Names and pronunciation
(add-a-lim′yu-mab) Humira, Humira Pen; Hyrimoz, (biosimilar); Abrilada (biosimilar); Hulio (biosimilar); Yusimly (biosimilar)
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Drug reference
(add-a-lim′yu-mab) Humira, Humira Pen; Hyrimoz, (biosimilar); Abrilada (biosimilar); Hulio (biosimilar); Yusimly (biosimilar)
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Func. class.: Antirheumatic agent (disease modifying), immunomodula- tor, anti-TNF
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Chem. class.: Recombinant human IgG1 monoclonal antibody, DMARD
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Do not confuse: Humira/HumuLIN/HumaLOG Humira Pen/Humapen Memoir
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ACTION: A form of human IgG1 monoclonal antibody specific for human tumor necrosis factor (TNF-α); elevated levels of TNF-α are found in patients with rheumatoid arthritis
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USES: Moderate to severe active rheu- matoid arthritis who are ≥18 yr of age and who have not responded to other disease-modifying agents, juvenile rheuma- toid arthritis (JRA), psoriatic arthritis, Crohn’s disease, moderate to severe plaque psoriasis, ankylosing spondylitis, ulcerative colitis, noninfectious uveitis, moderate- severe hidradenitis suppurativa
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CONTRAINDICATIONS: Hyper- sensitivity, breastfeeding, use of anakinra, abatacept Precautions: Pregnancy, children, geriatric patients, CNS demyelinating disease, lymphoma, HF, hepatitis B car- A riers, mannitol hypersensitivity, latex allergy, neoplastic disease, TB
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Black Box Warning: Active infections, risk of lymphomas/leukemias Black Box Warning: Increase: serious infections—other TNF blockers, rilonacept Increase: infection-azathioprine • Do not use with abatacept, anakinra; serious infections may occur • Do not give concurrently with live virus vaccines; immunizations should be brought up to date before treat- ment Drug/Lab Test Increase: ALT, cholesterol, lipids Black Box Warning: Infections (fever, flu- like symptoms, dyspnea, change in urina- tion, redness/swelling around any wounds), stop treatment if some serious infections including sepsis occur, may be fatal; patients with active infections should not be started on this product • May reactivate hepatitis B in chronic carriers, may be fatal Black Box Warning: Latent TB before therapy; treat before starting this product • Anaphylaxis, latex allergy: stop ther- apy if lupus-like syndrome develops • Blood dyscrasias: CBC, differential periodically Black Box Warning: Neoplastic disease (lymphomas/leukemia) in children, ado- lescents; hepatosplenic T-cell lymphoma is more likely in adolescent males with Crohn’s disease or ulcerative colitis
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SIDE EFFECTS CNS: Headache, Guillain-Barré syn- drome, MS CV: Hypertension, HF EENT: Sinusitis, optic neuritis GI: Abdominal pain, nausea HEMA: Leukopenia, thrombocytopenia INTEG: Rash, injection site reaction MISC: Flulike symptoms, increased cancer risk, risk of infection (TB, invasive fungal infections, other opportunistic infections), infections may be fatal; Stevens-Johnson syndrome, anaphylaxis, hyperlipidemia RESP: URI, pulmonary fibrosis, bronchitis
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INTERACTIONS
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DOSAGE AND ROUTES Rheumatoid arthritis/ankylosing spondylitis/psoriatic arthritis • Adult: SUBCUT 40 mg every other week or every week if not combined with methotrexate Juvenile rheumatoid arthritis • Child ≥2 yr/adolescent ≥30 kg: SUBCUT 40 mg every other week • Child ≥2 yr/adolescent ≥15 kg to <30 kg: SUBCUT 20 mg every other week • Child ≥2 yr/adolescent 10-<15 kg: SUBCUT 10 mg every other week Crohn’s disease/ulcerative colitis • Adult: SUBCUT 160 mg given as 4 injections on day 1 or 2 injections each on days 1 and 2, then 80 mg at wk 2 and 40 mg every other week starting at wk 4 Pediatric Crohn’s disease • Child >6 yr and ≥40 kg (88 lb): SUB- CUT 160 mg on day 1 (as 4 [40-mg] injections) or 40 mg (as 2 injections) (80 mg) × 2 days, then 80 mg after 2 wk (day 15), then 40 mg every other week (day 29) • Child >6 yr and 17-40 kg (37-88 lb): SUBCUT 80 mg day 1 (as 2 [40-mg] injections), then 40 mg after 2 wk (day 15), then 20 mg every other week (day 29) Plaque psoriasis/noninfectious uveitis Adult: SUBCUT 80 mg baseline as 2 injections, then 40 mg every other week starting 1 wk after initial dose (plaque psoriasis) Child >2 yr and ≥30 kg: SUBCUT 20 mg every other week Child ≤2 yr and ≤15 kg: SUBCUT 10 mg every other week Moderate hidradenitis suppurativa Adult/adolescent and ≥60 kg: SUBCUT 160 mg 1 day or split over 2 days, then 80 mg on day 15, then on day 29 give 40 mg weekly Adolescent and 30-60 kg: SUBCUT 80 mg on day 1 then 40 mg on day 8, then 40 mg every other week Available form: Injection prefilled pens/syringes 10 mg/0.1 mL, 10 mg/0.2 mL, 20 mg/0.2 mL, 20 mg/0.4 mL, 40 mg/0.4 mL, 40 mg/0.8 mL, 80 mg/0.8 mL; single-use vial 40 mg/0.8 mL
