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
Save this treatment for later
Not sure about your diagnosis?
Tired of the same old research?
Related Clinical Trials
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...
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.
A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Basket Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Patients With Anti-N-methyl-D-aspartic Acid Receptor (NMDAR) or Anti-leucine-rich Glioma-inactivated 1 (LGI1) Encephalitis
Summary: The purpose of this study is to assess the efficacy, safety, PK, and PD of satralizumab in participants with NMDAR and LGI1 encephalitis.
Related Latest Advances
Brand Information
Enspryng (Satralizumab)
1INDICATIONS AND USAGE
ENSPRYNG is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.
2DOSAGE FORMS AND STRENGTHS
Injection: 120 mg/mL clear, and colorless to slightly yellow solution in single-dose prefilled syringe or single-dose autoinjector.
3CONTRAINDICATIONS
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
4ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Infections
- Elevated Liver Enzymes
- Decreased Neutrophil Counts
- Hypersensitivity Reactions
4.1Clinical 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.
The safety of ENSPRYNG was evaluated in two randomized, placebo-controlled clinical trials [Study 1 evaluated ENSPRYNG without concurrent immunosuppressive therapy (IST) and Study 2 evaluated ENSPRYNG with concurrent IST], which included 41 anti-AQP4 seropositive patients treated with ENSPRYNG in Study 1 and 26 anti-AQP4 seropositive patients treated with ENSPRYNG in Study 2
Adverse reactions that occurred in Study 1 and Study 2 in more than 5% of patients treated with ENSPRYNG, and at a greater incidence than in patients who received placebo, are shown in
4.2Immunogenicity
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 Study 1 and 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.
5DESCRIPTION
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 with an approximate pH of 6. ENSPRYNG is supplied in a single-dose 1.0 mL prefilled syringe with a needle safety device or a single-dose 1.0 mL autoinjector that contains a prefilled syringe. Each prefilled syringe or autoinjector 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.
6CLINICAL STUDIES
The efficacy of ENSPRYNG for the treatment of NMOSD in adult patients was established in two studies. Study 1 was a randomized (2:1), placebo-controlled trial in 95 patients without concurrent IST (Study 1, NCT02073279) in which 64 patients were anti-AQP4 antibody positive and 31 patients were anti-AQP4 antibody negative.
Study 2 was a randomized (1:1), placebo-controlled trial in 76 adult patients with concurrent IST (Study 2, NCT02028884). Of these, 52 adult patients were anti-AQP4 antibody positive and 24 adult patients were anti-AQP4 antibody negative.
Patients met the following eligibility criteria:
- Study 1: Clinical evidence of 1 relapse in the previous 12 months
- Study 2: Clinical evidence of at least 2 relapses in the previous 2 years, at least one of which must have occurred in the previous year
- EDSS score of 0 to 6.5 (both studies)
- Study 1: Patients were excluded if previously treated with IST within an interval specified for each such therapy
- Study 2: One of the following baseline treatments at a stable dose as a monotherapy for 8 weeks prior to baseline: azathioprine, mycophenolate mofetil, oral corticosteroids
In Study 1, 41 anti-AQP4 antibody positive adult patients were randomized to and received ENSPRYNG and 23 received placebo. Females accounted for 76% of the ENSPRYNG group and 96% of the placebo group. The remaining baseline demographic characteristics were balanced between the treatment groups. The mean age was 44 years. Fifty percent were White, 22% were Black or African-American, and 20% were Asian. The mean EDSS score was 3.8.
In Study 2, 26 anti-AQP4 antibody positive adult patients were randomized to and received ENSPRYNG and 26 received placebo. All patients were receiving either concurrent azathioprine (42%), oral corticosteroids (52%), or mycophenolate mofetil (6%) during the trial. The baseline demographic and disease characteristics were balanced between the treatment groups. Females accounted for 100% of the study population. Forty-six percent of patients were White and 52% were Asian. The mean age was 46 years. The mean EDSS score was 4.0.
All potential relapses were adjudicated by a blinded Clinical Endpoint Committee (CEC). The primary efficacy endpoint for both studies was the time to the first CEC-confirmed relapse.
In Study 1, the time to the first CEC-confirmed relapse was significantly longer in ENSPRYNG-treated patients compared to patients who received placebo (risk reduction 55%; hazard ratio 0.45; p = 0.0184). In the anti-AQP4 antibody positive population, there was a 74% risk reduction; hazard ratio 0.26; p = 0.0014 (
In Study 2, the time to the first CEC-confirmed relapse was significantly longer in patients treated with ENSPRYNG compared to patients who received placebo (risk reduction 62%; hazard ratio 0.38; p = 0.0184). In the anti-AQP4 antibody positive population, there was a 78% risk reduction; hazard ratio 0.22; p = 0.0143 (
Figure 1 Study 1: Time to First CEC-Determined NMOSD Relapse in the Randomized Controlled Period in the ITT Population Anti-AQP4 Antibody Positive Patients
Figure 2 Study 2: Time to First CEC-Determined NMOSD Relapse in the Randomized Controlled Period in the ITT Population Anti-AQP4 Antibody Positive Patients
7PATIENT COUNSELING INFORMATION
Advise the patients to read the FDA-approved patient labeling (
8INSTRUCTIONS 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 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 seal 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 prefilled syringe in the refrigerator between
- 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 refrigeration should not be more than 8 days.
- Keep the syringe in its original carton away from direct sunlight.
- Always keep the syringe dry.
- Do not freeze ENSPRYNG. Do not use the prefilled syringe if it has been frozen.
- Do not shake.
