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VIBATIV is a brand name for Telavancin, supplied as a powder for solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE.............................................................................. 3 CONTRAINDICATIONS ................................................................................................... 4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Serious Warnings and Precautions Treatment of HAP/VAP in patients with pre-existing moderate to severe renal impairment (CrCl ≤50 mL/min) was associated with increased mortality observed versus vancomycin. Nephrotoxicity: new onset or worsening renal impairment has occurred.
Monitor renal function in all patients. VIBATIV IS NOT RECOMMENDED for use in patients with severe renal impairment (CrCl < 30 mL/min), and in patients with end stage renal disease (ESRD) requiring hemodialysis (see WARNINGS AND PRECAUTIONS - Renal).
Use of VIBATIV in patients with moderate renal impairment (CrCl 30 - 50 mL/min) should be considered only when the anticipated benefit to the patient outweighs the potential risk. g. serum creatinine) should be monitored MORE FREQUENTLY in this group (see WARNINGS AND PRECAUTIONS – Renal).
Women of childbearing potential should have a serum pregnancy test prior to administration of VIBATIV. Developmental and reproductive toxicology studies in both rats and rabbits demonstrated a low incidence of limb defects (see TOXICOLOGY - Reproductive and Developmental Toxicology).
There are no adequate and well-controlled studies in pregnant women with VIBATIV. VIBATIV should not be used during pregnancy unless the benefit to the mother outweighs the risk to the fetus. General VIBATIV should be administered over a period of not less than 60 minutes to avoid infusion- related reactions.
Rapid intravenous infusions of the glycopeptide class of antimicrobial agents, and VIBATIV, have been associated with “Red-man syndrome” like reactions including: flushing of the upper body, urticaria, pruritus, or rash. Stopping or slowing the infusion may result in cessation of these reactions (see ADVERSE REACTIONS).
As with other antibacterial drugs, use of VIBATIV may result in overgrowth of nonsusceptible organisms, including fungi. Patients should be carefully monitored during therapy. If superinfection occurs during therapy, appropriate measures should be taken.
Prescribing VIBATIV in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. Due to the risk of teratogenicity, women of child-bearing potential who are given VIBATIV should either abstain from sexual activity or use double-barrier means of contraception while on VIBATIV.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Drug interaction studies between VIBATIV and hormonal contraceptives have not been conducted. VIBATIV contains hydroxypropylbetadex, a cyclodextrin. Cyclodextrins have been associated with nephrotoxicity. The use of other medications that contain a cyclodextrin at the same time as VIBATIV is not recommended.
Product Monograph VIBATIVTM Page 6 of 55 Telavancin interferes with some laboratory coagulation tests, such as prothrombin time (PT), international normalized ratio (INR), activated partial thromboplastin time (aPTT), and activated clotting time (see DRUG INTERACTIONS – Drug-Laboratory Interactions).
Cardiovascular In a Phase 1 thorough QT study involving healthy adult volunteers, doses up to 15 mg/kg VIBATIV prolonged the QTc interval (see ACTION AND CLINICAL PHARMACOLOGY- Pharmacodynamics, Table 6). Patients with congenital long QT syndrome, known prolongation of the QTc interval, uncompensated heart failure, or severe left ventricular hypertrophy were not included in clinical trials of VIBATIV.
g. , amiodarone, sotalol) antiarrhythmic agents, or in other pro-arrhythmic conditions (see ACTION AND CLINICAL PHARMACOLOGY - Pharmacodynamics). It is expected that these patients may be more susceptible to drug-induced QT prolongation.
Many drugs that cause QT/QTc prolongation are suspected to increase the risk of a rare polymorphic ventricular tachyarrhythmia known as Torsades de pointes. Generally, the risk of Torsades de pointes increases with the magnitude of QT/QTc prolongation produced by the drug.
Pharmacokinetic studies between telavancin and drugs that prolong the QTc interval such as cisapride, erythromycin, antipsychotics, and tricyclic antidepressants have not been performed. It is recommended that VIBATIV be used with caution in patients taking concomitant medications with any risk of Torsades de pointes.
Ear and Labyrinth Disorders Ototoxicity has not been studied in patients treated with VIBATIV. Pharmacological class related ototoxicity cannot be excluded in these patients. Ototoxicity has been reported with use of telavancin (see ADVERSE REACTIONS).
Patients who develop signs and symptoms of impaired hearing or disorders of the inner ear during treatment with VIBATIV should be carefully evaluated and monitored. Gastrointestinal Clostridium difficile - associated disease (CDAD) Clostridium difficile - associated disease (CDAD) has been reported with use of many antibacterial agents, including VIBATIV (see ADVERSE REACTIONS).
CDAD may range in severity from mild diarrhea to fatal colitis. It is important to consider this diagnosis in patients who present with diarrhea, or symptoms of colitis, pseudomembranous colitis, toxic megacolon, or perforation of colon subsequent to the administration of any antibacterial agent.
CDAD has been reported to occur over two months after the administration of antibacterial agents. Product Monograph VIBATIVTM Page 7 of 55 Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of Clostridium difficile.
Clostridium difficile produces toxins A and B, which contribute to the development of CDAD. CDAD may cause significant morbidity and mortality. CDAD can be refractory to antimicrobial therapy. If the diagnosis of CDAD is suspected or confirmed, appropriate therapeutic […]