Entyvio Infusion

Vedolizumab

300mg

TAKEDA PHARMA A/S

Pack size	1 Glass Vial
Dispensing mode	POM
Source	DENMARK
Agent	Modern Pharmaceutical Co.
Retail Price	15751.00 AED

Indications

Entyvio Infusion is used for: Ulcerative colitis, Crohn's disease

Adult Dose

Intravenous Ulcerative colitis Adult: In patients with moderate to severe, refractory cases: 300 mg via infusion over 30 minutes at 0, 2, and 6 weeks, then every 8 weeks thereafter or every 4 weeks if response declines. Discontinue treatment after 14 weeks if no therapeutic benefit is achieved. If restarting treatment after interruption for up to 1 year, consider increasing dosing frequency to every 4 weeks. Crohn's disease Adult: In patients with moderate to severe, refractory cases: 300 mg via infusion over 30 minutes at 0, 2, and 6 weeks, then every 8 weeks thereafter or every 4 weeks if response declines. May give additional dose at week 10 in patients with inadequate response. Discontinue treatment by week 14, if no therapeutic benefit is achieved. If restarting treatment after interruption for up to 1 year, consider increasing dosing frequency to every 4 weeks.

Child Dose

Renal Dose

Administration

IV Preparation Reconstitution Reconstitute vial containing lyophilized powder with 4.8 mL sterile water for injection, using a syringe with a 21- to 25-gauge needle Insert 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 Gently swirl the vial for at least 15 seconds to dissolve the lyophilized powder; do NOT vigorously shake or invert 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 Visually inspect the reconstituted 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 Prior to withdrawing the reconstituted solution from the vial, gently invert vial 3 times Withdraw 5 mL (300 mg) of reconstituted solution using a syringe with a 21- to 25-gauge needle Discard any remaining portion of the reconstituted solution in the vial Further dilution Add the 5 mL (300 mg) of reconstituted solution to 250 mL 0.9% NaCl and gently mix the infusion bag Once reconstituted and diluted, use the infusion solution as soon as possible IV Administration Infuse IV over 30 minutes; do not administer as IV push or bolus Administer 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

Contra Indications

Hypersensitivity. Uncontrolled and active severe infections (e.g. TB, sepsis, cytomegalovirus, listeriosis) and opportunistic infections (e.g. progressive multifocal leukoencephalopathy).

Precautions

Patient with chronic severe infection or history of recurring severe infections. Pregnancy and lactation.

Pregnancy-Lactation

Pregnancy Available pharmacovigilance data, data from ongoing pregnancy registry, and data from published case reports and cohort studies in pregnant women have not identified an associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes associated with therapy; there are risks to mother and fetus associated with inflammatory bowel disease in pregnancy 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 2500 g) infants, and small for gestational age at birth Drug administered during pregnancy could affect immune responses in the in utero exposed newborn and infant; the clinical significance of low levels of drug in utero exposed infants is unknown; safety of administering live or live-attenuated vaccines in exposed infants is unknown Animal data No fetal harm was observed in animal reproduction studies with intravenous administration of vedolizumab to rabbits and monkeys at dose levels 20 times the recommended human dosage 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; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from drug or from underlying maternal condition

Interactions

May enhance adverse effect of natalizumab. Enhanced adverse/toxic effect with anti-tumour necrosis factor agents. May diminish therapeutic effect and enhance the adverse effects of live vaccines.

Adverse Effects

Side effects of Vedolizumab : >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)

Mechanism of Action

Vedolizumab, a humanised IgG1 monoclonal antibody, which selectively binds to α4ß7 integrin, expressed on gut homing T lymphocyte. This blocks the adhesion of α4ß7 to mucosal addressin cell adhesion molecule-1 (MAdCAM-1) thereby inhibiting the migration of memory T-lymphocytes across the gastrointestinal parenchymal tissue thus reducing inflammation.

Note

Entyvio 300mg Infusion manufactured by TAKEDA PHARMA A/S. Its generic name is Vedolizumab. Entyvio is availble in United Arab Emirates. Farmaco UAE drug index information on Entyvio Infusion is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.