Names and pronunciation
Ixifi
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Drug reference
Ixifi
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Func. class.: Biologic response modifiers
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Chem. class.: Tumor necrosis factor modifiers
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Do not confuse: Remicade/Renacidin inFLIXimab/riTUXimab
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ACTION: Monoclonal antibody that neu- tralizes the activity of tumor necrosis factor- alpha (TNF-α) found in Crohn’s disease; decreased infiltration of inflammatory cells
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USES: Ankylosing spondylitis, Crohn’s disease (adult/child), plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis (adult/child)
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Unlabeled uses: Behcet’s (uveitis) syn- drome, resistant Kawasaki disease, multi- system inflammatory syndrome in children
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CONTRAINDICATIONS: Hyper- sensitivity to murines, moderate to severe HF (NYHA class III/IV) Precautions: Pregnancy, breastfeeding, children, geriatric patients, COPD, hepa- totoxicity, hematologic abnormalities, hepatitis B, Guillain-Barré syndrome, seizures, multiple sclerosis I
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Black Box Warning: Infection, neoplastic disease, TB Black Box Warning: Fatal infections: discontinue if infection occurs, do not ad- minister to patients with active infection; identify TB before beginning treatment; a TB test should be obtained; if present, TB should be treated before patient receives product; exercise caution when switching from 1 DMARD to another Black Box Warning: For neoplas- tic disease in those <18 yr, including hepatosplenic T-cell lymphoma; usu- ally occurs in those with inflammatory bowel disease • Pregnancy/breastfeeding: does not cross placenta during 1st trimester, but does 2nd/3rd trimester; discontinue 8-10 wk before birth; do not breastfeed. Not to breastfeed while taking this product
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SIDE EFFECTS CNS: Headache, dizziness, depression, vertigo, fatigue, anxiety, fever, seizures, chills, flulike symptoms, demyelinating disease CV: Chest pain, hypo/hypertension, tachy cardia, HF, acute coronary syndrome GI: Nausea, vomiting, abdominal pain, stomatitis, constipation, dyspepsia, flatulence GU: Dysuria, urinary frequency HEMA: Anemia, leukopenia, thrombocy topenia, pancytopenia INTEG: Rash, dermatitis, urticaria, dry skin, sweating, flushing, hema- toma, pruritus, keratoderma blenorrhagicum MS: Myalgia, back pain, arthralgia RESP: URI, pharyngitis, bronchitis, cough, dyspnea, sinusitis SYST: Anaphylaxis, fatal infections, sep sis, malignancies, immunogenicity, Ste vens-Johnson syndrome, toxic epidermal necrolysis, sarcoidosis
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INTERACTIONS Increase: infections, neutropenia—TNF blockers (abatacept, anakinra, golim- umab, rilonacept); avoid concurrent use • Do not administer live vaccines con- currently
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DOSAGE AND ROUTES Rheumatoid arthritis (in combina- tion with methotrexate therapy) Adult: IV: 3 mg/kg at 0, 2, and 6 wk, followed by a maintenance regimen of 3 mg/kg every 8 wk thereafter; may adjust dose up to 10 mg/kg every 4-8 wk Ankylosing spondylitis Adult: IV: 5 mg/kg at 0, 2, and 6 wk, fol- lowed by 5 mg/kg every 6 wk thereafter Crohn’s disease Adult: IV: 5 mg/kg at 0, 2, and 6 wk, followed by 5 mg/kg every 8 wk thereaf- ter; may increase to 10 mg/kg every 8 wk in patients who respond but then lose their response. If no response by wk 14, consider discontinuing therapy Plaque psoriasis Adult: IV: 5 mg/kg at 0, 2, and 6 wk, fol- lowed by 5 mg/kg every 8 wk thereafter Psoriatic arthritis (with or without methotrexate) Adult: IV: 5 mg/kg at 0, 2, and 6 wk, fol- lowed by 5 mg/kg every 8 wk thereafter Ulcerative colitis Adult IV: 5 mg/kg at 0, 2, and 6 wk, followed by 5 mg/kg every 8 wk thereafter Crohn’s disease: Remicade/ Inflectra/Renflexis: Children ≥6 yr and adolescents: IV: Initial: 5 mg/kg/dose at 0, 2, and 6 wk, followed by maintenance: 5 mg/kg/dose every 8 wk thereafter Juvenile idiopathic arthritis; refractory to conventional disease-modifying drugs: Children ≥4 yr and adolescents: IV: Initial: 3 mg/kg at 0, 2, and 6 wk; then 3 to 6 mg/kg/dose every 8 wk thereafter in combination with methotrexate during induction and maintenance. Alternatively, some studies used 6 mg/kg/dose starting at wk 14 of a methotrexate induction regimen (wk 0 to 13); repeat dose (6 mg/kg/dose) at wk 16 and 20, then every 8 wk thereafter Kawasaki disease, refractory to IVIG: Infants and children: IV: 5 mg/kg/ dose as a single infusion Ulcerative colitis: Remicade: Children ≥6 yr and adolescents: IV: Initial: 5 mg/kg/dose at 0, 2, and 6 wk, followed by maintenance: 5 mg/kg/dose every 8 wk thereafter
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Available forms: Powder for inj 100 mg
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Administer: Intermittent IV INFUSION route • Pretreat with diphenhydrAMINE, acet- aminophen, predniSONE if a reaction is infusion related • Give immediately after reconstitution; reconstitute each vial with 10 mL sterile water for inj; further dilute total dose/250 mL of 0.9% NaCl inj to a total concentra- tion of 0.4-4 mg/mL; use 21-G or smaller needle for reconstitution; direct sterile water at glass wall of vial; gently swirl; do not shake; may foam; allow to stand for 5 min, give within 3 hr • Give over ≥2 hr, use polyethylene-lined infusion with in-line, sterile, low–protein- binding filter • Do not admix • Refrigerated storage; do not freeze
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Assess: • RA: pain, joints involved, ROM, aggra- vating ameliorating factors baseline and periodically • Plaque psoriasis: lesions, body areas affected baseline and periodically • Ulcerative colitis/Crohn’s disease: pain, cramping, diarrhea, change in life style baseline and periodically • GI symptoms: nausea, vomiting, ab- dominal pain • Periodic blood counts (CBC with dif- ferential), ANA titer, LFTs, baseline and periodically, may cause blood dyscrasia, discontinue if present • CV status: B/P, pulse, chest pain • Allergic reaction, anaphylaxis: rash, dermatitis, urticaria, dyspnea, hypotension, fever, chills; discontinue if severe, admin ister EPINEPHrine, corticosteroids, anti histamines; assess for allergies to murine proteins before starting therapy
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Evaluate: • Therapeutic response: absence of fe- ver, mucus in stools
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CLINICAL CONSIDERATIONS
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Patient and caregiver information: • That infusion reaction should be re- ported immediately • To notify prescriber immediately if in- fection occurs • To notify prescriber of GI symptoms, hypersensitivity reactions, heart symp- toms • Not to operate machinery or drive if dizziness, vertigo occur • To avoid live virus vaccinations; bring up-to-date before use • Malignancy: check skin for changes, growths, or color changes • Pregnancy/breastfeeding: identify if pregnancy is planned or suspected
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PHARMACOKINETICS Distributed to vascular compartment, half-life 9.5 days
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