Version November 2024
Dosage guidance:
Safety: Screen for tuberculosis (TB) infection (latent TB) prior to initiating treatment. Avoid use in patients with TB disease (active TB). Consider pretreatment with antituberculosis therapy in patients with TB infection. Discontinue use or avoid use in patients with clinically important active infections. Patients should be current with all age-appropriate immunizations prior to therapy.
Pustular psoriasis, generalized: Note: Dose and route of administration varies by place in therapy (acute flare [IV only] or maintenance [SUBQ]); use caution.
Maintenance, therapy initiation with no active flare: Children ≥12 years and Adolescents, weighing ≥40 kg: Initial: SUBQ: 600 mg (four 150 mg injections) once as a loading dose; begin maintenance dose 4 weeks later of 300 mg (two 150 mg injections) every 4 weeks.
Note: When initiating or reinitiating SUBQ maintenance therapy after IV treatment for an acute flare, no loading dose is needed and the first SUBQ dose (300 mg) should be administered 4 weeks after the last IV dose.
Acute flare: Children ≥12 years and Adolescents, weighing ≥40 kg: IV: 900 mg once; may repeat 900 mg dose in 1 week if symptoms persist.
Dosage adjustment for toxicity: Children ≥12 years and Adolescents, weighing ≥40 kg:
Hypersensitivity, anaphylaxis or other severe reaction: Discontinue spesolimab therapy immediately and initiate appropriate treatment.
Hypersensitivity, mild or moderate with IV infusion or other infusion-related reactions: Hold spesolimab therapy and administer appropriate therapy (eg, systemic antihistamines and/or corticosteroids); once reaction resolves, may restart infusion at a slower rate with gradually increasing rate to complete the infusion.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); however, the need for dosage adjustment is unlikely (not expected to undergo kidney elimination).
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); however, the need for dosage adjustment is unlikely (not expected to undergo hepatic elimination).
(For additional information see "Spesolimab: Drug information")
Dosage guidance:
Safety: Screen for tuberculosis (TB) infection (latent TB) prior to initiating treatment. Avoid use in patients with TB disease (active TB). Consider pretreatment with antituberculosis therapy in patients with TB infection. Discontinue use or avoid use in patients with clinically important active infections.
Dosage form information: Prefilled syringes for SUBQ administration are for treatment in patients who are not experiencing a psoriasis flare. The vials for IV administration are for treatment in patients who are experiencing a psoriasis flare. Patients who experience a flare during SUBQ administration may treat the flare with IV administration.
Pustular psoriasis, generalized:
Active flare: IV: 900 mg once; if flare persists, an additional 900 mg may be given one week later (Ref).
Maintenance therapy (following IV treatment of active flare): SUBQ: 300 mg (two 150 mg injections) starting 4 weeks after last IV dose, then every 4 weeks thereafter.
Maintenance therapy (initiation of therapy in patients without an active flare): SUBQ: 600 mg (four 150 mg injections) as a loading dose at week 0, followed by 300 mg (two 150 mg injections) at week 4, then every 4 weeks thereafter.
There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied); however, the need for dosage adjustment is unlikely (not expected to undergo kidney elimination).
There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied); however, the need for dosage adjustment is unlikely (not expected to undergo hepatic elimination).
Spesolimab may increase the risk of infection. Infections reported in clinical trials include bacteremia, bacteriuria, cellulitis, herpes simplex dermatitis, oral herpes simplex infection, pustules, serious infection, upper respiratory tract infection, and urinary tract infection (Ref).
Onset: Rapid; onset occurred within 1 week of spesolimab administration.
Risk factors:
• History of recurrent or chronic infections
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported adverse reactions are for IV administration in adults, unless otherwise noted as SUBQ in adolescents and adults.
