Enspryng

Last updated on RxList: 5/18/2021
Enspryng Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Enspryng?

Enspryng (satralizumab-mwge) is an interleukin-6 (IL-6) receptor antagonist used to treat neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

What Are Side Effects of Enspryng?

Side effects of Enspryng include:

Dosage for Enspryng

The initial dosing of Enspryng is 20 mg administered at Week 0, 1, and 2. Subsequent dosing of Enspryng is 20 mg administered monthly starting at Week 4.

Enspryng In Children

Safety and effectiveness of Enspryng in pediatric patients have not been established.

What Drugs, Substances, or Supplements Interact with Enspryng?

Enspryng may interact with other medicines such as:

Tell your doctor all medications and supplements you use.

Enspryng During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Enspryng; it is unknown how it might affect a fetus. Enspryng may cross the placenta and cause fetal B-cell depletion based on findings from animal studies. Females of childbearing potential should use effective contraception while receiving Enspryng and for 6 months after the last treatment of Enspryng. It is unknown if Enspryng passes into breast milk or how it could affect a nursing infant. Consult your doctor before breastfeeding.

Additional Information

Our Enspryng (satralizumab-mwge) Injection, for Subcutaneous Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Enspryng Consumer Information

Stop using this medicine and get emergency medical help if you have signs of an allergic reaction: hives; feeling light-headed; stomach pain, vomiting; difficult breathing; swelling of your face, lips, tongue, or throat.

You may get infections more easily, even serious or fatal infections. Call your doctor right away if you have signs of infection such as:

  • fever, chills, night sweats;
  • sore throat. ongoing cough, feeling very tired;
  • muscle pain;
  • diarrhea, stomach cramps;
  • loss of appetite, weight loss;
  • increased urination, burning when you urinate; or
  • skin sores, redness, swelling or tenderness.

Common side effects may include:

  • headache, joint pain;
  • nausea, stomach pain;
  • feeling tired;
  • pain in your arms, hands, legs, or feet;
  • rash; or
  • cold symptoms such as stuffy nose, runny nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Enspryng (Satralizumab-mwge Injection for Subcutaneous Administratio)

SLIDESHOW

Pink Eye (Conjunctivitis) Symptoms, Causes, Treatments See Slideshow
Enspryng Professional Information

SIDE EFFECTS

The following clinically significant adverse reactions are described elsewhere in the labeling:

  • Infections [see WARNINGS AND PRECAUTIONS]
  • Elevated Liver Enzymes [see WARNINGS AND PRECAUTIONS]
  • Decreased Neutrophil Counts [see WARNINGS AND PRECAUTIONS]
  • Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]

Clinical 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 [see Clinical Studies]. In the double-blind, controlled period, the median exposure time on ENSPRYNG treatment was approximately 2 years in Study 1 and approximately 3 years in Study 2. The median exposure time on placebo treatment was approximately 1 year in both Study 1 and 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 Table 3 and Table 4, respectively. The most common adverse reactions (15% or greater with ENSPRYNG in either) were nasopharyngitis, headache, upper respiratory tract infection, gastritis, rash, arthralgia, extremity pain, fatigue, and nausea.

Table 3 Adverse Reactions Occurring in 4 or More Patients Treated with ENSPRYNG and Greater Incidence than Placebo in Study 1

Adverse Reaction ENSPRYNG
(N = 41)
%
PLACEBO
(N = 23)
%
Rash 17 0
Arthralgia 17 0
Pain in extremity 15 9
Fatigue 15 4
Nausea 15 9
Nasopharyngitis 12 4
Pruritus 10 0
Depression 10 0
Cellulitis 10 0
Neutropenia 10 4
Blood creatine phosphokinase increased 10 4
Fall 10 4

Table 4 Adverse Reactions Occurring in 3 or More Patients Treated with ENSPRYNG and Greater Incidence than Placebo in Study 2

Adverse Reaction ENSPRYNG + IST
(N = 26)
%
PLACEBO + IST
(N = 26)
%
Nasopharyngitis 31 15
Headache 27 12
Upper respiratory tract infection 19 12
Gastritis 15 0
Arthralgia 12 0
Pharyngitis 12 8

Injection-Related Reactions

In Study 1 and Study 2, injection-related reactions were reported in 9% of patients treated with ENSPRYNG compared with 8% in patients receiving placebo. These reactions in the ENSPRYNG-treated patients were predominantly mild to moderate in severity, and most occurred within 24 hours after the injection. The most commonly reported systemic symptom was diarrhea. The reported local injection site reactions were pruritus, injection site reaction, and skin mass.

