Satralizumab: Drug information

For additional information see "Satralizumab: Patient drug information"

For abbreviations, symbols, and age group definitions show table

Brand Names: US

Enspryng

Brand Names: Canada

Enspryng

Pharmacologic Category

Interleukin-6 Receptor Antagonist;
Monoclonal Antibody

Dosing: Adult

Note: Administer all live or live-attenuated vaccines at least 4 weeks prior, and non-live vaccines at least 2 weeks prior to initiation of satralizumab. Assess patients for presence of any active infection; delay treatment until active infection is resolved. Screen for hepatitis B (hepatitis B surface antigen [HBsAg] and hepatitis B core antibody [HBcAb]) prior to initiation; do not administer to patients with active hepatitis B. Evaluate for tuberculosis (TB) infection/disease (latent/active TB) prior to initiation; for patients with TB disease or positive TB screening without a history of appropriate treatment, consult infectious disease specialist before initiating treatment. Assess ALT/AST and serum bilirubin prior to initiation; use with caution if ALT/AST >1.5 times ULN.

Neuromyelitis optica spectrum disorder

Neuromyelitis optica spectrum disorder: SubQ: Loading dose: 120 mg once every 2 weeks for 3 doses (weeks 0, 2, and 4), followed by maintenance dose: 120 mg once every 4 weeks.

Dosage for delayed or missed doses (reasons other than increased liver enzymes):

Missed loading dose: 120 mg as soon as possible (do not wait until next planned dose). If the second loading dose is delayed or missed, administer as soon as possible and administer the third (final) loading dose 2 weeks later. If the third loading dose is delayed or missed, administer as soon as possible and administer the first maintenance dose 4 weeks later.

Missed maintenance dose:

If <8 weeks since last dose: 120 mg as soon as possible (do not wait until the next planned dose). Reset dose schedule to every 4 weeks after delayed or missed dose administered.

If 8 to <12 weeks since last dose: 120 mg every 2 weeks for 2 doses (weeks 0 and 2), followed by 120 mg every 4 weeks. Note: “Week 0” refers to time of the first administration after the missed dose.

If ≥12 weeks since last dose: 120 mg every 2 weeks for 3 doses (weeks 0, 2, and 4), followed by 120 mg every 4 weeks. Note: “Week 0” refers to time of the first administration after the missed dose.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Dosing: Liver Impairment: Adult

Hepatic impairment prior to treatment initiation: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied). Use caution in patients with baseline ALT/AST >1.5 × ULN.

Hepatotoxicity during treatment:

ALT/AST >5 × ULN and any bilirubin elevation: Discontinue therapy; reinitiation not recommended.

ALT/AST >5 × ULN and not associated with bilirubin elevation: Interrupt therapy until ALT/AST return to normal range, then restart as follows:

If <12 weeks since last dose: Administer 120 mg every 4 weeks.

If ≥12 weeks since last dose: Administer 120 mg every 2 weeks for 3 doses (weeks 0, 2, and 4) followed by 120 mg every 4 weeks. Note: “Week 0” refers to time of the first administration after the missed dose.

Note: Monitor LFTs closely and discontinue therapy without reinitiation if subsequent increases in ALT/AST and/or bilirubin above ULN occur.

Dosing: Adjustment for Toxicity: Adult

Decreased neutrophil count: Neutrophil count <1,000/mm³ (confirmed by repeat testing): Interrupt therapy until neutrophil count returns to >1,000/mm³.

Dosing: Older Adult

Refer to adult dosing; use with caution.

Adverse Reactions (Significant): Considerations

Elevated liver enzymes

Mild to moderate elevations in liver enzymes have occurred, including increased serum alanine aminotransferase (ALT) and increased serum aspartate aminotransferase with or without increased bilirubin. The majority of reported cases were transient and/or resolved without dose interruption (Ref). May require dosage adjustment, treatment interruption, and/or treatment discontinuation.

Onset: Not well characterized; in 1 patient, elevations of ALT >5 times the upper limit of normal were observed 4 weeks after initiation of therapy.

Hematologic effects

Decreased platelet counts and neutropenia have occurred. The majority of reported cases were transient and/or resolved without dose interruption (Ref).

Hypersensitivity reactions

Hypersensitivity reactions, including anaphylaxis (fatal), skin rash, and urticaria, have occurred with other interleukin-6 (IL-6) receptor antagonists; anaphylaxis was not seen in satralizumab in clinical trials (Ref).

