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.
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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.
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 prefilled syringe. Each syringe delivers 1 mL of solution containing 120 mg of satralizumab-mwge, L-arginine (26.1 mg), L-histidine (3.1 mg), poloxamer 188 (0.5 mg), L-aspartic acid (pH adjustment), 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®(en-spryng) (satralizumab-mwge) Injection
Read this
Talk to your healthcare provider if you have any questions.
Important Information
- Each syringe is prefilled with a medicine called ENSPRYNG.
- Each carton of ENSPRYNG contains only 1 prefilled syringe.
- Each prefilled syringe can be used only 1 time.
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:
- take the needle cap off until you are ready to inject ENSPRYNG.
- use the syringe if it has been dropped or damaged.
- try to take the syringe apart at any time.
- leave the syringe unattended.
- re-use the same syringe.
How should I store the ENSPRYNG prefilled syringe?
- Keep the unused syringe in the refrigerator between
- Before giving an injection, if the ENSPRYNG is not opened, it can be removed from and placed back in the refrigerator if needed. The total combined time out of the refrigerator should not be more than 8 days at a temperature that does not go above 86°F (30°C).
- Keep the syringe in its original carton away from direct sunlight.
- Always keep the syringe dry.
Keep the ENSPRYNG syringe and all medicines out of the reach of children.
Do not:
- freeze the syringe.
- use the syringe if it has been frozen.
- shake.
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
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 warm up
- 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: 8/2020
ENSPRYNG
© 2020 Genentech, Inc. All rights reserved.
9PRINCIPAL 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
