Vedolizumab - Entyvio : Uses and PATIENT TEACHING

vedolizumab - Entyvio

ve-doe-liz-ue-mab (Entyvio) 

Do not confuse vedolizumab with certolizumab, eculizumab, natalizumab, omalizumab, tocilizumab. 

CLASSIFICATION Vedolizumab - Entyvio

• PHARMACOTHERAPEUTIC: Selective adhesion molecule inhibitor. Monoclonal antibody. 
• CLINICAL: GI agent
• Therapeutic Effect:Reduces chronic inflammation of colon

USES Vedolizumab

Treatment of adult pts with moderately to severely active ulcerative colitis (UC) who have had an inadequate response with, lost response to, or were intolerant to atumor necrosis factor (TNF) blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids. Treatment of adult pts with moderately to severely active Crohn’s disease (CD) who have had an inadequate response with, lost response to, or were intolerant to a TNF blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids. 

PRECAUTIONS Vedolizumab

Contraindications: 

Hypersensitivity to vedolizumab. 

Cautions: 

Hepatic impairment, immunocompromised pts, live vaccine administration. Active infections (not recommended during active infection), conditions predisposing to infections (e.g., diabetes, renal failure, open wounds, indwelling catheters). Preexisting or recent-onset CNS demyelinating disorders including multiple sclerosis. ACTION Binds to T-lymphocyte integrin receptors and blocks the interaction with mucosal addressin cell adhesion molecule-1 (MAdCAM-1). Inhibits migration and homing of memory T-lymphocytes into inflamed GI tissue. 

PHARMACOKINETICS 

Metabolism not specified. Excretion not specified. Half-life: 25 days. 

LIFESPAN CONSIDERATIONS Vedolizumab

Pregnancy/Lactation: 

Unknown if distributed in breast milk. Use caution when administering to nursing women. 

Children: 

Safety and efficacy not established. Elderly: No age-related precautions noted. 

INTERACTIONS DRUG Vedolizumab: 

Natalizumab may increase risk of progressive multifocal leukoencephalopathy (PML). Other TNF blockers (e.g., inFLIXimab) may increase risk of infection. 

HERBAL: None significant. 

FOOD: None known. 

LAB VALUES: May increase serum ALT, AST, bilirubin. 

AVAILABILITY 

(Rx) Lyophilized Powder for Injection: 300 mg. 

ADMINISTRATION/HANDLING Vedolizumab

IV 

• Do not administer IV push or bolus. 

• Reconstitute with Sterile Water for Injection and subsequently dilute with 0.9% NaCl only. 

• After infusion completed, f lush IV line with 30 mL of 0.9% NaCl. Reconstitution  

• Remove flip cap and swab with alcohol. 

• Reconstitute vial with 4.8 mL Sterile Water for Injection. Direct stream toward glass wall to avoid excessive foaming. 

• Gently swirl contents for at least 15 sec until completely dissolved. 

• Do not shake or invert vial. 

• Allow solution to sit at room temperature for up to 20 min to allow remaining foam to settle and powder to dissolve. If not fully dissolved after 20 min, allow additional 10 min for dissolution. Do not use if product is not dissolved within 30 min. 

•Visually inspect for particulate matter and discoloration. Do not use if discolored or if particle matter is observed. 

• Prior to withdrawing solution, invert vial 3 times to ensure mixing. 

• Withdraw 5 mL and further dilute in 250 mL 0.9% NaCl bag. 

• Infuse immediately. 

Rate of Administration 

• Infuse over 30 min. 

Storage Vedolizumab

• Reconstituted solution should appear clear to opalescent, colorless to light brownish yellow and free of particles. 

• May refrigerate diluted solution for up to 4 hrs. 

INDICATIONS/ROUTES/DOSAGE Vedolizumab

 Ulcerative Colitis and Crohn’s Disease IV: ADULTS, ELDERLY: 300 mg once at wk 0, wk 2, and wk 6, then every 8 wks thereafter. 

Discontinue in pts who do not show evidence of therapeutic benefit by wk 14.

Dosage in Renal Impairment : Use caution

Dosage in Hepatic Impairment: Use caution. Discontinue for jaundice or signs/symptoms of hepatic injury. 

SIDE EFFECTS of Vedolizumab

Occasional (13%–4%): 

Nasopharyngitis, headache, arthralgia, nausea, pyrexia, upper respiratory tract infection, fatigue, cough, bronchitis, influenza, back pain. Rare (3%): Rash, pruritus, sinusitis, oropharyngeal pain, extremity pain. 

ADVERSE EFFECTS/TOXIC REACTIONS Vedolizumab

Infusion-related reactions, including anaphylaxis, characterized by bronchospasm, dyspnea, flushing, hypotension, laryngeal edema, nausea, pyrexia, tachycardia, wheezing, vomiting, reported in less than 1% of pts. 

May increase risk of severe infections such as anal abscess, cytomegaloviral colitis, giardiasis, Listeria meningitis, Salmonella sepsis, TB, UTI, which may lead to fatal sepsis. PML (weakness, paralysis, vision loss, aphasia, cognition impairment) has occurred rarely; however, immunocompromised pts are at increased risk for development. 

Drug-induced hepatotoxicity with serum ALT, AST greater than 3 times upper limit of normal reported in less than 2% of pts. Malignancies including B-cell lymphoma, breast cancer, colon cancer, lung cancer of primary neuroendocrine carcinoma, lung neoplasm, malignant hepatic neoplasm, melanoma, renal cancer, squamous cell carcinoma, transitional cell carcinoma occur rarely. Immunogenicity (anti-vedolizumab antibodies) occurred in 4%–13% of pts. 

NURSING CONSIDERATIONS BASELINE 

ASSESSMENT 

Obtain CBC, LFT. Prior to initiating treatment, all pts should be up to date with all immunizations according to proper guidelines. 

Continuously screen for active infection. 

Evaluate for active TB and test for latent infection prior to and during treatment. 

Induration of 5 mm or greater with tuberculin skin test should be considered a positive result when assessing for latent TB.

 Antifungal therapy should be considered for those who reside in or travel to regions where mycoses are endemic. Have supplemental oxygen, anaphylaxis kit readily available. Conduct full neurologic exam. Question history of malignancies. 

INTERVENTION/EVALUATION Vedolizumab

 Routinely monitor LFT. Withhold treatment if acute infection, opportunistic infection, sepsis occurs and initiate appropriate antimicrobial therapy. Monitor for hypersensitivity reaction. Infusionrelated reactions generally occur within 2 hrs after infusion. Consider administration of antihistamine, antipyretic, and/or corticosteroid if mild to moderate hypersensitivity reaction occurs. If anaphylaxis occurs, provide immediate resuscitation support. Monitor for new onset or worsening of neurologic symptoms, esp. in pts with CNS disorders; may indicate PML. 

PATIENT/FAMILY TEACHING Vedolizumab

 • Blood levels, TB screening will be routinely monitored. 

• Therapy may lower immune system response. Report travel plans to possible endemic areas. 

• Do not receive live vaccines unless approved by your doctor. 

• Report history of fungal infections, multiple sclerosis, TB or close relatives who have active TB. 

• Infusion may cause severe allergic reactions such as face/tongue swelling, hives, itching, low blood pressure, trouble breathing, or, in some cases, anaphylaxis. 

• Do not breastfeed. 

• Abdominal pain, bruising, claycolored stools, dark-amber urine, fatigue, loss of appetite, yellowing of skin or eyes may indicate liver problem. 

• Paralysis, vision changes, impaired speech, altered mental status may indicate life-threatening neurologic event called progressive multifocal leukoencephalopathy (PML).