Infections

In Study 1, the rate of infections was 51 patients/100 patient-years (95% CI: 32, 78) in patients treated with ENSPRYNG compared with 108 patients/100 patient-years (95% CI: 52, 199) in patients receiving placebo. The rate of serious infections was 5 patients/100 patient-years (95% CI: 1, 14) in patients treated with ENSPRYNG compared with 4 patients/100 patient-years (95% CI: 0, 21) in patients receiving placebo.

In Study 2, the rate of infections was 168 patients/100 patient-years (95% CI: 100, 265) in patients treated with ENSPRYNG compared with 143 patients/100 patient-years (95% CI: 83, 229) in patients treated with placebo. The rate of serious infections was 4 patients/100 patient-years (95% CI: 1, 15) in patients treated with ENSPRYNG compared with 10 patients/100 patient-years (95% CI: 2, 28) in patients receiving placebo.

Laboratory Abnormalities

Decreased Neutrophil Count

Of the patients treated with ENSPRYNG, 10% had neutrophils below 1 × 109/L compared to 9% in placebo in Study 1. In Study 2, 15% patients had neutrophils below 1 × 109/L compared to 4% in placebo. There was one patient in Study 1 treated with ENSPRYNG with neutrophil counts < 0.5 × 109/L, and one patient in Study 2 discontinued ENSPRYNG because of neutropenia.

Decreased Platelet Count

In Study 1, a shift in platelet count decreases from normal at baseline to below the lower limit of normal (LLN) occurred in 26% of patients treated with ENSPRYNG compared to 5% of patients receiving placebo. In Study 2, decreases in platelet counts from normal at baseline to below the LLN occurred in 35% of patients treated with ENSPRYNG and in 17% of patients receiving placebo. None of the patients had a decrease in platelet count to less than 50 × 109/L.

Elevated Liver Enzymes

In Study 1, increases from normal at baseline to above ULN in ALT or AST occurred in 43% and 25% of patients treated with ENSPRYNG, respectively, compared to 13% and 9% of patients receiving placebo. In Study 2, increases from normal at baseline to above the ULN in ALT or AST occurred in 8% and 8% of patients treated with ENSPRYNG, respectively, compared to 12% and 19% of patients receiving placebo.

In Study 1 and Study 2 combined, elevations of ALT or AST greater than 3 times the ULN occurred in 3% of patients treated with ENSPRYNG, compared to no patients treated with placebo. These elevations were not associated with increases in total bilirubin. One patient receiving ENSPRYNG in Study 2 had an elevation of ALT above 5 times the ULN, which was observed 4 weeks after initiation of therapy, normalizing 78 days after discontinuation of ENSPRYNG.

Lipid Abnormalities

In Study 1 and Study 2, elevations in total cholesterol above 7.75 mmol/L (300 mg/dl) occurred in 12% and 15% of patients treated with ENSPRYNG, respectively, compared to no patients receiving placebo.

Elevations in triglycerides above 3.42 mmol/L (300 mg/dl) occurred in 27% and 12% of patients treated with ENSPRYNG in Study 1 and Study 2, respectively, compared to 13% and 8% of patients receiving placebo.

Fibrinogen Levels

In Study 1, the median percent reduction in fibrinogen was 38% in patients treated with ENSPRYNG compared to 5% in patients receiving placebo. In Study 2, the median percent reduction in fibrinogen level was 33% in patients treated with ENSPRYNG compared to 0% in patients receiving placebo.

Complement Levels

In Study 1, the median percent reduction in the C3 and C4 components of complement was 23% and 50% in patients treated with ENSPRYNG, respectively, compared to 0% and 1% patients receiving placebo. In Study 2, the median percent reduction in the C3 and C4 components of complement was 20% and 53% in patients treated with ENSPRYNG, respectively, compared to 0% and 1% in patients receiving placebo.

Body Weight

In the pool of Studies 1 and 2, body weight increases of at least 7% from baseline occurred in 30% of patients treated with ENSPRYNG compared to 8% of patients receiving placebo.

Body weight increases of at least 15% from baseline occurred in 6% of patients treated with ENSPRYNG compared to 4% of patients receiving placebo.

Immunogenicity

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.

DRUG INTERACTIONS

No Information Provided

Read the entire FDA prescribing information for Enspryng (Satralizumab-mwge Injection for Subcutaneous Administratio)

© Enspryng Patient Information is supplied by Cerner Multum, Inc. and Enspryng Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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