ENTYVIO Dosage & Rx Info | Uses, Side Effects

Entyvio Generic Name & Formulations

Legal Class

General Description

Vedolizumab 300mg/vial (lyophilized pwd for IV infusion after reconstitution and dilution); 108mg/0.68mL (soln for SC inj); both: preservative-free.

Pharmacological Class

Integrin receptor antagonist.

How Supplied

Single-dose vial (20mL), prefilled syringe, prefilled pen—1

Storage

Refrigerate Entyvio unopened vials, prefilled syringes, and prefilled pens at 2°C to 8°C (36° to 46°F).

If needed, the Entyvio prefilled syringe or pen can be left out of the
refrigerator in the original package at room temperature up to 25°C (77°F) for up to 7 days (for example, when traveling). Do not use Entyvio prefilled syringe or pen if left out of the refrigerator for more than 7 days.

Do not freeze Entyvio vial, prefilled syringe, or prefilled pen. Do not use Entyvio vial, prefilled syringe, or prefilled pen if it has been frozen.

Manufacturer

Takeda Pharmaceutical Company

Generic Availability

Mechanism of Action

Vedolizumab specifically binds to the 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.

Entyvio Indications

Indications

Moderately to severely active ulcerative colitis (UC) or Crohn’s disease (CD).

Entyvio Dosage and Administration

Adult

≥18yrs: IV regimen: give 300mg IV infusion over 30mins at Weeks 0, 2, and 6, then every 8 weeks thereafter. SC regimen: give SC inj into thighs, abdomen, or upper arms. After the first 2 IV doses given (Week 0 and Week 2), may be switched to 108mg by SC inj every 2 weeks at Week 6 and thereafter. For those with clinical response or remission beyond Week 6, may be switched from IV infusion to SC inj. For both regimens: discontinue if no therapeutic benefit by Week 14.

Children

<18yrs: not established.

Entyvio Contraindications

Not Applicable

Entyvio Boxed Warnings

Not Applicable

Entyvio Warnings/Precautions

Warnings/Precautions

Complete all immunizations according to current guidelines before initiating. Monitor for hypersensitivity reactions during and after infusion. Have epinephrine and antihistamines available. Discontinue if anaphylaxis or other serious infusion-related or hypersensitivity reactions occur. Active, severe infections: not recommended until controlled. Consider withholding if severe infection develops. History of recurring severe infections. Consider tuberculosis screening. Monitor for neurological signs/symptoms (those associated with progressive multifocal leukoencephalopathy [PML]); withhold dosing if suspected; permanently discontinue if confirmed. Discontinue if jaundice or significant liver injury occurs. Pregnancy. Nursing mothers.

Entyvio Pharmacokinetics

Absorption

Bioavailability: ~75% following a 108mg single-dose subcutaneous injection. Median time to maximum concentration was 7 days (range, 3 to 14 days) and mean maximum concentration was 15.4 mcg/mL following a 108mg single-dose subcutaneous injection.

Distribution

Volume of distribution: ~5 L.

Elimination

Half-life: ~24 days. Clearance: ~0.169 L/day.

Entyvio Interactions

Interactions

Avoid concomitant natalizumab, TNF blockers. Caution with concomitant live vaccines.

Entyvio Adverse Reactions

Adverse Reactions

Nasopharyngitis, headache, arthralgia, nausea, pyrexia, upper respiratory tract infection, fatigue, cough, bronchitis, influenza, back pain, rash, pruritus, sinusitis, oropharyngeal pain, pain in extremities; infusion-related or hypersensitivity reactions, PML.

Entyvio

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