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warnings and cautions
5 WARNINGS AND PRECAUTIONS Serious infections: Monitor patients for signs/symptoms and treat appropriately. ( 5.1 ) 5.1 Serious Infections Serious and life-threatening infections have occurred in patients treated with YARTEMLEA. Serious infections, independent of causality, were reported in 36% (10/28) of patients with TA-TMA receiving YARTEMLEA in clinical trials. These infections included sepsis, viral infections, pneumonia, bacteremia, fungal infection, gastroenteritis, respiratory tract infection and urosepsis. If YARTEMLEA is administered to patients with active infections, monitor closely for signs and symptoms of worsening infection and treat promptly.
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Serious Infections [see Warnings and Precautions ( 5.1 )] Most common adverse reactions (incidence > 20% and independent of causality) are viral infections, sepsis, hemorrhage, diarrhea, vomiting, nausea, neutropenia, pyrexia, fatigue and hypokalemia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Omeros Corporation at 1-844-YARTEM1 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety data described in this section reflect exposure to YARTEMLEA in the TA-TMA Study in which 28 adult patients received YARTEMLEA. In total, 24 patients received YARTEMLEA at a dose of 4 mg/kg intravenously once weekly for 4 or 8 weeks and 4 patients received 370 mg intravenously weekly for 8 weeks [see Clinical Studies ( 14 )] . The median duration of treatment with YARTEMLEA was 8 weeks (range: 2 to 16.4 weeks). Serious adverse reactions were reported in 61% of patients receiving YARTEMLEA. Serious adverse reactions in > 5% of patients who received YARTEMLEA included acute kidney injury, confusional state, acute respiratory failure, neutropenic sepsis, septic shock, pulmonary edema, and vomiting. Fatal adverse reactions occurred in 7% of patients, including neutropenic sepsis and septic shock. Adverse reactions leading to dosage interruptions occurred in 7% of patients who received YARTEMLEA and included Escherichia sepsis, pyrexia, pulmonary alveolar hemorrhage, and acute myocardial infarction. The most common adverse reactions (≥ 20%) were viral infections, sepsis, hemorrhage, diarrhea, vomiting, nausea, neutropenia, pyrexia, fatigue, and hypokalemia. Table 2 summarizes the adverse reactions, without regard to causality or relatedness to YARTEMLEA, in the TA-TMA Study. Table 2: Adverse Reactions (≥ 15%) in Patients Receiving YARTEMLEA in the TA-TMA Study * Grouped terms Adverse Reaction All Grades n (%) N = 28 Grade ≥ 3 n (%) N = 28 Hemorrhage* 12 (43) 2 (7) Diarrhea 10 (36) 2 (7) Infection, viral* 10 (36) 2 (7) Neutropenia* 10 (36) 10 (36) Pyrexia 10 (36) 1 (4) Vomiting 9 (32) 2 (7) Fatigue* 8 (29) 1 (4) Hypokalemia* 7 (25) 3 (11) Nausea 7 (25) 1 (4) Sepsis* 7 (25) 6 (21) Pneumonia* 5 (18) 4 (14) Hypotension* 5 (18) 3 (11) Abdominal pain* 5 (18) 1 (4) Anemia* 5 (18) 3 (11) Back pain 5 (18) 0 (0) An additional 221 adult and pediatric patients with TA-TMA were treated with YARTEMLEA in a global expanded access program (EAP) that included patients for whom YARTEMLEA was their initial treatment following diagnosis of TA-TMA as well as patients who had previously failed or stopped other treatments. The median number of YARTEMLEA doses received by the 221 patients in the EAP was 8 and the median duration of therapy was 5.5 weeks. No new clinically significant safety signals were identified in patients treated in the EAP.