spevigo
Pharmaranks rates Spevigo 3.6/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Spevigo (Spesolimab-Sbzo) is a medication used to treat Psoriasis.
Spesolimab-Sbzo · by Boehringer Ingelheim
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Spesolimab-Sbzo
- Form
- Injectable
- Strength
- SPESOLIMAB-SBZO 900MG
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- psoriasis
- Manufacturer
- Boehringer Ingelheim
- FDA application
- BLA761244
What is Spevigo?
From the FDA label: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…
How to use
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 ) 2.1 Testing 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…
Side effects
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 . 6.1 Clinical 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…
Warnings
Important safety information
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 ) 5.1 Infections 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. 5.2 Risk 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. 5.3 Hypersensitivity 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. 5.4 Vaccinations 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.
Who should not take Spevigo
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 )
Storing Spevigo, and how long it keeps
Quoted from this product’s own FDA label. Storage belongs to the product and its device, not to the drug in general — a pen and a tablet of the same medicine are kept completely differently.
- “Discard SPEVIGO 300 mg/2 mL prefilled syringes if kept at room temperature for more than 14 days.”
- “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.”
- “Store SPEVIGO prefilled syringes refrigerated between 2°C to 8°C (36°F to 46°F) in original carton to protect from light.”
- “Store SPEVIGO vials refrigerated between 2°C to 8°C (36°F to 46°F) in original carton to protect from light.”
- “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.”
May treat (source: NIH RxClass)
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
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Frequently asked questions
- What does Spevigo treat?
- Spevigo (Spesolimab-Sbzo) may be used to treat psoriasis, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How is Spevigo rated?
- pharmaranks gives Spevigo a composite score of 3.6 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- Is there a coupon or discount for Spevigo?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Spevigo. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Spevigo?
- Spevigo is marketed by Boehringer Ingelheim. You can see Boehringer Ingelheim's full profile, rating, and other products on pharmaranks.
- Is Spevigo a brand-name or generic drug?
- Spevigo is a brand-name product with the active ingredient Spesolimab-Sbzo.
- Is Spevigo available over the counter?
- No. Spevigo is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Spevigo come in?
- Spevigo is currently marketed as injectable, per the FDA's National Drug Code Directory.
- Is Spevigo FDA-registered?
- Spevigo is on record with the U.S. FDA under application number BLA761244. You can verify this on its official FDA label.
- Has Spevigo been recalled by the FDA?
- Spevigo has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Spevigo safe?
- There's no single safe-or-not verdict. pharmaranks gives Spevigo a recall-safety score of 72/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Spevigo?
- Spevigo's side effects are taken directly from its FDA label. From the label: 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 a… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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spevigo
72/100