Names and pronunciation
(ab-a-ta′sept) Orencia, Orencia ClickJet
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Drug reference
(ab-a-ta′sept) Orencia, Orencia ClickJet
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Func. class.: Antirheumatic agent (disease modifying)
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Chem. class.: Immunomodulator
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Do not confuse: Orencia/Oracea
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ACTION: A selective costimulation modulator; inhibits T lymphocytes, inhib- its production of tumor necrosis factor (TNF-α), interferon-γ, interleukin-2, which are involved in immune and inflam- matory reactions
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USES: Polyarticular juvenile rheuma- toid arthritis; moderate to severe rheu- matoid arthritis; acute, chronic rheuma- toid arthritis that has not responded to other disease-modifying agents; may use in combination with DMARDs; do not use with TNF antagonists (adalimumab, etan- ercept, inFLIXimab), anakinra
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CONTRAINDICATIONS: Hyper- sensitivity Precautions: Pregnancy, breastfeeding, children, geriatric patients, recurrent infections, COPD, TB, viral hepatitis, immunosuppression, neoplastic disease, respiratory infection
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SIDE EFFECTS CNS: Headache, asthenia, dizziness CV: Hypo/hypertension GI: Abdominal pain, dyspepsia, nausea, diarrhea, diverticulitis GU: UTI, pyelonephritis MS: Back pain INTEG: Rash, injection site reaction, flushing, urticaria, pruritus RESP: Pharyngitis, cough, URI, non- URI, rhinitis, wheezing SYST: Anaphylaxis, malignancies, serious infections, antibody development
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INTERACTIONS • Do not give concurrently with live virus vaccines; immunizations should be brought up to date prior to treatment • Do not use with TNF antagonists: adalim umab, etanercept, inFLIXimab; anakinra; infection may occur • Avoid use with corticosteroids, immu- nosuppressives, atropine, scopolamine, halothane, nitrous oxide
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DOSAGE AND ROUTES Rheumatoid arthritis/psoriatic arthritis • Adult: SUBCUT 125 mg within 1 day after single IV loading dose, then 125 mg weekly; weekly SUBCUT dose may be initiated without an IV loading dose for those unable to receive an infusion • Adult >100 kg (220 lb): IV INFUSION 1 g over 30 min, give at 2, 4 wk after first infusion, then q4wk • Adult 60-100 kg (132-220 lb): IV INFUSION 750 mg over 30 min, give at 2, 4 wk after first infusion, then q4wk • Adult <60 kg (132 lb): IV INFUSION 500 mg over 30 min, give at 2, 4 wk after first infusion, then q4wk Juvenile rheumatoid arthritis (JRA)/ juvenile idiopathic arthritis (JIA) • Adolescent and child ≥6 yr and >100 kg: IV INFUSION 1 g given over 30 min q2wk × 3 doses, then 1 g given over 30 min q4wk starting at wk 8 • Adolescent and child ≥6 yr and 75- 100 kg: IV INFUSION 750 mg over 30 min q2wk × 2 doses, then 750 mg given A over 30 min q4wk starting at wk 8 • Adolescent and child ≥6 yr and <75 kg: IV INFUSION 10 mg/kg given over 30 min q2wk × 3 doses, then 10 mg/kg q4wk starting at wk 8 Moderate/severe polyarticular juvenile idiopathic arthritis as monotherapy with or without methotrexate • Child/adolescent ≥2 yr and ≥50 kg: SUBCUT 125 mg q1wk • Child/adolescent ≥2 yr and 25-50 kg: SUBCUT 87.5 mg q1wk • Child/adolescent ≥2 yr and 10-25 kg: SUBCUT 50 mg q1wk
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Available forms: Lyophilized powder, single-use vials 250 mg; sol for SUBCUT injection 125 mg/mL
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Administer: • Storage in refrigerator; do not use expired vials, protect from light, do not freeze Intermittent IV INFUSION route • To reconstitute, use 10 mL sterile water for injection; insert syringe needle into vial and direct stream of sterile water for injection on the wall of vial; rotate vial until mixed; vent with needle (25 mg/mL); further dilute in 100 mL NS from a 100-mL infusion bag/bottle; withdraw the needed volume (2 vials remove 20 mL, 3 vials remove 30 mL, 4 vials remove 40 mL); slowly add the re- constituted solution from each vial into the infusion bag/bottle using the same disposable syringe supplied; mix gently; discard unused portions of vials; do not use if particulate is present or discol- ored; give over 30 min; use non–protein- binding filter (0.2-1.2 microns); protect from light • Do not admix with other solutions or medications SUBCUT route • Use prefilled syringe for SUBCUT only (do not use for IV); allow to warm to room temperature (30-60 min); inject into fronts of thighs, outer area of upper arm, or abdomen except for 2-inch area around the navel; do not inject into ten- der, bruised area • Rotate injection sites • Use ClickJet for SUBCUT only; let warm for 30 min after removal from re- frigerator, do not use if damaged or past expiration date
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Assess: • RA: pain, stiffness, ROM, swelling of joints during treatment baseline and periodically • HBV reactivation: Screen patient at risk prior to starting treatment • TB: for latent/active TB, viral hepatitis prior to beginning treatment • For injection site pain, swelling • Patient’s overall health at each visit; product should not be given with active infections; parenteral product contains maltose, glucose monitoring must be done with glucose-specific testing • Infection: sinusitis, UTI, influenza, bronchitis; serious infections have occurred; notify prescriber, therapy may need to be changed • Pregnancy/breastfeeding: assess whether pregnancy is planned or sus- pected; if pregnant, register by calling 877-311-8972; use only if benefits out- weigh fetal risk; do not breastfeed
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Evaluate: • Therapeutic response: decreased in- flammation, pain in joints
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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, not to use with alcohol • To use caution when driving; dizziness may occur • Not to have live virus vaccinations while taking this product or use alcohol, TNF antagonists, other immunosuppres- sants; bring vaccinations up to date prior to use of this product • About patient information included in packaging, including “do not shake” • How to inject and rotate injection sites • To immediately report signs of infec- tion: temperature, flu like symptoms, uri- nary burning/stinging, sinusitis • To avoid those with known infections • That product contains maltrose and may lead to elevated glucose levels in some glucose testing methods • To inform all prescribers that this product is being used
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PHARMACOKINETICS Half-life IV 13 days, SUBCUT 14.3 days, steady state 60 days; clearance increases with increased body weight
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• Adolescent and child ≥6 yr and >100 kg: IV INFUSION 1 g given over 30 min q2wk × 3 doses, then 1 g given over 30 min q4wk starting at wk 8
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• Adolescent and child ≥6 yr and 75- 100 kg: IV INFUSION 750 mg over 30 min q2wk × 2 doses, then 750 mg given A over 30 min q4wk starting at wk 8
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• Adolescent and child ≥6 yr and <75 kg: IV INFUSION 10 mg/kg given over 30 min q2wk × 3 doses, then 10 mg/kg q4wk starting at wk 8 Moderate/severe polyarticular juvenile idiopathic arthritis as monotherapy with or without methotrexate
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• Child/adolescent ≥2 yr and ≥50 kg: SUBCUT 125 mg q1wk
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• Child/adolescent ≥2 yr and 25-50 kg: SUBCUT 87.5 mg q1wk
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• Child/adolescent ≥2 yr and 10-25 kg: SUBCUT 50 mg q1wk
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