>10%: Infection: Infection (14%; serious infection: 3%) (table 1)
|
Drug (Spesolimab) |
Placebo |
Number of Patients (Spesolimab) |
Number of Patients (Placebo) |
Comments |
|---|---|---|---|---|
|
14% |
6% |
35 |
18 |
N/A |
|
3% |
0% |
35 |
18 |
Serious Infection |
1% to 10%:
Dermatologic: Cellulitis (3%) (table 2), herpes simplex dermatitis (≤3%) (table 3), prurigo, pruritus, pustules (Bachelez 2021), urticaria
|
Drug (Spesolimab) |
Placebo |
Number of Patients (Spesolimab) |
Number of Patients (Placebo) |
|---|---|---|---|
|
3% |
0% |
35 |
18 |
|
Drug (Spesolimab) |
Placebo |
Number of Patients (Spesolimab) |
Number of Patients (Placebo) |
Comments |
|---|---|---|---|---|
|
3% |
0% |
35 |
18 |
Combined term with oral herpes simplex infection |
Gastrointestinal: Nausea and vomiting, oral herpes simplex infection (≤3%) (table 4)
|
Drug (Spesolimab) |
Placebo |
Number of Patients (Spesolimab) |
Number of Patients (Placebo) |
Comments |
|---|---|---|---|---|
|
3% |
0% |
35 |
18 |
Combined term with herpes simplex dermatitis |
Genitourinary: Bacteriuria (3%) (table 5), urinary tract infection (6%) (table 6)
|
Drug (Spesolimab) |
Placebo |
Number of Patients (Spesolimab) |
Number of Patients (Placebo) |
|---|---|---|---|
|
3% |
0% |
35 |
18 |
|
Drug (Spesolimab) |
Placebo |
Number of Patients (Spesolimab) |
Number of Patients (Placebo) |
|---|---|---|---|
|
6% |
0% |
35 |
18 |
Immunologic: Antibody development (Bachelez 2021)
Infection: Bacteremia (3%) (table 7)
|
Drug (Spesolimab) |
Placebo |
Number of Patients (Spesolimab) |
Number of Patients (Placebo) |
|---|---|---|---|
|
3% |
0% |
35 |
18 |
Local: Infusion-site reaction (including bruising at injection site, hematoma at injection site)
Nervous system: Asthenia, fatigue, headache
Ophthalmic: Periorbital edema
Respiratory: Dyspnea, upper respiratory tract infection (3%) (table 8)
|
Drug (Spesolimab) |
Placebo |
Number of Patients (Spesolimab) |
Number of Patients (Placebo) |
|---|---|---|---|
|
3% |
0% |
35 |
18 |
Frequency not defined:
Hypersensitivity: Drug reaction with eosinophilia and systemic symptoms
Local: Injection-site reaction (SUBQ: including erythema at injection site, induration at injection site, pain at injection site, swelling at injection site, warm sensation at injection site, urticaria at injection site)
Neuromuscular & skeletal: Arthralgia (SUBQ)
Severe or life-threatening hypersensitivity (eg, drug reaction with eosinophilia and systemic symptoms) to spesolimab or any component of the formulation.
Concerns related to adverse effects:
• Guillain-Barre syndrome: Guillain-Barre syndrome has been reported in patients using spesolimab for unapproved indications.
• Hypersensitivity reactions: Hypersensitivity reactions have been reported, and may include immediate (eg, anaphylaxis) or delayed (eg, drug reaction with eosinophilia and systemic symptoms) reactions. Discontinue treatment if anaphylaxis or other serious allergic reaction occurs; ensure availability of medications for the treatment of hypersensitivity reactions during administration.
Disease-related concerns:
• Tuberculosis: Avoid use in patients with active tuberculosis.
Concurrent drug therapy issues:
• Immunizations: Complete all age-appropriate vaccinations according to immunization guidelines prior to initiating therapy. Avoid use of live vaccines in patients treated with spesolimab during therapy and for at least 16 weeks after treatment. Patients who recently received a live vaccine were excluded from the clinical trial (Bachelez 2021).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous [preservative free]:
Spevigo: Spesolimab-sbzo 450 mg/7.5 mL (60 mg/mL) (7.5 mL)
Solution Prefilled Syringe, Subcutaneous [preservative free]:
Spevigo: Spesolimab-sbzo 150 mg/mL (1 mL)
No
Solution (Spevigo Intravenous)
450 mg/7.5 mL (per mL): $4,172.45
Solution Prefilled Syringe (Spevigo Subcutaneous)
150 mg/mL (per mL): $10,431.14
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Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous:
Spevigo: Spesolimab-sbzo 450 mg/7.5 mL (60 mg/mL) (7.5 mL)
Parenteral:
IV: For treatment of acute flares due to generalized pustular psoriasis; to be administered in a health care setting equipped for management of hypersensitivity reactions. Should only be administered IV as a diluted solution for infusion protected from light; other dosage forms (ie, prefilled syringes) are not appropriate for IV administration.
