Spesolimab-Sbzo: uses, dosing, side effects & brands
Spesolimab-Sbzo is a medicine sold in the U.S. under one brand, for psoriasis. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Treats
- Psoriasis
- Available as
- Injectable
- Sold as
- Spevigo
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
How spesolimab-sbzo is dosed
From the FDA label for Spevigo (application BLA761244). Other spesolimab-sbzo products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
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…
Spesolimab-Sbzo 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…
Who shouldn’t take spesolimab-sbzo
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 )
Every spesolimab-sbzo product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Spevigo.
Related calculators
Frequently asked questions
What is spesolimab-sbzo?
Spevigo (Spesolimab-Sbzo) is a medication used to treat Psoriasis.
Can you take spesolimab-sbzo with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run spesolimab-sbzo against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does spesolimab-sbzo come in?
Across the brands we track, spesolimab-sbzo is currently marketed as injectable, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic spesolimab-sbzo?
We do not currently list a generic-labelled spesolimab-sbzo product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Spesolimab-Sbzo: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/spesolimab-sbzo
- MLA
- “Spesolimab-Sbzo: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/spesolimab-sbzo.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for spesolimab-sbzo on DailyMed (NIH) ↗.