Yartemlea (narsoplimab-wuug) is filed as MASP-2 monoclonal antibody. The sections below restate public label fields stored for this profile.
1 INDICATIONS AND USAGE YARTEMLEA is indicated for the treatment of adult and pediatric patients 2 years of age and older with hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA). YARTEMLEA is a MASP-2 inhibitor indicated for the treatment of adult and pediatric patients 2 years of age and older with hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA). ( 1 )
12.1 Mechanism of Action Narsoplimab-wuug inhibits MASP-2, the effector enzyme of the lectin pathway of the complement system, blocking lectin-dependent activation of complement component 3 (C3) and C4 without affecting the classical and alternative pathways of complement. In hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA), MASP-2 inhibition is thought to prevent lectin pathway-mediated cellular injury, including endothelial cell injury in small blood vessels.
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.
4 CONTRAINDICATIONS None None ( 4 )
Viral infections (>20%); Sepsis (>20%); Hemorrhage (>20%); Diarrhea (>20%); Vomiting (>20%); Nausea (>20%); Neutropenia (>20%); Pyrexia (>20%); Fatigue (>20%); Hypokalemia (>20%)
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.
2 DOSAGE AND ADMINISTRATION Weight (kg) Recommended Dosage Greater than or equal to 50 kg 370 mg given as an intravenous infusion over 30 minutes once weekly. Increase frequency to twice weekly if there is inadequate improvement in TA-TMA signs and symptoms. ( 2.1 ) Less than 50 kg 4 mg/kg given as an intravenous infusion over 30 minutes once weekly. Increase frequency to twice weekly if there is inadequate improvement in TA-TMA signs and symptoms. ( 2.1 ) See Full Prescribing Information for instructions on preparation and administration. ( 2.2 , 2.3 , 2.4 , 2.5 ) 2.1 Recommended Dosage The recommended dosage of YARTEMLEA is provided in Table 1 . Table 1: Recommended Dosage of YARTEMLEA in Adult and Pediatric Patients Two Years of Age and Older with TA-TMA Weight (kg) Recommended Dosage Greater than or equal to 50 kg 370 mg given as an intravenous infusion over 30 minutes once weekly. Increase frequency to twice weekly if there is inadequate improvement in TA-TMA signs and symptoms. Less than 50 kg 4 mg/kg given as an intravenous infusion over 30 minutes once weekly. Increase frequency to twice weekly if there is inadequate improvement in TA-TMA signs and symptoms. If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regular scheduled time. 2.2 Important Preparation and Administration Instructions Administer diluted YARTEMLEA as an intravenous infusion through a polyvinyl chloride (PVC) or PVC-lined infusion line with a 0.2-micron polyethersulfone (PES) in-line filter and a polyurethane catheter. For adults and pediatric patients weighing 10 kg or more , prepare YARTEMLEA in an intravenous bag, diluted to final concentration of 0.8 mg/mL to 8 mg/mL and administer by gravity infusion or via an infusion pump [see Dosage and Administration ( 2.3 and 2.5 )] . For pediatric patients weighing less than 10 kg , prepare YARTEMLEA in a polypropylene syringe, diluted to final concentration of 0.8 mg/mL and administer via a syringe pump [see Dosage and Administration ( 2.4 and 2.5 )] . 2.3 Preparation Instructions into an Intravenous Bag This section describes preparation of YARTEMLEA for adults and pediatric patients weighing 10 kg or more in an intravenous bag. 1. Preparation Use aseptic technique to prepare YARTEMLEA. Parenteral drug-product vial should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. YARTEMLEA is a clear to slightly opalescent, slightly yellow to yellow-brown solution. If discoloration or particles are observed in the vial, discard it. Calculate the dose (mg) based on the patient's body weight and the total volume (mL) of YARTEMLEA solution required. Remove the YARTEMLEA vial from the refrigerator and allow the vial to come to room temperature (18°C to 25°C [64°F to 77°F]) for 30 minutes. Vial must be used to prepare the appropriate dosing solution within 4 hours following removal from refrigerated storage. 2. Dilution for Intravenous Bag Infusion Withdraw the required volume of YARTEMLEA solution from the vial using a polypropylene syringe and dilute in a polyvinyl chloride (PVC) infusion bag of 5% Dextrose Injection, USP to make a final concentration of 0.8 mg/mL to 8 mg/mL with a total volume not to exceed 50 mL. Discard any unused portion left in the vial. Gently invert infusion bag 10 times to mix the diluted solution. Do not shake. Following dilution of YARTEMLEA in the infusion bag, the solution may become opalescent, and small translucent-to-white particles may appear. Discard prepared solution if particulate matter, other than translucent-to-white particles, is observed. 2.4 Preparation Instructions into an Intravenous Syringe This section describes preparation of YARTEMLEA for pediatric patients weighing less than 10 kg in a syringe. 