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ZEVTERA is a brand name for Ceftobiprole, supplied as a powder for solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: ZEVTERA (ceftobiprole medocaril) is indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms in patients 18 years of age and older: • Hospital-acquired pneumonia (HAP), excluding ventilator-associated pneumonia (VAP) Caused by: Staphylococcus aureus…
Verbatim from this product's HC label. Tap a section to expand.
). • Community-acquired pneumonia (CAP) Caused by: Staphylococcus aureus (including MRSA), Streptococcus pneumoniae, Escherichia coli, Klebsiella pneumoniae and Haemophilus influenzae (see 4 DOSAGE AND ADMINISTRATION). To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZEVTERA and other antibacterial drugs, ZEVTERA should be used only to treat or prevent infections that are proven or 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.
Appropriate specimens for bacteriological examination should be obtained in order to isolate and identify the causative organisms and to determine their susceptibility to ceftobiprole. Empiric therapy with ZEVTERA may be initiated before the results of these tests are known.
Once these results are available, antimicrobial therapy should be adjusted (see 4 DOSAGE AND ADMINISTRATION). 1 Pediatrics Pediatrics (< 18 years of age): As the safety and efficacy of ZEVTERA in children aged < 18 years have not yet been established, ZEVTERA is not recommended for use in pediatric patients.
2 Recommended Dose and Dosage Adjustment). 2 CONTRAINDICATIONS ZEVTERA is contraindicated in: • Patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see
). Immune Hypersensitivity Reactions As with all beta-lactam antibacterial agents, serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported. In case of severe hypersensitivity reactions, treatment with ZEVTERA must be discontinued immediately.
SERIOUS ACUTE HYPERSENSITIVITY (ANAPHYLACTIC) REACTIONS REQUIRE ADEQUATE EMERGENCY MEASURES. Before beginning treatment, it should be established whether the patient has a history of severe hypersensitivity reactions to ZEVTERA, to other cephalosporins or to any other type of beta-lactam agent.
Caution should be used if ZEVTERA is given to patients with a history of non-severe hypersensitivity to other beta-lactam agents. Neurologic Patients with pre-existing seizure disorders Seizures have been associated with the use of ZEVTERA.
Seizures occurred most commonly in patients with pre-existing CNS/seizure disorders during treatment with ZEVTERA. Therefore caution is advised when treating these patients. ZEVTERA (ceftobiprole medocaril) Page 10 of 38 Renal Renal clearance (CLCR) should be measured prior to ceftobiprole dosing.
Due to limited clinical data and an expected increased exposure of ZEVTERA and its metabolite, ZEVTERA should be used with caution in patients with severe renal impairment. 2 Recommended Dose and Dosage Adjustment. Renal toxicity in animals In animals, reversible renal toxicity was observed at high doses of ZEVTERA and was associated with precipitation of drug-like material in the distal tubules.
Although the clinical significance of this observation is unknown, it is advisable to correct hypovolemia to maintain normal urinary output in patients receiving ZEVTERA. Sensitivity/Resistance Development of drug-resistant bacteria Prescribing ZEVTERA in the absence of proven or strongly suspected bacterial infection is unlikely to provide benefit the patient and risks development of drug-resistant bacteria.
, Skin 10/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ............................................................................................
2 TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ......................................................................
4 1 INDICATIONS ............................................................................................................... 4 2 CONTRAINDICATIONS .................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 5 4 DOSAGE AND ADMINISTRATION ................................................................................. 7 5 OVERDOSAGE..............................................................................................................
7 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 7 7 WARNINGS AND PRECAUTIONS .................................................................................. 11 8 ADVERSE REACTIONS ................................................................................................
14 9 DRUG INTERACTIONS ................................................................................................ 14 10 CLINICAL PHARMACOLOGY .......................................................................................
15 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 18 12 SPECIAL HANDLING INSTRUCTIONS ........................................................................... 18 PART II: SCIENTIFIC INFORMATION .......................................................................................
ZEVTERA is contraindicated in: • Patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
• Patients who are hypersensitive to the cephalosporin class of antibacterials. , penicillins or carbapenems). ZEVTERA (ceftobiprole medocaril) Page 5 of 38
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Skin Severe Cutaneous Adverse Reactions Severe cutaneous adverse reactions (SCAR) such as acute generalized exanthematous pustulosis (AGEP), drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN) have been reported in association with beta-lactam treatment.
When SCAR is suspected, ZEVTERA should be discontinued and appropriate therapy and/or measures should be taken. 1 Pregnant Women There are no adequate and well-controlled studies with ZEVTERA in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development.
As no data in exposed human pregnancies are available, ZEVTERA should not be used during pregnancy unless strictly necessary. 2 Breast-feeding Animal studies have shown the excretion of ceftobiprole/metabolites in milk at low concentrations.
It is unknown whether ceftobiprole is excreted in human milk and the risk of diarrhea and fungal infection of the mucous membranes in the breast-fed infant cannot be excluded. The possibility of sensitization should be taken into account.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from ZEVTERA therapy, taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman. 3 Pediatrics Pediatrics (< 18 years of age): ZEVTERA is not recommended for use in pediatric patients.
2 Recommended Dose and Dosage Adjustment). 3%). 4%) of adverse events were reported as mild to moderate in severity. 3% for all comparators. Less frequently reported, but more serious, adverse reactions include thrombocytopenia, agranulocytosis, anaphylaxis, Clostridium difficile colitis, convulsion, agitation (including anxiety, panic attacks and nightmares), and renal failure.
2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. 0 ZEVTERA (ceftobiprole medocaril) Page 12 of 38 Ceftobiprole Comparator* […]
20 13 PHARMACEUTICAL INFORMATION ............................................................................ 20 14 CLINICAL TRIALS ........................................................................................................
21 15 MICROBIOLOGY ........................................................................................................ 27 16 NON-CLINICAL TOXICOLOGY .....................................................................................
30 PATIENT MEDICATION INFORMATION .................................................................................. 33 ZEVTERA (ceftobiprole medocaril) Page 4 of 38 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS ZEVTERA (ceftobiprole medocaril) is indicated for the treatment of the following infections when caused by susceptible strains of the designated […]