SPEVIGO spesolimab-sbzo 60 mg/mL Injection, 2 vials — NDC 0597-0035-10 (Billing 00597-0035-10)
This is a package of 2 vials of SPEVIGO spesolimab-sbzo 60 mg/mL Injection from Boehringer Ingelheim Pharmaceuticals, Inc., marketed since Sep 2022 and currently FDA-listed, this package's marketing is listed to end Nov 2027. It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 0597-0035-10 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 0597 labeler · 0035 product · 10 package
- Package marketed since
- Sep 1, 2022
- Package marketing ended
- Nov 30, 2027
- Sample package
- No — commercial package
- Barcode (UPC)
- 0305970035107
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 083792
- GCN: 52851
- GPI-14 (Medi-Span): 90250577702050
- HICL (First Databank): 048270
- AHFS class code: 84:06.28.00
- RxCUI (RxNorm): 2610422
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Interleukin-36 Receptor Antagonist class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Spesolimab-sbzo is used for the treatment of generalized pustular psoriasis (GPP; a skin disease in which pus-filled bumps form on some areas of the body) in adults and children 12 years of age and older weighing at least 40 kg (88 lbs). Spesolimab-sbzo is in a class of medications called monoclonal immunoglobulin G1 antibodies. It works by blocking a certain substance in the immune system that may cause GPP.
Read the full MedlinePlus article ↗Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Spesolimab-sbzo — tap one for details:
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $9,530.01 | $19,060.02 / 2 vials |
| Medicare Part B allowsASP · J1747 | $65.728 / J1747 unit | — |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 5, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Billing & reimbursement
Where does this data come from?
- CMS ASP NDC-HCPCS crosswalk · refreshed Sep 22, 2026
- DMEPDAC NDC-HCPCS crosswalk
- openFDA NSDE billing units · refreshed Sep 7, 2026
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 00597-0035-10 You're viewing this Main listing | 2 VIAL, GLASS in 1 CARTON / 7.5 mL in 1 VIAL, GLASS | 2022-09-01 | Nov 30, 2027 | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Spevigo 60 mg/mLthis 00597-0035-10 | Boehringer | 2 vials | — | — | FDA listed | — |
| Spevigo 60 mg/mL 50222-0360-72 | LEO | 2 vials | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Purple Book · refreshed Oct 5, 2026
- CMS NADAC weekly file
Availability & biosimilar status
Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.
Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.
🛈 What do these terms mean?
- Biologic patent
- A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
- Reference-product exclusivity
- A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
- Interchangeable exclusivity
- The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
- Earliest biosimilar (LOE)
- The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.
Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.
| Code | What it grants | Expires |
|---|---|---|
| RefProduct | Reference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this date | Sep 1, 2034 |
Is there a biosimilar for SPEVIGO 450 MG/7.5 ML VIAL?
Why do different websites show different biosimilar dates?
Can a biosimilar launch before the last patent expires?
What does “current Purple Book estimate” mean?
What does “FDA listed” mean?
What does a patent or protection date mean here?
Where does this data come from?
- FDA Purple Book · refreshed Oct 5, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 5, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Boehringer Ingelheim Pharmaceuticals, Inc. labeler code 00597
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- Micardis HCT telmisartan and hydrochlorothiazide 80 mg; 25 mg Tablet NDC 0597-0042-37
- Micardis HCT telmisartan and hydrochlorothiazide 40 mg; 12.5 mg Tablet NDC 0597-0043-37
- Micardis HCT telmisartan and hydrochlorothiazide 80 mg; 12.5 mg Tablet NDC 0597-0044-37
- Spiriva HandiHaler TIOTROPIUM BROMIDE 18 ug Capsule NDC 0597-0075-41
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE SPEVIGO is indicated for the treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients 12 years of age and older and weighing at least 40 kg. SPEVIGO is an interleukin-36 receptor antagonist indicated for the treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients 12 years of age and older and weighing at least 40 kg. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Subcutaneous Dosage for Treatment of GPP When Not Experiencing a Flare Administer a subcutaneous loading dose of 600 mg, followed by 300 mg subcutaneously 4 weeks later and every 4 weeks thereafter. ( 2.3 ) Subcutaneous Use After Intravenous SPEVIGO for Treatment of GPP Flare: Four weeks after treatment with intravenous SPEVIGO, initiate or reinitiate subcutaneous SPEVIGO at a dose of 300 mg administered every 4 weeks. A loading dose is not required following treatment of a GPP flare with intravenous SPEVIGO.
( 2.3 ) See full prescribing information for preparation and administration instructions. ( 2.2 , 2.5 ) Intravenous Dosage for Treatment of GPP Flare Must be diluted before intravenous use. Administer as a single 900 mg dose by intravenous infusion over 90 minutes.
If flare symptoms persist, may administer an additional intravenous 900 mg dose one week after the initial dose. ( 2.4 ) See full prescribing information for preparation and administration instructions and storage of the diluted solution. ( 2.2 , 2.5 )
2.1Testing and Procedures Prior to Treatment Initiation Evaluate patients for active or latent tuberculosis (TB) infection. SPEVIGO initiation is not recommended in patients with active TB infection. Consider initiating treatment of latent TB prior to initiation of SPEVIGO [see Warnings and Precautions (5.2) ] .
Complete all age-appropriate vaccinations according to current immunization guidelines prior to initiating SPEVIGO for treatment of GPP [see Warnings and Precautions (5.4) ] .
2.2Important Administration Information Subcutaneous Use for Treatment of GPP When Not Experiencing a Flare SPEVIGO prefilled syringes are for subcutaneous use for treatment of GPP when not experiencing a flare. When using SPEVIGO 300 mg/2 mL prefilled syringe: If the healthcare professional determines that it is appropriate, a patient 12 years of age or older may self-inject or the caregiver may administer the loading dose and the subsequent doses of SPEVIGO after proper training in subcutaneous injection technique.
