3%), and were generally mild to moderate in severity. The safety profile was similar when comparing patients receiving intravenous tedizolid phosphate alone to patients who received oral administration alone, except for a higher reported rate of gastrointestinal disorders associated with oral administration.
Safety was additionally evaluated in a randomised, double-blind, multicenter study conducted in China, the Philippines, Taiwan, and the US, which included a total 292 adult patients treated with tedizolid phosphate 200 mg administered IV and/or oral once daily for 6 days, and 297 patients treated with linezolid 600 mg administered IV and/or oral every 12 hours for 10 days for ABSSSI.
7%) in tedizolid phosphate treated subjects than in the linezolid control group (0%), particularly among Asian patients. These findings suggest a higher frequency of infusion related reactions (phlebitis) than was observed in previous clinical studies with tedizolid phosphate.
Tabulated list of adverse reactions The following adverse reactions have been identified in two comparative pivotal Phase 3 studies and one post-authorisation study in adults treated with Sivextro (Table 2). Increased ALT, increased AST and liver function tests abnormal were the only adverse drug reactions reported in one comparative Phase 3 study in patients 12 to < 18 years of age.
Adverse reactions are classified by preferred term and System Organ Class, and by frequency. Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥1/10 000 to < 1/1 000); very rare (< 1/10 000); not known (cannot be estimated from the available data).
Table 2:
Adverse reactions by body system and frequency reported in clinical trials and/or post-marketing use System organ class Frequency Adverse reactions Infections and infestations Uncommon: Vulvovaginal mycotic infection, fungal infection, vulvovaginal candidiasis, abscess, Clostridioides difficile colitis, dermatophytosis, oral candidiasis, respiratory tract infection Uncommon: LymphadenopathyBlood and lymphatic system disorders Not known*: Thrombocytopenia* Immune system disorders Uncommon: Drug hypersensitivity Metabolism and nutrition disorders Uncommon: Dehydration, diabetes mellitus inadequate control, hyperkalaemia Psychiatric disorders Uncommon: Insomnia, sleep disorder, anxiety, nightmare Common: Headache, dizzinessNervous system disorders Uncommon: Somnolence, dysgeusia, tremor, paraesthesia, hypoaesthesia Eye disorders Uncommon: Vision blurred, vitreous floaters Cardiac disorders Uncommon: Bradycardia Vascular disorders Uncommon: Flushing, hot flush Respiratory, thoracic and mediastinal disorders Uncommon: Cough, nasal dryness, pulmonary congestion Common: Nausea, diarrhoea, vomitingGastrointestinal disorders Uncommon: Abdominal pain, constipation, abdominal discomfort, dry mouth, dyspepsia, abdominal pain upper, flatulence, gastro-oesophageal reflux disease, haematochezia, retching Common: Pruritus generalisedSkin and subcutaneous tissue disorders Uncommon: Hyperhidrosis, pruritus, rash, urticaria, alopecia, rash erythematous, rash generalised, acne, pruritus allergic, rash maculo-papular, rash papular, rash pruritic Musculoskeletal and connective tissue disorders Uncommon: Arthralgia, muscle spasms, back pain, limb discomfort, neck pain Renal and urinary disorders Uncommon: Urine odour abnormal Reproductive system and breast disorders Uncommon: Vulvovaginal pruritus System organ class Frequency Adverse reactions Common: Fatigue, infusion site reactions (phlebitis)General disorders and administration site conditions Uncommon: Chills, infusion site pain, irritability, pyrexia, infusion related reaction, peripheral oedema Investigations Uncommon: Grip strength decreased, transaminases increased, white blood cell count decreased * Based on post-marketing reports.
Since these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency which is therefore categorised as not known. Paediatric population In studies of paediatric patients from birth to < 18 years of age, the safety profile of tedizolid phosphate was generally similar to the profile observed in adults.
1%). The safety of tedizolid phosphate in adolescents was evaluated in one phase 3 clinical trial, which included 91 paediatric patients (12 to < 18 years of age) with ABSSSI treated with IV and/or oral Sivextro 200 mg for 6 days and 29 patients treated with comparator agents for 10 days.
The safety of tedizolid phosphate (intravenously and/or orally) was also evaluated in 2 clinical trials that included multiple dosing of 83 children < 12 years of age. These included 44 children 6 to < 12 years of age receiving a median 9 days of dosing (range 1-12 days), 16 children 2 to < 6 years of age receiving a median 9 days of dosing (range 2-14 days), 15 children 28 days to < 2 years of age receiving a median 10 days of dosing (range 6-11 days), and 8 neonates < 28 days of age (4 full-term and 4 preterm) receiving median 3 days of dosing (range 3 days).
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal […]