Vedolizumab (Entyvio hcp) is a humanized monoclonal antibody that binds to the alpha-4beta-7 integrin (an important contributor to chronic inflammation.

Entyvio in Crohn's disease:

Entyvio is used in the treatment of moderately to severely active Crohn disease in those patients who have had an inadequate response with or were not tolerating TNF inhibitors or immunomodulators or demonstrated dependence on corticosteroids.

Entyvio (Vedolizumab) in Ulcerative colitis:

• It is also used in the treatment of moderately to severely active ulcerative colitis in patients who have had an inadequate response with or were not tolerating TNF inhibitors or immunomodulators or demonstrated dependence on corticosteroids.

Entyvio hcp prescribing information:

Before initiating treatment, all patients should be guided with all immunizations according to current immunization guidelines.

Entyvio ( Vedolizumab) Dose in Adults

Entyvio (Vedolizumab) in the treatment of Crohn's disease or ulcerative colitis:

• It is given 300 mg intravenously at 0, 2, and 6 weeks
• It is then given every 8 weeks thereafter.
• Stop therapy in patients who have no evidence of benefit by week 14.

Entyvio ( Vedolizumab) Dose in Childrens

It is not recommended for use in children.

Vedolizumab (Entyvio) FDA Pregnancy Risk Factor: B

• Vedolizumab crosses the placenta.
• It is not yet known if live vaccines can be administered to infants who have been exposed to Entyvio in utero.
• Preterm delivery, low birth weight, and small gestational age are all possible outcomes of inflammatory bowel disease.
• Pregnancy should not be a time for relapse.
• Very little information is available on the pregnancy use of vedolizumab.
• In some cases, however, it is appropriate to use.
• Women can use Entyvio during pregnancy if necessary.
• The current guidelines recommend that the last dose of vedolizumab be given 6-10 weeks before the expected date of delivery to reduce placental transfer (or 4 to 5 weeks before delivery, if the maternal dose was given every 4 weeks).
• You can resume treatment 48 hours after delivery.

Use Vedolizumab, Entyvio, during lactation

• Breast milk contains Vedolizumab.
• Breastfeeding during treatment should be considered in light of the risks to infants, the benefits to mothers, and the benefits to the infant.
• They note that breastfeeding is compatible with the maternal use of Vedolizumab.

Entyvio ( Vedolizumab) use in Renal disease:

• There are no dosage adjustments given in the manufacturer's labeling.

Entyvio hcp ( Vedolizumab) use in liver disease:

• There are no dosage adjustments given the manufacturer's labeling.
•  Stop if  jaundice or signs of hepatic injury are present

Common Side Effects of Vedolizumab (Entyvio hcp) Include:

• Central nervous system:

  • Headache

• Immunologic:

  • Antibody development

• Neuromuscular & skeletal:

  • Arthralgia

• Respiratory:

  • Nasopharyngitis

Less Common Side Effects of Entyvio (Vedolizumab) Include:

• Central nervous system:

  • Fatigue

• Dermatologic:

  • Pruritus
  • Skin rash

• Gastrointestinal:

  • Nausea

• Hepatic:

  • Increased serum ALT
  • Increased serum AST

• Infection:

  • Influenza

• Neuromuscular & skeletal:

  • Back pain
  • Limb pain

• Respiratory:

  • Upper respiratory tract infection
  • Cough
  • Bronchitis
  • Oropharyngeal pain
  • Sinusitis

• Miscellaneous:

  • Fever
  • Infusion-related reaction

Contraindication to Vedolizumab (Entyvio hcp) includes:

• Severe or severe allergic reactions to vedolizumab or any component of the formulation
• Patients with severe or opportunistic infections, such as active severe infections, should not be given this medication.

Warnings and precautions

• Hypersensitivity reactions
  • Anaphylaxis and hypersensitivity reactions were also seen.
  • There have been allergic reactions such as dyspnea and rash.
  • The time it takes for symptoms to manifest can vary depending on whether they occur during or after the infusion.
  • Stop administering medication immediately if you experience serious reactions.
• Infections
  • Use of it is associated with an increased chance of developing infections, i.e. upper respiratory and nasal mucosa infection.
  • Patients treated for serious infections include sepsis and anal abscess as well as tuberculosis, sepsis and salmonella sepsis.
  • Patients with severe infections should not use it.
  • If a patient develops a serious infection, he should discontinue therapy.
  • Patients with a history of severe, recurring infections should be cautious.
  • It is important to screen for tuberculosis.
• Injury to the liver:
  • Patients who received vedolizumab, also known as Entyvio hcp, experienced an increase in transaminase (and bilirubin) levels.
  • Patients with jaundice or any other indication of serious liver injuries such as fatigue, anorexia, and dark urine should be stopped from therapy.
  • Entyvio effects on the brain - Progressive multifocal encephalopathy
  • Integrin receptor antagonists, including Entyvio, have been linked to progressive multifocal Leukoencephalopathy(PML), a rare but deadly opportunistic infection in the central nervous system that is caused by the John Cunningham virus (JC).
  • Monitoring patients for neurological symptoms such as vision disturbances, progressive weakness or clumsiness on one side of their bodies, changes in memory, thinking, orientation, personality changes, and confusion should be done.
  • The symptoms could worsen over several days or even weeks.
  • It can lead to death or severe disability within weeks or months.
  • Stop therapy if PML is suspected and consult a neurologist
  • Stop treatment immediately if PML is confirmed

Vedolizumab: Drug Interaction

Monitor the patient when administering Entyvio infusion:

• Patients should be observed until the infusion is complete.
• Monitor for LFT, allergic reactions, tuberculosis screening according to local practice
• Look for clinical features of infection.
• Look for any new or worsening neurological signs.

How to administer Vedolizumab (Entyvio hcp)?

• Infuse over 30 minutes intravenously.
• Intravenous push or bolus should not be given.
• After infusion, flush with 30 mL of sterile 0.9% sodium chloride injection or LR.
• Patients should be observed during infusion (until complete)
• Observe for hypersensitivity reactions; discontinue if a reaction occurs.

Mechanism of action of Vedolizumab (Entyvio hcp):

• Vedolizumab, a monoclonal humanized antibody that binds the alpha-4 beta-7 Integrin, is available as a humanized monoclonal antibody.
• It prevents the interaction between alpha4beta7integrin and mucosal addressin-cell adhesion molecule-1(MAdCAM-1).
• It prevents memory T-lymphocytes from crossing the endothelium into inflamed tissue gastrointestinal parenchymal.
• It has been suggested that the interaction between the alpha4beta7 and MAdCAM-1 integrins is an important contributor to chronic inflammation, which is a hallmark of Crohn's disease and ulcerative colitis.

Half-life elimination: 25 days

Distribution: V: 5 L

International Brands of Vedolizumab:

• Entyvio (Costs around $3200 per month)
• Kynteles

Entyvio (Vedolizumab) Brands in Pakistan.

No Brands available in Pakistan.