2 hours) to complete the treatment course of 4 to 14 days total (IV plus oral), at the discretionof the investigator. The mean age was 56.4 years, 40.3 % of patients were 65 years of age and older,16.1 % were 75 years of age and older, 50 % were female, and approximately 17.8 % had moderate tosevere renal impairment.
Clinical Trial Experience in Patients with cIAI
Trial 2 included 233 adult patients treated with imipenem/cilastatin plus relebactam (116 subjects withimipenem 500 mg/cilastatin 500 mg and relebactam 125 mg and 117 subjects with imipenem500 mg/cilastatin 500 mg plus relebactam 250 mg), and 114 patients treated with imipenem500 mg/cilastatin 500 mg, administered intravenously over 30 minutes every 6 hours for 4 to 14 days, atthe discretion of the investigator. The mean age was 49.1 years, 22.8 % of the patients were 65 years ofage and older, 9.8 % were 75 years of age and older, and 42.1 % were female.
Serious Adverse Reactions and Adverse Reactions Leading to DiscontinuationIn Trials 1 and 2, serious adverse reactions occurred in 3.2 % (7/216) of patients receiving imipenem500 mg/cilastatin 500 mg plus relebactam 250 mg and 5.1 % (11/214) of patients receiving imipenem500 mg/cilastatin 500 mg. There were no deaths reported in patients receiving imipenem500 mg/cilastatin 500 mg plus relebactam 250 mg or imipenem 500 mg/cilastatin 500 mg alone. Deathswere reported in 1.4 % (3/215) of patients receiving imipenem 500 mg/cilastatin 500 mg plus relebactam125 mg (not an approved dose).
Adverse reactions leading to discontinuation occurred in 1.9 % (4/216) of patients receiving imipenem500 mg/cilastatin 500 mg plus relebactam 250 mg and 2.3 % (5/214) of patients receiving imipenem500 mg/cilastatin 500 mg.
Common Adverse Reactions
In Trials 1 and 2, adverse reactions occurred during the protocol-specified follow-up period, which was IVtherapy plus 14 days following completion of therapy, in 39 % (85/216) of patients receiving imipenem500 mg/cilastatin 500 mg plus relebactam 250 mg and 36 % (77/214) of patients receiving imipenem500 mg/cilastatin 500 mg. Table 3 lists the most common adverse reactions occurring in ≥1 % of patients receiving imipenem 500 mg/cilastatin 500 mg plus relebactam 250 mg or imipenem 500 mg/cilastatin500 mg in Trials 1 and 2.
Table 3: Adverse Reactions Occurring in Greater Than or Equal to 1% of Patients ReceivingImipenem/Cilastatin plus Relebactam 250 mg or Imipenem/Cilastatin in Trials 1 and 2
Imipenem/Cilastatin and
Relebactam 250 mga
(N=216)
N (%)
IMI + Placebob
(N=214)
N (%)
Blood and lymphatic system disorders
Anemiac
2 (1%) 4 (2%)
Gastrointestinal disorders
Diarrhea 12 (6%) 9 (4%)
Nausea 12 (6%) 12 (6%)
Vomiting 7 (3%) 4 (2%)
General disorders and administration site conditions
Phlebitis/Infusion site reactionsd
5 (2%) 3 (1%)
Pyrexia 5 (2%) 3 (1%)
Laboratory Investigations
Alanine aminotransferase increased 7 (3%) 4 (2%)
Aspartate aminotransferase increased 6 (3%) 3 (1%)
Lipase increased 3 (1%) 4 (2%)
Blood creatinine increased 1 (<1%) 3 (1%)
Nervous system disorders
Headache 9 (4%) 5 (2%)
Central nervous system adverse reactionse
2 (1%) 5 (2%)
Vascular disorders
Hypertensionf
4 (2%) 6 (3%)
a
Imipenem/Cilastatin (500 mg/500 mg) + Relebactam (250 mg), IV every 6 hours.
b
Imipenem/Cilastatin (500 mg/500 mg) + Placebo, IV every 6 hours.
cAnemia includes anemia and hemoglobin decreased.
d
Infusion site reactions include infusion site phlebitis, infusio |