In pediatric patients 12 years of age and older, administer SPEVIGO under the supervision of an adult. When using SPEVIGO 150 mg/mL prefilled syringe: If required, the 600 mg subcutaneous loading dose of SPEVIGO is to be administered by a healthcare professional [see Dosage and Administration (2.3) ] . For subsequent 300 mg doses, if the healthcare professional determines that it is appropriate, a patient 12 years of age or older may self-inject or the caregiver may administer SPEVIGO after proper training in subcutaneous injection technique.
In pediatric patients 12 years of age and older, administer SPEVIGO under the supervision of an adult. If a patient experiences a GPP flare while receiving subcutaneous SPEVIGO, the GPP flare may be treated with intravenous SPEVIGO [see Dosage and Administration (2.4) ] . Intravenous Use for Treatment of GPP Flare SPEVIGO vials are for intravenous use for treatment of GPP flare.
Intravenous infusion of SPEVIGO is only to be administered by a healthcare professional in a healthcare setting. Prepare SPEVIGO intravenous infusion by diluting SPEVIGO single-dose vials [see Dosage and Administration (2.5) ] . Do not mix SPEVIGO with other medicinal products.
2.3Recommended Subcutaneous Dosage for Treatment of GPP When Not Experiencing a Flare The recommended dosage of SPEVIGO for treatment of GPP when not experiencing a flare in adults and pediatric patients 12 years of age and older and weighing at least 40 kg is a loading dose of 600 mg followed by 300 mg administered subcutaneously 4 weeks later and every 4 weeks thereafter. Initiating or Reinitiating Subcutaneous SPEVIGO After Treatment of a GPP Flare with Intravenous SPEVIGO Four weeks after treatment of a GPP flare with intravenous SPEVIGO [see Dosage and Administration (2.4) ] , initiate or reinitiate subcutaneous SPEVIGO for treatment of GPP at a dose of 300 mg administered every 4 weeks.
A subcutan… [Excerpted — this section continues on DailyMed.]
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS SPEVIGO is a colorless to slightly brownish-yellow, clear to slightly opalescent solution available as: For Subcutaneous Use Injection: 300 mg/2 mL (150 mg/mL) solution in a single-dose prefilled syringe ( 3 ) Injection: 150 mg/mL solution in a single-dose prefilled syringe ( 3 ) For Intravenous Use Injection: 450 mg/7.5 mL (60 mg/mL) solution in a single-dose vial ( 3 ) For subcutaneous use: Injection: 300 mg/2 mL (150 mg/mL) solution in a single-dose prefilled syringe Injection: 150 mg/mL in a single-dose prefilled syringe For intravenous use: Injection: 450 mg/7.5 mL (60 mg/mL) in a single-dose vial for dilution prior to intravenous infusion
⛔ Contraindications ▾
4 CONTRAINDICATIONS SPEVIGO is contraindicated in patients with severe or life-threatening hypersensitivity to spesolimab-sbzo or to any of the excipients in SPEVIGO. Reported hypersensitivity reactions have included drug reaction with eosinophilia and systemic symptoms (DRESS) and anaphylaxis [see Warnings and Precautions (5.3) and Adverse Reactions (6) ] . Severe or life-threatening hypersensitivity to spesolimab-sbzo or to any of the excipients in SPEVIGO ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Infections: SPEVIGO may increase the risk of infections. Treatment with SPEVIGO is not recommended during any clinically important active infection. Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur during or after treatment.
If a clinically important active infection develops, discontinue SPEVIGO until the infection resolves or is adequately treated. ( 5.1 ) Risk of Tuberculosis (TB): Evaluate patients for TB prior to initiating treatment with SPEVIGO. ( 5.2 ) Hypersensitivity and Infusion-Related Reactions: Hypersensitivity reactions, including anaphylaxis and drug reaction with eosinophilia and systemic symptoms (DRESS), and infusion-related reactions may occur.
Discontinue SPEVIGO immediately and initiate appropriate treatment if a serious hypersensitivity reaction occurs. ( 5.3 ) Vaccinations: Avoid use of live vaccines during and for at least 16 weeks after treatment with SPEVIGO. ( 5.4 )
5.1Infections SPEVIGO may increase the risk of infections. During the one-week placebo-controlled period in the Effisayil-1 trial, infections were reported in 14% of subjects treated with SPEVIGO compared with 6% of subjects treated with placebo [see Adverse Reactions (6.1) ] . In patients with a chronic infection or a history of recurrent infection, consider the potential risks and expected clinical benefits of treatment prior to prescribing SPEVIGO.
Treatment with SPEVIGO is not recommended in patients with any clinically important active infection until the infection resolves or is adequately treated. Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur during or after treatment with SPEVIGO. If a patient develops a clinically important active infection, discontinue SPEVIGO therapy until the infection resolves or is adequately treated.
5.2Risk of Tuberculosis Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with SPEVIGO. Avoid use of SPEVIGO in patients with active TB infection. Consider initiating anti-TB therapy prior to initiating SPEVIGO in patients with latent TB or a history of TB in whom an adequate course of treatment cannot be confirmed. Monitor patients for signs and symptoms of active TB during and after SPEVIGO treatment.
5.3Hypersensitivity and Infusion-Related Reactions Serious hypersensitivity reactions, including anaphylaxis and delayed reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported during and following administration of SPEVIGO. These reactions can occur with the first dose or subsequent doses [see Adverse Reactions (6.1) ] . SPEVIGO is contraindicated in patients with severe or life-threatening hypersensitivity to spesolimab-sbzo or to any of the excipients in SPEVIGO.
If a patient develops signs of anaphylaxis or other serious hypersensitivity, discontinue SPEVIGO immediately and initiate appropriate treatment. If a patient develops mild or moderate hypersensitivity during an intravenous infusion or other infusion-related reactions, stop SPEVIGO infusion and consider appropriate medical therapy (e.g., systemic antihistamines and/or corticosteroids). Upon resolution of the reaction, the infusion may be restarted at a slower infusion rate with gradual increase to complete the infusion.
