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IV Dilution  ENTYVIO- vedolizumab injection

 ENTYVIO- vedolizumab injection

[ Usual Diluents ] [ Standard Dilution ] [ Storage and Stability ]
DESCRIPTION CLINICAL PHARMACOLOGY INDICATIONS AND USAGE
CONTRAINDICATIONS PRECAUTIONS ADVERSE REACTIONS
DOSAGE AND ADMINISTRATION HOW SUPPLIED WARNINGS
PRESCRIBING HIGHLIGHTS:  Please see package insert for additional information and possible updates to ensure safe and effective use of this medication. The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment. Neither GlobalRPh Inc. nor any other party involved in the preparation of this program shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material. Please read the disclaimer carefully BEFORE accessing or using this site. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER.  

Drug UPDATES:   [Drug information  /  PDF]  
PACKAGE INSERT -Dosing:  Click (+) next to Dosage and Administration section (drug info link)
 

Usual Diluents top of page

NS

Standard Dilutions   [Amount of drug] [Infusion volume] [Infusion rate] top of page

[300mg]  [250 ml]  [30 minutes]

Administer ENTYVIO as an intravenous infusion over 30 minutes. Do not administer as an intravenous push or bolus. ENTYVIO lyophilized powder must be reconstituted with Sterile Water for injection and diluted in 250 mL of sterile 0.9% Sodium Chloride injection prior to administration. After the infusion is complete, flush with 30 mL of sterile 0.9% Sodium Chloride injection.

Reconstitution Instructions

Reconstitute ENTYVIO at room temperature. ENTYVIO should be reconstituted and prepared by a trained medical professional using aseptic technique by the following procedure:

1.
Remove the flip-off cap from the single-dose vial and wipe with alcohol swab. Reconstitute ENTYVIO vial containing lyophilized powder with 4.8 mL of Sterile Water for injection, using a syringe with a 21 to 25 gauge needle.
2.
Insert the syringe needle into the vial through the center of the stopper and direct the stream of Sterile Water for injection to the glass wall of the vial to avoid excessive foaming.
3.
Gently swirl the vial for at least 15 seconds to dissolve the lyophilized powder. Do not vigorously shake or invert.
4.
Allow the solution to sit for up to 20 minutes at room temperature to allow for reconstitution and for any foam to settle; the vial can be swirled and inspected 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.
5.
Visually inspect the reconstituted ENTYVIO solution for particulate matter and discoloration prior to 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.
6.
Prior to withdrawing the reconstituted ENTYVIO solution from the vial, gently invert vial three times.
7.
Withdraw 5 mL (300 mg) of reconstituted ENTYVIO solution using a syringe with a 21 to 25 gauge needle. Discard any remaining portion of the reconstituted solution in the vial.

Dilution Instructions

Add the 5 mL (300 mg) of reconstituted ENTYVIO solution to 250 mL of sterile 0.9% Sodium Chloride and gently mix the infusion bag. Do not add other medicinal products to the prepared infusion solution or intravenous infusion set. Once reconstituted and diluted, use the infusion solution as soon as possible.

Stability data:

Stability
Refrigerated
Stability
Room Temp.
Reconstituted
Vial/Powder
Notes P-Insert
UUpdated
Unopened vials:
Refrigerate unopened vials at 2° to 8°C (36º to 46ºF). Retain in original package to protect from light.

Solution:
If necessary, the infusion solution may be stored for up to four hours at 2° to 8°C (36º to 46ºF). Do not freeze. Discard any unused portion of the infusion solution.
Vials:: discard unused solution. Vials: discard unused solution. 5/2014

WARNINGS  top of page

See warnings and precautions below.


DESCRIPTION  top of page

Description:
ENTYVIO (vedolizumab), an integrin receptor antagonist, is a humanized IgG1 monoclonal antibody produced in Chinese hamster ovary cells that binds to the human a4ß7 integrin. ENTYVIO has an approximate molecular weight of 147 kilodaltons.

ENTYVIO is supplied as a sterile, white to off-white, preservative-free, lyophilized cake for intravenous infusion. After reconstitution with 4.8 mL Sterile Water for Injection, USP, the resulting pH is approximately 6.3.

Each single-use vial contains 300 mg vedolizumab, 23 mg L-histidine, 21.4 mg L-histidine monohydrochloride, 131.7 mg L-arginine hydrochloride, 500 mg sucrose and 3 mg polysorbate 80.

CLINICAL PHARMACOLOGY: top of page

Mechanism of Action:
Vedolizumab is a humanized monoclonal antibody that specifically binds to the a4ß7 integrin and blocks the interaction of a4ß7 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. Vedolizumab does not bind to or inhibit function of the a4ß1 and aEß7 integrins and does not antagonize the interaction of a4 integrins with vascular cell adhesion molecule-1 (VCAM-1).

The a4ß7 integrin is expressed on the surface of a discrete subset of memory T-lymphocytes that preferentially migrate into the gastrointestinal tract. MAdCAM-1 is mainly expressed on gut endothelial cells and plays a critical role in the homing of T-lymphocytes to gut lymph tissue. The interaction of the a4ß7 integrin with MAdCAM-1 has been implicated as an important contributor to the chronic inflammation that is a hallmark of ulcerative colitis and Crohn’s disease.

INDICATIONS AND USAGE  top of page


1.1 Adult Ulcerative Colitis

ENTYVIO (vedolizumab) is indicated for:

inducing and maintaining clinical response,
inducing and maintaining clinical remission,
improving the endoscopic appearance of the mucosa, and
achieving corticosteroid-free remission

in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to a tumor necrosis factor (TNF) blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids.

