For Patients & Caregivers

ENSPRYNG resources

Quicklinks

Clinical resources
Patient support resources
Helpful links

Clinical resources

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Treatment initiation guide

Printable resource to help you start your patients on treatment with ENSPRYNG

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IL-6 in NMOSD brochure

Informational brochure explaining the significance of IL-6 in NMOSD

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Core data brochure

Comprehensive resource with ENSPRYNG efficacy and safety data, dosing, administration, monitoring, and patient access

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Patient support resources

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Treatment discussion guide

A worksheet to help patients discuss treatment options with their healthcare provider

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Patient brochure

A comprehensive guide for patients and their caregivers to learn about treatment with ENSPRYNG

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Clinical Education Manager flyer

An informational flyer about CEMs for ENSPRYNG

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Injection pocket guide

ENSPRYNG self-administration guide in a compact booklet for your patients to carry with them

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Helpful links to connect your patients with the NMOSD community

Get information or connect with others living with neuromyelitis optica spectrum disorder (NMOSD) through the following organizations*:

The Guthy-Jackson Charitable Foundation

The Sumaira Foundation

The Siegel Rare Neuroimmune Association

Connor B. Judge Foundation

National Organization for Rare Disorders (NORD)

National Institute of Neurological Disorders and Stroke

*By selecting any of these links, you will be visiting a site not controlled by or affiliated with Genentech, Inc. Genentech is neither affiliated with nor endorses any of these organizations. We do not make any representation or guarantee as to the accuracy of the information contained on sites we do not own or control. These links are provided for informational purposes only.

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Quick start with ENSPRYNG

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Important Safety Information & Indication

Indication

ENSPRYNG is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

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
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.

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.

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 (≥15% in either trial) were nasopharyngitis (31%), headache (27%), upper respiratory tract infection (19%), rash (17%), arthralgia (17%), extremity pain (15%), gastritis (15%), fatigue (15%), and nausea (15%).

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.

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    • Data on file. Genentech, Inc. South San Francisco, CA.

      Data on file. Genentech, Inc. South San Francisco, CA.

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      Data on file. Genentech, Inc. South San Francisco, CA.

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      Data on file. Genentech, Inc. South San Francisco, CA.

    • Data on file. Genentech, Inc. South San Francisco, CA.

      Data on file. Genentech, Inc. South San Francisco, CA.

    • Data on file. Genentech, Inc. South San Francisco, CA.

      Data on file. Genentech, Inc. South San Francisco, CA.

    • Data on file. Genentech, Inc. South San Francisco, CA.

      Data on file. Genentech, Inc. South San Francisco, CA.

    • Data on file. Genentech, Inc. South San Francisco, CA.

      Data on file. Genentech, Inc. South San Francisco, CA.

    • Kleiter I, Traboulsee A, Palace J, et al. Long-term Efficacy of Satralizumab in AQP4-IgG-Seropositive Neuromyelitis Optica Spectrum Disorder From SAkuraSky and SAkuraStar. Neurol Neuroimmunol Neuroinflamm. 2022;10(1):e200071. doi:10.1212/NXI.0000000000200071

      Kleiter I, Traboulsee A, Palace J, et al. Long-term Efficacy of Satralizumab in AQP4-IgG-Seropositive Neuromyelitis Optica Spectrum Disorder From SAkuraSky and SAkuraStar. Neurol Neuroimmunol Neuroinflamm. 2022;10(1):e200071. doi:10.1212/NXI.0000000000200071

    • Data on file. Genentech, Inc. South San Francisco, CA.

      Data on file. Genentech, Inc. South San Francisco, CA.

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