Drug Safety-related Labeling Changes (SrLC)

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Drug Safety-related Labeling Changes (SrLC) Database

ANDA	Abbreviated New Drug Application
BLA	Biologics License Application
CDER	Center for Drug Evaluation and Research
MG	Medication Guide
NDA	New Drug Application
PCI	Patient Counseling Information
PI	Patient Information
PLR	Physician Labeling Rule
PLLR	Pregnancy and Lactation Labeling Rule
Italics	For the most part, italics indicate an FDA comment such as: Additions and/or revisions underlined These italics usually appear at the beginning of the section. In some cases, italics may be an inherent part of the label, and will most often appear in the body of the section.
Underlines	Any text that is underlined indicates text that has been added or revised. There are exceptions where underlining occurs in a section subtitle or heading. This is the case when there is just one word underlined in the body of the text.

Sections

BW	Box Warning
WP	Warnings and Precautions all in one section (PLR-format) Warnings as one section (pre-PLR format) Precautions as one section (pre-PLR format)
AR	Adverse Reactions (in pre-PLR format, this may be a subheading under precautions).
DI	Drug Interactions (in pre-PLR format, this may be a subheading under precautions).
USP	Use in Specific Populations (Inclusive on one or more of the following: Pregnancy; Lactation (PLLR- format); Nursing Mothers (pre-PLLR format); Females and Males of Reproductive Potential (PLLR format only); Pediatric Use, Geriatric Use, Renal Impairment, Hepatic Impairment, Sex, Race (these last six may be a subheading of precautions if label in pre-PLLR format.
PCI/PI/MG	Patient Counseling Information (PLR format only) - summarizes the information that a health care provider should convey to a patient (or caregiver when applicable) when a counseling discussion is taking place (e.g., a physician prescribing a drug during an office visit, a nurse providing discharge instructions at a hospital, or a pharmacist conveying information at a pharmacy). Patient Information - FDA approved patient labeling. Medication Guide - paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events.

Only NDAs and CDER regulated BLAs are included in this database. ANDAs are not included.

Applications that remain active, even if the product has been discontinued, undergo safety-related labeling changes.

SPEVIGO (BLA-761244)

(SPESOLIMAB-SBZO)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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10/21/2025 (SUPPL-7)

Approved Drug Label (PDF)

4 Contraindications

Additions and/or revisions underlined:

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)].

5 Warnings and Precautions

5.3 Hypersensitivity and Infusion-Related Reactions

Additions and/or revisions underlined:

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.

. . .

6 Adverse Reactions

6.2 Postmarketing Experience

Newly added subsection

The following adverse reactions have been identified during postapproval use of SPEVIGO. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Immune System Disorders: Immediate systemic hypersensitivity reactions, including anaphylaxis.

05/28/2025 (SUPPL-6)

Approved Drug Label (PDF)

6 Adverse Reactions

6.1 Clinical Trials Experience

Updates to Table 1 under “Nausea”, please refer to label to view Table 1.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

…

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

Additions and/or revisions underlined:

…

How will I receive SPEVIGO?

When given under the skin (subcutaneously) for treatment of GPP when not experiencing a flare:

Read the detailed “Instructions for Use” that comes with SPEVIGO for information on how to prepare and inject a dose of SPEVIGO and how to properly throw away (dispose of) used SPEVIGO prefilled syringes.
SPEVIGO prefilled syringes come in two different strengths (300 mg/2 mL or 150 mg/mL). Your healthcare provider will prescribe the prefilled syringe that is right for you.
…
How should I store 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.
If needed, SPEVIGO 300 mg/2 mL prefilled syringes may also be stored at room temperature up to 77°F (25°C) for up to 14 days. Throw away (dispose of) SPEVIGO 300 mg/2 mL prefilled syringes that have been left at room temperature for more than 14 days.
…

03/18/2024 (SUPPL-3)

Approved Drug Label (PDF)

4 Contraindications

Additions and/or revisions underlined:

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) [see Warnings and Precautions (5.3) and Adverse Reactions (6.1)].

5 Warnings and Precautions

5.1 Infections

Additions and/or revisions underlined:

…

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.

5.3 Hypersensitivity and Infusion-Related Reactions

Additions and/or revisions underlined:

…

If a patient develops signs of anaphylaxis or other serious hypersensitivity, discontinue SPEVIGO immediately and initiate appropriate treatment. SPEVIGO is contraindicated in patients with severe or life-threatening hypersensitivity to spesolimab-sbzo or to any of the excipients in SPEVIGO [see Contraindications (4)].

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

Additions and/or revisions underlined:

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.

6 Adverse Reactions

Addition of the following to the bulleted line listing:

Hypersensitivity and Infusion-Related Reactions [see Warnings and Precautions (5.3)]

6.1 Clinical Trials Experience

Extensive changes; please refer to label for complete information

8 Use in Specific Populations

8.4 Pediatric Use

Additions and/or revisions underlined:

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.

8.5 Geriatric Use

Additions and/or revisions underlined:

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.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

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)].

…

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].

Instruct patients or caregivers to subcutaneously administer two 150 mg/mL prefilled syringes to achieve a complete 300 mg dose of SPEVIGO [see Dosage and Administration (2.5) and Instructions for Use].

MEDICATION GUIDE

Extensive changes; please refer to label for complete information