For Patients & Caregivers

Treat Differently

Patient portrayal

ENSPRYNG® (satralizumab-mwge) is now approved for the treatment of Thyroid Eye Disease (TED) regardless of TED activity or duration in adults1

The first and only FDA-approved anti-IL-6 treatment for TED1*

Efficacy data across key TED symptoms1†

Including proptosis, diplopia, and signs and symptoms of ocular inflammation.1,2‡

A well-established safety profile1

Supported by over 7 years of clinical experience with consistent safety.3

Flexibility of subcutaneous self-administration1

After proper training and approval from a healthcare provider, your patients can self-administer ENSPRYNG.1

*While the precise mechanism by which ENSPRYNG exerts therapeutic effects in TED is unknown, it is presumed to involve inhibition of IL-6 mediated signaling via binding to membrane-bound and soluble IL-6 receptors.1
†ENSPRYNG met its primary endpoint in SATRAGO-2 at Week 24 in the active TED population, but did not achieve statistical significance in SATRAGO-1. Primary endpoint was measured by a proptosis responder rate at Week 24 in the active TED population, where a proptosis response was defined as a patient with a ≥2 mm reduction in proptosis in the study eye from baseline without deterioration (≥2 mm increase in proptosis) in the non-study eye. In SATRAGO-1, difference in LS means for ENSPRYNG was 17.9% (CI: [95%] -1.6%, 37.3%). In SATRAGO-2, difference in LS means for ENSPRYNG was 29.5% (CI: [95%] 11.5%, 46.2%).1
 ‡Improvements in diplopia over 6 months was a secondary endpoint observed at Week 24 in SATRAGO-2.1

ENSPRYNG (satralizumab-mwge) is a prescription medicine indicated for the treatment of adults with thyroid eye disease (TED), regardless of TED activity or duration in adult patients.

ENSPRYNG is the first and only FDA-approved anti-IL-6 treatment for TED. While the precise mechanism by which ENSPRYNG exerts therapeutic effects in TED is unknown, it is presumed to involve inhibition of IL-6-mediated signaling via binding to membrane-bound and soluble IL-6 receptors.

ENSPRYNG has been studied in two pivotal Phase 3 clinical trials in TED. ENSPRYNG met its primary endpoint in SATRAGO-2 at Week 24 in the active TED population, but did not achieve statistical significance in SATRAGO-1. Primary endpoint was measured by a proptosis responder rate at Week 24 in the active TED population, where a proptosis response was defined as a patient with a ≥2 mm reduction in proptosis in the study eye from baseline without deterioration (≥2 mm increase in proptosis) in the non-study eye. In SATRAGO-1, difference in LS means for ENSPRYNG was 17.9% (CI: [95%] -1.6%, 37.3%). In SATRAGO-2, difference in LS means for ENSPRYNG was 29.5% (CI: [95%] 11.5%, 46.2%). ENSPRYNG also demonstrated efficacy beyond proptosis, with improvements in diplopia observed in SATRAGO-2.

ENSPRYNG can be self-administered by subcutaneous injections under the guidance of a healthcare provider, following proper training and approval. Regular monitoring is advised. Review the TED patient monitoring information.

ENSPRYNG has a well-established safety profile, supported by over 7 years of clinical experience with consistent safety. ENSPRYNG may cause serious side effects including infections, elevated liver enzymes, decreased neutrophil counts, and hypersensitivity reactions. These are not all the possible side effects of ENSPRYNG. Review the ENSPRYNG safety profile in TED.

CI=confidence interval; FDA=Food and Drug Administration; IL-6=interleukin 6; LS=least squares; TED=thyroid eye disease.

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. Neurimmunol Neurinflamm. 2025; 12(5):e200450.

      Bennett JL, et al. Neurol. Neurimmunol Neurinflamm. 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; 27:237–253

      Ezra DG, et al. Rev Endocr Metab Disord. 2026; 27:237–253

    • 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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