5.4Vaccinations Prior to initiating SPEVIGO for treatment of GPP, complete all age-appropriate vaccinations according to current immunization guidelines. Avoid use of live vaccines in patients during and for at least 16 weeks after treatment with SPEVIGO. No specific studies have been conducted in SPEVIGO-treated patients who have recently received live viral or live bacterial vaccines.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: Infections [see Warnings and Precautions (5.1) ] Hypersensitivity and Infusion-Related Reactions [see Warnings and Precautions (5.3) ] Treatment of GPP When Not Experiencing a Flare: SPEVIGO has been associated with an increased incidence (≥9 cases per 100 patient-years) of injection site reaction, urinary tract infection, arthralgia, and pruritus. ( 6.1 ) Treatment of GPP Flare: The most common adverse reactions (≥5%) are asthenia and fatigue, headache, nausea, pruritus and prurigo, infusion site hematoma and bruising, and urinary tract infection.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Boehringer Ingelheim Pharmaceuticals, Inc. at (800) 542-6257 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Adverse Reactions with Intravenous SPEVIGO for Treatment of GPP Flare (Study Effisayil-1) SPEVIGO was studied in Study Effisayil-1, a randomized, double-blind, placebo-controlled study comparing a single intravenous 900 mg dose of SPEVIGO (n=35) with placebo (n=18) in subjects with generalized pustular psoriasis (GPP) flare.
Subjects in either treatment group who continued to experience flare symptoms at Week 1 were eligible to receive a single open-label intravenous dose of 900 mg of SPEVIGO (second dose and first dose for subjects in the SPEVIGO and placebo groups, respectively). At Week 1, 12 (34%) subjects and 15 subjects (83%) in the SPEVIGO and placebo groups, respectively, received open-label SPEVIGO. After Week 1 to Week 12, subjects in either treatment group whose GPP flare reoccurred after achieving a clinical response were eligible to receive a single open-label rescue intravenous dose of 900 mg of SPEVIGO, with a maximum of 3 total doses of SPEVIGO throughout the study.
Six subjects received a single open-label rescue dose of SPEVIGO. Thirty-six subjects received 1 dose of SPEVIGO, 13 subjects received 2 doses of SPEVIGO, and 2 subjects received 3 doses of SPEVIGO throughout the study [see Clinical Studies (14) ] . Subjects ranged in age from 21 to 69 years (mean age of 43 years); 45% were White and 55% were Asian; and 68% were female.
Table 1 summarizes selected adverse reactions that occurred at a rate of at least 1% and at a higher rate in the intravenous SPEVIGO group than in the placebo group through Week 1. Table 1 Selected Adverse Reactions Occurring in ≥1% of the Intravenous SPEVIGO Group and More Frequently than in the Placebo Group through Week 1 in Subjects with GPP Flare (Study Effisayil-1) Adverse Reaction Intravenous SPEVIGO N = 35 n (%) Placebo N = 18 n (%) Asthenia and Fatigue 3 (9) 1 (6) Headache 3 (9) 1 (6) Nausea 2 (6) 0 Pruritus and prurigo 2 (6) 0 Infusion site hematoma and bruising 2 (6) 0 Urinary tract infection 2 (6) 0 Bacteremia 1 (3) 0 Bacteriuria 1 (3) 0 Cellulitis 1 (3) 0 Herpes dermatitis and oral herpes 1 (3) 0 Upper respiratory tract infection 1 (3) 0 Dyspnea 1 (3) 0 Eye edema 1 (3) 0 Urticaria 1 (3) 0 Specific Adverse Reactions Infections The most frequent adverse reactions that occurred in subjects treated with intravenous SPEVIGO were infections.
During the 1-week placebo-controlled period in Study Effisayil-1, infections were reported in 14% of subjects treated with SPEVIGO compared with 6% of subjects treated with placebo. Serious infection (urinary tract infection) was reported in 1 subject (3%) treated with SPEVIGO and no subjects treated with placebo. Infections observed through Week 1 in Study Effisayil-1 in subjects treated with SPEVIGO were mild (29%) to moderate (71%).
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) Two cases of DRESS w… [Excerpted — this section continues on DailyMed.]
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary The limited data on the use of SPEVIGO in pregnant women are insufficient to inform a drug-associated risk of adverse pregnancy-related outcomes. Human IgG is known to cross the placental barrier; therefore, SPEVIGO may be transmitted from the mother to the developing fetus. In an animal reproduction study, intravenous administration of a surrogate antibody against IL36R in mice during the period of organogenesis did not elicit any reproductive toxicity (see Data ) .
The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Data Animal Data Embryo-fetal development and pre- and postnatal development toxicity studies were performed in mice using a surrogate mouse specific IL36R antagonist monoclonal antibody. In the embryo-fetal development study, the surrogate was administered intravenously at doses up to 50 mg/kg to pregnant female mice twice weekly during the period of organogenesis. The surrogate was not associated with embryo-fetal lethality or fetal malformations.
In the pre- and postnatal development toxicity study, the surrogate was administered intravenously at doses up to 50 mg/kg to pregnant female mice twice weekly from gestation day 6 through lactation day 18. There were no maternal effects observed. There were no treatment-related effects observed on postnatal developmental, neurobehavioral, or reproductive performance of offspring.
8.2Lactation Risk Summary There are no data on the presence of spesolimab-sbzo in human milk, the effects on the breastfed infant, or the effects on milk production. Spesolimab-sbzo is a monoclonal antibody and is expected to be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for SPEVIGO and any potential adverse effects on the breastfed infant from SPEVIGO or from the underlying maternal condition.
8.4Pediatric Use The safety and effectiveness of SPEVIGO for the treatment of GPP have been established in pediatric patients 12 years of age and older and weighing at least 40 kg. Use of SPEVIGO for this indication is supported by data from a randomized, placebo-controlled study which included 6 pediatric subjects 14 to 17 years of age with a history of GPP treated with subcutaneous SPEVIGO (Study Effisayil-2) and evidence from an adequate and well-controlled study of intravenous SPEVIGO in adults with GPP (Study Effisayil-1), with additional pharmacokinetic analyses showing similar drug exposure levels in adults and pediatric subjects 12 years of age and older and weighing 40 kg or more [see Adverse Reactions (6.1) , Clinical Pharmacology (12.3) , and Clinical Studies (14) ] .
The safety and effectiveness of SPEVIGO in pediatric patients younger than 12 years of age or in pediatric patients weighing less than 40 kg have not been established.
