VABOMERE (meropenem/vaborbactam)

There are 0 contraindications.

There are 6 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Chronic kidney disease stage 3A (moderate) GFR 45-59 ml/min
Chronic kidney disease stage 3B (moderate) GFR 30-44 ml/min
Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min
Chronic kidney disease stage 5 (failure) GFr<15 ml/min
Clostridioides difficile infection
Kidney disease with likely reduction in glomerular filtration rate (GFr)

There are 4 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Cerebral lesions
Lower seizure threshold
Seizure disorder
Thrombocytopenic disorder

There are 29 severe adverse reactions.

More Frequent	Less Frequent
Injection site sequelae	Abnormal hepatic function tests Hypersensitivity drug reaction Hypokalemia

Rare/Very Rare

Agranulocytosis Anaphylaxis Angioedema Azotemia Clostridioides difficile infection Deep venous thrombosis DRESS syndrome Eosinophilia Hemolytic anemia Hyperbilirubinemia Hyperkalemia Hypoglycemic disorder Hypotension Increased alanine transaminase Increased aspartate transaminase Jaundice Kidney disease with reduction in glomerular filtration rate (GFr) Leukopenia Neutropenic disorder Rhabdomyolysis Seizure disorder Thrombocytopenic disorder Thrombocytosis Thrombophlebitis Urticaria

There are 22 less severe adverse reactions.

More Frequent	Less Frequent
Diarrhea Headache disorder Phlebitis after infusion	Nausea Oral candidiasis

Rare/Very Rare
Acute abdominal pain Anorexia Chest discomfort Delirium Dizziness Fever Hallucinations Hyperglycemia Insomnia Lethargy Pain Paresthesia Pharyngitis Pruritus of skin Skin rash Tremor Vulvovaginal candidiasis

Fetal malformations (e.g., supernumerary lung lobes, interventricular septal defect) were observed in rabbits receiving IV vaborbactam during organogenesis at doses approximately equivalent to or greater than the maximum recommended human dose. Similar malformations or fetal toxicity were not observed in offspring from pregnant rats receiving IV vaborbactam during organogenesis or from late pregnancy and through lactation at doses equivalent to approximately 1.6 times the maximum recommended human dose.

No fetal toxicity or malformations were observed in pregnant rats or cynomolgus monkeys receiving IV meropenem during organogenesis at doses up to 1.6 or 1.2 times the maximum recommended human dose, respectively. Human data are insufficient to determine whether there is a drug-associated risk of major birth defects or miscarriages if the fixed combination of meropenem and vaborbactam, meropenem alone, or vaborbactam alone is used in pregnant women.

Meropenem has been reported to be distributed into human milk. It is not known whether vaborbactam is distributed into human milk. The benefits of breast-feeding and the importance of meropenem and vaborbactam to the woman should be considered along with potential adverse effects on the breast-fed child from the drug or from the underlying maternal condition.

No overall differences in safety and efficacy of meropenem and vaborbactam were observed in patients 65 years of age and older compared with younger adults, but greater sensitivity in some older individuals cannot be ruled out. Meropenem is substantially eliminated by the kidneys, and the risk of adverse reactions to the drug may be greater in patients with renal impairment. Because geriatric patients are more likely to have decreased renal function, dosage should be selected with caution and renal function monitoring should be considered.

Dosage adjustments in geriatric patients should be based on renal function. Population pharmacokinetic analysis indicates that the pharmacokinetics of meropenem and vaborbactam in geriatric patients is similar to that in younger adults.