Flush IV line with NS before infusion; infuse over 90 minutes through in-line filter (0.2 micron); after completion of infusion, flush line with NS. Do not administer other medications through the same line during the spesolimab infusion.
Infusion-related reaction:
Mild to moderate reactions: Stop infusion and administer appropriate therapy (eg, systemic antihistamines and/or corticosteroids). After resolution of symptoms, may resume infusion at a slower rate; may gradually increase back to original rate to complete infusion; total infusion time including stopped time for treatment should not exceed 180 minutes.
Severe reaction (including anaphylaxis): Immediately stop infusion and administer appropriate therapy; do not rechallenge.
SUBQ: Prefilled syringe: Loading doses should be administered by a health care provider in a health care setting. Subsequent doses may be self-administered after adequate training; self-administration by patients 12 to 17 years of age requires adult supervision. Allow syringe to reach room temperature (~15 to 30 minutes) prior to administration. Administer in the abdomen or upper thighs, alternating between the 2 sites; allow at least 1 inch between sites. When using multiple syringes, administer each injection one right after the other. Do not administer into bruised, erythematous, indurated, scarred, or tender skin.
IV: Vials are for IV use only, to be administered by a health care provider in a health care setting. Must be diluted prior to administration. Flush IV line with NS before and after infusion. Administer by IV infusion over 90 minutes using a sterile, nonpyrogenic, low protein binding in-line filter (0.2 micron). Do not administer other medications through the same line during the spesolimab infusion. If an infusion related reaction occurs, stop the infusion immediately. For mild to moderate reactions, once symptoms resolve may resume infusion at a slower rate and gradually increase to complete the infusion; the total infusion time (including stop time) should not exceed 180 minutes.
SUBQ: Prefilled syringes are for SUBQ use only; loading dose is to be administered by a health care provider and the maintenance may be self-injected or administered by a caregiver after proper training. Allow syringe to reach room temperature (~15 to 30 minutes) prior to administration. Administer in the abdomen or upper thighs alternating between the 2 sites; allow at least 1 inch between sites. When using multiple syringes, administer each injection one right after the other. Do not administer into bruised, erythematous, indurated, scarred, or tender skin.
Prefilled syringes: Store at 2°C to 8°C (36°F to 46°F) in the outer carton to protect from light. Do not freeze; discard if frozen even if thawed.
Vials: Store at 2°C to 8°C (36°F to 46°F) in the outer carton to protect from light. Do not freeze. If needed, unopened vials that are protected from light may be stored at room temperature of 20°C to 25°C (68°F to 77°F) for up to 24 hours. If diluted solution is not used immediately, it may be stored at 2°C to 8°C (36°F to 46°F) for up to 4 hours (protected from light).
An FDA-approved patient medication guide, which is available with the product information and at https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761244s003lbl.pdf#page=16, must be dispensed with this medication.
Treatment of generalized pustular psoriasis (FDA approved in ages ≥12 years weighing ≥40 kg and adults).
