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VABOMERE is a brand name for Meropenem, supplied as a powder for solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: VABOMERE (meropenem and vaborbactam) is indicated in adults for the treatment of the following infections known or suspected to be caused by carbapenem-resistant, vaborbactam/meropenem- susceptible Gram-negative bacteria • Complicated urinary tract infections (cUTI), including pyelonephritis • Complicated…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing considerations • VABOMERE should be used to treat infections due to aerobic Gram-negative organisms in adult patients with limited treatment options only after consultation with a healthcare professional with appropriate experience in the management of infectious diseases.
73m2. The duration of treatment is for up to 14 days. 73m2. The recommended dosage of VABOMERE in patients with varying degrees of renal function is presented in Table 1. For patients with changing renal function, monitor serum creatinine concentrations and eGFR at least daily and adjust the dosage of VABOMERE accordingly.
Meropenem and vaborbactam are removed by hemodialysis. For patients maintained on hemodialysis, administer VABOMERE after hemodialysis session. 212 if African American) b All doses of VABOMERE are administered intravenously over 3 hours.
c Doses adjusted for renal impairment should be administered after a hemodialysis session. d The total duration of treatment is for up to 14 days. • Hepatic impairment A pharmacokinetic study conducted with an intravenous formulation of meropenem in patients with hepatic impairment has shown no effects of liver disease on the pharmacokinetics of meropenem.
The primary phase 3 studies (505 and 506) excluded patients with significant hepatic disease or dysfunction. Vaborbactam does not undergo hepatic metabolism. Therefore, the systemic clearance of meropenem and vaborbactam is not expected to be affected by hepatic impairment.
• Paediatric population < 18 years of age The safety and efficacy of VABOMERE in pediatric patients below the age of 18 years have not been established. No data are available. VABOMERE is not recommended for use in pediatric patients below the age of 18 years.
• Geriatric patients ≥ 65 years of age No dosage adjustment in geriatric patients is necessary. 3 Reconstitution Standard aseptic techniques must be used for solution preparation and administration. The VABOMERE powder for solution must be reconstituted and further diluted prior to use.
Reconstitution To prepare the required dose for intravenous infusion, constitute the appropriate number of vials, as determined from Table 2 below. 9% Sodium Chloride Injection, USP, from an infusion bag and constitute each vial of VABOMERE.
, are generally mild in severity and resolve on withdrawal or dose reduction. Studies show that both meropenem and vaborbactam are readily dialyzable and effectively removed by hemodialysis; however, no information is available on the use of hemodialysis to treat overdosage.
For management of a suspected drug overdose, contact your regional poison control centre. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 3: Dosage Forms, Strengths, Composition and Packaging VABOMERE is supplied as a white to light yellow sterile powder for solution in single-dose vial.
Each vial delivers 1000 mg each of meropenem and vaborbactam in 50 mL Type I clear glass vial, fitted with 20 mm bromobutyl rubber stopper and sealed with 20 mm aluminum ‘flip-off’ overseal. The drug product is supplied in packs of 6 vials.
7 WARNINGS AND PRECAUTIONS Hypersensitivity Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving therapy with β-lactam antibiotics, including Meropenem for Injection. 5 Post-Market Adverse Reactions).
There have been reports of individuals with a history of penicillin hypersensitivity who have experienced severe reactions when treated with another β-lactam antibiotic. Before initiating therapy with Meropenem for Injection, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, other β-lactam antibiotics and other allergens.
If an allergic reaction to Meropenem for Injection occurs, discontinue the drug immediately. Anaphylactic reactions require immediate treatment with epinephrine. Oxygen, intravenous steroids, antihistamines and airway management, including intubation, may be required.
Severe cutaneous adverse reactions (SCAR), such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS, erythema multiforme Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Intravenous Powder for solution, 1 g Meropenem (as meropenem trihydrate) and 1 g vaborbactam per vial Sodium carbonate Product Monograph VABOMERE Meropenem and Vaborbactam Page 9 of 36 (EM) and acute generalised exanthematous pustulosis (AGEP) have been reported in patients receiving meropenem, a component of VABOMERE.
, spectrum of activity of meropenem/vaborbactam, 15 MICROBIOLOGY) To reduce the development of drug-resistant bacteria and maintain the effectiveness of VABOMERE and other antibacterial drugs, VABOMERE should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria.
When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
1 Pediatrics Pediatrics (< 18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 2 Geriatrics Geriatrics (≥ 65 years of age): Evidence from clinical studies suggests that use in the geriatric population is not associated with differences in safety and effectiveness.
2 CONTRAINDICATIONS VABOMERE is contraindicated in patients with: • Hypersensitivity to this drug or to any ingredients of the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
g. g. penicillins, cephalosporins or monobactams). 1 Dosing considerations • VABOMERE should be used to treat infections due to aerobic Gram-negative organisms in adult patients with limited treatment options only after consultation with a healthcare professional with appropriate experience in the management of infectious diseases.
73m2. The duration of treatment is for up to 14 days. 73m2. The recommended dosage of VABOMERE in patients with varying degrees of renal function is presented in Table 1. For patients with changing renal function, monitor serum creatinine concentrations and eGFR at least daily and adjust the dosage of VABOMERE accordingly.
VABOMERE is contraindicated in patients with: • Hypersensitivity to this drug or to any ingredients of the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
g. g. penicillins, cephalosporins or monobactams). Product Monograph VABOMERE Meropenem and Vaborbactam Page 5 of 36
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Only Polyolefin infusion bags are acceptable at present for administration. 05 g/ml. 3 ml. The reconstituted solution is not for direct injection. The reconstituted solution must be diluted before intravenous infusion. 9% Sodium Chloride Injection, USP infusion bag before intravenous infusion.