8.5Geriatric Use There were 2 (6%) intravenous SPEVIGO-treated subjects 65 to 74 years of age and no subjects 75 years of age or older in Study Effisayil-1. There were 6 (7%) subcutaneous SPEVIGO-treated subjects 65 to 74 years of age and 1 (1%) subject 75 years of age in Study Effisayil-2. Clinical studies of SPEVIGO did not include sufficient numbers of subjects 65 years of age and older to determine whether they respond differently from younger adult subjects.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary The limited data on the use of SPEVIGO in pregnant women are insufficient to inform a drug-associated risk of adverse pregnancy-related outcomes. Human IgG is known to cross the placental barrier; therefore, SPEVIGO may be transmitted from the mother to the developing fetus. In an animal reproduction study, intravenous administration of a surrogate antibody against IL36R in mice during the period of organogenesis did not elicit any reproductive toxicity (see Data ) .
The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Data Animal Data Embryo-fetal development and pre- and postnatal development toxicity studies were performed in mice using a surrogate mouse specific IL36R antagonist monoclonal antibody. In the embryo-fetal development study, the surrogate was administered intravenously at doses up to 50 mg/kg to pregnant female mice twice weekly during the period of organogenesis. The surrogate was not associated with embryo-fetal lethality or fetal malformations.
In the pre- and postnatal development toxicity study, the surrogate was administered intravenously at doses up to 50 mg/kg to pregnant female mice twice weekly from gestation day 6 through lactation day 18. There were no maternal effects observed. There were no treatment-related effects observed on postnatal developmental, neurobehavioral, or reproductive performance of offspring.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of SPEVIGO for the treatment of GPP have been established in pediatric patients 12 years of age and older and weighing at least 40 kg. Use of SPEVIGO for this indication is supported by data from a randomized, placebo-controlled study which included 6 pediatric subjects 14 to 17 years of age with a history of GPP treated with subcutaneous SPEVIGO (Study Effisayil-2) and evidence from an adequate and well-controlled study of intravenous SPEVIGO in adults with GPP (Study Effisayil-1), with additional pharmacokinetic analyses showing similar drug exposure levels in adults and pediatric subjects 12 years of age and older and weighing 40 kg or more [see Adverse Reactions (6.1) , Clinical Pharmacology (12.3) , and Clinical Studies (14) ] .
The safety and effectiveness of SPEVIGO in pediatric patients younger than 12 years of age or in pediatric patients weighing less than 40 kg have not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use There were 2 (6%) intravenous SPEVIGO-treated subjects 65 to 74 years of age and no subjects 75 years of age or older in Study Effisayil-1. There were 6 (7%) subcutaneous SPEVIGO-treated subjects 65 to 74 years of age and 1 (1%) subject 75 years of age in Study Effisayil-2. Clinical studies of SPEVIGO did not include sufficient numbers of subjects 65 years of age and older to determine whether they respond differently from younger adult subjects.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Spesolimab-sbzo is a humanized monoclonal immunoglobulin G1 antibody that inhibits interleukin-36 (IL-36) signaling by specifically binding to the IL36R. Binding of spesolimab-sbzo to IL36R prevents the subsequent activation of IL36R by its ligands (IL-36 α, β and γ) and downstream activation of pro-inflammatory and pro-fibrotic pathways. The precise mechanism linking reduced IL36R activity and the treatment of flares of GPP is unclear.
12.2Pharmacodynamics The pharmacodynamics of SPEVIGO in the treatment of patients with GPP have not been fully characterized.
12.3Pharmacokinetics A population pharmacokinetic model was developed based on data collected from healthy subjects, patients with GPP, and patients with other diseases. After a single intravenous dose of 900 mg of SPEVIGO, the population PK model-estimated AUC 0-∞ (95% CI) and C max (95% CI) in a typical anti-drug antibody (ADA)-negative patient with GPP were 4750 (4510, 4970) mcg ∙ day/mL and 238 (218, 256) mcg/mL, respectively. After subcutaneous SPEVIGO 600 mg LD followed by 300 mg every 4 weeks, the mean steady-state trough concentration ranged from 33.4 mcg/mL to 42.3 mcg/mL.
When administered intravenously, spesolimab-sbzo AUC increased dose-proportionally from 0.3 to 20 mg/kg, and CL and terminal half-life were independent of dose. Following subcutaneous single dose administration, spesolimab-sbzo exposure increased slightly more than dose-proportionally across the dose range of 150 mg to 600 mg due to increased bioavailability at higher doses. Absorption Following subcutaneous single dose administration of SPEVIGO in healthy volunteers, peak plasma concentrations were achieved between 5.5 to 7 days after dosing.
After subcutaneous administration in the abdomen, absolute bioavailability (90% CI) was slightly higher at higher doses with estimated values of 58 (51, 66)%, 65 (60, 69)%, and 72 (65, 79)% at 150 mg, 300 mg, and 600 mg, respectively. Based on limited data, absolute bioavailability (90% CI) in the thigh was approximately 85 (77, 94)% following a subcutaneous dose of 300 mg SPEVIGO. Distribution Based on the population pharmacokinetic analysis, the typical total volume of distribution at steady state was
6.4L. Elimination Metabolism The metabolic pathway of spesolimab-sbzo has not been characterized. As a humanized IgG1 monoclonal antibody, spesolimab-sbzo is expected to be degraded into small peptides and amino acids via catabolic pathways in a manner similar to endogenous IgG.
Excretion In the linear dose range (0.3 to 20 mg/kg), based on the population PK model, spesolimab-sbzo clearance (95% CI) in a typical GPP patient without ADA, weighing 70 kg was 0.184 (0.175, 0.194) L/day. The terminal half-life was 25.5 (24.4, 26.3) days. Specific Populations Age, Gender, and Race Based on population pharmacokinetic analyses, age, gender, and race did not have an effect on the pharmacokinetics of spesolimab-sbzo.
Hepatic and Renal Impairment As a monoclonal antibody, spesolimab-sbzo is not expected to undergo hepatic or renal elimination. No formal study of the effect of hepatic or renal impairment on the pharmacokinetics of spesolimab-sbzo was conducted. Body Weight Spesolimab-sbzo concentrations were increased in subjects with lower body weight and decreased in subjects with higher body weight.
