IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

SPEVIGO is contraindicated in patients with severe or life-threatening hypersensitivity to spesolimabsbzo or to any of the excipients in SPEVIGO. Reactions have included drug reaction with eosinophilia and systemic symptoms (DRESS).

Please see additional Important Safety Information below and full Prescribing Information, including Medication Guide.

Coding for SPEVIGO*

These codes are not all-inclusive; appropriate codes can vary by patient, site of care, and payor. Correct coding is the responsibility of the provider submitting the claim for item or service.

Please check with the payor to verify codes and billing requirement. BI does not make any representation or guarantee concerning reimbursement or coverage for any service or item.

How Supplied

SPEVIGO is available to providers directly via a distribution agreement
with McKesson^®, ASD^®, CuraScript^®†, and Cardinal^®*† or through our
dedicated Specialty Pharmacy Provider, Accredo^®.

Questions:

^*The information provided by Boehringer Ingelheim regarding potential billing codes for SPEVIGO is for informational purposes only. It is not intended to constitute advice or be regarded as a substitute for advice. Providers should not rely upon the information as a basis for making any decisions and Boehringer Ingelheim makes no representations or warranties about the completeness, accuracy, reliability, or suitability of the information.

^†Emergency Delivery service for expedited product shipping may be available.

IMPORTANT SAFETY INFORMATION (continued)   

WARNINGS AND PRECAUTIONS  

Infections: SPEVIGO may increase the risk of infections. 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 for use 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 after treatment with SPEVIGO.  

Risk of Tuberculosis: Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with SPEVIGO. Do not administer SPEVIGO to 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. 

Hypersensitivity and Infusion-Related Reactions:

• SPEVIGO-associated hypersensitivity reactions may include immediate reactions such as anaphylaxis and delayed reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS).

• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported in clinical trials with spesolimab-sbzo in subjects with GPP.

• 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 infusion-related reactions, stop SPEVIGO infusion and consider appropriate medical therapy (eg, 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.

Vaccinations: Avoid use of live vaccines in patients treated with SPEVIGO. No specific studies have been conducted in SPEVIGO-treated patients who have recently received live viral or live bacterial vaccines. 

ADVERSE REACTIONS

Most common adverse reactions reported in greater than or equal to 5% of patients treated with SPEVIGO in the clinical trial were asthenia and fatigue, nausea and vomiting, headache, pruritus and prurigo, infusion site hematoma and bruising, and urinary tract infection (UTI). 

Specific Adverse Reactions

• Infections: The most frequent adverse reactions that occurred in subjects treated with SPEVIGO were infections. During the 1-week placebo-controlled period of the Effisayil-1 clinical trial, infections were reported in 14% of subjects treated with SPEVIGO compared with 6% of subjects treated with placebo. Serious infection (UTI) was reported in 1 subject (3%) in the SPEVIGO group and no subjects in the placebo group. Infections observed through Week 1 in 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 were reported in Study Effisayil-1 in subjects with GPP who were treated with spesolimab-sbzo. RegiSCAR DRESS validation scoring (with the following categories: “no”, “possible”, “probable”, or “definite” DRESS) was applied to the reported cases. Reported cases were assessed as “no DRESS” and “possible DRESS”.

Clinical Development

• Guillain-Barre syndrome (GBS): Among approximately 750 subjects exposed to spesolimab-sbzo during clinical development, GBS was reported in 3 subjects who received various doses of spesolimab-sbzo via various methods of administration in clinical trials for unapproved indications.

• Injection Site Reactions: During clinical development, injection site reactions (including injection site erythema, injection site swelling, injection site pain, injection site induration, and injection site warmth) occurred with spesolimab-sbzo.

INDICATION