Entyvio 300mg Inj, 1 Vial

Vedolizumab is a humanized monoclonal antibody that specifically binds to the α4β7 integrin, which is expressed on the surface of a subset of gut-homing T lymphocytes. By binding to α4β7 integrin, vedolizumab blocks the interaction of α4β7 integrin with mucosal addressin cell adhesion molecule-1 (MAdCAM-1), which is primarily expressed on endothelial cells of the gastrointestinal tract. This interaction prevents the migration of these gut-homing T lymphocytes across the endothelium into the inflamed gastrointestinal parenchyma, thereby reducing inflammation in the gut.

Serious Side Effects: Seek Medical Attention Immediately

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of infection, including:
+ Fever
+ Chills
+ Severe sore throat
+ Ear or sinus pain
+ Cough
+ Increased or changed sputum production
+ Painful urination
+ Mouth sores
+ Wounds that won't heal
Signs of liver problems, such as:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Signs of high blood pressure, including:
+ Severe headache or dizziness
+ Fainting
+ Changes in vision
Shortness of breath
Dizziness
Flushing
Fast or abnormal heartbeat
A rare but serious brain condition called progressive multifocal leukoencephalopathy (PML) may occur. If you experience any of the following symptoms, contact your doctor immediately:
+ Confusion
+ Memory problems
+ Depression
+ Changes in behavior
+ Weakness on one side of the body
+ Difficulty speaking or thinking
+ Balance problems
+ Changes in vision

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only mild ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or don't go away, contact your doctor:

Back pain
Common cold symptoms
Headache
Joint pain
Upset stomach
Nose or throat irritation
Pain in arms or legs
Feeling tired or weak
Injection site reactions, such as bruising, itching, pain, redness, swelling, or other symptoms

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you currently have an infection.
* If you are taking any of the following medications: Adalimumab, Certolizumab, Etanercept, Golimumab, Infliximab, or Natalizumab.

Please note that this is not an exhaustive list of all potential interactions. To ensure your safety, it is crucial to discuss all of your medications (including prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. Before starting, stopping, or changing the dosage of any medication, consult with your doctor to confirm that it is safe to do so in conjunction with this medication.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regular blood tests will be necessary, as directed by your doctor, to monitor your condition. Be sure to discuss any concerns or questions with your doctor.

As this medication may increase your risk of developing infections, some of which can be severe or life-threatening, it is crucial to take precautions. To minimize this risk, wash your hands frequently and avoid close contact with individuals who have infections, colds, or flu.

Before starting treatment with this drug, you may need to undergo a tuberculosis (TB) test. Additionally, ensure that you are up to date with all recommended vaccinations. However, consult your doctor before receiving any vaccines, as some may not be effective or may increase the risk of infection when used in conjunction with this medication.

Some patients may experience severe side effects during or after the infusion, which can occur several hours after the infusion is complete. If you experience any adverse effects during or after the infusion, promptly notify your doctor.

If you are pregnant, planning to become pregnant, or breastfeeding, it is essential to discuss the potential benefits and risks of this medication with your doctor. If you have used this drug during pregnancy, be sure to inform your baby's doctor.

• Live vaccines (e.g., measles, mumps, rubella, polio, BCG, yellow fever, varicella, rotavirus, live attenuated influenza vaccine) during vedolizumab treatment.

• Immunosuppressants (e.g., TNF inhibitors, corticosteroids, azathioprine, 6-mercaptopurine, methotrexate): Concomitant use may increase the risk of serious infections. Use with caution.
• Natalizumab: Concomitant use is not recommended due to potential additive immunosuppressive effects and increased risk of progressive multifocal leukoencephalopathy (PML).

• Signs of infection (fever, chills, persistent cough, fatigue, skin lesions, painful urination)
• Symptoms of infusion-related reactions (rash, itching, hives, shortness of breath, dizziness, flushing, headache)
• Signs of liver injury (yellowing of skin/eyes, dark urine, severe abdominal pain, unusual fatigue)
• New or worsening neurological symptoms (confusion, memory problems, difficulty walking, vision changes, weakness on one side of the body, personality changes)

Vedolizumab is a humanized monoclonal antibody and is known to cross the placenta. Limited data from clinical trials and post-marketing experience suggest that vedolizumab does not increase the risk of major birth defects or miscarriage. However, due to limited data, use during pregnancy should be considered only if the potential benefit outweighs the potential risk to the fetus. Live vaccines are not recommended for infants exposed to vedolizumab in utero until 6 months of age.

Vedolizumab is present in human milk. The amount of vedolizumab in breast milk is low, and systemic absorption by a breastfed infant is expected to be minimal due to its large molecular weight and susceptibility to proteolytic degradation in the infant's gastrointestinal tract. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for vedolizumab and any potential adverse effects on the breastfed infant from vedolizumab or from the underlying maternal condition. Monitor breastfed infants for signs of infection.

Approved for use in pediatric patients 6 years of age and older with moderately to severely active ulcerative colitis or Crohn's disease. Dosing is the same as adults (300 mg IV at weeks 0, 2, 6, then every 8 weeks). Safety and efficacy in pediatric patients younger than 6 years have not been established.

No overall differences in safety or effectiveness were observed between elderly patients (≥65 years) and younger patients, but greater sensitivity of some older individuals cannot be ruled out. No specific dose adjustment is required based on age.

• Vedolizumab is gut-selective, meaning it primarily targets inflammation in the gastrointestinal tract, potentially leading to a lower risk of systemic immunosuppression compared to other biologics.
• Onset of action can be slower than some other biologics; patients may not see full benefit for several weeks or months.
• Patients should be screened for TB and HBV prior to initiation.
• Infusion reactions are possible, so patients should be monitored during and after infusions.
• The risk of Progressive Multifocal Leukoencephalopathy (PML) is very low with vedolizumab, but patients should be educated on neurological symptoms and report them immediately.
• Live vaccines are contraindicated during treatment and for 6 months after discontinuation.

• TNF inhibitors (e.g., Infliximab, Adalimumab, Golimumab, Certolizumab pegol)
• Interleukin-12/23 inhibitors (e.g., Ustekinumab)
• Janus Kinase (JAK) inhibitors (e.g., Tofacitinib, Upadacitinib)
• S1P receptor modulators (e.g., Ozanimod)
• Immunomodulators (e.g., Azathioprine, 6-mercaptopurine, Methotrexate)
• Corticosteroids (e.g., Prednisone, Budesonide)
• 5-aminosalicylates (5-ASAs) (e.g., Mesalamine, Sulfasalazine)

If your symptoms or health problems persist or worsen, it is essential to contact your doctor for further guidance. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed to do so by a healthcare professional, do not flush medications down the toilet or drain. If you are unsure about the proper disposal method, consult your pharmacist for advice. Many communities have drug take-back programs, which your pharmacist can help you locate. Some medications may come with an additional patient information leaflet; check with your pharmacist to see if this applies to your prescription. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it was taken to ensure prompt and effective treatment.