Neuromyelitis Optica Treatments
Find Neuromyelitis Optica Treatments
Brand Name
Enspryng
Generic Name
Satralizumab
View Brand Information FDA approval date: August 14, 2020
Form: Injection
What is Enspryng (Satralizumab)?
ENSPRYNG is indicated for the treatment of neuromyelitis optica spectrum disorder in adult patients who are anti-aquaporin-4 antibody positive. ENSPRYNG is an interleukin-6 receptor antagonist indicated for the treatment of neuromyelitis optica spectrum disorder in adult patients who are anti-aquaporin-4 antibody positive.
Approved To Treat
Top Global Experts
Save this treatment for later
Not sure about your diagnosis?
Tired of the same old research?
Related Clinical Trials
Real-World Effectiveness and Safety of Satralizumab in the Early Treatment of Attacks in Neuromyelitis Optica Spectrum Disorder: A Multicenter Prospective Cohort Study
Summary: This study is a multicenter, prospective cohort study designed to enroll 50 NMOSD patients who receive Satralizumab treatment during the early phase of an NMOSD attack. Follow-up visits will be conducted at baseline, 3 months, and 6 months to record and assess EDSS scores, modified Rankin Scale (mRS) scores, EQ-5D scores, Activities of Daily Living (ADL) scores, relapse events, safety data, and ex...
A Phase III, Multicenter, Open-Label, Uncontrolled Study To Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, And Pharmacodynamics Of Satralizumab In Pediatric Patients With AQP4 Antibody Positive Neuromyelitis Optica Spectrum Disorder (NMOSD)
Summary: This study will primarily evaluate the pharmacokinetics of satralizumab in pediatric patients aged 2-11 years with anti-aquaporin-4 (AQP4) antibody seropositive neuromyelitis optica spectrum disorder (NMOSD). Efficacy, safety, tolerability, and pharmacodynamics will be evaluated in a descriptive manner, given the small number of patients who will be enrolled in this study.
Prospective Cohort Study of cLinical and Imaging Patterns of neUroinflammation disEases (CLUE)
Summary: CLUE is a prospective study to assess structural and functional changes of the brain, spinal cord, and optic nerve, as well as the inflammatory environment in patients with neuroinflammatory and demyelinating diseases. Participants will receive magnetic resonance (MR) techniques including DIR, DKI, QSM, Rs-fMRI, conventional sequences (T1WI/T2WI/FLAIR), and the MR metabolic SPICE sequence, and wil...
Related Latest Advances
Brand Information
Enspryng (Satralizumab)
1DOSAGE FORMS AND STRENGTHS
ENSPRYNG is a clear, and colorless to slightly yellow solution available as:
- Injection: 120 mg/mL in single-dose prefilled syringe.
- Injection: 120 mg/mL in single-dose autoinjector.
- Injection: 180 mg/1.5 mL in single-dose autoinjector
2CONTRAINDICATIONS
ENSPRYNG is contraindicated in patients with:
- A known hypersensitivity to satralizumab or any of the inactive ingredients
- Active Hepatitis B infection
- Active or untreated latent tuberculosis
3ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Infections
- Elevated Liver Enzymes
- Decreased Neutrophil Counts
- Hypersensitivity Reactions
3.1Clinical 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.
3.2Immunogenicity
As with all therapeutic proteins, there is a potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of anti-satralizumab-mwge antibodies in the studies described below with the incidence of antibodies in other studies or to other products may be misleading.
In NMOSD Study 1 and NMOSD Study 2, anti-drug-antibodies (ADAs) were observed in 73% and 38% of patients receiving ENSPRYNG in the double-blind period, respectively. The ability of these ADAs to neutralize satralizumab-mwge binding is unknown. Patients with higher body weight and lower exposure were more likely to develop ADAs (irrespective of treatment with IST). Exposure was lower in ADA positive patients. Although anti-satralizumab-mwge antibody development was not found to affect the efficacy of ENSPRYNG in these patients, the available data are too limited to make definitive conclusions. Immunogenicity does not have a clinically-relevant impact on safety. Based on the available information, neither dose interruption nor modification is warranted in those patients who develop ADAs.
