Narsoplimab

Narsoplimab is a prescription medication indicated for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) in adult and pediatric patients aged 2 years and older.

• Narsoplimab is available under the following different brand names: Yartemlea, narsoplimab-wuug 

Common side effects of Narsoplimab include:

• viral infections
• sepsis
• hemorrhage
• diarrhea 
• vomiting 
• nausea
• neutropenia
• fever
• fatigue 
• hypokalemia

Serious side effects of Narsoplimab include:

• serious life-threatening infections (including neutropenic sepsis and septic shock)
• acute kidney injury 
• confusional state
• acute respiratory failure 
• pulmonary edema

Rare side effects of Narsoplimab include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Injection, solution

• 370 mg/2 mL (185 mg/mL) single-dose vial
• Hematopoietic Stem Cell Transplant-associated Thrombotic Microangiopathy

Adult and pediatric dosage

• Weighing less than 50 kg: 4 mg/kg IV once weekly
• Weighing 50 kg and more: 370 mg IV once weekly
• Increase frequency to twice weekly if there is inadequate improvement in TA-TMA signs and symptoms

Dosage Considerations – Should be Given as Follows: 

See “Dosages”

Tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Visit the RxList Drug Interaction Checker for any drug interactions. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Narsoplimab?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Narsoplimab?”

Cautions

Serious infections

• Serious and life-threatening infections reported
• These infections included sepsis, viral infections, pneumonia, bacteremia, fungal infection, gastroenteritis, respiratory tract infection, and urosepsis
• If administered to patients with active infections, monitor closely for signs and symptoms of worsening infection and treat promptly

Pregnancy and Lactation

• Available data on use during pregnancy are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes

Clinical considerations

• Placental transport of endogenous IgG antibodies increases as pregnancy progresses and peaks during the third trimester
• Therefore, it is expected that narsoplimab will be present in infants exposed in utero during the third trimester
• Consider the potential clinical impact of narsoplimab exposure on infants exposed in utero

Lactation

• There are no data on the presence of narsoplimab in human milk, effects on breastfed children, or effects on milk production
• Narsoplimab is present in the milk of lactating mice
• Endogenous maternal IgG and monoclonal antibodies are transferred into human milk
• Effects of local gastrointestinal exposure and the extent of systemic exposure in breastfed children are unknown