The clinical impact of body weight on spesolimab-sbzo plasma concentrations is unknown. Pediatric Patients The pharmacokinetics of spesolimab-sbzo have not been studied in pediatric subjects below the age of 12 years. The plasma pharmacokinetics of spesolimab-sbzo observed in pediatric subjects 12 years of age and older and weighing 40 kg or more following subcutaneous administration were consistent with that observed in adults.
Drug Interaction Studies No formal drug interactions studies have been conducted with spesolimab-sbzo. In patients with GPP, spesolimab-sbzo is not expected to cause cytokine-mediated CYP int… [Excerpted — this section continues on DailyMed.]
🧬 Mechanism of Action ▾
12.1Mechanism of Action Spesolimab-sbzo is a humanized monoclonal immunoglobulin G1 antibody that inhibits interleukin-36 (IL-36) signaling by specifically binding to the IL36R. Binding of spesolimab-sbzo to IL36R prevents the subsequent activation of IL36R by its ligands (IL-36 α, β and γ) and downstream activation of pro-inflammatory and pro-fibrotic pathways. The precise mechanism linking reduced IL36R activity and the treatment of flares of GPP is unclear.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied SPEVIGO (spesolimab-sbzo) injection is a sterile, preservative-free, colorless to slightly brownish-yellow, clear to slightly opalescent solution available as follows: Prefilled syringes (for subcutaneous use) NDC Number 0597-7705-41: Each carton contains one single-dose 300 mg/2 mL (150 mg/mL) prefilled syringe. NDC Number 0597-7705-72: Each carton contains two single-dose 300 mg/2 mL (150 mg/mL) prefilled syringes. NDC Number 0597-0620-20: Each carton contains two single-dose 150 mg/mL prefilled syringes.
Single-dose vials (for intravenous use) NDC Number 0597-0035-10: Each carton contains two single-dose 450 mg/7.5 mL (60 mg/mL) glass vials. Storage and Handling Prefilled syringes 300 mg/2 mL: Store SPEVIGO prefilled syringes refrigerated between 2°C to 8°C (36°F to 46°F) in original carton to protect from light. Do not freeze.
Do not use if frozen even if it has been thawed. If needed, SPEVIGO 300 mg/2 mL prefilled syringes may be stored at room temperature up to a maximum of 25°C (77°F) for up to 14 days in the original carton to protect from light. Discard SPEVIGO 300 mg/2 mL prefilled syringes if kept at room temperature for more than 14 days.
150 mg/mL: Store SPEVIGO prefilled syringes refrigerated between 2°C to 8°C (36°F to 46°F) in original carton to protect from light. Do not freeze. Do not use if frozen even if it has been thawed.
Single-dose vials Store SPEVIGO vials refrigerated between 2°C to 8°C (36°F to 46°F) in original carton to protect from light. Do not freeze. Prior to use, may store unopened SPEVIGO vials at room temperature, 20°C to 25°C (68°F to 77°F), for up to 24 hours in the original carton to protect from light.
📦 Storage and Handling ▾
Storage and Handling Prefilled syringes 300 mg/2 mL: Store SPEVIGO prefilled syringes refrigerated between 2°C to 8°C (36°F to 46°F) in original carton to protect from light. Do not freeze. Do not use if frozen even if it has been thawed.
If needed, SPEVIGO 300 mg/2 mL prefilled syringes may be stored at room temperature up to a maximum of 25°C (77°F) for up to 14 days in the original carton to protect from light. Discard SPEVIGO 300 mg/2 mL prefilled syringes if kept at room temperature for more than 14 days. 150 mg/mL: Store SPEVIGO prefilled syringes refrigerated between 2°C to 8°C (36°F to 46°F) in original carton to protect from light.
Do not freeze. Do not use if frozen even if it has been thawed. Single-dose vials Store SPEVIGO vials refrigerated between 2°C to 8°C (36°F to 46°F) in original carton to protect from light.
Do not freeze. Prior to use, may store unopened SPEVIGO vials at room temperature, 20°C to 25°C (68°F to 77°F), for up to 24 hours in the original carton to protect from light.
📋 Description ▾
11 DESCRIPTION Spesolimab-sbzo, an interleukin-36 receptor antagonist, is a humanized monoclonal IgG1 antibody (mAb) against human IL-36R produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Spesolimab-sbzo has a molecular weight of approximately 146 kDa. SPEVIGO (spesolimab-sbzo) injection is a sterile, preservative-free, colorless to slightly brownish-yellow, clear to slightly opalescent solution supplied in a single-dose prefilled syringe for subcutaneous use.
Each 2 mL prefilled syringe contains 300 mg spesolimab-sbzo, arginine hydrochloride (10.6 mg), glacial acetic acid (0.64 mg), polysorbate 20 (0.80 mg), sodium acetate (6.50 mg), sucrose (102.8 mg), and Water for Injection, USP with a pH of 5.2 to 5.8. Each 1 mL prefilled syringe contains 150 mg spesolimab-sbzo, arginine hydrochloride (5.3 mg), glacial acetic acid (0.32 mg), polysorbate 20 (0.40 mg), sodium acetate (3.25 mg), sucrose (51.4 mg), and Water for Injection, USP with a pH of 5.2 to 5.8. SPEVIGO (spesolimab-sbzo) injection is a sterile, preservative-free, colorless to slightly brownish-yellow, clear to slightly opalescent solution supplied in a single-dose vial for intravenous use.
Each 7.5 mL vial contains 450 mg spesolimab-sbzo, arginine hydrochloride (39.5 mg), glacial acetic acid (2.4 mg), polysorbate 20 (3.0 mg), sodium acetate (24.5 mg), sucrose (386 mg), and Water for Injection, USP with a pH of 5.2 to 5.8.
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Infections Inform patients that SPEVIGO may lower the ability of their immune system to fight infections. Instruct patients of the importance of communicating any history of infections to the healthcare provider and contacting their healthcare provider if they develop any signs or symptoms of clinically important infection during or after treatment with SPEVIGO [see Warnings and Precautions (5.1) ] .