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Administer: SUBCUT route • Do not admix with other solutions or medications; do not use filter; protect from light; give at 45-degree angle using abdomen, thighs; rotate injection sites; discard unused portions • Don’t inject in bruised, red, tender, abraded areas; use in SUBCUT only
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Assess: • RA: pain; stiffness; ROM; swelling of joints prior to, during treatment • Crohn’s disease/ulcerative colitis: bowel pattern, cramping, abdominal pain, bleeding • For injection site pain, swelling, red- ness—usually occurs after 2 injections (4-5 days); use cold compress to relieve pain/swelling
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Evaluate: • Therapeutic response: decreased in- flammation, pain in joints, decreased joint destruction
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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; review provided medication guide with patient • To refrigerate in container that prod- uct was received in; to dispose of needles and equipment as instructed • That if medication is not taken when due, inject dose as soon as remembered and inject next dose as scheduled • Not to take any live virus vaccines dur- ing treatment • To report signs of infection, allergic reaction, 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 register if pregnant at 877-311-8972 • Prefilled pen use: Using an alcohol swab, clean area, do not use if solution is cloudy or particulate is present, remove gray cap, the pen is activated, pinch skin and place at 90-degree angle, press but- ton, hold until solution is inserted, remove, dispose of properly • To do regular skin assessments and report changes to provider
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PHARMACOKINETICS Absorption 65%, distributed to synovial fluid, half-life 2 wk, lower clearance with advancing age (40-75 yr), onset up to 24 wk (inflammation)
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• Adult: SUBCUT 40 mg every other week or every week if not combined with methotrexate Juvenile rheumatoid arthritis
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• Child ≥2 yr/adolescent ≥30 kg: SUBCUT 40 mg every other week
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• Child ≥2 yr/adolescent ≥15 kg to <30 kg: SUBCUT 20 mg every other week
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• Child ≥2 yr/adolescent 10-<15 kg: SUBCUT 10 mg every other week Crohn’s disease/ulcerative colitis
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• Adult: SUBCUT 160 mg given as 4 injections on day 1 or 2 injections each on days 1 and 2, then 80 mg at wk 2 and 40 mg every other week starting at wk 4 Pediatric Crohn’s disease
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• Child >6 yr and ≥40 kg (88 lb): SUB- CUT 160 mg on day 1 (as 4 [40-mg] injections) or 40 mg (as 2 injections) (80 mg) × 2 days, then 80 mg after 2 wk (day 15), then 40 mg every other week (day 29)
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• Child >6 yr and 17-40 kg (37-88 lb): SUBCUT 80 mg day 1 (as 2 [40-mg] injections), then 40 mg after 2 wk (day 15), then 20 mg every other week (day 29) Plaque psoriasis/noninfectious uveitis Adult: SUBCUT 80 mg baseline as 2 injections, then 40 mg every other week starting 1 wk after initial dose (plaque psoriasis) Child >2 yr and ≥30 kg: SUBCUT 20 mg every other week Child ≤2 yr and ≤15 kg: SUBCUT 10 mg every other week Moderate hidradenitis suppurativa Adult/adolescent and ≥60 kg: SUBCUT 160 mg 1 day or split over 2 days, then 80 mg on day 15, then on day 29 give 40 mg weekly Adolescent and 30-60 kg: SUBCUT 80 mg on day 1 then 40 mg on day 8, then 40 mg every other week Available form: Injection prefilled pens/syringes 10 mg/0.1 mL, 10 mg/0.2 mL, 20 mg/0.2 mL, 20 mg/0.4 mL, 40 mg/0.4 mL, 40 mg/0.8 mL, 80 mg/0.8 mL; single-use vial 40 mg/0.8 mL
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