl) <30 ml/min, including patients undergoing haemodialysis (see section 4.4).

Acute renal failure (see section 4.4).

Pregnancy (see section 4.6).

Special warnings and precautions for use

Renal impairment

In the clinical studies, patients with pre existing acute renal failure receiving telavancin had an increased risk of mortality. All-cause mortality was 32/73 (44%) in the telavancin group and 16/64 (25%) in the vancomycin group, whereas in patients without acute renal failure at baseline it was 118/678 (17%) and 124/688 (18%), respectively. Therefore, the use of telavancin in patients with pre-existing acute renal failure and in patients with severe renal impairment is contraindicated (see section 4.3).

Renal adverse reactions

In the pooled clinical studies (NP and complicated skin and soft tissue infection (cSSTI)), renal adverse reactions were reported more frequently in patients receiving telavancin compared with vancomycin (3.8% vs. 2.2%, respectively). Renal function (serum creatinine and urinary output for oliguria/anuria) should be monitored daily for at least the first 3 to 5 days of therapy and every 48 to 72 hours thereafter in all patients receiving telavancin. Initial dose and dosage adjustments during treatment should be made based on calculated or measured creatinine clearance according to the dosing regimen in section 4.2. If renal function markedly decreases during treatment, the benefit of continuing telavancin should be assessed.

Other factors that may increase the risk of nephrotoxicity

Caution should be used when prescribing VIBATIV to patients receiving concomitant nephrotoxic medicines, those with pre existing renal disease or with co-morbidity known to predispose to kidney dysfunction (e.g. diabetes mellitus, congestive heart failure, hypertension).

Infusion related reactions

Rapid intravenous infusions of antimicrobial agents of the class of glycopeptides have been associated with red man syndrome-like reactions, including flushing of the upper body, urticaria, pruritus or rash (see section 4.8). Stopping or slowing the infusion may result in cessation of these reactions. Infusion related reactions can be limited if the daily dose is infused over a 1 hour period.

Hypersensitivity

Hypersensitivity reactions, including anaphylaxis, have been reported with telavancin, and may be life-threatening. If an allergic reaction to telavancin occurs, discontinue treatment and institute appropriate therapy.

Cross hypersensitivity reactions, including anaphylaxis, have been reported in patients with a history of vancomycin allergy. Caution should be exercised when prescribing telavancin to patients with a prior history of hypersensitivity reaction to vancomycin. If an allergic reaction to telavancin occurs, discontinue treatment and institute appropriate therapy.

QTc prolongation

A clinical QTc study with telavancin doses of 7.5 and 15 mg/kg versus vehicle and an active comparator (400 mg moxifloxacin) showed that once daily dosing for 3 days resulted in a mean vehicle corrected increase in QTcF by 4.1 and 4.5 millisecond, respectively, compared to a 9.2 millisecond increase observed with the comparator.

Cross hypersensitivity reactions, including anaphylaxis, have been reported in patients with a history of vancomycin allergy. Caution should be exercised when prescribing telavancin to patients with a prior history of hypersensitivity reaction to vancomycin. If an allergic reaction to telavancin occurs, discontinue treatment and institute appropriate therapy.

Ototoxicity

As with other glycopeptides, ototoxicity (deafness and tinnitus) has been reported in patients treated with telavancin (see section 4.8). Patients who develop signs and symptoms of impaired hearing or disorders of the inner ear during treatment with telavancin should be carefully evaluated and monitored (see section 4.8). Patients receiving telavancin in conjunction with or sequentially with other medicinal products with known ototoxic potential should be carefully monitored and the benefit of telavancin evaluated if hearing deteriorates.

Superinfection

The use of antibiotics may promote the overgrowth of non-susceptible micro-organisms. If superinfection occurs during therapy, appropriate measures should be taken.

Antibiotic-associated colitis and pseudomembranous colitis

Antibiotic-associated colitis and pseudomembranous colitis have been reported with nearly all antibacterial agents, including telavancin (see section 4.8), and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhoea during or shortly following treatment.

Concomitant antibiotic coverage

Telavancin is active against Gram-positive bacteria only (see section 5.1 for information on the antimicrobial spectrum). In mixed infections where Gram-negative and/or certain types of anaerobic bacteria are suspected, VIBATIV should be co-administered with appropriate antibacterial agent(s).

Specific patient groups

The nosocomial pneumonia (NP) studies excluded known or suspected pulmonary disease like granulomatous diseases, lung cancer, or other malignancy metastatic to the lungs; cystic fibrosis or active tuberculosis; Legionella pneumophila pneumonia; meningitis, endocarditis, or osteomyelitis; refractory shock defined as supine systolic blood pressure <90 mm Hg for >2 hours with evidence of hypoperfusion or requirement for high-dose sympathomimetic agents. Also patients with baseline QTc >500 msec, congenital long QT syndrome, uncompensated heart failure, or abnormal K+ or Mg2+ blood levels that could not be corrected, severely neutropenic (absolute neutrophil count <500/mm3) or anticipated to develop severe neutropenia due to prior or planned chemotherapy, or who had HIV with CD4 count <100/mm3 during the last 6 months were excluded.