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vedolizumab

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Overview

What is Entyvio?

Vedolizumab, an integrin receptor antagonist, is a humanized IgG monoclonal antibody produced in Chinese hamster ovary cells that binds to the human α4β7 integrin. ENTYVIO has an approximate molecular weight of 147 kilodaltons.

ENTYVIO (vedolizumab) for injection 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 final concentration is 60 mg/mL with a deliverable volume of 5 mL (300 mg) and the resulting pH is approximately 6.3.

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



What does Entyvio look like?



What are the available doses of Entyvio?

For injection: 300 mg vedolizumab in a single-dose vial. ()

What should I talk to my health care provider before I take Entyvio?

How should I use Entyvio?

ENTYVIO (vedolizumab) is indicated for:

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.

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What interacts with Entyvio?

Sorry No Records found


What are the warnings of Entyvio?

Sorry No Records found


What are the precautions of Entyvio?

Sorry No Records found


What are the side effects of Entyvio?

Sorry No records found


What should I look out for while using Entyvio?

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) .


What might happen if I take too much Entyvio?

Sorry No Records found


How should I store and handle Entyvio?

Carton containing two epinephrine injection, USP auto-injectors 0.3 mg: NDC 0115-1694-49. Carton containing one epinephrine injection, USP auto-injector 0.3 mg: NDC 0115-1694-30. Carton containing two epinephrine injection, USP auto-injectors 0.15 mg: NDC 0115-1695-49. Carton containing one epinephrine injection, USP auto-injector 0.15 mg: NDC 0115-1695-30. Rx onlyCarton containing two epinephrine injection, USP auto-injectors 0.3 mg: NDC 0115-1694-49. Carton containing one epinephrine injection, USP auto-injector 0.3 mg: NDC 0115-1694-30. Carton containing two epinephrine injection, USP auto-injectors 0.15 mg: NDC 0115-1695-49. Carton containing one epinephrine injection, USP auto-injector 0.15 mg: NDC 0115-1695-30. Rx onlyENTYVIO (vedolizumab) for injection is supplied in sterile 20 mL single-dose glass vials, containing 300 mg of vedolizumab as a white to off-white lyophilized cake.Refrigerate unopened vials at 2° to 8°C (36° to 46°F). Retain in original package to protect from light.ENTYVIO (vedolizumab) for injection is supplied in sterile 20 mL single-dose glass vials, containing 300 mg of vedolizumab as a white to off-white lyophilized cake.Refrigerate unopened vials at 2° to 8°C (36° to 46°F). Retain in original package to protect from light.


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Vedolizumab is a humanized monoclonal antibody that 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. Vedolizumab does not bind to or inhibit function of the α4β1 and αEβ7 integrins and does not antagonize the interaction of α4 integrins with vascular cell adhesion molecule-1 (VCAM-1).

The α4β7 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 α4β7 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.

Non-Clinical Toxicology
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) .

Interaction with central nervous system depressants other than benzodiazepines has not been specifically studied; however, no deleterious interactions were seen when flumazenil was administered after narcotics, inhalational anesthetics, muscle relaxants and muscle relaxant antagonists administered in conjunction with sedation or anesthesia.

Particular caution is necessary when using flumazenil in cases of mixed drug overdosage since the toxic effects (such as convulsions and cardiac dysrhythmias) of other drugs taken in overdose (especially cyclic antidepressants) may emerge with the reversal of the benzodiazepine effect by flumazenil (see ).

The use of flumazenil is not recommended in epileptic patients who have been receiving benzodiazepine treatment for a prolonged period. Although flumazenil exerts a slight intrinsic anticonvulsant effect, its abrupt suppression of the protective effect of a benzodiazepine agonist can give rise to convulsions in epileptic patients.

Flumazenil blocks the central effects of benzodiazepines by competitive interaction at the receptor level. The effects of nonbenzodiazepine agonists at benzodiazepine receptors, such as zopiclone, triazolopyridazines and others, are also blocked by flumazenil.

The pharmacokinetics of benzodiazepines are unaltered in the presence of flumazenil and vice versa.

There is no pharmacokinetic interaction between ethanol and flumazenil.

In UC Trials I and II and CD Trials I and III, hypersensitivity reactions occurred including a case of anaphylaxis (one out of 1434 patients [0.07%]). Allergic reactions including dyspnea, bronchospasm, urticaria, flushing, rash, and increased blood pressure and heart rate have also been observed. The majority were mild to moderate in severity as assessed by the investigator. Experience with other biologic medications suggests that hypersensitivity reactions and anaphylaxis to ENTYVIO may vary in their time of onset from during infusion or immediately post-infusion to occurring up to several hours post-infusion.

If anaphylaxis or other serious allergic reactions occur, discontinue administration of ENTYVIO immediately and initiate appropriate treatment (e.g., epinephrine and antihistamines).

The following topics are also discussed in detail in the Warnings and Precautions section:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).