1.2 Adult Crohn’s Disease

ENTYVIO (vedolizumab) is indicated for:

achieving clinical response,
achieving clinical remission, and
achieving corticosteroid-free remission

in adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to a tumor necrosis factor (TNF) blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids.


CONTRAINDICATIONS top of page

Contraindications:
ENTYVIO is contraindicated in patients who have had a known serious or severe hypersensitivity reaction to ENTYVIO or any of its excipients (such as dyspnea, bronchospasm, urticaria, flushing, rash and increased heart rate)


PRECAUTIONS top of page

WARNINGS AND PRECAUTIONS:
Hypersensitivity Reactions (including anaphylaxis): Discontinue ENTYVIO if anaphylaxis or other serious allergic reactions occur. ( 5.1)
Infections: Treatment with ENTYVIO is not recommended in patients with active, severe infections until the infections are controlled. Consider withholding ENTYVIO in patients who develop a severe infection while on treatment with ENTYVIO. ( 5.2)
Progressive Multifocal Leukoencephalopathy: Although no cases have been observed in ENTYVIO clinical trials, JCV infection resulting in progressive multifocal leukoencephalopathy (PML) and death has occurred in patients treated with another integrin receptor antagonist. A risk of PML cannot be ruled out. Monitor patients for any new or worsening neurological signs or symptoms. ( 5.3)

ADVERSE REACTIONS top of page

ADVERSE REACTIONS:

Most common adverse reactions (incidence geq3% and geq1% higher than placebo): nasopharyngitis, headache, arthralgia, nausea, pyrexia, upper respiratory tract infection, fatigue, cough, bronchitis, influenza, back pain, rash, pruritus, sinusitis, oropharyngeal pain, and pain in extremities. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals at 1-877-TAKEDA-7 (1-877-825-3327) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 5/2014
See PACKAGE INSERT for PATIENT COUNSELING INFORMATION and Medication Guide.

DOSAGE AND ADMINISTRATION  top of page

DOSAGE AND ADMINISTRATION:

2.1 Important Administration Instructions

Administer ENTYVIO as an intravenous infusion over 30 minutes. Do not administer as an intravenous push or bolus. ENTYVIO lyophilized powder must be reconstituted with Sterile Water for injection and diluted in 250 mL of sterile 0.9% Sodium Chloride injection prior to administration [see Dosage and Administration (2.4)]. After the infusion is complete, flush with 30 mL of sterile 0.9% Sodium Chloride injection.

ENTYVIO should be administered by a healthcare professional prepared to manage hypersensitivity reactions including anaphylaxis, if they occur. Appropriate monitoring and medical support measures should be available for immediate use. Observe patients during infusion and until the infusion is complete.

2.2 Prior to Administration of ENTYVIO

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

2.3 Dosage in Adults with Ulcerative Colitis or Crohn’s Disease

The recommended dosage of ENTYVIO in adults with ulcerative colitis or Crohn's disease is 300 mg administered by intravenous infusion at zero, two and six weeks and then every eight weeks thereafter.

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

2.4 Reconstitution and Dilution Instructions

Reconstitution Instructions

Reconstitute ENTYVIO at room temperature. ENTYVIO should be reconstituted and prepared by a trained medical professional using aseptic technique by the following procedure:

1.
Remove the flip-off cap from the single-dose vial and wipe with alcohol swab. Reconstitute ENTYVIO vial containing lyophilized powder with 4.8 mL of Sterile Water for injection, using a syringe with a 21 to 25 gauge needle.
2.
Insert the syringe needle into the vial through the center of the stopper and direct the stream of Sterile Water for injection to the glass wall of the vial to avoid excessive foaming.
3.
Gently swirl the vial for at least 15 seconds to dissolve the lyophilized powder. Do not vigorously shake or invert.
4.
Allow the solution to sit for up to 20 minutes at room temperature to allow for reconstitution and for any foam to settle; the vial can be swirled and inspected 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.
5.
Visually inspect the reconstituted ENTYVIO solution for particulate matter and discoloration prior to 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.
6.
Prior to withdrawing the reconstituted ENTYVIO solution from the vial, gently invert vial three times.
7.
Withdraw 5 mL (300 mg) of reconstituted ENTYVIO solution using a syringe with a 21 to 25 gauge needle. Discard any remaining portion of the reconstituted solution in the vial.

Dilution Instructions

Add the 5 mL (300 mg) of reconstituted ENTYVIO solution to 250 mL of sterile 0.9% Sodium Chloride and gently mix the infusion bag. Do not add other medicinal products to the prepared infusion solution or intravenous infusion set. Once reconstituted and diluted, use the infusion solution as soon as possible.

Storage

If necessary, the infusion solution may be stored for up to four hours at 2° to 8°C (36º to 46ºF). Do not freeze. Discard any unused portion of the infusion solution.


HOW SUPPLIED  top of page

DOSAGE FORMS AND STRENGTHS:
ENTYVIO for injection: 300 mg of vedolizumab as a lyophilized cake in single dose 20 mL vials for reconstitution.

Storage and Stability top of page


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



Disclaimer
The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment. Neither GlobalRPh Inc. nor any other party involved in the preparation of this program shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material.  PLEASE READ THE DISCLAIMER CAREFULLY BEFORE ACCESSING OR USING THIS SITE. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER.
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