Dosing and administration

SPEVIGO SC (subcutaneous) dosing and administration

SPEVIGO SC prefilled syringes are for subcutaneous use for treatment of GPP when not experiencing a flare¹

The recommended dose of SPEVIGO SC for treatment of GPP in adults and adolescents ≥12 years of age and weighing at least 40 kg is a subcutaneous loading dose of 600 mg (four 150 mg injections), followed by 300 mg (two 150 mg injections) administered subcutaneously 4 weeks later and every 4 weeks thereafter.¹

GPP treatment when not experiencing a flare: SPEVIGO SC¹

A subcutaneous loading dose is not required following treatment of a GPP flare with SPEVIGO IV (intravenous).¹

Dose diagram showing recommended dose of Spevigo® IV and SC for GPP treatment

SPEVIGO initiation is not recommended 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.¹

For subsequent 300 mg doses, if the healthcare professional determines that it is appropriate, a patient 12 years of age and older and weighing at least 40 kg may self-inject or caregivers may administer SPEVIGO after proper training in subcutaneous injection technique. In pediatric patients 12 to 17 years of age, administer SPEVIGO under the supervision of an adult. The two 150 mg/mL prefilled syringes should be injected, one right after the other. A different injection site should be chosen for each of the 2 injections, at least 1 inch away from each other.¹ Alternate between the upper thigh and abdomen injection sites for each complete dose.¹

Avoid use of live vaccines in patients during and for at least 16 weeks after treatment with SPEVIGO. Complete all age-appropriate vaccinations according to current immunization guidelines prior to initiating SPEVIGO.¹

GPP=generalized pustular psoriasis; GPPPGA=Generalized Pustular Psoriasis Physician Global Assessment; IV=intravenous; SC=subcutaneous; TB=tuberculosis.

Initiating/reinitiating SPEVIGO SC after treatment with SPEVIGO IV

SPEVIGO IV vials are intended for intravenous use for treatment of GPP when experiencing a flare¹

SPEVIGO IV is supplied as a sterile concentrate solution in a single-dose vial. Each vial contains 450 mg of spesolimab-sbzo in 7.5 mL (60 mg/mL) concentrate solution for infusion. SPEVIGO IV is administered by intravenous infusion as a single (two 450 mg/7.5 mL vials) 900 mg dose over 90 minutes.¹

GPP treatment when initiating SPEVIGO SC after SPEVIGO IV

Four weeks after treatment with SPEVIGO IV, SPEVIGO SC can be initiated or reinitiated at a dose of 300 mg (two 150 mg injections) administered every 4 weeks for the treatment of GPP. A subcutaneous loading dose is not required following treatment of a GPP flare with SPEVIGO IV.¹

Dose diagram showing recommended dose of Spevigo® SC and SC for GPP treatment

For subsequent 300 mg doses, if the healthcare professional determines that it is appropriate, a patient 12 years of age and older and weighing at least 40 kg may self inject or caregivers may administer SPEVIGO after proper training in subcutaneous injection technique. In pediatric patients 12 to 17 years of age, administer SPEVIGO under the supervision of an adult. The two 150 mg/mL prefilled syringes should be injected, one right after the other. A different injection site should be chosen for each of the 2 injections, at least 1 inch away from each other.¹ Alternate between the upper thigh and abdomen injection sites for each complete dose.¹

*
Pustular clearance was defined as GPPPGA pustular subscore of 0 (no visible pustules).¹
†
Flare control defined as GPPPGA total score ≤1 and was reported for the 12-week study period.²
‡
In Effisayil® 1, flare persistence was defined as GPPPGA total score ≥2 and GPPPGA pustulation subscore ≥2.²

SPEVIGO IV dosing and administration when experiencing a flare

GPP treatment when experiencing a flare: SPEVIGO IV

The recommended dose of SPEVIGO IV for GPP flare treatment in adults and pediatric patients ≥12
years of age is a single continuous IV infusion of 900 mg administered over 90 minutes. If flare
symptoms persist, an additional IV infusion dose may be administered 1 week after the initial dose.¹

*
Pustular clearance was defined as GPPPGA pustulation subscore of 0 (no visible pustules).¹
†
In EFFISAYIL 1, flare persistence was defined as GPPPGA total score ≥2 and GPPPGA pustulation subscore ≥2.²

DRESS=drug reaction with eosinophilia and systemic symptoms.

References

SPEVIGO® [package insert]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc; March 2024.
Bachelez H, Choon SE, Marrakchi S, et al; for the Effisayil 1 Trial Investigators. Trial of spesolimab for generalized pustular psoriasis. N Engl J Med. 2021;385(26):2431-2440. doi:10.1056/NEJMoa2111563
Choon SE, Lebwohl MG, Marrakchi S, et al. Study protocol of the global Effisayil 1 phase II, multicentre, randomised, double-blind, placebo-controlled trial of spesolimab in patients with generalized pustular psoriasis presenting with an acute flare. BMJ Open. 2021;11(3):e043666. doi:10.1136/bmjopen-2020-043666

INDICATION

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.

IMPORTANT SAFETY INFORMATION

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).

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 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.

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.

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 hypersensitivity during an intravenous infusion or other 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: 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

Intravenous SPEVIGO for Treatment of GPP Flare (Study Effisayil-1): Most common adverse reactions reported in ≥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 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 (UTI) was reported in 1 subject (3%) in the SPEVIGO group and no subjects in the placebo group. 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 were reported in Study Effisayil-1 in subjects with GPP who were treated with intravenous SPEVIGO. 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.”

Subcutaneous SPEVIGO for Treatment of GPP When Not Experiencing a Flare (Study Effisayil-2): Regarding the exposure-adjusted incidence rates for subjects on randomized treatment prior to receiving rescue treatment for flare or completing trial without a flare, the rate per 100-patient years for injection site reaction (including erythema, pain, swelling, induration, urticaria, and warmth at the injection site) was 31.6 for the subcutaneous SPEVIGO cohort (600 mg loading dose followed by 300 mg every 4 weeks) vs 12.7 for the placebo cohort. The rate per 100-patient years for UTI was 18 for SPEVIGO vs 0 for placebo. The rate per 100-patient years for pruritus was 8.8 for SPEVIGO vs 0 for placebo. The rate per 100-patient years for arthralgia was 13.3 for SPEVIGO vs 6 for the placebo cohort. There were 3 subjects who discontinued subcutaneous SPEVIGO due to treatment-emergent adverse events of psoriasis compared to no subjects in the placebo cohort who discontinued placebo for any treatment-emergent adverse event.

Safety in Study Effisayil-2 After Flare: In Effisayil-2, subjects who experienced a GPP flare and received at least one dose of an open-label single intravenous 900 mg dose of SPEVIGO were treated with open-label subcutaneous SPEVIGO 300 mg. These subjects (n=19) received subcutaneous dosing at every 12 weeks, which could have been increased to every 4 weeks based on GPPPGA total score or pustulation subscore increased by ≥1 from any previous open-label maintenance visit. The reported safety profile of open-label subcutaneous SPEVIGO use after treatment of GPP flare with open-label intravenous SPEVIGO use was consistent with the safety profiles of use of SPEVIGO from Trial Effisayil-1 and randomized controlled data from Trial Effisayil-2.

Clinical Development of Spesolimab-sbzo

Guillain-Barre Syndrome (GBS): Among approximately 835 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.

SPECIFIC POPULATIONS

Pediatric 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. 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.

CL-SPG-100005 03.19.2024

Please see SPEVIGO Prescribing Information, including Medication Guide.