Narsoplimab

Narsoplimab is used to treat thrombotic microangiopathy (TA-TMA) after a stem cell transplant in adults and in children who are at least 2 years old.

Narsoplimab may also be used for reasons not mentioned in this medication guide.

Narsoplimab is given as an infusion into a vein over 30 minutes. A healthcare provider will give you this injection.

Narsoplimab is usually given once per week. Your doctor will decide your treatment schedule based on the condition being treated.

Doses are based on weight. Your dose may change if you gain or lose weight.

Call your doctor if your symptoms do not improve, or if they get worse.

You may get infections more easily, including serious or fatal infections. You will need frequent medical tests.

If you have an infection, you will be monitored closely to ensure it does not get worse.

You may get infections more easily, including serious or fatal infections. Call your doctor if you have flu symptoms, a cough, an upset stomach, vomiting, night sweats, neck stiffness, confusion, or vision problems.

Tell your doctor if you have or have ever had:

• an active or recent infection.

Using narsoplimab may raise your chance of getting some infections like sepsis, pneumonia, viral or fungal infections, stomach or urinary tract infections, and bloodstream infections. Ask your doctor about your specific risk.

It is not known if narsoplimab can harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Ask a doctor if it is safe to breastfeed while using narsoplimab.

Get emergency medical help if you notice signs of an allergic reaction: hives, trouble breathing, swelling of your face, lips, tongue, or throat.

You may become more susceptible to infections, including serious or life-threatening infections. Contact your doctor immediately if you notice signs of infection such as:

• fever, chills, sore throat;
• mouth sores, red or swollen gums;
• upset stomach, diarrhea, vomiting;
• pale skin, easy bruising, unusual bleeding; or
• chest discomfort, wheezing, dry cough or hack, rapid weight loss.

Common side effects of narsoplimab may include:

• infection;
• bleeding;
• nausea, vomiting, diarrhea;
• low white blood cell counts;
• low blood potassium; or
• fever, tiredness.

This is not a complete list of side effects and others may happen. Call your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

Usual Adult Dose for Hematopoietic Stem Cell Transplant-Associated Thrombotic Microangiopathy:

Weight less than 50 kg: 4 mg/kg IV once a week-If inadequate improvement in signs/symptoms: 4 mg/kg IV twice a weekWeight at least 50 kg: 370 mg IV once a week-If inadequate improvement in signs/symptoms: 370 mg IV twice a weekComments:-Administer as an IV infusion over 30 minutes.Use: For the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA)

Usual Pediatric Dose for Hematopoietic Stem Cell Transplant-Associated Thrombotic Microangiopathy:

2 years and older:-Weight less than 50 kg: 4 mg/kg IV once a week---If inadequate improvement in signs/symptoms: 4 mg/kg IV twice a week-Weight at least 50 kg: 370 mg IV once a week---If inadequate improvement in signs/symptoms: 370 mg IV twice a weekComments:-Administer as an IV infusion over 30 minutes.Use: For the treatment of TA-TMA

Call your doctor for instructions if you miss an appointment for your Narsoplimab injection.

In a medical setting, an overdose will be treated quickly.

Follow your doctor's instructions on any restrictions regarding food, drinks, or activities.

Other drugs may change how narsoplimab works, including prescription and over-the-counter medicines, vitamins, and herbal products. Inform your doctor about all other medicines you are taking.