Names and pronunciation
(ve′-doe-liz′ue-mab) Entyvio
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Drug reference
(ve′-doe-liz′ue-mab) Entyvio
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Func. class.: GI antiinflammatory Chem class.: Integrin receptor antagonist
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ACTION: A specific integrin receptor antagonist that inhibits the migration of specific memory T-lymphocytes across the endothelium into inflamed gastroin testinal parenchymal tissue, reduces chronic inflammation in ulcerative colitis and Crohn’s disease
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USES: For moderately to severely active ulcerative colitis/Crohn’s disease
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CONTRAINDICATIONS: Hyper sensitivity Precautions: Hepatic disease, infec tions, progressive multifocal leukoen cephalopathy (PML), pregnancy, breast V feeding, live vaccines, TB, human antichimeric antibody (HACA)
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SIDE EFFECTS CNS: Headache, fatigue, dizziness GI: Nausea, vomiting MISC: Rash, pruritus, infusion-related reactions MS: Arthralgia, back pain RESP: Cough, bronchospasm SYST: Anaphylaxis, progressive multifo- cal leukoencephalopathy (PML), increased infection risk, pyrexia
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INTERACTIONS Increase: infection risk—immunosup pressives, natalizumab, antineoplastics Do not use with tumor necrosis factor (TNF) modifiers Decrease: immune response—vaccines, toxoids
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DOSAGE AND ROUTES • Adult: IV INFUSION 300 mg give over 30 min at weeks 0, 2, and 6 as induction therapy, then 300 mg q8wk, continue if response occurs by week 14
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Available forms: Powder for injection 300-mg/20-mL vial
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Administer: • Full response by 6 wk; those who do not respond by week 14 are unlikely to respond • Give as IV infusion only, do not use as an IV push or bolus • Make sure all immunizations are up to date • Reconstitute with 4.8 mL of sterile water for injection, using a syringe with a 21- to 25-gauge needle • Insert the syringe needle into the vial and direct the stream of sterile water for injection to the glass wall of the vial, gently swirl, do not shake • Allow the solution to stand up to 20 min at room temperature • Once dissolved, product should be clear or opalescent, colorless to light brownish yellow, and free of visible par ticulates. Discard if discolored or if for eign particles are present • Before withdrawing solution from vial, gently invert 3 times. Withdraw 5 mL (300 mg) using a 21- to 25-gauge needle. Discard remaining product • Dilute by adding the 5 mL (300 mg) of reconstituted product to 250 mL of sterile 0.9% NaCl and gently mix bag. Do not mix with other medications. Give product if necessary, may be stored for up to 4 hr re frigerated, do not freeze. Infuse over 30 min; then, flush line with 30 mL of sterile 0.9% NaCl injection. Discard any unused solution
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Assess: • Ulcerative colitis/Crohn’s disease: monitor symptoms before and after treat ment • Infection: fever, fatigue, malaise; flu like symptoms, UTI, URI signs/symptoms sore throat, cough, dyspnea, reaction at infusion site • Hypersensitivity: swelling of lips, tongue, throat, face; rash; wheezing; hy- pertension; if serious reactions occur, discontinue product • Liver dysfunction: elevated hepatic enzymes, jaundice, malaise, nausea, vomiting, abdominal pain, and an- orexia are indication of severe liver injury, may be fatal or may require a liver transplant; if hepatic dysfunction is suspected, discontinue • Tuberculosis (TB) latent/active: ob- tain TB skin test both before and during treatment; do not give in active infections • Progressive multifocal leukoencepha- lopathy (PML): increased weakness on one side or clumsiness of limbs, visual dis- turbance, and changes in thinking, memory, and orientation leading to confusion and personality changes; severe disability or death can occur over weeks or months
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Evaluate: • Therapeutic response: lessening of ul cerative colitis and Crohn’s disease
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CLINICAL CONSIDERATIONS
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Patient and caregiver information: • About the symptoms of infection and to report to health care provider immediately • To report allergic reactions, PML; teach symptoms • Not to use live virus vaccines while tak ing this product; to bring vaccinations up-to-date before starting this product • The reason for product, expected re sult • Risk of infection is increased, to notify health care professional of fever, chills, trouble breathing • To discuss with health care profes sional all Rx, OTC, herbals, supplements taken • To report planned or suspected preg nancy, or if breastfeeding; if pregnant, call 877-825-3327 to enroll in the Entyvia Pregnancy Registry HIGH ALERT
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PHARMACOKINETICS Absorption complete, onset up to 6 wk, duration up to 8 wk, half-life 25 days
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• Adult: IV INFUSION 300 mg give over 30 min at weeks 0, 2, and 6 as induction therapy, then 300 mg q8wk, continue if response occurs by week 14
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