Adverse reactions were evaluated for 1425 patients treated with SIVEXTRO in two Phase 2 and four Phase 3 clinical trials (three Phase 3 trials for 6 days of therapy and one Phase 3 trial for 7-21 days of therapy). The median age of patients treated with SIVEXTRO in the Phase 2 and Phase 3 trials was 44 years, ranging between 17 and 94 years old. The majority of patients treated with SIVEXTRO were male (66%) and White (67%).
Serious Adverse Reactions and Adverse Reactions Leading to Discontinuation: Serious adverse reactions occurred in 37/1425 (2.6%) of patients treated with SIVEXTRO and in 25/1000 (2.5%) of patients treated with the comparator. SIVEXTRO was discontinued due to an adverse reaction in 14/1425 (1%) of patients and the comparator was discontinued due to an adverse reaction in 13/1000 (1.3%) of patients.
Most Common Adverse Reactions: The most common adverse reactions in patients treated with SIVEXTRO were nausea (7.1%), headache (4.5%), diarrhea (3.6%), vomiting (2.7%), and dizziness (1.6%). The median time of onset of adverse reactions was 5 days for both SIVEXTRO and linezolid with 12% occurring on the second day of treatment in both treatment groups.
Table 9 lists selected adverse reactions occurring in at least 2% of patients treated with SIVEXTRO in clinical trials. (See Table 9.)
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The following selected adverse reactions were reported in SIVEXTRO-treated patients at a rate of less than 2% in these clinical trials: Blood and Lymphatic System Disorders: anemia.
Cardiovascular: palpitations, tachycardia.
Eye Disorders: asthenopia, vision blurred, visual impairment, vitreous floaters.
Immune System Disorders: drug hypersensitivity.
Infections and Infestations: Clostridium difficile colitis, oral candidiasis, vulvovaginal mycotic infection.
Investigations: hepatic transaminases increased (ALT increased, AST increased), gamma-glutamyltransferase (GGT) increased, white blood cell count decreased.
Nervous System Disorders: hypoesthesia, paresthesia, VIIth nerve paralysis.
Psychiatric Disorders: insomnia.
Skin and Subcutaneous Tissue Disorders: pruritus, urticaria, dermatitis.
Vascular Disorders: flushing, hypertension.
Laboratory Parameters: Hematology laboratory abnormalities that were determined to be potentially clinically significant in the pooled Phase 3 ABSSSI clinical trials are provided in Table 10. (See Table 10.)
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Myelosuppression: Phase 1 studies conducted in healthy adults exposed to SIVEXTRO for 21 days showed a possible dose and duration effect on hematologic parameters beyond 6 days of treatment. In the Phase 3 trials, clinically significant changes in these parameters were generally similar for both treatment arms (see Table 10). Thrombocytopenia has been reported in patients treated with tedizolid phosphate in post-marketing experience. Most cases of thrombocytopenia occurred with treatment lasting longer than the recommended duration.
Peripheral and Optic Neuropathy: Peripheral and optic neuropathy have been described in patients treated with another member of the oxazolidinone class for longer than 28 days. In Phase 3 trials, reported adverse reactions for peripheral neuropathy and optic nerve disorders were similar between both treatment arms (peripheral neuropathy 1.2% vs. 0.7% for tedizolid phosphate and linezolid, respectively; optic nerve disorders 0.3% vs. 0.1%, respectively). No data are available for patients exposed to SIVEXTRO for longer than 6 days.
Post-marketing Experience: The following adverse drug reaction, not listed previously, has been reported during worldwide post-marketing experience: Blood and Lymphatic System Disorders: Thrombocytopenia.
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