- Throw away (dispose of) the prefilled syringe if it has been frozen, exposed to light or temperatures above 86°F (30°C), or has been out of the refrigerator for more than 8 days.
- Keep the ENSPRYNG syringe 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
- Take the carton containing the syringe out of the refrigerator and place it on a clean, flat work surface (like a table).
- Check the expiration (EXP) date on the back of the carton
- Check the front of the carton to make sure it is sealed
If the expiration date has passed or the seal is broken, do not use. Then go to
- Open the sealed carton
- Carefully lift the syringe out of the carton by holding the barrel
Check the syringe
(See
- Check the expiration date on the syringe.
- Check the syringe for any damage.
- Check that the liquid through the viewing window is clear and colorless to slightly yellow.
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
- After you have checked the syringe, place it on a clean, flat work surface (like a table) for
Wash your hands
- Wash your hands with soap and water.
Choose the injection site
- Choose your injection site in either:
Choose a different injection site for
Clean the injection site
- Wipe the injection site with an alcohol pad and let it air dry.
Inject ENSPRYNG
- Hold the barrel of the syringe between your thumb and index finger. With your other hand, pull the needle cap straight off. You may see a drop of liquid at the end of the needle. This is normal and will not affect your dose
- Throw away the needle cap in a puncture-resistant sharps container immediately. See
- Hold the barrel of the syringe using your thumb and index finger. With your other hand, pinch the area of skin you have cleaned
- Use a quick, dart-like motion to insert the needle at an angle between 45° to 90°
- After the needle is inserted, let go of the pinched skin.
- Slowly inject all of the medicine by gently pushing the plunger all the way down until it touches the activation guards
- Gently release the plunger and allow the needle to come out of the skin at the same angle it was inserted
Taking care of the injection site
- There may be a little bleeding at the injection site. You can press a cotton ball or gauze over the injection site but
Disposing of ENSPRYNG
- Put your used syringe in an FDA-cleared sharps disposal container immediately after use
This
Manufactured by:
U.S. License No.: 1048
Approved: 6/2026
ENSPRYNG
© 2026 Genentech, Inc. All rights reserved.
9INSTRUCTIONS 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 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 autoinjector in the original carton in the refrigerator between 36°F to 46°F (2°C to 8°C) until ready to use.
- 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.
- Keep the autoinjector in the original carton away from direct sunlight.
- Do not freeze ENSPRYNG. Do not use the autoinjector if it has been frozen.
- Do not shake.
- Throw away (dispose of) the autoinjector if it has been frozen, exposed to light or temperatures above 86°F (30°C), or has been out of the refrigerator for more than 8 days.
- 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
- Gather supplies needed for your injection.
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 sharps disposal container (See
Remove the autoinjector
- Take the ENSPRYNG autoinjector carton out of the refrigerator.
- Open the carton and take the autoinjector out of the tray.
Check the autoinjector
- Check the expiration (EXP) date on the autoinjector.
- Do not inject if the expiration date (EXP) has passed.
- Check the medicine through the viewing window. The medicine should be clear or slightly yellow. There should be no particles in it.
- Do not inject if the medicine looks cloudy, discolored, or has particles in it. You may see small air bubbles. This is normal and you should not try to remove them.
- Check the autoinjector for any damage.
- Do not use if the autoinjector is cracked or broken.
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 a sharps disposal container (See
Let your autoinjector reach room temperature
- Place the autoinjector on a clean, flat surface (like a table) for 30 minutes. This allows the medicine to reach room temperature.
- Do not speed up the warming process in any way, such as using a microwave, warm water, or direct sunlight.
- Do not remove the cap until you are ready to inject.
Choose the injection site
- You can inject ENSPRYNG in the stomach area (abdomen) or front of the thigh.
- Do not inject into the 2 inches (5 cm) area around the belly button.
- Do not inject into moles, scars, or areas where the skin is tender, bruised, red, hard, or not intact.
Choose a different injection site for
Clean your skin
- Wash your hands with soap and water.
- Clean the injection site with an alcohol pad and let it air dry.
- Do not fan or blow on the area you have cleaned.
- Do not touch the injection site again before you inject.
Remove the cap
- Hold the autoinjector with the cap pointing up. Then pull the cap straight off.
- Do not clean the green needle shield. This may activate the autoinjector.
- Do not put the cap back on after it has been removed. This may activate the autoinjector.
Place onto the skin
- Hold the autoinjector so that you can
- Do not change the angle of the injection.
Push firmly and hold in place
- Push firmly and hold down the autoinjector against the skin.
The first click indicates the injection has started.
- The
- Do not lift the autoinjector if the green plunger is moving. This may cause a loss of medicine.
- Keep holding down the autoinjector firmly.
- Watch the green plunger as it moves down. Or check if the green plunger has already filled the entire viewing window (See Step 15).
Check the green plunger
- Before removing the autoinjector from the injection site, check that the green plunger fills the viewing window entirely.
- If the green plunger does not fill the viewing window, you may not have received the full dose. Safely throw away (dispose of) the autoinjector in a sharps disposal container (See Step 17) and contact your healthcare provider.
Remove the autoinjector
- Remove the autoinjector by lifting it straight up from the skin.
- The green needle shield will lock into place, covering the needle when the injection is complete.
Dispose of the autoinjector
- Put the used autoinjector and the cap in an FDA-cleared sharps disposal container right away after use.
- Do not throw away (dispose of) the autoinjector in your household trash.
Check the injection site
- There may be a small amount of blood or medicine at the injection site.
- Do not rub or massage the area where you have injected.
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
Approved: 6/2026
10PRINCIPAL 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
11PRINCIPAL 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