1. Preparation Use aseptic technique to prepare YARTEMLEA. Parenteral drug-product vial should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. YARTEMLEA is a clear to slightly opalescent, slightly yellow to yellow-brown solution. If discoloration or particles are observed in the vial, discard it. Calculate the dose (mg) based on the patient's body weight and the total volume (mL) of YARTEMLEA solution required. Remove the YARTEMLEA vial from the refrigerator and allow the vial to come to room temperature (18°C to 25°C [64°F to 77°F]) for 30 minutes. Vial must be used to prepare the appropriate dosing solution within 4 hours following removal from refrigerated storage. 2. Dilution for Intravenous Syringe Infusion Withdraw the required volume of YARTEMLEA solution from the vial using a polypropylene syringe. Discard any unused portion left in the vial. Dilute in 5% Dextrose Injection, USP to make a final concentration of 0.8 mg/mL with a total volume not to exceed 50 mL. Gently invert syringe 10 times to mix the diluted solution. Do not shake. Following dilution of YARTEMLEA in the syringe, the solution may become opalescent, and small translucent-to-white particles may appear. Discard prepared solution if particulate matter, other than translucent-to-white particles, is observed. Remove air bubbles from the syringe before administration. 2.5 Storage and Administration Storage of Diluted Product If the prepared diluted solution is not used immediately, store the diluted YARTEMLEA solution at room temperature at 18°C to 25°C (64°F to 77°F) for up to 4 additional hours. Discard unused YARTEMLEA solution if not used within 4 hours from the time of dilution to the end of the infusion. Administration Administer YARTEMLEA diluted solution intravenously by gravity infusion or via infusion pump (for solution prepared in an intravenous bag) or via syringe pump (for solution prepared in a syringe) over 30 minutes through a PVC or PVC-lined infusion line with a 0.2-micron polyethersulfone (PES) in-line filter and a polyurethane catheter. Flush the intravenous line at the end of the infusion with sufficient volume of 5% Dextrose Injection, USP to clear the line of YARTEMLEA infusion solution. Do not co-administer other drugs through the same intravenous line.
17 PATIENT COUNSELING INFORMATION Serious infections: Inform patients and caregivers that treatment with complement inhibitors has been associated with an increased risk of serious infections. As YARTEMLEA is a complement inhibitor, advise patients and/or caregivers to immediately report any signs or symptoms suggestive of infections [see Warnings and Precautions ( 5.1 )] . Manufactured by: Omeros Corporation 201 Elliott Avenue West Seattle, WA 98119 US license 2141 This product, or its use, may be covered by one or more US patents, including US Patent Nos. 9,011,860, 10,047,165, and 10,683,367, in addition to others, including patents pending. YARTEMLEA is a trademark of Omeros Corporation. © 2025 Omeros Corporation
According to its FDA label, Yartemlea (narsoplimab-wuug) is approved for: 1 INDICATIONS AND USAGE YARTEMLEA is indicated for the treatment of adult and pediatric patients 2 years of age and older with hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA). YARTEMLEA is a MASP-2 inhibitor indicated for the treatment of adult a… For medical advice, please talk to your prescriber or pharmacist.
Yartemlea (narsoplimab-wuug) belongs to the MASP-2 monoclonal antibody class of medications.
The FDA label lists Yartemlea (narsoplimab-wuug) as: 3 DOSAGE FORMS AND STRENGTHS Injection: 370 mg/2 mL (185 mg/mL) as a clear to slightly opalescent, slightly yellow to yellow-brown solution in a single-dose vial. Injection: 370 mg/2 mL (185 mg/mL) in a single-dose vial. ( 3 ); intravenous route. Available strengths and packaging vary by manufacturer.
Not yet. As of the most recent FDA data we ingest, no A-rated generic equivalent is listed for Yartemlea. Availability changes as patents expire.
Our ingest of the FDA label for Yartemlea (narsoplimab-wuug) does not include a Boxed Warning at this time. See the full label on DailyMed for the current, authoritative version.
The FDA Enforcement Report does not show an active/ongoing recall for Yartemlea (narsoplimab-wuug) in our latest ingest. Recall data can change daily — verify at FDA.gov.
The FDA record lists the approval date for Yartemlea (narsoplimab-wuug) as 2025-12-23.
The FDA label lists Omeros Corporation as a labeler/manufacturer of Yartemlea (narsoplimab-wuug). Multiple firms may market generics of the same molecule.
The FDA label states: "Store YARTEMLEA vials refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light until time of use. Do not freeze. Do not shake. Do not use beyond the expiration date stamped on the carton." Follow the packaging insert for the authoritative guidance.
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