Names and pronunciation
(us′te-kin′ue-mab) Stelara
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Drug reference
(us′te-kin′ue-mab) Stelara
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Func. class.: Immune response modi- fier, antipsoriatic agent
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Chem. class.: Monoclonal antibody, interleukin-12 inhibitor
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ACTION: Interleukin (IL)-12, IL-23 antagonist, binds to an interleukin protein, decreases inflammation
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USES: Plaque psoriasis (adult/child), psoriatic arthritis
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CONTRAINDICATIONS: Hyper sensitivity, sepsis, active infections Precautions: Pregnancy, breastfeeding, children ≤18 yr, geriatric patients, surgery, TB, diabetes mellitus, immunosuppression
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SIDE EFFECTS CNS: Headache, leukoencephalopathy, depression, dizziness, fatigue HEMA: Bleeding INTEG: Injection site reaction, pruritus, skin irritation, erythema, exfoliative der- matitis, erythrodermic psoriasis SYST: Serious infections, malignancies MS: Myalgia, back pain RESP: URI, oropharyngeal pain
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INTERACTIONS • Do not give concurrently with vac- U cines; immunizations should be brought up-to-date before treatment • Avoid use with immunosuppressives
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DOSAGE AND ROUTES Moderate to severe plaque psoriasis • Adult ≥100 kg with plaque psoriasis: SUBCUT 90 mg, repeat in 4 wk, then 90 mg q12wk starting wk 16 • Adult <100 kg SUBCUT 45 mg, repeat in 4 wk, then 45 mg q12wk starting wk 16 • Child 6-17 yr, >100 kg: SUBCUT 90 mg, repeat in 4 wk, then q12wk • Child 6-17 yr, 60-100 kg: SUBCUT 45 mg, repeat in 4 wk, then q12wk • Child 6-17 yr, <60 kg: SUBCUT 0.75 mg/kg repeat in 4 wk, then q12wk Crohn’s disease/ulcerative colitis • Adult (weight-based dosing): IV single induction dose >85 kg, 520 mg; >55– 85 kg, 390 mg; ≤55 kg, 260 mg; main- tenance: 90 mg SUBCUT q8wk, starting 8 wk after induction dose
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Available forms: Solutions for inj 45 mg/0.5 mL, 90 mg/mL, 130/25 mL
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Administer: • Do not shake the syringe or vial • Visually inspect for particulate matter and discoloration before use; solution should be colorless to slightly yellow and may contain a few small translucent or white particles. Do not use if discolored, cloudy, or if foreign particulate matter is present IV route • Preparation: use an IV infusion only for the induction treatment of Crohn’s disease • Each vial is for single use only • Calculate the dose and number of vials needed based on patient weight; each 26-mL vial contains 130 mg of product • Withdraw and discard a volume of the 0.9% sodium chloride injection from a 250-mL infusion bag equal to the volume of needed product to be added • Withdraw 26 mL of product from each vial needed and add it to 250-mL infusion bag. The final volume in the infusion bag should be 250 mL • Gently mix; do not shake • Storage: diluted solution must be used within 4 hr (no preservative). If admini stration is not immediate, store for up to 4 hr at room temperature up to 25°C (77°F). Do not freeze; discard unused portion IV infusion route • Give the diluted product over ≥1 hr • Use only an infusion set with an in-line, sterile, nonpyrogenic, low protein-binding filter (pore size 0.2 micron) • Do not infuse in the same line with other agents SUBCUT route The first injection needs to be under the supervision of a qualified health care professional • Inject in the front part of the middle thigh, the gluteal or abdominal region, and the outer area of the upper arm • Do not give where skin is tender, bruised, red, or indurated • Rotate injection sites. If a second injec- tion is needed because two 45-mg vials or prefilled syringes are used for a 90-mg dose, repeat the injection process, and use a different injection site • For the vial, use a 27-gauge, 0.5-inch needle to withdraw the dose • The needle cover of the prefilled syringe contains latex. Persons allergic to natural rubber or latex should not handle the cover of the prefilled syringe
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Assess: • Bring immunizations up-to-date before starting treatment; do not administer live vaccines during treatment and for 3 mo after treatment ends • Infection: monitor for fever, sore throat, cough; do not use during active infections • Malignancy: skin cancer may occur, especially in older patients who have used ultraviolet treatments with immunosup- pressants • TB: TB testing should be done before starting treatment • For inj-site pain, swelling, rash • Pregnancy/breastfeeding: pregnant patients should enroll in the Stelara pregnancy registry, 1-877-311-8972; use only if benefits outweigh fetal risk; cautious use in breastfeeding, excretion unknown
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Evaluate: • Therapeutic response: decreased plaque psoriasis
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CLINICAL CONSIDERATIONS
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Patient and caregiver information: • That product must be continued for prescribed time to be effective; to use as prescribed • Not to receive live vaccinations during treatment • To notify prescriber of possible infec- tion (upper respiratory or other) or al- lergic reactions • Injection techniques and disposal of equipment; not to reuse needles, syringes • That follow-up will be needed v
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PHARMACOKINETICS Maximum serum concentration: 13.5 days after a single 45-mg subcut dose, 7 days after a single 90-mg subcut dose; half-life 14.9-45.6 days
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• Adult ≥100 kg with plaque psoriasis: SUBCUT 90 mg, repeat in 4 wk, then 90 mg q12wk starting wk 16
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• Adult <100 kg SUBCUT 45 mg, repeat in 4 wk, then 45 mg q12wk starting wk 16
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• Child 6-17 yr, >100 kg: SUBCUT 90 mg, repeat in 4 wk, then q12wk
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• Child 6-17 yr, 60-100 kg: SUBCUT 45 mg, repeat in 4 wk, then q12wk
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• Child 6-17 yr, <60 kg: SUBCUT 0.75 mg/kg repeat in 4 wk, then q12wk Crohn’s disease/ulcerative colitis
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• Adult (weight-based dosing): IV single induction dose >85 kg, 520 mg; >55– 85 kg, 390 mg; ≤55 kg, 260 mg; main- tenance: 90 mg SUBCUT q8wk, starting 8 wk after induction dose
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