Genentech is here to support starting your patients on ENSPRYNG as quickly as possible

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No additional vaccines required before starting treatment

Beyond routine vaccinations, no additional vaccines are required before starting ENSPRYNG.3*

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Monthly at-home self-administration after training

After proper training by a healthcare provider, patients can start self-administering ENSPRYNG at home or on the go.3

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Majority of patients covered

~75% of commercial patients nationwide have unrestricted first-line coverage for ENSPRYNG—no need for patient to fail other therapies.52

Free sample doses for your practice

The ENSPRYNG sample program provides the first 2 months of treatment—3 loading doses and the first maintenance dose‡§—to help you become familiar with it by:

  • Building experience for you and your eligible NMOSD patients
  • Helping you determine whether a self-administered treatment is the appropriate option for your patients

Learn more and submit sample requests with your local Genentech representative, or call the Sample Accountability Call Center at 1-866-736-2717 (Monday through Friday, 8 AM to 6 PM ET)

*According to immunization guidelines, all immunizations should be administered at least 4 weeks prior to initiation of ENSPRYNG for live or live-attenuated vaccines and, wherever possible, at least 2 weeks prior for non-live vaccines.3
Because drug coverage policies can change, please check with the health plan directly to confirm coverage for individual patients. Coverage policies current as of November 2024.
Drug samples may not be sold, purchased, traded, or offered for sale, purchase, or trade, utilized to seek reimbursement, or otherwise distributed in a manner not permitted by applicable law. Samples may only be distributed to practitioners who are licensed or authorized under applicable law to prescribe the drug product and whose practices are relevant to the FDA-approved product labeling for ENSPRYNG. Distribution of the sample does not obligate use or continuing use of ENSPRYNG. You may not advertise or otherwise use the program as a means of promoting your services or Genentech products to patients. Genentech reserves the right to deny fulfillment of the sample to anyone deemed ineligible in accordance with stated program criteria.
§Annual sample limits per healthcare provider apply.

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Get in touch

Connect with a representative to answer any questions you have about ENSPRYNG.

Helpful resources for your practice

Here you will find downloadable resources about ENSPRYNG for you and your patients, along with a selection of links for community support

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.

    • 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.