vedolizumab (Rx)

Brand and Other Names:Entyvio
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injection, lyophilized powder for reconstitution

  • 300mg/vial (300mg/5mL after reconstituted)

Ulcerative Colitis

Indicated for adults with moderate-to-severe active ulcerative colitis

300 mg IV at weeks 0, 2, and 6, THEN

300 mg IV q8weeks

Discontinue therapy in patients who show no evidence of therapeutic benefit by Week 14

Crohn Disease

Indicated for adults with moderate-to-severe active Crohn disease

300 mg IV at weeks 0, 2, and 6, THEN

300 mg IV q8weeks

Discontinue therapy in patients who show no evidence of therapeutic benefit by Week 14

Dosage Modifications

Renal or hepatic impairment

  • Not studied

Dosing Considerations

Before initiating treatment, all patients should be brought up to date with all immunizations according to current immunization guidelines

Graft vs Host Disease (Orphan)

Orphan designations for prevention and treatment of graft versus host disease (GVHD)

Sponsor

  • Millennium Pharmaceuticals, Inc; 40 Landsdowne St; Cambridge, Massachusetts 02139

Safety and efficacy not established

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Interactions

Interaction Checker

and vedolizumab

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            All Interactions Sort By:
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            Adverse Effects

            >10%

            Nasopharyngitis (13%)

            Headache (12%)

            Arthralgia (12%)

            1-10%

            Nausea (9%)

            Pyrexia (9%)

            Upper respiratory tract infection (7%)

            Fatigue (6%)

            Cough (5%)

            Bronchitis (4%)

            Influenza (4%)

            Back pain (4%)

            Rash (3%)

            Pruritus (3%)

            Sinusitis (3%)

            Oropharyngeal pain (3%)

            Pain in extremities (3%)

            <1%

            Infections (0.85% per patient-year)

            Infusion-related hypersensitivity (0.07%)

            Serious infections (0.06% per patient-year)

            Postmarketing Reports

            Anaphylaxis

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            Warnings

            Contraindications

            Hypersensitivity

            Cautions

            Allergic reactions including dyspnea, bronchospasm, urticaria, flushing, rash, and increased BP and HR observed

            Increased risk for developing infections; serious infections have also been reported, including anal abscess, sepsis (some fatal), tuberculosis, salmonella sepsis, Listeria meningitis, giardiasis, and cytomegaloviral colitis

            Elevated liver transaminases and/or bilirubin reported; discontinue if jaundice occurs or other evidence of liver injury (eg, fatigue, anorexia, right upper abdominal discomfort); the combination of elevated transaminase and bilirubin without evidence of obstruction is generally recognized as an important predictor of severe liver injury that may lead to death or the need for liver transplantation

            Infusion-related reactions and hypersensitivity reactions

            • Infusion-related reactions and hypersensitivity reactions have been reported, including anaphylaxis, dyspnea, bronchospasm, urticaria, flushing, rash, and increased blood pressure and heart rate
            • May occur with the first or subsequent infusions and may vary in their time of onset from during infusion or up to several hours postinfusion
            • If anaphylaxis or other serious infusion-related or hypersensitivity reactions occur, discontinue immediately and initiate appropriate treatment

            Progressive multifocal leukoencephalopathy (PML)

            • Another integrin receptor antagonist (natalizumab) has been associated with PML, a rare and often fatal opportunistic infection of the CNS
            • Vedolizumab inhibits α4β7 integrin; whereas, natalizumab inhibits both α4β7 (gut integrin) and α4β1 (CNS integrin)
            • In vedolizumab clinical trials, monitor for PML with frequent and regular screenings and evaluations of any new, unexplained neurological symptoms, as necessary
            • While zero cases of PML were identified among patients with at least 24 months of vedolizumab exposure, a risk of PML cannot be ruled out
            • No claims of comparative safety to other integrin receptor antagonists can be made based on these data

            Drug interaction overview

            • Immunizations for each patient should be current before initiating treatment; patients may receive non-live vaccines (eg, influenza vaccine injection) and may receive live vaccines if the benefits outweigh the risks; there are no data on secondary transmission of infection by live vaccines in patients receiving vedolizumab
            • Owing to the potential for increased risk of PML and other infections, avoid use with natalizumab
            • Owing to the potential for increased risk of infections, avoid use with TNF blockers
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            Pregnancy & Lactation