Infection

Interleukin-6 (IL-6) receptor antagonists, including satralizumab, have immunosuppressive effects that are reversible with discontinuation. An increased risk of infection (including severe infections or potentially fatal infections) has been observed with satralizumab; an increased risk for cellulitis, nasopharyngitis, upper respiratory tract infection, and pharyngitis was noted in clinical trials. Clinicians should be aware of the potential for hepatitis B virus (HBV) reactivation or tuberculosis that exists with the use of immunosuppressant therapies, including IL-6 receptor antagonists.

Mechanism: Dose- and time-related; related to pharmacologic action (ie, immunosuppressive effects).

Risk factors:

• Presence of active infection, including localized infections

• Tuberculosis: Preexisting tuberculosis risk factors; tuberculosis infection

• HBV reactivation: Chronic carriers of HBV [HBsAg+]; patients who are negative for HBsAg and positive for HB core antibody [HBcAb+]

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling and without concurrent immunosuppressive therapy unless otherwise specified.

>10%:

Dermatologic: Skin rash (17%) (table 1)

**Satralizumab: Adverse Reaction: Skin Rash**
Drug (Satralizumab)	Placebo	Number of Patients (Satralizumab)	Number of Patients (Placebo)
17%	0%	41	23

Endocrine & metabolic: Hypercholesterolemia (total cholesterol >300 mg/dL: 12%), increased serum triglycerides (>300 mg/dL: 27%), weight gain (28%)

Gastrointestinal: Gastritis (with concurrent immunosuppressant therapy: 15%), nausea (15%)

Hematologic & oncologic: Decreased platelet count (26%; with concurrent immunosuppressant therapy: 35%) (table 2), neutropenia (10%; with concurrent immunosuppressant therapy: 15%) (table 3)Neutropenia

**Satralizumab: Adverse Reaction: Decreased Platelet Count**
Drug (Satralizumab)	Placebo	Number of Patients (Satralizumab)	Number of Patients (Placebo)	Comments
35%	17%	26	26	With concurrent immunosuppressant therapy
26%	5%	41	23	N/A

**Satralizumab: Adverse Reaction: Neutropenia**
Drug (Satralizumab)	Placebo	Number of Patients (Satralizumab)	Number of Patients (Placebo)	Comments
15%	4%	26	26	With concurrent immunosuppressant therapy
10%	9%	41	23	N/A

Hepatic: Increased serum alanine aminotransferase (43%; with concurrent immunosuppressant therapy: 8%) (table 4), increased serum aspartate aminotransferase (25%; with concurrent immunosuppressant therapy: 8%) (table 5)

**Satralizumab: Adverse Reaction: Increased Serum Alanine Aminotransferase**
Drug (Satralizumab)	Placebo	Number of Patients (Satralizumab)	Number of Patients (Placebo)	Comments
43%	13%	41	23	N/A
8%	12%	26	26	With concurrent immunosuppressant therapy

**Satralizumab: Adverse Reaction: Increased Serum Aspartate Aminotransferase**
Drug (Satralizumab)	Placebo	Number of Patients (Satralizumab)	Number of Patients (Placebo)	Comments
25%	9%	41	23	N/A
8%	19%	26	26	With concurrent immunosuppressant therapy

Immunologic: Antibody development (73%)

Infection: Infection (54%; including severe infection: 10%) (Traboulsee 2020) (table 6)

**Satralizumab: Adverse Reaction: Infection**
Drug (Satralizumab)	Placebo	Number of Patients (Satralizumab)	Number of Patients (Placebo)	Source
54%	44%	63	32	Traboulsee 2020
Severe: 10%	9%	63	32	Traboulsee 2020

Nervous system: Fatigue (15%), headache (with concurrent immunosuppressant therapy: 27%)

Neuromuscular & skeletal: Arthralgia (17%), limb pain (15%)

Respiratory: Nasopharyngitis (12%; with concurrent immunosuppressant therapy: 31%) (table 7), pharyngitis (with concurrent immunosuppressant therapy: 12%) (table 8), upper respiratory tract infection (with concurrent immunosuppressant therapy: 19%) (table 9)

**Satralizumab: Adverse Reaction: Nasopharyngitis**
Drug (Satralizumab)	Placebo	Number of Patients (Satralizumab)	Number of Patients (Placebo)	Comments
31%	15%	26	26	With concurrent immunosuppressant therapy
12%	4%	41	23	N/A

