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Satralizumab: uses, dosing, side effects & brands

Satralizumab is a medicine sold in the U.S. under one brand, for neuromyelitis optica. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.

By the pharmaranks editorial teamReviewed against the FDA (openFDA label, NDC Directory & Enforcement) sourcesUpdated Jul 24, 2026How we research

Key facts

Treats
Neuromyelitis Optica
Available as
Injectable
Sold as
Enspryng
Prescription?
Prescription only
Generic available?
Not in our catalog

How satralizumab is dosed

From the FDA label for Enspryng (application BLA761149). Other satralizumab products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.

Hepatitis B virus, tuberculosis, and liver transaminase screening is required before the first dose. ( 2.1 ) Prior to every use, determine if there is an active infection. ( 2.2 ) The recommended loading dosage of ENSPRYNG for the first three administrations is 120 mg by subcutaneous injection at Weeks 0, 2, and 4, followed by a maintenance dosage of 120 mg every 4 weeks. ( 2.2 ) See Full Prescribing Information for important preparation and administration instructions. ( 2.3 ) 2.1 Assessments Prior to the First Dose of ENSPRYNG Hepatitis B Virus Screening Prior to initiating ENSPRYNG, perform Hepatitis B virus (HBV) screening. ENSPRYNG is contraindicated in patients with active HBV confirmed by positive results for surface antigen [HBsAg] and anti-HBV tests. For patients who are negative for HBsAg and positive for HB core antibody [HBcAb+] or are carriers of HBV [HBsAg+], consult liver disease experts before starting and during treatment with ENSPRYNG [see Contraindications (4) and Warnings and Precautions (5.1) ] . Tuberculosis Screening Prior to initiating ENSPRYNG, evaluate for active tuberculosis and test for latent infection. For patients with active tuberculosis or positive tuberculosis screening without a history of appropriate treatment, consult infectious disease experts before initiating treatment with ENSPRYNG [see Contraindications (4) and Warnings and Precautions…

Satralizumab side effects

The following clinically significant adverse reactions are described elsewhere in the labeling: Infections [see Warnings and Precautions (5.1) ] Elevated Liver Enzymes [see Warnings and Precautions (5.2) ] Decreased Neutrophil Counts [see Warnings and Precautions (5.3) ] Hypersensitivity Reactions [see Warnings and Precautions (5.4) ] The most common adverse reactions (incidence at least 15%) are nasopharyngitis, headache, upper respiratory tract infection, gastritis, rash, arthralgia, extremity pain, fatigue, and nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Genentech at 1-888-835-2555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice. The safety of ENSPRYNG was evaluated in two randomized, placebo-controlled clinical trials [Study 1 evaluated ENSPRYNG without concurrent immunosuppressive therapy (IST) and Study 2 evaluated ENSPRYNG with concurrent IST], which included 41 anti-AQP4 seropositive patients treated with ENSPRYNG in Study 1 and 26 anti-AQP4 seropositive patients treated with ENSPRYNG in Study 2 [see Clinical Studies (14) ] . In the double-blind,…

Who shouldn’t take satralizumab

ENSPRYNG is contraindicated in patients with: A known hypersensitivity to satralizumab or any of the inactive ingredients [see Warnings and Precautions (5.4) ] Active Hepatitis B infection [see Warnings and Precautions (5.1) ] Active or untreated latent tuberculosis [see Warnings and Precautions (5.1) ] Known hypersensitivity to satralizumab or any of the inactive ingredients ( 4 ) Active Hepatitis B infection ( 4 ) Active or untreated latent tuberculosis ( 4 )

Every satralizumab product we track (1)

Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.

Only one: Enspryng.

What people report to the FDA about satralizumab

The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 277 reports naming satralizumab, and the FDA flagged 94% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:

  • neuromyelitis optica spectrum disorder67 reports
  • urinary tract infection30 reports
  • muscular weakness21 reports
  • hypoaesthesia19 reports
  • optic neuritis18 reports
  • pneumonia18 reports
  • infection17 reports
  • fatigue16 reports

Read these as a signal, not a rate. A report does not mean satralizumab caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.

Source: openFDA drug/event (FAERS), retrieved July 26, 2026.

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Frequently asked questions

What is satralizumab?

Enspryng (Satralizumab) is a medication used to treat Neuromyelitis Optica.

Can you take satralizumab with other medicines?

It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run satralizumab against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.

What forms does satralizumab come in?

Across the brands we track, satralizumab is currently marketed as injectable, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.

Is there a generic satralizumab?

We do not currently list a generic-labelled satralizumab product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.

Cite this page
APA
pharmaranks. (2026, July 24). Satralizumab: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/satralizumab
MLA
“Satralizumab: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/satralizumab.

We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.

Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.

Read the full FDA label for satralizumab on DailyMed (NIH) ↗.