The intravenous infusion of the diluted solution must be completed within 4 hours if stored at room temperature (15-30 °C) or 22 hours if stored refrigerated at 2°C to 8°C. To dilute the constituted solution, withdraw the full or partial constituted vial contents from each vial and add it back into the infusion bag in accordance with Table 2 below.
Visually inspect the diluted VABOMERE solution for particulate matter and discoloration prior to administration (the color of the VABOMERE infusion solution for administration ranges from colorless to light yellow). Discard unused portion after use.
From a microbiological point of view, the product should be used immediately upon reconstitution and dilution. 9% Sodium Chloride Injection.
Table 2:
Reconstitution VABOMERE dose (meropenem/ vaborbactam) Number of vials to constitute for further dilution Volume to withdraw from each constituted vial for further dilution Volume of infusion bag* Final infusion concentration of VABOMERE 4 g (2 g/2 g) 2 vials Entire contents (approx.
21 mL) 250 mL 16 mg/mL 500 mL 8 mg/mL 1,000 mL 4 mg/mL 2 g (1 g/1 g) 1 vial Entire contents (approx. 3 mg/mL 125 mL 8 mg/mL 250 mL 4 mg/mL * Only Polyolefin infusion bags are acceptable at present for administration. 4 Administration Intravenous use.
VABOMERE is administered by intravenous infusion over 3 hours. 5 Missed Dose If you think you have missed a dose, tell your healthcare professional straight away. • If a dose is missed then it should be given as soon as practically possible after the scheduled time and subsequent doses should be given at 8 hour intervals from the revised dose time.
Product Monograph VABOMERE Meropenem and Vaborbactam Page 8 of 36
If signs and symptoms suggestive of these reactions appear, VABOMERE should be withdrawn immediately, and an alternative treatment should be considered. Neurologic Seizures Seizures have been reported during treatment with meropenem, a component of VABOMERE.
Based on experience with meropenem, diminished renal function and central nervous system lesions may increase the risk of seizures. Patients with known seizure disorders should continue anticonvulsant therapy. Patients who develop focal tremors, myoclonus, or seizures should be evaluated neurologically and placed on anticonvulsant therapy if not already instituted.
If necessary, the dose of meropenem/vaborbactam should be adjusted based on renal function. Alternatively, meropenem/vaborbactam should be discontinued. 3 Drug-Drug Interactions) Case reports in the literature have shown that co-administration of carbapenems, including meropenem, to patients receiving valproic acid or divalproex sodium may reduce plasma levels of valproic acid to concentrations below the therapeutic range as a result of this interaction, thus increasing the risk of breakthrough seizures.
Antibacterials other than carbapenems should be considered to treat infections in patients whose seizures are well controlled on valproic acid or divalproex sodium. If administration of VABOMERE is necessary, supplemental anticonvulsant therapy should be considered.
Driving and Operating Machinery No studies on the ability to drive and use machines have been performed. However, when driving or operating machines, it should be taken into account that headache, paresthesia, and convulsions have been reported for Meropenem for Injection.
Gastrointestinal • Clostridioides difficile-associated Diarrhea Clostridioides difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including VABOMERE, and may range in severity from mild diarrhea to fatal colitis.
Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin- producing isolates of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy.
CDAD must be considered in all patients who present with diarrhea following antibacterial drug use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against C. Product Monograph VABOMERE Meropenem and Vaborbactam Page 10 of 36 difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial drug treatment of C.
difficile, and surgical evaluation should be instituted as clinically indicated. • Gastrointestinal Hemorrhage Gastrointestinal hemorrhage was observed with VABOMERE treatment, including 1 fatal case with concomitant heparin use. Gastrointestinal hemorrhage may suggest treatment interruption as well as other appropriate measures.
General Controlled sodium intake VABOMERE contains 250 mg of sodium per vial, equivalent to 12,5% of the WHO recommended maximum daily intake of 2 g of sodium for an adult, which could be relevant to patients with congestive heart failure or other reasons for […]
Meropenem and vaborbactam are removed by hemodialysis. For patients maintained on hemodialysis, administer VABOMERE after hemodialysis session. 212 if African American) b All doses of VABOMERE are administered intravenously over 3 hours.
c Doses adjusted for renal impairment should be administered after a hemodialysis session. d The total duration of treatment is for up to 14 days. • Hepatic impairment A pharmacokinetic study conducted with an intravenous formulation of meropenem in patients with hepatic impairment has shown no effects of liver disease on the pharmacokinetics of meropenem.
The primary phase 3 studies (505 and 506) excluded patients with significant hepatic disease or dysfunction. Vaborbactam does not undergo hepatic metabolism. Therefore, the systemic clearance of meropenem and vaborbactam is not expected to be affected by hepatic impairment.
• Paediatric population < 18 years of age The safety and efficacy of VABOMERE in pediatric patients below the age of 18 years have not been established. No data are available. VABOMERE is not recommended for use in pediatric patients below the age of 18 years.
• Geriatric patients ≥ 65 years of age No dosage adjustment in geriatric patients is necessary. 3 Reconstitution Standard aseptic techniques must be used for solution preparation and administration. The VABOMERE powder for solution must be reconstituted and further diluted prior to use.
Reconstitution To prepare the required dose for intravenous infusion, constitute the appropriate number of vials, as determined from Table 2 below. 9% Sodium Chloride Injection, USP, from an infusion bag and constitute each vial of VABOMERE.
Only Polyolefin infusion bags are acceptable at present for administration. 05 g/ml. 3 ml. The […]