In TED Study 3 and TED Study 4, anti-drug-antibodies (ADAs) were observed in 44.8% and 39.1% of patients receiving ENSPRYNG, respectively. The ability of these ADAs to neutralize satralizumab-mwge binding is unknown. ADA incidence is similar in the 120 mg (50 of 119, 42%) and 180 mg (5 of 12, 41.7%) dose groups. Exposure was lower in ADA positive patients. Immunogenicity does not appear to have a clinically-relevant impact on safety, efficacy or PD.
4DESCRIPTION
Satralizumab-mwge is a recombinant humanized anti-human interleukin 6 (IL-6) receptor monoclonal antibody based on a human IgG2 framework. Each light chain and heavy chain consists of 214 and 443 amino acids, respectively. Satralizumab-mwge is a glycoprotein with an approximate molecular weight of 143 kDa and is produced by recombinant DNA technology in Chinese hamster ovary cells. The binding of satralizumab-mwge to the IL-6 receptor is pH-sensitive.
ENSPRYNG (satralizumab-mwge) injection for subcutaneous administration is supplied as a sterile, clear, colorless to slightly yellow solution with no preservative, and with an approximate pH of 6. ENSPRYNG is supplied in a single-dose 1 mL prefilled syringe with a needle safety device or a single-dose 1 mL or 1.5 mL autoinjector that contains a prefilled syringe.
Each prefilled syringe delivers 1 mL of solution containing 120 mg satralizumab-mwge, L-arginine (26.1 mg), L-aspartic acid (pH adjustment), L-histidine (3.1 mg), poloxamer 188 (0.5 mg), and Water for Injection, USP.
Each prefilled autoinjector delivers either:
- 1 mL of solution containing 120 mg satralizumab-mwge, L-arginine (26.1 mg), L-aspartic acid (pH adjustment), L-histidine (3.1 mg), poloxamer 188 (0.5 mg), and Water for Injection, USP.
- 1.5 mL of solution containing 180 mg satralizumab-mwge, L-arginine (39.2 mg), L-aspartic acid (pH adjustment), L-histidine (4.65 mg), poloxamer 188 (0.75 mg), and Water for Injection, USP.
5PATIENT COUNSELING INFORMATION
Advise the patients to read the FDA-approved patient labeling (
6INSTRUCTIONS FOR USE
ENSPRYNG
(satralizumab-mwge)
Injection, for subcutaneous use
single-dose prefilled syringe
(satralizumab-mwge)
Injection, for subcutaneous use
single-dose prefilled syringe
Read this
Your healthcare provider will show you or your caregiver how to use the ENSPRYNG syringe the right way. Talk to your healthcare provider if you have any questions.
Important information you need to know before injecting ENSPRYNG
- Do not use the ENSPRYNG prefilled syringe until your healthcare provider has trained you or your caregiver on the right way to inject.
- Do not share your ENSPRYNG syringe with other people. You may give them a serious infection or get a serious infection from them.
- Do not use if the expiration (EXP) date has passed.
- Do not use if the seals on the carton have been broken.
- Do not try to take the syringe apart at any time.
- Do not take the needle cap off until you are ready to inject ENSPRYNG.
- Do not use the syringe if it has been dropped or damaged.
- Do not re-use the same syringe. Each prefilled syringe can be used only 1 time.
- Do not inject through clothing.
How should I store the ENSPRYNG prefilled syringe?
- Store ENSPRYNG in the refrigerator between 36°F to 46°F (2°C to 8°C) in the original carton to protect from light.
- Do not freeze. Do not use ENSPRYNG if it has been frozen.
- Do not shake.
- The ENSPRYNG carton can be stored at room temperature up to 86°F (30°C) for up to 8 days.
- If ENSPRYNG is removed from and returned to the refrigerator the total combined time out of the refrigerator should not be more than 8 days.
- Always keep in the original carton to protect from light.
- Keep ENSPRYNG and all medicines out of the reach of children.
Supplies needed to give your injection
Each ENSPRYNG carton contains:
- 1 prefilled syringe for 1-time use only.
Not included in the carton:
- 1 alcohol pad
- 1 sterile cotton ball or gauze
- 1 small bandage
- 1 FDA-cleared, puncture-resistant sharps container for safe disposal of the needle cap and used syringe. See
Always check that you have the right medicine and dose that your healthcare provider prescribed.
ENSPRYNG prefilled syringe
After use:
The syringe has a needle-shield that automatically covers the needle when the injection is complete.
