Satralizumab

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

• ENSPRYNG 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.

• 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 )contraindicated

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 (5.1) ] . Liver Transaminase Screening Liver transaminases and serum bilirubin should be assessed prior to initiation of treatment with ENSPRYNG [see Warnings and Precautions (5.2) ] .

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. ( 5.1 ) Elevated Liver Enzymes: Monitor ALT and AST levels during treatment; interruption of ENSPRYNG may be required. ( 5.2 ) Decreased Neutrophil Counts: Monitor neutrophils during treatment. ( 5.3 ) 5.1 Infections An increased risk of infections, including serious and potentially fatal infections, has been observed in patients treated with IL-6 receptor antagonists, including ENSPRYNG. The most common infections reported in a randomized clinical trial of patients treated with ENSPRYNG who were not on other chronic immunosuppressant therapies (Study 1), and that occurred more often than in patients receiving placebo, were nasopharyngitis (12%) and cellulitis (10%). The most common infections in patients who were on an additional concurrent immunosuppressant, and that occurred more often than in patients receiving placebo, were nasopharyngitis (31%), upper respiratory infection (19%), and pharyngitis (12%). Delay ENSPRYNG administration in patients with an active infection, including localized infections, until the infection is resolved. Hepatitis B Virus (HBV) Reactivation Risk of HBV reactivation has been observed with other immunosuppressant therapies. Patients with chronic HBV infection were excluded from clinical trials. Perform HBV screening in all patients before initiation of treatment with ENSPRYNG. Do not administer ENSPRYNG to patients with active hepatitis.

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, controlled period, the median exposure time on ENSPRYNG treatment was approximately 2 years in Study 1 and approximately 3 years in Study 2.

8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ENSPRYNG during pregnancy. Healthcare providers are encouraged to register patients and pregnant women are encouraged to register themselves by calling 1-833-277-9338. Risk Summary There are no adequate data on the developmental risk associated with the use of ENSPRYNG in pregnant women. In an animal reproduction study, no adverse effects on maternal animals or fetal development were observed in pregnant monkeys and their offspring, with administration of satralizumab-mwge at doses up to 50 mg/kg/week (see Data ) . In the U.S. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2 – 4% and 15 – 20%, respectively. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. Clinical Considerations Fetal/neonatal adverse reactions Monoclonal antibodies are increasingly transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester. Risks and benefits should be considered prior to administering live or live-attenuated vaccines to infants exposed to ENSPRYNG in utero [see Warnings and Precautions (5.1) ] .

Metabolism

The pharmacokinetics of ENSPRYNG have been characterized both in Japanese and Caucasian healthy volunteers, and in NMOSD patients. The pharmacokinetics in NMOSD patients using the recommended dose were characterized using population pharmacokinetic analysis methods based on a database of 154 patients.

• Aug 14, 2020BLABLA761149Genentech

1. 1Neuromyelitis Optica Spectrum Disorder27217%
2. 2Off Label Use1539.8%
3. 3Urinary Tract Infection1278.1%
4. 4Pneumonia976.2%
5. 5Covid-19644.1%
6. 6Fatigue603.8%
7. 7No Adverse Event593.8%
8. 8Hypoaesthesia533.4%
9. 9Pain483.1%
10. 10Headache473.0%
11. 11Infection442.8%
12. 12Muscular Weakness422.7%
13. 13Arthralgia412.6%
14. 14Optic Neuritis362.3%
15. 15Fall342.2%

The 10 most recently updated of 18 ClinicalTrials.gov registrations naming Satralizumab as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Study To Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, And Pharmacodynamics Of Satralizumab In Pediatric Patients With Aquaporin-4 Antibody Positive Neuromyelitis Optica Spectrum Disorder (NMOSD)
  Recruiting · Phase 3 · Interventional · 8 enrolled · Hoffmann-La Roche
  NCT05199688updated 2026-06-09
• A Study to Evaluate the Efficacy, Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Satralizumab in Participants With Anti-N-methyl-D-aspartic Acid Receptor (NMDAR) or Anti-leucine-rich Glioma-inactivated 1 (LGI1) Encephalitis
  Recruiting · Phase 3 · Interventional · 120 enrolled · Hoffmann-La Roche
  NCT05503264updated 2026-06-08
• A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease
  Active not recruiting · Phase 3 · Interventional · 152 enrolled · Hoffmann-La Roche
  NCT05271409updated 2026-06-08
• A Study to Assess the Efficacy and Safety of Satralizumab in Duchenne Muscular Dystrophy (DMD)
  Active not recruiting · Phase 2 · Interventional · 30 enrolled · Hoffmann-La Roche
  NCT06450639updated 2026-05-15
• A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Thyroid Eye Disease
  Active not recruiting · Phase 3 · Interventional · 127 enrolled · Hoffmann-La Roche
  NCT06106828updated 2026-05-14
• Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Thyroid Eye Disease
  Active not recruiting · Phase 3 · Interventional · 131 enrolled · Hoffmann-La Roche
  NCT05987423updated 2026-05-05
• Rituximab Versus Ravulizumab, Inebilizumab, Satralizumab, and Eculizumab in NMOSD
  Not yet recruiting · Phase 4 · Interventional · 540 enrolled · Massachusetts General Hospital
  NCT07010302updated 2026-03-16
• Monoclonal Antibody-Based Therapies for AQP4-Positive NMOSD
  Recruiting · Observational · 200 enrolled · Tongji Hospital
  NCT06885957updated 2025-09-08
• Satralizumab in the Treatment of Pulmonary Arterial Hypertension (SATISFY-JP Trial)
  Active not recruiting · Phase 2 · Interventional · 20 enrolled · International University of Health and Welfare
  NCT05679570updated 2025-09-03
• Study to Evaluate the Efficacy and Safety of Satralizumab in FSHD1
  Active not recruiting · Phase 2 · Interventional · 46 enrolled · Centre Hospitalier Universitaire de Nice
  NCT06222827updated 2025-03-26

Frequently asked questions

How does Satralizumab work?

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

What is Satralizumab used for?

According to FDA labeling, Satralizumab carries indications including: ENSPRYNG 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Satralizumab?

Satralizumab is classified as Interleukin inhibitors, Antibody Interactions, Interleukin 6 Receptor Antagonists, Unknown Physiological Effect.

What are the brand names for Satralizumab?

Satralizumab is marketed under brand names including Enspryng.

What are the contraindications for Satralizumab?

Satralizumab labeling lists contraindications including: 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 ). Always consult the full prescribing information and a clinician.