YARTEMLEA (narsoplimab-wuug)

The PK profile of narsoplimab-wuug has been characterized in healthy subjects and in patients. PK of narsoplimab-wuug is less than dose-proportional for 2 and 4 mg/kg weekly IV dosing, with an accumulation ratio ranging from 1.02 to 1.75 at 4 mg/kg IV weekly dosing. Narsoplimab-wuug steady state (measured at day 36) geometric mean C max is 36.9 μg/mL, with geometric mean AUC 0-tau of 2314 μg·h/mL following 4 mg/kg administered intravenously in healthy subjects. Narsoplimab-wuug steady state is r...

The efficacy of YARTEMLEA was assessed in (i) a single-arm, open-label study (TA-TMA Study) that enrolled 28 adult patients who developed TA-TMA following hematopoietic stem-cell transplantation (HCT) and (ii) 19 adult and pediatric patients with TA-TMA with evaluable patient-level response data enrolled in an expanded access program (EAP). In the TA-TMA Study, 24 patients received YARTEMLEA 4 mg/kg intravenously once weekly and 4 patients received YARTEMLEA 370 mg intravenously once weekly. The median number of YARTEMLEA administrations received by the 28 TA-TMA Study patients plus the 19 EAP...

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 Clinic...

None None ( 4 )

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 YAR...