Hypersensitivity and Infusion-Related Reactions Inform patients that hypersensitivity and infusion-related reactions may occur with SPEVIGO. Advise patients to seek immediate medical attention if they experience any symptoms of a serious hypersensitivity reaction [see Warnings and Precautions (5.3) ] . Vaccinations Advise patients to avoid receiving live vaccines during and for at least 16 weeks after treatment with SPEVIGO.
Instruct patients to inform the healthcare provider that they are taking SPEVIGO prior to a potential vaccination [see Warnings and Precautions (5.4) ] . Administration Instructions for Subcutaneous SPEVIGO for Treatment of GPP When Not Experiencing a Flare If a patient 12 years of age and older or caregiver is to administer subcutaneous SPEVIGO, instruct them on injection technique and assess their ability to inject subcutaneously to ensure the proper administration of SPEVIGO. Provide training to patients or caregivers on preparation and administration of subcutaneous SPEVIGO and on proper needle and syringe disposal [see Dosage and Administration (2.5) and Instructions for Use ] .
If more than one injection is needed to achieve the recommended dose, instruct patients to administer each injection subcutaneously one right after the other and to choose a different injection site for each injection, at least 1 inch away from the other injection sites [see Dosage and Administration (2.5) and Instructions for Use] .
💬 Medication Guide ▾
MEDICATION GUIDE SPEVIGO ® (spea VEE go) (spesolimab-sbzo) injection, for subcutaneous or intravenous use This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 05/2025 What is the most important information I should know about SPEVIGO?
SPEVIGO may cause serious side effects, including: Infections. SPEVIGO may lower the ability of your or your child's immune system to fight infections and may increase your or your child's risk of infections. Your healthcare provider should check you or your child for infections and tuberculosis (TB) before starting treatment with SPEVIGO and may treat you or your child for TB before you begin treatment with SPEVIGO if you have a history of TB or have active TB.
Your healthcare provider should watch you or your child closely for signs and symptoms of TB during or after treatment with SPEVIGO. Tell your healthcare provider right away if you or your child have an infection or have symptoms of an infection during or after treatment with SPEVIGO, including: fevers, chills, or sweats muscle aches cough shortness of breath blood in your phlegm (mucus) burning when you urinate urinating more often than normal Allergic reactions and infusion-related reactions. Serious allergic reactions may happen during or after your or your child's SPEVIGO injection.
If you or your child have a serious allergic reaction, your healthcare provider will stop treatment with SPEVIGO. If you or your child are given SPEVIGO in a vein (intravenously) and have an infusion-related reaction, your healthcare provider will stop your or your child's SPEVIGO infusion and treat your or your child's symptoms and may restart SPEVIGO at a slower infusion rate. Tell your healthcare provider or get emergency medical help right away if you or your child get any of the following symptoms during or after your or your child's SPEVIGO injection: feeling faint, dizzy, or lightheaded swelling of your face, eyelids, lips, mouth, tongue, or throat trouble breathing or throat tightness fever mouth sores chest tightness hives or skin rash that is different than the rash from generalized pustular psoriasis (GPP) itching swollen lymph nodes See " What are the possible side effects of SPEVIGO? " for more information about side effects.
What is SPEVIGO? SPEVIGO is a prescription medicine used to treat generalized pustular psoriasis (GPP) in adults and children 12 years of age and older who weigh at least 88 pounds (40 kg). It is not known if SPEVIGO is safe and effective in children under 12 years of age or who weigh less than 88 pounds (40 kg).
Do not receive SPEVIGO if you or your child have had a severe or life-threatening allergic reaction to spesolimab-sbzo or any of the ingredients in SPEVIGO. See the end of this Medication Guide for a complete list of ingredients in SPEVIGO. Before you or your child receive SPEVIGO, tell your healthcare provider about all of your medical conditions, including if you or your child: have an infection that does not go away or that keeps coming back.
See " What is the most important information I should know about SPEVIGO? " have TB or have been in close contact with someone with TB. have recently received or are scheduled to receive an immunization (vaccine). You or your child should not receive live vaccines during and for at least 16 weeks after treatment with SPEVIGO. You or your child should be brought up to date with all vaccines before starting SPEVIGO. are pregnant or plan to become pregnant.
It is not known if SPEVIGO can harm your or your child's unborn baby. are breastfeeding or plan to breastfeed. It is not known if SPEVIGO passes into your breast milk. Talk to your healthcare provider about the best way to feed your or your child's baby during treatment with SPEVIGO.
Tell your healthcare provider about all the medicines you or your child take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. How will I receive SPEVIGO? When give… [Excerpted — this section continues on DailyMed.]
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics A population pharmacokinetic model was developed based on data collected from healthy subjects, patients with GPP, and patients with other diseases. After a single intravenous dose of 900 mg of SPEVIGO, the population PK model-estimated AUC 0-∞ (95% CI) and C max (95% CI) in a typical anti-drug antibody (ADA)-negative patient with GPP were 4750 (4510, 4970) mcg ∙ day/mL and 238 (218, 256) mcg/mL, respectively. After subcutaneous SPEVIGO 600 mg LD followed by 300 mg every 4 weeks, the mean steady-state trough concentration ranged from 33.4 mcg/mL to 42.3 mcg/mL.
When administered intravenously, spesolimab-sbzo AUC increased dose-proportionally from 0.3 to 20 mg/kg, and CL and terminal half-life were independent of dose. Following subcutaneous single dose administration, spesolimab-sbzo exposure increased slightly more than dose-proportionally across the dose range of 150 mg to 600 mg due to increased bioavailability at higher doses. Absorption Following subcutaneous single dose administration of SPEVIGO in healthy volunteers, peak plasma concentrations were achieved between 5.5 to 7 days after dosing.
