Prescription medicine
Satralizumab Brand names: Enspryng
Satralizumab (Enspryng) is a prescription medicine with an FDA approval on record since 2020. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the satralizumab FDA label on DailyMed (effective June 22, 2026, Genentech, Inc.); the BLA 761149 record on Drugs@FDA; every satralizumab label on DailyMed.
Highlights of the record
FDA label of June 22, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageENSPRYNG is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.
Forms and strengths
- 120 mg/ml
Injection (solution).
On the market
- Earliest approval on file
- August 14, 2020 Enspryng, Genentech; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 1,684 through July 30, 2026
What is satralizumab used for?
From the label: indications and usageENSPRYNG is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. ENSPRYNG is an interleukin-6 (IL-6) receptor antagonist indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.
Source: FDA drug label (Enspryng), Genentech, Inc., effective June 22, 2026 (SPL set 64c156a4-9bad-4d45-a294-0733c141f47b), via openFDA; the full label on DailyMed
What does the patient leaflet for satralizumab say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about ENSPRYNG?ENSPRYNG may cause serious side effects including: 1. Infections. ENSPRYNG can increase your risk of serious infections some of which can be life-threatening. Talk to your healthcare provider if you are being treated for an infection or call them right away if you think you have signs of an infection, with or without a fever, such as: chills, feeling tired, muscle aches, cough that will not go away or a sore throat. skin redness, swelling, tenderness, pain or sores on your body. diarrhea, belly pain, or feeling sick. burning when you urinate or urinating more often than usual. Your healthcare provider will check if you have an infection and treat it if needed before you start or continue to take ENSPRYNG. Your healthcare provider should test you for hepatitis and tuberculosis (TB) before you start taking ENSPRYNG. All required vaccinations should be completed before starting ENSPRYNG. People using ENSPRYNG should not be given 'live' or 'live-attenuated' vaccines. 'Live' or 'live-attenuated' vaccines should be given at least 4 weeks before you start ENSPRYNG. Your healthcare provider may recommend that you get a 'non-live' (inactivated) vaccine, such as some of the seasonal flu vaccines. If you plan to get a 'non-live' (inactivated) vaccine, it should be given, whenever possible, at least 2 weeks before you start ENSPRYNG. 2. Increased liver enzymes. Your healthcare provider should order blood tests to check your liver enzymes before and while you are taking ENSPRYNG. Your healthcare provider will tell you how often you will need to have these blood tests. Make sure you get all of your follow-up blood tests as ordered by your healthcare provider. Your healthcare provider will tell you if you need to wait to start ENSPRYNG if your liver enzymes are increased. 3. […]
From the patient leaflet: How should I store ENSPRYNG?Store ENSPRYNG in the refrigerator between 36°F to 46°F (2°C to 8°C) in the original carton. Protect from light. Do not freeze. Do not use ENSPRYNG if it has been frozen. Do not shake. The ENSPRYNG carton can be stored at room temperature up to 86°F (30°C) for up to 8 days. If ENSPRYNG is removed from and returned to the refrigerator the total combined time out of the refrigerator should not be more than 8 days. Always keep in the original carton to protect from light.
Source: FDA drug label (Enspryng), Genentech, Inc., effective June 22, 2026 (SPL set 64c156a4-9bad-4d45-a294-0733c141f47b), via openFDA; the full label on DailyMed
Is there a generic for satralizumab (Enspryng)?
No generic satralizumab is approved (Drugs@FDA, October 8, 2026).
- 2020 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for satralizumab?
The FDA Adverse Event Reporting System holds 1,684 reports that list satralizumab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 99 are coded as a death and 649 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Satralizumab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other