6 ADVERSE REACTIONS The following adverse reactions are also discussed in the Warnings and Precautions section of labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.2)] Infusion Related Reactions [see Warnings and Precautions (5.3)] Clostridium difficile-associated Diarrhea [see Warnings and Precautions (5.4)] Osteomyelitis [see Warnings and Precautions (5.6)] The most common adverse reactions (≥3%) in patients treated with ORBACTIV were headache, nausea, vomiting, limb and subcutaneous abscesses, 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 ORBACTIV cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. ORBACTIV has been evaluated in two, double-blind, controlled ABSSSI clinical trials, which included 976 adult patients treated with a single 1200 mg intravenous dose of ORBACTIV and 983 patients treated with intravenous vancomycin for 7 to 10 days. The median age of patients treated with ORBACTIV was 45.6 years, ranging between 18 and 89 years of age with 8.8% ≥65 years of age. Patients treated with ORBACTIV were predominantly male (65.4%), 64.4% were Caucasian, 5.8% were African American, and 28.1% were Asian. Safety was evaluated for up to 60 days after dosing. In the pooled ABSSSI clinical trials, serious adverse reactions were reported in 57/976 (5.8%) patients treated with ORBACTIV and 58/983 (5.9%) treated with vancomycin. The most commonly reported serious adverse reaction was cellulitis in both treatment groups: 11/976 (1.1%) in ORBACTIV and 12/983 (1.2%) in the vancomycin arms, respectively. The most commonly reported adverse reactions (≥3%) in patients receiving a single 1200 mg dose of ORBACTIV in the pooled ABSSSI clinical trials were: headache, nausea, vomiting, limb and subcutaneous abscesses, and diarrhea. In the pooled ABSSSI clinical trials, ORBACTIV was discontinued due to adverse reactions in 36/976 (3.7%) of patients; the most common reported reactions leading to discontinuation were cellulitis (4/976, 0.4%) and osteomyelitis (3/976, 0.3%). Table 1 provides selected adverse reactions occurring in ≥1.5% of patients receiving ORBACTIV in the pooled ABSSSI clinical trials. There were 540 (55.3%) patients in the ORBACTIV arm and 559 (56.9%) patients in the vancomycin arm, who reported ≥1 adverse reaction. Table 1: Incidence of Selected Adverse Reactions Occurring in ≥1.5% of Patients Receiving ORBACTIV in the Pooled ABSSSI Clinical Trials Adverse Reactions ORBACTIV N=976 (%) Vancomycin N=983 (%) Gastrointestinal disorders Diarrhea 36 (3.7) 32 (3.4) Nausea 97 (9.9) 103 (10.5) Vomiting 45 (4.6) 46 (4.7) Nervous system disorders Dizziness 26 (2.7) 26 (2.6) Headache 69 (7.1) 66 (6.7) General disorders and administration Infusion site phlebitis 24 (2.5) 15 (1.5) Infusion site reaction 19 (1.9) 34 (3.5) Infections and infestations Abscess (limb and subcutaneous) 37 (3.8) 23 (2.3) Investigations Alanine aminotransferase increased 27 (2.8) 15 (1.5) Aspartate aminotransferase increased 18 (1.8) 15 (1.5) Cardiac disorders Tachycardia 24 (2.5) 11 (1.1) The following selected adverse reactions were reported in ORBACTIV-treated patients at a rate of less than 1.5%: Blood and lymphatic system disorders: anemia, eosinophilia General disorders and administration site conditions: infusion site erythema, extravasation, induration, pruritis, rash, edema peripheral Immune system disorders: hypersensitivity Infections and infestations: osteomyelitis Investigations: total bilirubin increased, hyperuricemia Metabolism and nutrition disorders: hypoglycemia Musculoskeletal and connective tissue disorders: tenosynovitis, myalgia Respiratory, thoracic and mediastinal disorders: bronchospasm, wheezing Skin and subcutaneous tissue disorders: urticaria, angioedema, erythema multiforme, pruritis, leucocytoclastic vasculitis, rash.