**Satralizumab: Adverse Reaction: Pharyngitis**
Drug (Satralizumab)	Placebo	Number of Patients (Satralizumab)	Number of Patients (Placebo)	Comments
12%	8%	26	26	With concurrent immunosuppressant therapy

**Satralizumab: Adverse Reaction: Upper Respiratory Tract Infection**
Drug (Satralizumab)	Placebo	Number of Patients (Satralizumab)	Number of Patients (Placebo)	Comments
19%	12%	26	26	With concurrent immunosuppressant therapy

1% to 10%:

Dermatologic: Cellulitis (10%) (table 10), pruritus (10%)

**Satralizumab: Adverse Reaction: Cellulitis**
Drug (Satralizumab)	Placebo	Number of Patients (Satralizumab)	Number of Patients (Placebo)
10%	0%	41	23

Local: Injection-site reaction (including injection-site pruritus and residual mass at injection site)

Nervous system: Depression (10%), falling (10%)

Neuromuscular & skeletal: Increased creatine phosphokinase in blood specimen (10%)

Frequency not defined:

Gastrointestinal: Diarrhea

Hematologic & oncologic: Decreased serum fibrinogen, disorder of hemostatic components of blood (reduction in C3 and C4 complement levels)

Contraindications

Hypersensitivity to satralizumab or any component of the formulation; active hepatitis B infection; tuberculosis (TB) disease (active TB) or untreated TB infection (latent TB).

Warnings/Precautions

Other warnings/precautions:

• Immunizations: Immunization with live-attenuated or live vaccines is not recommended during therapy.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Prefilled Syringe, Subcutaneous [preservative free]:

Enspryng: Satralizumab-mwge 120 mg/mL (1 mL)

Generic Equivalent Available: US

Pricing: US

Solution Prefilled Syringe (Enspryng Subcutaneous)

120 mg/mL (per mL): $21,229.79

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Prefilled Syringe, Subcutaneous:

Enspryng: Satralizumab-mwge 120 mg/mL (1 ea)

Administration: Adult

SubQ: Prior to use, remove prefilled syringe from refrigeration and carton and allow to sit at room temperature for 30 minutes; do not warm product in any other way. Administer the full amount in the prefilled syringe (1 mL). Administer subcutaneously into the abdomen or thigh. Rotate injection sites with each administration; avoid injecting into moles, scars, or tender, bruised, red, or hard skin. After proper training, patients may self-inject, or the patient's caregiver may administer satralizumab.

Medication Guide and/or Vaccine Information Statement (VIS)

An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:

Enspryng: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761149s005lbl.pdf#page=16

Use: Labeled Indications

Neuromyelitis optica spectrum disorder: Treatment of neuromyelitis optica spectrum disorder in adults who are anti-aquaporin-4 (AQP4) antibody positive.

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

Abrocitinib: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid

Antithymocyte Globulin (Equine): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of immunosuppressive therapy is reduced. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor

Baricitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Baricitinib. Risk X: Avoid

BCG Products: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of BCG Products. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Brincidofovir: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Brincidofovir. Risk C: Monitor

Brivudine: May increase adverse/toxic effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid

Chikungunya Vaccine (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Chikungunya Vaccine (Live). Risk X: Avoid

Cladribine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Cladribine. Risk X: Avoid

Coccidioides immitis Skin Test: Coadministration of Immunosuppressants (Therapeutic Immunosuppressant Agents) and Coccidioides immitis Skin Test may alter diagnostic results. Management: Consider discontinuing therapeutic immunosuppressants several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider Therapy Modification

COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor

COVID-19 Vaccine (mRNA): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups. See CDC guidance for details. Risk D: Consider Therapy Modification

COVID-19 Vaccine (Subunit): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of COVID-19 Vaccine (Subunit). Risk C: Monitor

CycloSPORINE (Systemic): Interleukin-6 (IL-6) Inhibiting Therapies may decrease serum concentration of CycloSPORINE (Systemic). Risk C: Monitor

CYP Substrates (Narrow Therapeutic Index/Sensitive with Inducers): Interleukin-6 (IL-6) Inhibiting Therapies may decrease serum concentration of CYP Substrates (Narrow Therapeutic Index/Sensitive with Inducers). Risk C: Monitor

CYP2C9 Substrates (Narrow Therapeutic Index/Sensitive with Inducers): Interleukin-6 (IL-6) Inhibiting Therapies may decrease serum concentration of CYP2C9 Substrates (Narrow Therapeutic Index/Sensitive with Inducers). Risk C: Monitor

