For Patients & Caregivers

Patient monitoring prior to and during ENSPRYNG® treatment1

Assessments before administering ENSPRYNG1

  • Infection assessment
    Identify and resolve any active infection before every dose of ENSPRYNG1
  • Hepatitis B virus screening
    ENSPRYNG should not be initiated in patients with active HBV1
  • Tuberculosis screening
    Evaluate for active tuberculosis and test for latent infection. If positive, consult infectious disease experts prior to initiation of ENSPRYNG1
  • Liver transaminase screening
    Liver transaminases and serum bilirubin should be assessed prior to initiation of treatment1
  • Vaccination
    No additional vaccines required before starting treatment. Administer live or live-attenuated vaccines at least 4 weeks prior, and non-live vaccines at least 2 weeks prior, to initiating ENSPRYNG1

Patient monitoring during ENSPRYNG treatment1

  • Liver transaminases
    Monitor ALT and AST levels every 4 weeks for the first 3 months of treatment, followed by every 3 months for 1 year, and thereafter as clinically necessary1
  • Neutrophil counts
    Monitor neutrophils 4 to 8 weeks after initiation of therapy and thereafter at regular clinically determined intervals1

Monitoring schedule: patient’s first year on ENSPRYNG1

*Time of first administration.
†Liver transaminases should be assessed prior to initiation of ENSPRYNG.

Managing changes in liver transaminase during ENSPRYNG treatment1

Dose management1

If ALT or AST levels exceed 5 x the ULN, discontinue ENSPRYNG as follows:1
  • If any bilirubin elevation is detected
    Discontinue ENSPRYNG; reinitiation is not recommended1
  • If bilirubin is normal
    When ALT or AST return to normal and a benefit-risk assessment is performed, restart treatment per schedule below1

Upon restarting treatment, closely monitor liver parameters. Discontinue and do not restart ENSPRYNG if ALT, AST, or bilirubin rise above the ULN.1

Time since last dose Recommended dosage for restart of treatment

<12 weeks

Restart at the recommended dosage by subcutaneous injection every 4 weeks

≥12 weeks

Restart at the recommended dosage by subcutaneous injection at Weeks 0‡, 2 and 4, followed by recommended dosage every 4 weeks

‡Time of first administration after the missed dose.

Managing changes in neutrophil count during ENSPRYNG treatment1

Dose management1

  • If neutrophil count is below 1.0 x 109/L and confirmed by repeat testing, ENSPRYNG should be interrupted1
  • Resume treatment once neutrophil count is >1.0 X 109/L1

Clinical trial experience in SATRAGO-1 and SATRAGO-21

Liver transaminases: ALT and AST levels rose above the ULN in 25.2% and 11.5% of patients treated with ENSPRYNG respectively, vs 7.3% and 4.8% of patients receiving placebo. One patient (0.8%) in the placebo group experienced an AST elevation of >3 to 5 x ULN.1§

Neutrophil count: Decreased neutrophil counts through Week 24 were observed in 28.2% of patients treated with ENSPRYNG compared with 9.7% of patients receiving placebo.1

§These elevations were not associated with increases in total bilirubin. Overall post-baseline, liver function tests abnormalities were infrequent, predominantly of low grade, with no evidence of drug-induced liver injury or hepatotoxicity.

ALT=alanine aminotransferase; AST=aspartate aminotransferase; HBV=hepatitis B virus; ULN=upper limit of normal.

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Safety

Discover a well-established safety profile.1

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Important Safety Information & Indication

Indication

ENSPRYNG® (satralizumab-mwge)  is indicated for the treatment of thyroid eye disease (TED) regardless of TED activity or duration in adult patients.

Contraindications

ENSPRYNG is contraindicated in patients with a known hypersensitivity to satralizumab or any of the inactive ingredients, an active hepatitis B infection, or active or untreated latent tuberculosis.

Warnings and Precautions

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, 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. For patients who are chronic carriers of HBV [HBsAg+] or are negative for HBsAg and positive for HB core antibody [HBcAb+], consult liver disease experts before starting and during treatment with ENSPRYNG.