After subcutaneous administration in the abdomen, absolute bioavailability (90% CI) was slightly higher at higher doses with estimated values of 58 (51, 66)%, 65 (60, 69)%, and 72 (65, 79)% at 150 mg, 300 mg, and 600 mg, respectively. Based on limited data, absolute bioavailability (90% CI) in the thigh was approximately 85 (77, 94)% following a subcutaneous dose of 300 mg SPEVIGO. Distribution Based on the population pharmacokinetic analysis, the typical total volume of distribution at steady state was
6.4L. Elimination Metabolism The metabolic pathway of spesolimab-sbzo has not been characterized. As a humanized IgG1 monoclonal antibody, spesolimab-sbzo is expected to be degraded into small peptides and amino acids via catabolic pathways in a manner similar to endogenous IgG.
Excretion In the linear dose range (0.3 to 20 mg/kg), based on the population PK model, spesolimab-sbzo clearance (95% CI) in a typical GPP patient without ADA, weighing 70 kg was 0.184 (0.175, 0.194) L/day. The terminal half-life was 25.5 (24.4, 26.3) days. Specific Populations Age, Gender, and Race Based on population pharmacokinetic analyses, age, gender, and race did not have an effect on the pharmacokinetics of spesolimab-sbzo.
Hepatic and Renal Impairment As a monoclonal antibody, spesolimab-sbzo is not expected to undergo hepatic or renal elimination. No formal study of the effect of hepatic or renal impairment on the pharmacokinetics of spesolimab-sbzo was conducted. Body Weight Spesolimab-sbzo concentrations were increased in subjects with lower body weight and decreased in subjects with higher body weight.
The clinical impact of body weight on spesolimab-sbzo plasma concentrations is unknown. Pediatric Patients The pharmacokinetics of spesolimab-sbzo have not been studied in pediatric subjects below the age of 12 years. The plasma pharmacokinetics of spesolimab-sbzo observed in pediatric subjects 12 years of age and older and weighing 40 kg or more following subcutaneous administration were consistent with that observed in adults.
Drug Interaction Studies No formal drug interactions studies have been conducted with spesolimab-sbzo. In patients with GPP, spesolimab-sbzo is not expected to cause cytokine-mediated CYP interactions as a perpetrator.
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics The pharmacodynamics of SPEVIGO in the treatment of patients with GPP have not been fully characterized.
🔬 Clinical Studies ▾
14 CLINICAL STUDIES Intravenous SPEVIGO for Treatment of GPP Flare (Study Effisayil-1) A randomized, double-blind, placebo-controlled study (Study Effisayil-1) [NCT03782792] was conducted to evaluate the clinical efficacy and safety of intravenous SPEVIGO in adult subjects with flares of generalized pustular psoriasis (GPP). Subjects were randomized if they had a flare of GPP of moderate-to-severe intensity, as defined by: A Generalized Pustular Psoriasis Physician Global Assessment (GPPPGA) total score of at least 3 (moderate) [the total GPPPGA score ranges from 0 (clear) to 4 (severe)], The presence of fresh pustules (new appearance or worsening of pustules), GPPPGA pustulation sub score of at least 2 (mild), and At least 5% of body surface area covered with erythema and the presence of pustules.
Subjects were required to discontinue systemic and topical therapy for GPP prior to receiving study drug. A total of 53 subjects were randomized (2:1) to receive a single intravenous dose of 900 mg SPEVIGO (N=35) or placebo (N=18) (administered over 90 minutes) during the double-blind portion of the study. The study population consisted of 32% male and 68% female.
The mean age was 43 years (range: 21 to 69 years); 55% of subjects were Asian and 45% were White. For ethnicity, there were no subjects that identified as Hispanic or Latino in the study. Most subjects included in the study had a GPPPGA pustulation sub score of 3 (43%) or 4 (36%), and subjects had a GPPPGA total score of 3 (81%) or 4 (19%).
In this study, 25% of subjects had been previously treated with biologic therapy for GPP. At baseline acute flare, of the subjects with white blood cell count (WBC) assessments, 45% and 31% of subjects in the intravenous SPEVIGO and placebo groups, respectively, had (WBC) >12 × 10 9 /L. Seventeen percent and 11% of subjects in the intravenous SPEVIGO and placebo groups, respectively, had temperature >38° Celsius.
Of the subjects with WBC assessments, 12% and 6% of subjects in the SPEVIGO and placebo groups, respectively, had both WBC >12 × 10 9 /L and temperature >38° Celsius [see Adverse Reactions (6.1) ]. The primary endpoint of the study was the proportion of subjects with a GPPPGA pustulation sub score of 0 (indicating no visible pustules) at Week 1 after treatment. Clinical Response The results of the primary endpoint are presented in Table 2 .
Table 2 GPPPGA Pustulation Sub Score at Week 1 in Adult Subjects with Flares of GPP in Study Effisayil-1 (Intravenous SPEVIGO) Intravenous SPEVIGO (N=35) Placebo (N=18) GPPPGA = Generalized Pustular Psoriasis Physician Global Assessment Subjects achieving a GPPPGA pustulation sub score of 0, n (%) 19 (54) 1 (6) Risk difference versus placebo, % (95% CI) 49 (21, 67) In Study Effisayil-1, subjects in either treatment group who continued to experience flare symptoms at Week 1 were eligible to receive a single open-label intravenous dose of 900 mg of SPEVIGO (second dose and first dose for subjects in the SPEVIGO and placebo groups, respectively).
At Week 1, 12 (34%) subjects and 15 subjects (83%) in the intravenous SPEVIGO and placebo groups, respectively, received open-label SPEVIGO. In subjects who were randomized to intravenous SPEVIGO and received an open-label dose of SPEVIGO at Week 1, 5 (42%) subjects had a GPPPGA pustulation sub score of 0 at Week 2 (one week after their second dose of SPEVIGO). This study did not include sufficient numbers of subjects to determine if there are differences in response according to biological sex, age, race, baseline GPPPGA pustulation sub score, and baseline GPPPGA total score.
Subcutaneous SPEVIGO for Treatment of GPP When Not Experiencing a Flare (Study Effisayil-2) A randomized, double-blind, placebo-controlled study (Study Effisayil-2) [NCT04399837] evaluated the efficacy and safety of SPEVIGO for subcutaneous administration in adults and pediatric subjects (12 years of age and older and weighing at least 40 kg) with a history of at least two GPP fl… [Excerpted — this section continues on DailyMed.]