CYP3A4 Substrates (Narrow Therapeutic Index/Sensitive with Inducers): Interleukin-6 (IL-6) Inhibiting Therapies may decrease serum concentration of CYP3A4 Substrates (Narrow Therapeutic Index/Sensitive with Inducers). Risk C: Monitor

Dengue Tetravalent Vaccine (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Dengue Tetravalent Vaccine (Live). Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Denosumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Denosumab. Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and immunosuppressants. If combined, monitor for signs/symptoms of serious infections. Risk D: Consider Therapy Modification

Deucravacitinib: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid

Efgartigimod Alfa: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor

Etrasimod: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid

Filgotinib: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid

HMG-CoA Reductase Inhibitors (Statins): Interleukin-6 (IL-6) Inhibiting Therapies may decrease serum concentration of HMG-CoA Reductase Inhibitors (Statins). Risk C: Monitor

Inebilizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Inebilizumab. Risk C: Monitor

Influenza Virus Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating immunosuppressants if possible. If vaccination occurs less than 2 weeks prior to or during therapy, revaccinate 2 to 3 months after therapy discontinued if immune competence restored. Risk D: Consider Therapy Modification

Leflunomide: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents. Risk D: Consider Therapy Modification

Mumps- Rubella- or Varicella-Containing Live Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Nadofaragene Firadenovec: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid

Natalizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Natalizumab. Risk X: Avoid

Nipocalimab: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor

Ocrelizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ocrelizumab. Risk C: Monitor

Ofatumumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ofatumumab. Risk C: Monitor

Pidotimod: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Pidotimod. Risk C: Monitor

Pimecrolimus: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Pimecrolimus. Risk X: Avoid

Pneumococcal Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Pneumococcal Vaccines. Risk C: Monitor

Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Polymethylmethacrylate: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase hypersensitivity effects of Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider Therapy Modification

Rabies Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider Therapy Modification

Ritlecitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ritlecitinib. Risk X: Avoid

Rozanolixizumab: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor

Ruxolitinib (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ruxolitinib (Topical). Risk X: Avoid

Sipuleucel-T: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants prior to initiating sipuleucel-T therapy. Risk D: Consider Therapy Modification

Sphingosine 1-Phosphate (S1P) Receptor Modulators: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk C: Monitor

Tacrolimus (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Tacrolimus (Topical). Risk X: Avoid

Talimogene Laherparepvec: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid

Tertomotide: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Tertomotide. Risk X: Avoid

Theophylline: Interleukin-6 (IL-6) Inhibiting Therapies may decrease serum concentration of Theophylline. Risk C: Monitor

Tofacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Tofacitinib. Management: Coadministration of tofacitinib with potent immunosuppressants is not recommended. Use with non-biologic disease-modifying antirheumatic drugs (DMARDs) was permitted in psoriatic arthritis clinical trials. Risk X: Avoid

Typhoid Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Typhoid Vaccine. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Ublituximab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ublituximab. Risk C: Monitor

Upadacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Upadacitinib. Risk X: Avoid

Vaccines (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Vaccines (Live). Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Vaccines (Non-Live/Inactivated/Non-Replicating): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Give non-live/inactivated/non-replicating vaccines at least 2 weeks prior to starting immunosuppressants when possible. Patients vaccinated less than 14 days before or during therapy should be revaccinated at least 2 to 3 months after therapy is complete. Risk D: Consider Therapy Modification

Yellow Fever Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Yellow Fever Vaccine. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Zoster Vaccine (Live/Attenuated): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Zoster Vaccine (Live/Attenuated). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Zoster Vaccine (Live/Attenuated). Risk X: Avoid

Pregnancy Considerations

Satralizumab is a humanized monoclonal antibody (IgG₂). Human IgG crosses the placenta. Fetal exposure is dependent upon the IgG subclass, maternal serum concentrations, placental integrity, newborn birth weight, and GA, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis and the highest during the third trimester (Clements 2020; Palmeira 2012; Pentsuk 2009).

Maternal neuromyelitis optica spectrum disorder (NMOSD) may be associated with adverse pregnancy outcomes. Information related to the treatment of NMOSD in pregnancy is limited; agents other than satralizumab may be preferred (Borisow 2018; Chang 2020; Holmøy 2021; Kim 2020; Zhu 2020).