Tuberculosis
Tuberculosis has occurred in patients treated with other IL-6 receptor antagonists. Patients should be evaluated for tuberculosis risk factors and tested for latent infection prior to initiating ENSPRYNG. Consider anti-tuberculosis therapy prior to initiation of ENSPRYNG in patients with a history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent tuberculosis but having risk factors for tuberculosis infection. Consult infectious disease experts regarding whether initiating anti-tuberculosis therapy is appropriate before starting treatment. Patients should be monitored for the development of signs and symptoms of tuberculosis with ENSPRYNG, even if initial tuberculosis testing is negative.

Vaccinations
Live or live-attenuated vaccines should not be given concurrently with ENSPRYNG because clinical safety has not been established. Administer all immunizations according to immunization guidelines at least 4 weeks prior to initiation of ENSPRYNG for live or live-attenuated vaccines and, whenever possible, at least 2 weeks prior to initiation of ENSPRYNG for non-live vaccines.

Elevated Liver Enzymes
Mild and moderate elevations of liver enzymes have been observed in patients treated with ENSPRYNG at a higher incidence than in patients receiving placebo. ALT and AST levels should be monitored every 4 weeks for the first 3 months of treatment, followed by every 3 months for one year, and thereafter, as clinically indicated.

Decreased Neutrophil Counts
Decreases in neutrophil counts were observed in patients treated with ENSPRYNG at a higher incidence than placebo. Neutrophil counts should be monitored 4 to 8 weeks after initiation of therapy, and thereafter at regular clinically determined intervals.

Hypersensitivity Reactions
Hypersensitivity reactions, including rash, urticaria, and fatal anaphylaxis, have occurred with other IL-6 receptor antagonists.


Use in Specific Populations

Pregnancy
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 ENSPRYNG at doses up to 50 mg/kg/week. 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. ENSPRYNG should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.

Lactation
No information is available on the presence of ENSPRYNG in human milk, the effects of ENSPRYNG on the breastfed infant, or the effects of ENSPRYNG on milk production. ENSPRYNG was excreted in the milk of lactating monkeys administered ENSPRYNG throughout pregnancy. Human IgG is excreted in human milk and the potential for absorption in the infant is unknown. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ENSPRYNG and any potential adverse effects on the breastfed infant from ENSPRYNG or from the underlying maternal condition.

Pediatric Use
Safety and effectiveness in pediatric patients have not been established.

Geriatric Use
Clinical studies of ENSPRYNG did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently from younger patients. However, population pharmacokinetic analyses in patients with NMOSD did not show that age affected the pharmacokinetics of ENSPRYNG. In general, caution should be used when dosing the elderly, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant diseases or other drug therapy.

Most Common Adverse Reactions
The most common adverse reactions in patients with TED (incidence ≥5% and greater than placebo) were upper respiratory tract infection (5%), and alanine aminotransferase increased (5%).

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

For additional safety information, please see the full Prescribing Information and Medication Guide.

    • ENSPRYNG [package insert]. South San Francisco, CA: Genentech, Inc; 2026.

      ENSPRYNG [package insert]. South San Francisco, CA: Genentech, Inc; 2026.

    • Subramanian P, et al. Presented at North American Neuro-Ophthalmology Society (NANOS) 52nd Annual Meeting. March 20-24, 2026.

      Subramanian P, et al. Presented at North American Neuro-Ophthalmology Society (NANOS) 52nd Annual Meeting. March 20-24, 2026.

    • Bennett JL, et al. Neurol Neuroimmunol Neuroinflamm. 2025;12(5):e200450.

      Bennett JL, et al. Neurol Neuroimmunol Neuroinflamm. 2025;12(5):e200450.

    • Murdock J, et al. Front. Ophthalmol. 2025; 5:1544436.

      Murdock J, et al. Front. Ophthalmol. 2025; 5:1544436.

    • Ezra DG, et al. Rev Endocr Metab Disord. 2026; 27(2):237-253.

      Ezra DG, et al. Rev Endocr Metab Disord. 2026; 27(2):237-253.

    • Ezra DG, et al. Ophthalmol Ther. 2025; 14(12):3119-3132.

      Ezra DG, et al. Ophthalmol Ther. 2025; 14(12):3119-3132.

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