The following serious events are described in greater detail in the WARNINGS AND PRECAUTIONS section
- Hypersensitivity reactions [see WARNINGS AND PRECAUTIONS]
- Clostridium difficile-associated diarrhea [see WARNINGS AND PRECAUTIONS]
- Direct Coombs' test seroconversion [see WARNINGS AND PRECAUTIONS]
Adverse Reactions from 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.
Teflaro was evaluated in four controlled comparative Phase 3 clinical trials (two in ABSSSI and two in CABP) which included 1300 adult patients treated with Teflaro (600 mg administered by IV over 1 hour every 12h) and 1297 patients treated with comparator (vancomycin plus aztreonam or ceftriaxone) for a treatment period up to 21 days. The median age of patients treated with Teflaro was 54 years, ranging between 18 and 99 years old. Patients treated with Teflaro were predominantly male (63%) and Caucasian (82%).
Serious Adverse Events and Adverse Events Leading to Discontinuation
In the four pooled Phase 3 clinical trials, serious adverse events occurred in 98/1300 (7.5%) of patients receiving Teflaro and 100/1297 (7.7%) of patients receiving comparator drugs. The most common SAEs in both the Teflaro and comparator treatment groups were in the respiratory and infection system organ classes (SOC). Treatment discontinuation due to adverse events occurred in 35/1300 (2.7%) of patients receiving Teflaro and 48/1297 (3.7%) of patients receiving comparator drugs with the most common adverse events leading to discontinuation being hypersensitivity for both treatment groups at a rate of 0.3% in the Teflaro group and 0.5% in comparator group.
Most Common Adverse Reactions
No adverse reactions occurred in greater than 5% of patients receiving Teflaro. The most common adverse reactions occurring in > 2% of patients receiving Teflaro in the pooled phase 3 clinical trials were diarrhea, nausea, and rash.
Table 4 lists adverse reactions occurring in ≥ 2% of patients receiving Teflaro in the pooled Phase 3 clinical trials. TEFLARO® (ceftaroline fosamil) injection for intravenous (IV) use Page 8 of 23
Table 4: Adverse Reactions Occurring in ≥ 2% of Patients Receiving Teflaro in the Pooled Phase 3 Clinical Trials
|System Organ Class/ Preferred Term||Pooled Phase 3 Clinical Trials (four trials, two in ABSSSI and two in CABP)|
|Metabolism and nutrition disorders|
|Skin and subcutaneous tissue disorders|
|a Comparators included vancomycin 1 gram IV every 12h plus aztreonam 1 gram IV every 12h in the Phase 3 ABSSSI trials, and ceftriaxone 1 gram IV every 24h in the Phase 3 CABP trials.|
Other Adverse Reactions Observed During Clinical Trials of Teflaro
Following is a list of additional adverse reactions reported by the 1740 patients who received Teflaro in any clinical trial with incidences less than 2%. Events are categorized by System Organ Class.
Blood and lymphatic system disorders - Anemia, Eosinophilia, Neutropenia, Thrombocytopenia
Cardiac disorders - Bradycardia, Palpitations
Gastrointestinal disorders - Abdominal pain
General disorders and administration site conditions - Pyrexia
Hepatobiliary disorders - Hepatitis
Immune system disorders - Hypersensitivity, Anaphylaxis
Infections and infestations - Clostridium difficile colitis
Metabolism and nutrition disorders - Hyperglycemia, Hyperkalemia
Nervous system disorders - Dizziness, Convulsion
Renal and urinary disorders - Renal failure
Skin and subcutaneous tissue disorders - Urticaria