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity and mutagenicity studies have not been conducted with spesolimab-sbzo. No adverse effects on fertility were observed in male or female mice that were intravenously administered a surrogate antibody to IL36R at doses up to 50 mg/kg twice weekly.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity and mutagenicity studies have not been conducted with spesolimab-sbzo. No adverse effects on fertility were observed in male or female mice that were intravenously administered a surrogate antibody to IL36R at doses up to 50 mg/kg twice weekly.
📖 Instructions for Use ▾
INSTRUCTIONS FOR USE SPEVIGO ® (spea VEE go) (spesolimab-sbzo) injection, for subcutaneous use 150 mg/mL Two 150 mg/mL single-dose prefilled syringes for a total of 300 mg dose This Instructions for Use contains information on how to inject SPEVIGO. Read both sides of this Instructions for Use before you use SPEVIGO for the first time and each time you get a refill. There may be new information.
This information does not take the place of talking to your healthcare provider about your or your child's medical condition or treatment. Your healthcare provider should show you or your child the right way to inject SPEVIGO before you try to inject yourself or your child for the first time. In children 12 years of age and older, SPEVIGO should be given under the supervision of an adult.
SPEVIGO is for one-time use only. Do not reuse the prefilled syringes. Your healthcare provider has prescribed a dose of SPEVIGO for you or your child that requires 2 injections (2 prefilled syringes) to deliver a complete dose.
You must inject the contents of both SPEVIGO prefilled syringes that come in the carton to deliver the complete dose. Getting to know SPEVIGO: SPEVIGO comes in a prefilled syringe with a safety cover. The needle is pulled back into the safety cover after injection.
Guide to parts: The figure below shows SPEVIGO before use, and after use with the activated safety cover. Important information you need to know before injecting SPEVIGO: You must inject the contents of both SPEVIGO prefilled syringes to deliver a complete dose. Inspect the SPEVIGO carton to be sure that you have the correct medicine, 2 prefilled syringes for your or your child's prescribed dose, for any damage, and the expiration date (EXP).
Do not use SPEVIGO if the liquid is cloudy or contains flakes or large or colored particles. Do not use SPEVIGO if the expiration date (EXP) has passed. Do not use SPEVIGO if the prefilled syringe has been dropped.
Do not remove the cap until you are ready to inject. Inject SPEVIGO under the skin (subcutaneous injection) in either the upper thighs or stomach-area (abdomen). Do not inject SPEVIGO into any other area of the body.
Storing SPEVIGO: Store SPEVIGO prefilled syringes in the refrigerator between 36°F to 46°F (2°C to 8°C). Do not freeze SPEVIGO. Do not use SPEVIGO if frozen, even if it has been thawed.
Store SPEVIGO in the original carton until use to protect from light. Keep SPEVIGO and all medicines out of the reach of children. Step 1 Gather supplies Take the SPEVIGO carton out of the refrigerator and remove the prefilled syringes from the carton.
Gather supplies listed above and place them on a clean, flat work surface in a well-lit area. If you do not have all the supplies listed above, contact your pharmacist. See Step 10: "Throwing away (disposing of) the used SPEVIGO prefilled syringes and caps." Step 2 Preparing to inject SPEVIGO Wait 15 to 30 minutes to allow the medicine to reach room temperature to avoid discomfort during injection.
Do not speed up the warming process in any way, such as using the microwave or placing the syringe in warm water. Do not leave the prefilled syringes in direct sunlight. Do not remove the needle cap until you are ready to inject.
Wash your hands well with soap and water and dry them. Step 3 Inspecting the prefilled syringes Check both prefilled syringes now: Check to make sure the medicine name SPEVIGO and the dose on your prefilled syringes match your or your child's prescribed dose. Check the expiration date (EXP) on both prefilled syringes.
Do not use if the expiration date has passed. Check both prefilled syringes for damage, cracks, and leakage. Do not use if any part of the prefilled syringes appear cracked, broken, or are leaking.
Make sure the medicine in both prefilled syringes is clear and colorless to slightly brownish-yellow. It may contain tiny white or clear particles. Do not use if the medicine is cloudy or has flakes or large or colored particles in it.
It is norm… [Excerpted — this section continues on DailyMed.]
📄 Recent Major Changes ▾
Dosage and Administration ( 2.2 , 2.3 , 2.5 ) 05/2025 Contraindications ( 4 ) 10/2025 Warnings and Precautions ( 5.3 ) 10/2025
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL - 450 mg/7.5 mL Vial Carton NDC 0597-0035-10 Rx only DISPENSE WITH ENCLOSED MEDICATION GUIDE Spevigo ® (spesolimab-sbzo) Injection 450 mg/7.5 mL per vial (60 mg/mL) For Intravenous Infusion after Dilution Discard Unused Portion Prepare both vials in carton for a complete dose of 900 mg Contents: contains TWO - 450 mg/7.5 mL single-dose vials Boehringer Ingelheim PRINCIPAL DISPLAY PANEL - 450 mg/7.5 mL Vial Carton
PRINCIPAL DISPLAY PANEL - 150 mg Syringe Carton NDC 0597-0620-20 ATTENTION PHARMACIST: This Entire Carton is to be Dispensed as a Unit with Enclosed Medication Guide. Spevigo ® (spesolimab-sbzo) Injection 150 mg/mL per Syringe For Subcutaneous Use Only For a complete 300 mg dose, two 150 mg syringes are required. Inject one syringe after the other.
TWO 150 mg Single-Dose Prefilled Syringes Rx only Boehringer Ingelheim Principal Display Panel - 150 mg Syringe Carton
PRINCIPAL DISPLAY PANEL - 300 mg/2 mL Syringe Carton NDC 0597-7705-41 ATTENTION PHARMACIST: This Entire Carton is to be Dispensed as a Unit with Enclosed Medication Guide. Spevigo ® (spesolimab-sbzo) injection 300 mg/2 mL (150 mg/mL) For Subcutaneous Use Only 1 Single-Dose Prefilled Syringe Rx only Boehringer Ingelheim PRINCIPAL DISPLAY PANEL - 300 mg/2 mL Syringe Carton
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