Prepare to use ENSPRYNG
Check the syringe
(See
If the expiration (EXP) date has passed, the syringe is damaged or the liquid is cloudy, discolored or has particles in it, do not use. Then go to
Let your syringe reach room temperature
Wash your hands
Choose the injection site
Choose a different injection site for
Clean the injection site
Inject ENSPRYNG
Taking care of the injection site
Disposing of ENSPRYNG
This
Manufactured by:
U.S. License No.: 1048
Revised: 10/2026
ENSPRYNG
© 2026 Genentech, Inc. All rights reserved.
7INSTRUCTIONS FOR USE
ENSPRYNG
(satralizumab-mwge)
injection, for subcutaneous use
single-dose prefilled autoinjector
(satralizumab-mwge)
injection, for subcutaneous use
single-dose prefilled autoinjector
Read this
Important information you need to know before injecting ENSPRYNG
- Do not use the ENSPRYNG autoinjector until your healthcare provider has trained you or your caregiver on the right way to inject.
- Do not use if the expiration (EXP) date has passed.
- Do not use if the seals on the carton have been broken.
- Do not try to take the autoinjector apart at any time.
- Do not remove the cap until you are ready to inject.
- Do not use if the autoinjector has been damaged or dropped.
- Do not touch or clean the green needle shield.
- Do not try to re-use the same autoinjector. Each prefilled autoinjector can be used only one time.
- Do not inject through clothing.
How should I store the ENSPRYNG autoinjector?
- Store ENSPRYNG in the refrigerator between 36°F to 46°F (2°C to 8°C) in the original carton to protect from light.
- Do not freeze. Do not use ENSPRYNG if it has been frozen.
- Do not shake.
- The ENSPRYNG carton can be stored at room temperature up to 86°F (30°C) for up to 8 days.
- If ENSPRYNG is removed from and returned to the refrigerator the total combined time out of the refrigerator should not be more than 8 days.
- Always keep in the original carton to protect from light.
- Keep ENSPRYNG and all medicines out of the reach of children.
ENSPRYNG autoinjector
Always check that you have the right medicine and dose that your healthcare provider prescribed.
Before use
After use
Prepare to use ENSPRYNG
Included in the carton:
- ENSPRYNG autoinjector
Not included in the carton:
- 1 alcohol pad
- 1 sterile cotton ball or gauze
- 1 small adhesive bandage
- 1 FDA-cleared sharps disposal container (See
Remove the autoinjector
Check the autoinjector
If the expiration date has passed, the autoinjector is damaged or the medicine is cloudy, discolored or has particles in it, do not use. Safely throw away (dispose of) the autoinjector in an FDA-cleared sharps disposal container (See
Let your autoinjector reach room temperature
Choose the injection site
Choose a different injection site for
Clean your skin
Remove the cap
Place onto the skin
Push firmly and hold in place
Check the green plunger
Remove the autoinjector
Dispose of the autoinjector
Check the injection site
Disposal of the autoinjector
When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about the safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal.
Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this.
Do not recycle your used sharps disposal container.
Keep the sharps disposal container out of the reach of children.
Manufactured by:
U.S. License No.: 1048
ENSPRYNG® is a registered trademark of Chugai Pharmaceutical Co., Ltd., Tokyo, Japan
© 2026 Genentech, Inc. All rights reserved.
This
Revised: 10/2026
8PRINCIPAL DISPLAY PANEL - 120 mg/mL Syringe Carton
NDC 50242-007-01
Rx only
Enspryng
120 mg/mL
For Subcutaneous Use.
Refrigerate at 2°C to 8°C (36°F to 46°F) in original carton to protect from light.
ATTENTION PHARMACIST: Each patient is required to receive the enclosed
1 prefilled syringe
Genentech
10240933
9PRINCIPAL DISPLAY PANEL - 120 mg/mL Autoinjector Carton
NDC 50242-007-55
Enspryng
120 mg/mL
For Subcutaneous Use.
ATTENTION PHARMACIST: Each patient is required to receive the enclosed Medication Guide.
Rx only
1 Single-Dose Autoinjector. Discard after use.
Genentech
11034843
10PRINCIPAL DISPLAY PANEL - 180 mg/1.5 mL Autoinjector Carton
NDC 50242-005-01
Enspryng
180 mg/1.5 mL
For Subcutaneous Use.
ATTENTION PHARMACIST: Each patient is required to receive the enclosed Medication Guide.
1 Single-Dose Autoinjector. Discard after use.
R
Genentech
11044874
