Ertapenem (Page 4 of 8)

6.2 Post-Marketing Experience

The following additional adverse reactions have been identified during the post-approval use of Ertapenem for injection. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Gastrointestinal Disorders: teeth staining

Immune System Disorders: anaphylaxis including anaphylactoid reactions

Musculoskeletal and Connective Tissue Disorders: muscular weakness

Nervous System Disorders: coordination abnormal, depressed level of consciousness, dyskinesia, gait disturbance, myoclonus, tremor, encephalopathy (recovery was prolonged in patients with renal impairment)

Psychiatric Disorders: altered mental status (including aggression, delirium), hallucinations

Skin and Subcutaneous Tissue Disorders: Acute Generalized Exanthematous Pustulosis (AGEP), Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS syndrome), hypersensitivity vasculitis

6.3 Adverse Laboratory Changes in Clinical Trials

Adults Receiving Ertapenem for injection as Treatment Regimen

Laboratory adverse experiences that were reported during therapy in ≥2.0% of adult patients treated with Ertapenem for injection in clinical trials are presented in Table 6. Drug-related laboratory adverse experiences that were reported during therapy in ≥2.0% of adult patients treated with Ertapenem for injection, including those who were switched to therapy with an oral antimicrobial, in clinical trials were ALT increased (6.0%), AST increased (5.2%), serum alkaline phosphatase increased (3.4%), and platelet count increased (2.8%). Ertapenem for injection was discontinued due to laboratory adverse experiences in 0.3% of patients.

Table 6 Incidence * (%) of Laboratory Adverse Experiences Reported During Study Therapy Plus 14-Day Follow-Up in ≥2.0% of Adult Patients Treated With Ertapenem for injection in Clinical Trials
Adverse laboratory experiences ERTAPENEM for injection 1 g daily (n =766) Piperacillin/ Tazobactam 3.375 g q6h (n =755) ERTAPENEM for injection §1 g daily (n =1122) Ceftriaxone §1 or 2 g daily (n =920)
*
Number of patients with laboratory adverse experiences/Number of patients with the laboratory test
Includes Phase IIb/III Complicated intra-abdominal infections, Complicated skin and skin structure infections and Acute pelvic infections trials
Number of patients with one or more laboratory tests
§
Includes Phase IIb/III Community acquired pneumonia and Complicated urinary tract infections, and Phase IIa trials
ALT increased 8.8 7.3 8.3 6.9
AST increased 8.4 8.3 7.1 6.5
Serum alkaline phosphatase increased 6.6 7.2 4.3 2.8
Eosinophils increased 1.1 1.1 2.1 1.8
Hematocrit decreased 3.0 2.9 3.4 2.4
Hemoglobin decreased 4.9 4.7 4.5 3.5
Platelet count increased 6.5 6.3 4.3 3.5
Urine RBCs increased 2.5 2.9 1.1 1.0
Urine WBCs increased 2.5 3.2 1.6 1.1

Additional laboratory adverse experiences that were reported during therapy in >0.1% of patients treated with Ertapenem for injection in clinical trials include: increases in serum creatinine, serum glucose, BUN, total, direct and indirect serum bilirubin, serum sodium and potassium, PT and PTT; decreases in serum potassium, serum albumin, WBC, platelet count, and segmented neutrophils.

In a clinical trial for the treatment of diabetic foot infections in which 289 adult diabetic patients were treated with Ertapenem for injection, the laboratory adverse experience profile was generally similar to that seen in previous clinical trials.

Prophylaxis of Surgical Site Infection following Elective Colorectal Surgery

In a clinical trial in adults for the prophylaxis of surgical site infection following elective colorectal surgery in which 476 patients received a 1 g dose of Ertapenem for injection 1 hour prior to surgery and were then followed for safety 14 days post-surgery, the overall laboratory adverse experience profile was generally comparable to that observed for Ertapenem for injection in previous clinical trials.

Pediatric Patients Receiving Ertapenem for injection as a Treatment Regimen

Laboratory adverse experiences that were reported during therapy in ≥2.0% of pediatric patients treated with Ertapenem for injection in clinical trials are presented in Table 7. Drug-related laboratory adverse experiences that were reported during therapy in ≥2.0% of pediatric patients treated with Ertapenem for injection, including those who were switched to therapy with an oral antimicrobial, in clinical trials were neutrophil count decreased (3.0%), ALT increased (2.2%), and AST increased (2.1%).

Table 7 Incidence * (%) of Specific Laboratory Adverse Experiences Reported During Study Therapy Plus 14-Day Follow-Up in ≥2.0% of Pediatric Patients Treated With Ertapenem for injection in Clinical Trials
Adverse laboratory experiences ERTAPENEM for injection (n =379) Ceftriaxone (n =97) Ticarcillin/ Clavulanate (n =24)
*
Number of patients with laboratory adverse experiences/Number of patients with the laboratory test; where at least 300 patients had the test
Number of patients with one or more laboratory tests
ALT Increased 3.8 1.1 4.3
AST Increased 3.8 1.1 4.3
Neutrophil Count Decreased 5.8 3.1 0.0

Additional laboratory adverse experiences that were reported during therapy in >0.5% of patients treated with Ertapenem for injection in clinical trials include: alkaline phosphatase increased, eosinophil count increased, platelet count increased, white blood cell count decreased and urine protein present.

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