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Molecule

Satralizumab

Available on requestBiologicOrphanCold chainImmunology and transplantRheumatology
Presentations
2
Brands
1
Manufacturers
1
Available from stock
0

Satralizumab is a prescription medicine indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive, among other approved uses. It is available as injection for subcutaneous use. MedsAcross supplies Satralizumab 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
L04AC Immunosuppressive drug, subgroup L04AC · Immunosuppressive drug
US FDA first approval
14 August 2020
EU status
Authorised
Orphan designation
Yes
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Subcutaneous
Dosage forms
Injection
Biologic
Yes
Identifiers
UNII YB18NF020MCAS 1535963-91-7DrugBank DB15762Q58218746

Clinical information

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

Uses

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. the treatment of thyroid eye disease (TED) regardless of TED activity or duration in adult patients.

Source: US FDA prescribing information

How it works

The precise mechanism by which satralizumab-mwge exerts therapeutic effects in NMOSD and TED is unknown but is presumed to involve inhibition of IL-6-mediated signaling through binding to soluble and membrane-bound IL-6 receptors.

Source: US FDA prescribing information

Dosing overview

Hepatitis B virus, tuberculosis, and liver transaminase screening is required before the first dose. Prior to every use, determine if there is an active infection. The recommended loading dosage of ENSPRYNG is: NMOSD: 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. TED: for body weight 40-100kg, 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. For body weight >100 kg: for the first three administrations is 180 mg by subcutaneous injection at Weeks 0, 2, and 4, followed by a maintenance dosage of 180 mg every 4 weeks. See Full Prescribing Information for important preparation and administration instructions.

Source: US FDA prescribing information

Contraindications

ENSPRYNG is contraindicated in patients with: A known hypersensitivity to satralizumab or any of the inactive ingredients Active Hepatitis B infection Active or untreated latent tuberculosis Known hypersensitivity to satralizumab or any of the inactive ingredients. Active Hepatitis B infection. Active or untreated latent tuberculosis

Source: US FDA prescribing information

Warnings and precautions

Infections: Delay ENSPRYNG administration in patients with an active infection until the infection is resolved. Vaccination with live or live-attenuated vaccines is not recommended during treatment. Elevated Liver Enzymes: Monitor ALT and AST levels during treatment, interruption of ENSPRYNG may be required. Decreased Neutrophil Counts: Monitor neutrophils during treatment.

Source: US FDA prescribing information

Side effects

The following clinically significant adverse reactions are described elsewhere in the labeling: Infections Elevated Liver Enzymes Decreased Neutrophil Counts Hypersensitivity Reactions The most common adverse reactions in patients with NMOSD (incidence at least 15%) are nasopharyngitis, headache, upper respiratory tract infection, gastritis, rash, arthralgia, extremity pain, fatigue, and nausea. The most common adverse reactions in patients with TED (incidence at least 5%) are upper respiratory tract infection, and alanine aminotransferase increased.

Source: US FDA prescribing information

Storage

Refrigerate at 2°C to 8°C (36°F to 46°F) in original carton to protect from light. Do not freeze. ENSPRYNG can be stored out of refrigeration for a maximum of 8 days at a temperature that does not exceed 30°C (86°F). If ENSPRYNG is removed from and returned to the refrigerator, the total combined time out of refrigeration should not exceed 8 days. Do not shake. Always keep in the original carton to protect from light.

Source: US FDA prescribing information

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

All presentations

2 presentations of Satralizumab, sorted by availability.

MedicineManufacturerRegisterAvailability
Enspryng 120 mg/1 mL injectionSubcutaneous Cold chainGenentechUS FDAAvailable on request
Enspryng 180 mg/1.5 mL injectionSubcutaneous Cold chainGenentechUS 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 14 August 2020Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Conditions

Conditions linked to Satralizumab in public data. This is not a list of approved uses, see the clinical information.

Questions and answers

Is Satralizumab available for export from India?

Yes, on request. MedsAcross lists 2 presentations of Satralizumab and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Satralizumab have?

The catalogue lists 1 brand names for Satralizumab, including Enspryng.

Is Satralizumab approved by the US FDA?

Yes. The US FDA first approved Satralizumab on 14 August 2020, according to Drugs@FDA.

Is Satralizumab authorised in the European Union?

Yes. Satralizumab has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.

Does Satralizumab need cold chain shipping?

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

Which ATC class is Satralizumab in?

Satralizumab is classified under ATC code L04AC (Immunosuppressive drug, subgroup L04AC).

References

  1. Enspryng prescribing information (Genentech). U.S. National Library of Medicine, DailyMed. Retrieved 23 October 2026
  2. Enspryng: European public assessment report (EPAR). European Medicines Agency. Retrieved 21 August 2026

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