Names and pronunciation
(broe-dal′-ue-mab) Siliq
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Drug reference
(broe-dal′-ue-mab) Siliq
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Func. class.: Immunosuppressive
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Chem. class.: Recombinant human IgG2 monoclonal antibody
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Do not confuse: Siliq/Actiq
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ACTION: Human IgG2 monoclonal antibody that binds to interleukin-17 receptor A (IL-17RA) and prevents IL-17 cytokines from activating the receptor
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USES: For the treatment of moder- ate to severe plaque psoriasis in adult patients who are candidates for pho- totherapy or systemic therapy and who have failed to respond or have lost response to other systemic thera- pies
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CONTRAINDICATIONS: Hyper- sensitivity, Crohn’s disease Precautions: Pregnancy, breastfeeding, children, depression, geriatric patients, immunosuppression, infection, suicidal ideation, vaccination
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Black Box Warning: Suicidal ideation Black Box Warning: The drug is avail- able only through a restricted program (Siliq Risk Evaluation and Mitigation Strategy [REMS] Program). Prescribers must be certified in the program. Patients must sign a patient-prescriber agree- ment form. For information, visit the Siliq REMS website or call 855-511-6135 Black Box Warning: Suicidal ideation: assess risks and benefits of treatment when considering use in those with a history of depression or psychosis Black Box Warning: Suicidal ideation: to seek medical attention for suicidal ideation, new-onset or worsening de- pression, anxiety, or other mood changes
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SIDE EFFECTS CNS: Headache, fatigue, suicidal ideation EENT: Sinusitis GI: Nausea, diarrhea MS: Arthralgia INTEG: Erythema, pruritus HEMA: Bleeding, neutropenia MISC: Infection, injection site reactions, antibody formation, pharyngitis, TB
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INTERACTIONS • Increase: altered effect of each product—CYP450 enzymes (carBAMaze- pine, cyclosporine, ethosuximide, fosphe- nytoin, phenytoin, tacrolimus, theophyl- line, aminophylline, warfarin); monitor if products are initiated or discontinued; dose adjustments may be needed • Do not give concurrently with live virus vaccines; bring immunizations up-to-date before treatment Drug/Lab Decrease: ANC
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DOSAGE AND ROUTES • Adult: SUBCUT 210 mg at wk 0, 1, and 2, then 210 mg q2wk; discon- tinue if inadequate response after 12-16 wk • Available forms: Prefilled syringe 210 mg/1.5 mL
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Administer: SUBCUT route • Remove prefilled syringe from refrig- erator and allow to reach room temperature (about 30 min) without removing the needle cap; once brought to room temperature, do not return to the refrigerator • If needed, the prefilled syringe may be stored at room temperature for up to 14 days • Discard after 14 days • Do not shake • Visually inspect for particulate matter and discoloration; do not use if discol- ored, cloudy, or foreign particulate mat- ter is present • Do not use where skin is tender, bruised, red, hard, thick, scaly, or af- fected by psoriasis B • Each single-use prefilled syringe con- tains 210 mg/1.5 mL of product. Inject the entire 1.5 mL contents of the syringe. No preservatives are present; discard un- used portion • Protect from light, do not freeze
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Assess: • For injection site pain, swelling, redness; use cold compress to relieve pain/swelling • Infection: fever, flulike symptoms, dys- pnea, change in urination, redness/swell- ing around any wounds; stop treatment if present; serious infections including sepsis may occur, may be fatal; patients with active infections should not be started on this product • TB: test for TB before starting product; do not use in active TB; for latent TB, give antituberculosis therapy before use of product; monitor closely for signs and symptoms of active TB infection during and after treatment • Pregnancy/breastfeeding: no data for use in pregnancy, breastfeeding; excre- tion in breast milk unknown
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Evaluate: • Therapeutic response: decrease in le- sions
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CLINICAL CONSIDERATIONS
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Patient and caregiver information: • About self-administration if appropri- ate: injection should be made in thigh, abdomen, upper arm; rotate sites at least 1 inch from old site; do not inject in ar- eas that are bruised, red, hard; not to use if dropped on hard surface, use new sy- ringe • That if medication is not taken when due, to inject dose as soon as remem- bered and inject the next dose as sched- uled • Not to take any live virus vaccines dur- ing treatment • To report signs of infection (fever, sweats, or chills; muscle aches; weight loss; cough; warm, red, or painful skin or sores on the body different from psoria- sis; diarrhea or stomach pain; shortness of breath; blood in phlegm [mucus]; burn- ing in urination or urinating more often than normal); allergic reactions (itching, rash) • To tell provider of all prescription and OTC medications, herbals, and supple- ments currently taken • That a patient-prescriber agreement form is required to be signed
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PHARMACOKINETICS Onset unknown, peak 3 days, duration unknown, half-life unknown
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• Adult: SUBCUT 210 mg at wk 0, 1, and 2, then 210 mg q2wk; discon- tinue if inadequate response after 12-16 wk
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• Available forms: Prefilled syringe 210 mg/1.5 mL
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