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Molecule

Narsoplimab

Available on requestBiologicOrphanCold chainOncology
Presentations
1
Brands
1
Manufacturers
1
Available from stock
0

Narsoplimab is a prescription medicine 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). It is available as injection for intravenous use. MedsAcross supplies Narsoplimab for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

ATC classification
L01FX Cancer medicines (antineoplastics), subgroup L01F, subgroup L01FX · Cancer medicines (antineoplastics), subgroup L01F
US FDA first approval
23 December 2025
EU status
Opinion
Orphan designation
Yes
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Intravenous
Dosage forms
Injection
Biologic
Yes
Identifiers
UNII FT24ZQQ5RP

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

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).

Source: US FDA prescribing information

How it works

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.

Source: US FDA prescribing information

Dosing overview

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. See Full Prescribing Information for instructions on preparation and administration.

Source: US FDA prescribing information

Warnings and precautions

Serious infections: Monitor patients for signs/symptoms and treat appropriately. 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.

Source: US FDA prescribing information

Side effects

The following clinically significant adverse reactions are described elsewhere in the labeling: Serious Infections Most common adverse reactions (incidence > 20% and independent of causality) are viral infections, sepsis, hemorrhage, diarrhea, vomiting, nausea, neutropenia, pyrexia, fatigue and hypokalemia.

Source: US FDA prescribing information

Storage

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.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

1 presentations of Narsoplimab, sorted by availability.

MedicineManufacturerRegisterAvailability
Yartemlea 370 mg/2 mL injectionIntravenous Cold chainOmerosUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 23 December 2025Drugs@FDA
EU (EMA)OpinionEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Questions and answers

Is Narsoplimab available for export from India?

Yes, on request. MedsAcross lists 1 presentations of Narsoplimab and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Narsoplimab have?

The catalogue lists 1 brand names for Narsoplimab, including Yartemlea.

Is Narsoplimab approved by the US FDA?

Yes. The US FDA first approved Narsoplimab on 23 December 2025, according to Drugs@FDA.

Does Narsoplimab need cold chain shipping?

At least one listed presentation of Narsoplimab must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.

Which ATC class is Narsoplimab in?

Narsoplimab is classified under ATC code L01FX (Cancer medicines (antineoplastics), subgroup L01F, subgroup L01FX).

References

  1. YARTEMLEA prescribing information (Omeros). U.S. National Library of Medicine, DailyMed. Retrieved 20 January 2026

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