            Pregnancy

            Available pharmacovigilance data, data from the ongoing pregnancy registry, and data from published case reports and cohort studies in pregnant women have not identified an drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes

            Pregnancy registry

            • Monitors pregnancy outcomes in women exposed to during pregnancyInformation about the registry can be obtained by calling 1-877-TAKEDA7 (1-877-825-3327)

            Disease-associated maternal and embryo/fetal risk

            • Published data suggest that the risk of adverse pregnancy outcomes in women with inflammatory bowel disease (IBD) is associated with increased disease activity
            • Adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2,500 g) infants, and small for gestational age at birth

            Fetal/Neonatal adverse reactions

            • Administered during pregnancy could affect immune responses in the in utero exposed newborn and infant
            • Clinical significance of low levels of vedolizumab in utero-exposed infants is unknown
            • Safety of administering live or live-attenuated vaccines in exposed infants is unknown

            Lactation

            Available published literature suggests presence of vedolizumab in human milk

            Effects of local gastrointestinal exposure and expected low systemic exposure to vedolizumab on breastfed infant unknown

            There are no data on effects of vedolizumab on breastfed infant, or effects on milk production

            Consider developmental and health benefits of breastfeeding along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from drug or from underlying maternal condition

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Recombinant humanized monoclonal antibody that binds specifically to α4β7 integrin and blocks the interaction of α4β7 integrin with mucosal addressin cell adhesion molecule-1 (MAdCAM-1) and inhibits the migration of memory T-lymphocytes across the endothelium into inflamed gastrointestinal parenchymal tissue

            Does not bind to or inhibit function of α4β1 and αEβ7 integrins and does not antagonize α4 integrins interaction with vascular cell adhesion molecule-1 (VCAM-1)

            Elicits no activity against α4β1 integrin, and therefore there has no effect on CNS inflammation

            Absorption

            Trough serum concentration (ulcerative colitis): 26.3 mcg/mL (Week 6); 11.2 mcg/mL (Week 46)

            Trough serum concentration (Crohns disease): 27.4 mcg/mL (Week 6); 13 mcg/mL (Week 46)

            Distribution

            Vd: 5 L

            Elimination

            Half-life: 25 days

            Clearance (linear): 0.157 L/day

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            Administration

            IV Compatibilities

            0.9% NaCl

            Lactated Ringer

            IV Preparation

            Reconstitution

            • Reconstitute vial with 4.8 mL sterile water for injection
            • Direct stream of sterile water for injection to the glass wall of the vial to avoid excessive foaming
            • Gently swirl the vial for at least 15 seconds to dissolve the lyophilized powder; do NOT vigorously shake or invert
            • Allow solution to sit for up to 20 minutes at room temperature to allow for reconstitution and for any foam to settle; swirl and inspect for dissolution during this time
            • If not fully dissolved after 20 minutes, allow another 10 minutes for dissolution; do NOT use the vial if the drug product is not dissolved within 30 minutes
            • Visually inspect the reconstituted solution for particulate matter and discoloration before administration; solution should be clear or opalescent, colorless to light brownish-yellow and free of visible particulates
            • Do not administer reconstituted solution showing uncharacteristic color or containing particulates
            • Before withdrawing the reconstituted solution from the vial, gently invert vial 3 times
            • Withdraw 5 mL (300 mg) of reconstituted solution to 250 mL 0.9% NaCl and gently mix the infusion bag any remaining portion of the reconstituted solution in the vial; discard any unused solution remaining in the vial

            IV Administration

            Infuse over 30 min

            Do not administer as an IV push or bolus

            After infusion is complete, flush with 30 mL of sterile 0.9% NaCl or sterile Lactated Ringer

            Storage

            Unopened vials

            • Refrigerate unopened vials at 2-8°C (36-46ºF)
            • Retain in original package to protect from light

            Diluted infusion solution

            • If necessary, may be stored for up to 4 hr at 2-8°C (36- 46ºF)
            • Do not freeze
            • Discard any unused portion of the infusion solution
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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.