Names and pronunciation
(spes-o′li-mab) Spevigo
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Drug reference
(spes-o′li-mab) Spevigo
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Func. class.: Systemic antipsoriasis agent
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Chem. class.: Monoclonal immuno- globulin antibody ACTIONS: Humanized monoclonal immunoglobulin G1 (IgG1) antibody that inhibits interleukin-36 (IL-36) signaling by specifically binding to the IL-36 recep- tor (IL36R) and prevents downstream activation of proinflammatory and profi- brotic pathways.
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USES: Generalized pustular psoriasis (GPP) flares
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CONTRAINDICATIONS Hypersensitivity, serious rash Precautions: Pregnancy, breastfeeding, TB, infection, vaccination
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SIDE EFFECTS GI: Diarrhea, nausea, vomiting, gastritis INTEG: Pruritus, infusion-related reactions MISC: Infection, Guillian-Barre syn- drome, DRESS
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INTERACTIONS Do not give concurrently with live virus vaccines; immunizations should be brought up to date prior to treatment NURSING CONSIDERATIONS
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DOSAGE AND ROUTES Generalized pustular psoriasis (GPP) flares Adults: IV INFUSION 900 mg over 90 min. A second 900-mg IV infusion may be given 1 wk after the initial dose if flare symptoms persist
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Available forms: Solution for injection (IV) 450 mg/7.5 mL (60 mg/mL)
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Administer: IV infusion route • Visually inspect for particulate matter and discoloration prior to use, the solu- tion should be colorless to slightly brownish-yellow, clear to slightly opales- cent. Do not use if the solution is cloudy, discolored, or contains large or colored particulates • Dilution: Use aseptic technique; re- move and discard 15 mL from a 100-mL container of sterile 0.9% sodium chlo- ride injection; slowly add 15 mL of spe- solimab solution (complete contents from two 450-mg/7.5-mL vials) into the 0.9% sodium chloride injection, gently mix; do not add or mix with other medi- cations or diluents • Administer diluted solution immedi- ately, give as a continuous infusion over 90 min through an IV line containing a sterile, non-pyrogenic, low-protein- binding in-line filter (pore size of 0.2 microns) • A preexisting IV line may be used for administration of the infusion if the line is flushed with sterile 0.9% sodium chlo- ride injection prior to and at the end of the infusion. No other infusion should be administered in parallel via the same IV access • If the infusion is slowed or temporar- ily stopped, the total infusion time (in- cluding stop time) must not exceed 180 min • Storage: If not used immediately, the diluted solution may be stored 2 hr re- frigerated at 36° to 46°F (2° to 8°C) for no more than 4 hr, protect from light
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Assess: • Plaque psoriasis: improvement in raised, red, inflamed lesions; dry skin with cracking and bleeding; itching, burning, or painful skin; silvery, scaly plaques; pitted nails or separation from the nail bed • Infections (fever, flulike symptoms, dyspnea, change in urination, redness/ swelling around any wounds), stop treat- ment if some serious infections occur, may be fatal; patients with active infec- tions should not be started on this prod- uct • Latent TB prior to therapy; obtain TB test, if positive, treat before starting this product • Pregnancy/breastfeeding: identify if pregnancy is planned or suspected, ef- fects in pregnancy or breastfeeding are unknown
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Evaluate: • Therapeutic response: improvement in symptoms of plaque psoriasis
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Patient and caregiver information: • Not to take any live virus vaccines dur- ing treatment • To report signs of infection, allergic re- action, TB, immediately • To advise all health care professionals of Rx, OTC, herbals, supplements taken • Pregnancy/breastfeeding: to advise health care professional if pregnancy is planned or suspected or if breastfeeding • To do regular skin assessments and report changes to provider APPENDIX A
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PHARMACOKINETICS Terminal half-life 25.5 days
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