Data collection to monitor pregnancy and infant outcomes following exposure to satralizumab is ongoing. Health care providers are encouraged to enroll patients exposed to satralizumab during pregnancy in the pregnancy exposure registry (1-833-277-9338); patients may also enroll themselves.

Breastfeeding Considerations

It is not known if satralizumab is present in breast milk.

Satralizumab is a humanized monoclonal antibody (IgG₂). Human IgG is present in breast milk; concentrations are dependent upon IgG subclass and postpartum age (Anderson 2021).

According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.

Monitoring Parameters

Hepatitis B virus screening (hepatitis B surface antigen [HBsAg] and hepatitis B core antibody [HBcAb] tests prior to therapy initiation); tuberculosis (TB) evaluation and risk factor assessment (prior to initiation), signs/symptoms of TB (throughout treatment); ALT/AST (prior to initiation, every 4 weeks for the first 3 months of treatment, then every 3 months for 1 year, and then as clinically warranted); serum bilirubin (prior to initiation and as clinically warranted); neutrophil counts (4 to 8 weeks after initiation and then at regular clinically determined intervals); signs/symptoms of any active infection (prior to each treatment).

Mechanism of Action

Satralizumab is an antagonist of the interleukin-6 (IL-6) receptor. Satralizumab is presumed to inhibit IL-6-mediated signaling through binding to soluble and membrane-bound IL-6 receptors.

Pharmacokinetics (Adult Data Unless Noted)

Distribution: Central V_d: ~3.5 L; peripheral V_d: ~2 L.

Bioavailability: 85%.

Half-life elimination: ~30 days (range: 22 to 37 days).

Brand Names: International

International Brand Names by Country

For country code abbreviations (show table)

(AE) United Arab Emirates: Enspryng;
(AR) Argentina: Enspryng;
(AT) Austria: Enspryng;
(BR) Brazil: Enspryng;
(CH) Switzerland: Enspryng;
(CL) Chile: Enspryng;
(CO) Colombia: Enspryng;
(CZ) Czech Republic: Enspryng;
(DE) Germany: Enspryng;
(EC) Ecuador: Enspryng;
(ES) Spain: Enspryng;
(FI) Finland: Enspryng;
(FR) France: Enspryng;
(GB) United Kingdom: Enspryng;
(HK) Hong Kong: Enspryng;
(HU) Hungary: Enspryng;
(IT) Italy: Enspryng;
(JP) Japan: Enspryng;
(LV) Latvia: Enspryng;
(MX) Mexico: Enspryng;
(MY) Malaysia: Enspryng;
(NL) Netherlands: Enspryng;
(NO) Norway: Enspryng;
(PE) Peru: Enspryng;
(PL) Poland: Enspryng;
(PR) Puerto Rico: Enspryng;
(QA) Qatar: Enspryng;
(SE) Sweden: Enspryng;
(TW) Taiwan: Enspryng;
(ZA) South Africa: Enspryng

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Borisow N, Hellwig K, Paul F. Neuromyelitis optica spectrum disorders and pregnancy: relapse-preventive measures and personalized treatment strategies. EPMA J. 2018;9(3):249-256. doi:10.1007/s13167-018-0143-9
Chang VTW, Chang HM. Review: recent advances in the understanding of the pathophysiology of neuromyelitis optica spectrum disorder. Neuropathol Appl Neurobiol. 2020;46(3):199-218. doi:10.1111/nan.12574 [PubMed 31353503]
Clements T, Rice TF, Vamvakas G, et al. Update on transplacental transfer of IgG subclasses: impact of maternal and fetal factors. Front Immunol. 2020;11:1920. doi:10.3389/fimmu.2020.01920 [PubMed 33013843]
Enspryng (satralizumab) [prescribing information]. South San Francisco, CA: Genentech Inc; March 2022.
Heo YA. Satralizumab: first approval. Drugs. 2020;80(14):1477-1482. doi:10.1007/s40265-020-01380-2 [PubMed 32797372]
Holmøy T, Høglund RA, Illes Z, Myhr KM, Torkildsen Ø. Recent progress in maintenance treatment of neuromyelitis optica spectrum disorder. J Neurol. 2021;268(12):4522-4536. doi:10.1007/s00415-020-10235-5 [PubMed 33011853]
Kim SH, Huh SY, Jang H, et al. Outcome of pregnancies after onset of the neuromyelitis optica spectrum disorder. Eur J Neurol. 2020;27(8):1546-1555. doi:10.1111/ene.14274 [PubMed 32320109]
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Satralizumab: Drug information