Dosing and administration of SPEVIGO IV and SPEVIGO SC

SPEVIGO treats all phases of GPP with ongoing and acute dosing options¹

Prior to initial treatment with SPEVIGO IV (intravenous) or SPEVIGO SC (subcutaneous), evaluate patient for tuberculosis infection (TB)^a and complete all age-appropriate vaccinations.^b

SPEVIGO SCfor ongoing treatment
when not experiencing
a GPP flare

For 12+ years of age
and weighing at least 40 kg

LOADING DOSE^C

600 mg

2 x 300 mg or 4 x 150 mg Prefilled syringes

Every
4 weeks^d

300 mg

1 x 300 mg or 2 x 150 mg Prefilled syringes

^cWhen initiating or reinitiating SPEVIGO SC 4 weeks after receiving SPEVIGO IV, no loading dose is required.

SPEVIGO IVfor GPP flare treatment

For 12+ years of age
and weighing at least 40 kg

900 mg

2 x 450 mg/7.5 mL vials Administered over 90 minutes

If flare symptoms persist,
an additional IV dose may
be administered 1 week
after the initial dose

SPEVIGO SCfor ongoing treatment

Four weeks after treatment with SPEVIGO IV, initiate or reinitiate SPEVIGO SC at a dose of 300 mg administered every 4 weeks.
A subcutaneous loading dose is not required following treatment of a GPP flare with SPEVIGO IV.

For 12+ years of age and weighing at least 40 kg

SPEVIGO SCfor ongoing treatment
when not experiencing
a GPP flare

LOADING DOSE^C600 mg

2 x 300 mg
or 4 x 150 mg Prefilled syringes

Every 4 weeks^d

300 mg

1 x 300 mg
or 2 x 150 mg Prefilled syringes

^cWhen initiating or reinitiating SPEVIGO SC 4 weeks after receiving SPEVIGO IV, no loading dose is required.

For 12+ years of age and weighing at least 40 kg

SPEVIGO IVfor GPP flare treatment

900 mg

2 x 450 mg/7.5 mL vials Administered over
90 minutes

If flare symptoms persist, an additional IV dose may be administered 1 week after the initial dose

SPEVIGO SCfor ongoing treatment

Four weeks after treatment with SPEVIGO IV, initiate or reinitiate SPEVIGO SC at a dose of 300 mg administered every 4 weeks. A subcutaneous loading dose is not required following treatment of a GPP flare with SPEVIGO IV.

Monitor patients for hypersensitivity reactions, such as DRESS or active TB infection.

SPEVIGO SC 300 mg prefilled syringe: patients may self-administer if the healthcare professional determines that it is appropriate.^d

SPEVIGO SC 150 mg prefilled syringe: loading dose to be administered by a healthcare professional. For subsequent 300 mg doses, patients may self-administer if the healthcare professional determines that it is appropriate.^d

DRESS, drug reaction with eosinophilia and systemic symptoms; GPP, generalized pustular psoriasis.

^aSPEVIGO 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.

^bAvoid the use of live vaccines in patients during and for at least 16 weeks after treatment with SPEVIGO.

^dIf the healthcare professional determines that it is appropriate, a patient 12 years of age or older may self-inject or the caregiver may administer SPEVIGO SC after proper training in subcutaneous injection technique.

FAQ

When should I use SPEVIGO SC and SPEVIGO IV?

Learn more by watching this video

Watch expert Dr Raj Chovatiya, Associate Professor of Medicine at Northwestern University, discuss the differences between SPEVIGO formulations, and provide guidance on when to use them.

Please see Important Safety Information below.

Dr. Raj Chovatiya has been compensated for his time.

Transcript

The two formulations of SPEVIGO address two distinct phases of GPP in adults and pediatric patients 12 years of age and older, weighing at least 40 kg. SPEVIGO IV treats GPP flares. SPEVIGO subcutaneous is used to treat GPP when patients are not experiencing a flare. Based on the clinical trials for SPEVIGO, a patient experiencing a GPP flare should receive SPEVIGO as an intravenous infusion to help treat symptoms which may include pustulation, erythema and scaling.

Subcutaneous SPEVIGO should be given every four weeks to help reduce the risk of a GPP flare. This continuous treatment every four weeks with subcutaneous SPEVIGO will also help manage your patient's chronic GPP, after an initial subcutaneous loading dose or IV. If a patient has received SPEVIGO IV and is continuing treatment with subcutaneous SPEVIGO, a loading dose is not required.

FAQ

How long should patients stay on SPEVIGO SC?

Learn more by watching this video

Watch expert Dr Raj Chovatiya, Associate Professor of Medicine at Northwestern University, clarify how treatment length with SPEVIGO SC could translate into continuous benefits for patients with GPP.

Please see Important Safety Information below.

Dr. Raj Chovatiya has been compensated for his time.

Transcript

Healthcare providers should decide the length of time to remain on subcutaneous SPEVIGO based on each specific patient case. It's important to remember GPP is a chronic inflammatory disease with a high patient burden and an unpredictable course that can include recurring flares.

For my GPP patients, my goals are to treat any acute flares, reduce the risk of future flares, and manage the chronic symptoms of the disease. SPEVIGO is the only FDA-approved treatment that addresses the acute and chronic symptoms of GPP. Evidence from the Effisayil 2 clinical study demonstrates that continuous subcutaneous treatment with SPEVIGO may help to reduce the risk of a future GPP flare.

Of note, three patients experienced a GPP flare within the first four weeks after one dose of subcutaneous SPEVIGO treatment. No patients experienced a flare in the SPEVIGO arm of the trial after week four through the end of the trial at week 48.

Enroll patients in the SPEVIGO Patient Support Program

Start with support

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 (88 lb).

Please see SPEVIGO Prescribing Information, including Medication Guide.

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) and anaphylaxis.

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:

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.
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 (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, headache, nausea, 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.

Please see SPEVIGO Prescribing Information, including Medication Guide.

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Reference

SPEVIGO. Prescribing Information. LEO Pharma Inc.