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program
Abrocitinib: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination
Antithymocyte Globulin (Equine): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of immunosuppressive therapy is reduced. Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor therapy
Baricitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Baricitinib. Risk X: Avoid combination
BCG Products: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of BCG Products. Risk X: Avoid combination
Brincidofovir: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Brincidofovir. Risk C: Monitor therapy
Brivudine: May enhance the adverse/toxic effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination
Chikungunya Vaccine (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Chikungunya Vaccine (Live). Risk X: Avoid combination
Cladribine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Cladribine. Risk X: Avoid combination
Coccidioides immitis Skin Test: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the diagnostic effect of Coccidioides immitis Skin Test. Management: Consider discontinuing therapeutic immunosuppressants several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider therapy modification
COVID-19 Vaccine (Adenovirus Vector): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Adenovirus Vector). Management: Administer a 2nd dose using an mRNA COVID-19 vaccine (at least 4 weeks after the primary vaccine dose) and a bivalent booster dose (at least 2 months after the additional mRNA dose or any other boosters). Risk D: Consider therapy modification
COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor therapy
COVID-19 Vaccine (mRNA): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups. See CDC guidance for details. Risk D: Consider therapy modification
COVID-19 Vaccine (Subunit): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Subunit). Risk C: Monitor therapy
COVID-19 Vaccine (Virus-like Particles): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Virus-like Particles). Risk C: Monitor therapy
Dengue Tetravalent Vaccine (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Dengue Tetravalent Vaccine (Live). Risk X: Avoid combination
Denosumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Denosumab. Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and immunosuppressants. If combined, monitor for signs/symptoms of serious infections. Risk D: Consider therapy modification
Deucravacitinib: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination
Efgartigimod Alfa: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
Etrasimod: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination
Filgotinib: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination
Inebilizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Inebilizumab. Risk C: Monitor therapy
Influenza Virus Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating immunosuppressants if possible. If vaccination occurs less than 2 weeks prior to or during therapy, revaccinate 2 to 3 months after therapy discontinued if immune competence restored. Risk D: Consider therapy modification
Leflunomide: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents. Risk D: Consider therapy modification
Mumps- Rubella- or Varicella-Containing Live Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Mumps- Rubella- or Varicella-Containing Live Vaccines. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Mumps- Rubella- or Varicella-Containing Live Vaccines. Risk X: Avoid combination
Nadofaragene Firadenovec: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid combination
Natalizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Natalizumab. Risk X: Avoid combination
Ocrelizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ocrelizumab. Risk C: Monitor therapy
Ofatumumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ofatumumab. Risk C: Monitor therapy
Pidotimod: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Pidotimod. Risk C: Monitor therapy
Pimecrolimus: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Pimecrolimus. Risk X: Avoid combination
Pneumococcal Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Pneumococcal Vaccines. Risk C: Monitor therapy
Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Risk X: Avoid combination
Polymethylmethacrylate: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the potential for allergic or hypersensitivity reactions to Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider therapy modification
Rabies Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider therapy modification
Ritlecitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ritlecitinib. Risk X: Avoid combination
Rozanolixizumab: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
Ruxolitinib (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ruxolitinib (Topical). Risk X: Avoid combination
Sipuleucel-T: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants prior to initiating sipuleucel-T therapy. Risk D: Consider therapy modification
Sphingosine 1-Phosphate (S1P) Receptor Modulator: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk C: Monitor therapy
Tacrolimus (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Tacrolimus (Topical). Risk X: Avoid combination
Talimogene Laherparepvec: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid combination
Tertomotide: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Tertomotide. Risk X: Avoid combination
Tofacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Tofacitinib. Management: Coadministration of tofacitinib with potent immunosuppressants is not recommended. Use with non-biologic disease-modifying antirheumatic drugs (DMARDs) was permitted in psoriatic arthritis clinical trials. Risk X: Avoid combination
Typhoid Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Typhoid Vaccine. Risk X: Avoid combination
Ublituximab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ublituximab. Risk C: Monitor therapy
Upadacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Upadacitinib. Risk X: Avoid combination
Vaccines (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination
Vaccines (Non-Live/Inactivated/Non-Replicating): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Give non-live/inactivated/non-replicating vaccines at least 2 weeks prior to starting immunosuppressants when possible. Patients vaccinated less than 14 days before or during therapy should be revaccinated at least 2 to 3 months after therapy is complete. Risk D: Consider therapy modification
Yellow Fever Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Yellow Fever Vaccine. Risk X: Avoid combination
Spesolimab is a humanized monoclonal antibody (IgG1). Human IgG crosses the placenta. Fetal exposure is dependent upon the IgG subclass, maternal serum concentrations, placental integrity, newborn birth weight, and gestational age, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis and the highest during the third trimester (Clements 2020; Palmeira 2012; Pentsuk 2009).
Hypersensitivity reactions (immediate [including anaphylaxis] and delayed [including drug reaction with eosinophilic and systemic symptoms]); signs/symptoms of infection including tuberculosis.
Spesolimab, a humanized monoclonal antibody, binds to interleukin-36 (IL36) receptor and prevents binding of endogenous IL36 which prevents activation of proinflammatory and profibrotic pathways by endogenous IL36. The precise role of reduced IL36 receptor activity in generalized pustular psoriasis is unknown.
Bioavailability: SUBQ: Absolute: ~85% to 90% (abdominal administration).
Distribution: 6.4 L at steady state.
Half-life elimination: 25.5 days (median).
Time to peak: SUBQ: 5.5 to 7 days.
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