Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in the Warnings and Precautions section: Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] Seizure Potential [see Warnings and Precautions (5.2) ] Rhabdomyolysis [see Warnings and Precautions (5.3) ] Clostridioides difficile -associated Diarrhea [see Warnings and Precautions (5.4) ] Risk of Breakthrough Seizures Due to Drug Interaction with Valproic Acid [see Warnings and Precautions (5.5) ] Thrombocytopenia [see Warnings and Precautions (5.6) ] Potential for Neuromotor Impairment [see Warnings and Precautions (5.7) ] Development of Drug-Resistant Bacteria [see Warnings and Precautions (5.8) ] Overgrowth of Non-susceptible Organisms [see Warnings and Precautions (5.9) ] The most frequently reported adverse reactions occurring in ≥3% of patients treated with VABOMERE were headache, phlebitis/infusion site reactions, and diarrhea.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Melinta Therapeutics at 1-844-633-6568 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience 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.
VABOMERE was evaluated in a Phase 3 comparator-controlled clinical trial in cUTI, including pyelonephritis, which included 272 patients treated with VABOMERE and 273 patients treated with the comparator piperacillin/tazobactam 4.5 grams (piperacillin 4 g/tazobactam 0.5 g) every 8 hours.
After a minimum of 15 doses of IV therapy, patients could be switched to oral levofloxacin (500 mg daily every 24 hours) to complete the treatment course.
Mean duration of IV therapy was 8 days in both treatment groups.
Mean duration of IV and oral therapy was 10 days;
patients with baseline bacteremia could receive up to 14 days of treatment.
The mean age of patients treated with VABOMERE was 53 years (range 18 to 92 years), and 32% of patients were 65 years of age or older.
Patients were predominantly female (66.5%) and White (93.4%).
5 WARNINGS AND PRECAUTIONS Hypersensitivity reactions were reported with the use of VABOMERE.
Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving beta-lactam antibacterial drugs.
Discontinue infusion if signs of acute hypersensitivity occur.
( 5.1 ) Seizures and other adverse Central Nervous System experiences have been reported during treatment with meropenem, a component of VABOMERE.
( 5.2 ) Rhabdomyolysis: If signs or symptoms of rhabdomyolysis are observed, discontinue VABOMERE and initiate appropriate therapy.
Like all medications, Vabomere can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: