Entyvio Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage Patient Counseling Information MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Vedolizumab

Indications/Uses

Moderate to severe active ulcerative colitis & Crohn's disease in adults who had inadequate response w/, lost response to or were intolerant to either conventional therapy or tumor necrosis factor-α (TNFα) antagonist.

Click to view Entyvio detailed prescribing information

Dosage/Direction for Use

Ulcerative colitis & Crohn's disease IV 300 mg infusion at wk 0, 2 & 6 wk then every 8 wk thereafter, may be increased to every 4 wk. SC 108 mg once every 2 wk, 1st SC maintenance dose to be administered in place of next scheduled IV dose & every 2 wk thereafter.

Click to view Entyvio detailed prescribing information

Overdosage

View Entyvio overdosage for action to be taken in the event of an overdose.

Contraindications

Hypersensitivity. Soln for inj: Active severe infections eg, TB, sepsis, cytomegalovirus, listeriosis & opportunistic infections eg, progressive multifocal leukoencephalopathy.

Click to view Entyvio detailed prescribing information

Special Precautions

Discontinue use if severe infusion-related, anaphylactic or other severe reactions occur or progressive multifocal leukoencephalopathy is confirmed. Not to be administered as IV push or bolus. Not to be initiated in active, severe infections eg, TB, sepsis, cytomegalovirus, listeriosis & opportunistic infections. Controlled chronic or history of recurring severe infections. Increased risk of malignancy. Not recommended in patients previously treated w/ biologic immunosuppressants eg, natalizumab. Concomitant use w/ non-live & live vaccines. May affect ability to drive & use machines. Renal or hepatic impairment. Pregnancy & lactation. Childn ≤17 yr. Soln for inj: Patients w/ severe active disease at baseline not previously treated w/ TNFα antagonists. Not recommended in patients previously treated w/ rituximab. Women of childbearing potential should use adequate contraception & continue for at least 18 wk after last dose.

Click to view Entyvio detailed prescribing information

Use In Pregnancy & Lactation

Click to view Entyvio detailed prescribing information

Adverse Reactions

Nasopharyngitis; headache; arthralgia. URTI, bronchitis, flu, sinusitis; cough, oropharyngeal pain; nausea; rash, pruritus; back pain, pain in extremities; pyrexia, fatigue. Soln for inj: Pneumonia, Clostridium difficile infection, gastroenteritis, pharyngitis, herpes zoster; paraesthesia; HTN; nasal congestion; anal abscess & fissure, dyspepsia, constipation, abdominal distension, flatulence, haemorrhoids; eczema, erythema, night sweats, acne; muscle spasms & weakness; inj site reactions.

Click to view Entyvio detailed prescribing information

Caution For Usage

For caution against possible variation of physical aspect of medicine... Click to view Entyvio detailed prescribing information

Storage

View Entyvio storage conditions for details to ensure optimal shelf-life.

Description

View Entyvio description for details of the chemical structure and excipients (inactive components).

Action

View Entyvio mechanism of action for pharmacodynamics and pharmacokinetics details.

MIMS Class

GIT Regulators, Antiflatulents & Anti-Inflammatories / Immunosuppressants

ATC Classification

L04AG05 - vedolizumab ; Belongs to the class of monoclonal antibodies. Used as immunosuppressants.

Regulatory Classification

Patient Counseling Information

View Entyvio patient counselling information

Presentation/Packing

Form

Entyvio infusion conc 300 mg

Packing/Price

(single-dose) 1's

Form

Entyvio soln for inj 108 mg/0.68 mL

Packing/Price

1's;2's

Entyvio

vedolizumab

Manufacturer:

Takeda

Distributor:

Zuellig Pharma