Sivextro Adverse Reactions




Zuellig Pharma
Full Prescribing Info
Adverse Reactions
Adverse Reactions in Clinical Trials: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be compared directly to rates from clinical trials of another drug and may not reflect rates observed in practice.
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).
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.
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