Entyvio 108mg/0.68ml Inj, 0.68ml
It is used to treat Crohn's disease.It is used to treat ulcerative colitis.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Immunosuppressant, Integrin Receptor Antagonist
Pharmacologic Class
Selective Adhesion Molecule Inhibitor, Humanized Monoclonal Antibody
Pregnancy Category
Not assigned
FDA Approved
Mar 2020
DEA Schedule
Not Controlled
Overview
What is this medicine?
Entyvio is a medicine used to treat Crohn's disease and ulcerative colitis, which are types of inflammatory bowel disease. It works by targeting specific immune cells in your gut to reduce inflammation and help your intestines heal. It's given as an injection under the skin, usually every two weeks, after you've received initial doses through an IV.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered via injection into the fatty tissue of the skin, typically on the top of the thigh or in the belly area. If someone else is giving you the injection, it may be administered into the outer area of the upper arm.
If you will be self-administering the injection, your doctor or nurse will provide guidance on the proper technique. Before and after handling the medication, wash your hands thoroughly.
Preparing the Medication for Use
If the medication has been stored in the refrigerator, allow it to come to room temperature for 30 minutes before use. Do not heat the medication or expose it to direct sunlight.
Important Administration Guidelines
Rotate the injection site with each use to avoid damaging the skin.
Do not shake the medication.
The solution should be colorless to faintly yellow; do not use if it has changed color or appears cloudy, leaking, or contains particles.
Avoid injecting into skin within 2 inches (5 cm) of the belly button or into moles, scars, or irritated, tender, bruised, red, hard, or broken skin.
* Do not use the medication if it has been dropped or damaged.
Device Malfunction or Uncertainty
If your injection device is not functioning properly or you are unsure if you received the full dose, contact your doctor or pharmacist for assistance.
Disposal of Used Devices
Each prefilled pen or syringe is for single use only; discard the used device after administration. Dispose of needles in a designated needle/sharp disposal box and do not reuse needles or other items. When the box is full, follow local regulations for proper disposal. If you have any questions, consult with your doctor or pharmacist.
Storage and Disposal
Store the medication in the refrigerator, but do not freeze. Keep it in the original container to protect it from light. Do not use the medication if it has been frozen.
Missed Dose
If you miss a dose, take it as soon as you remember. After taking the missed dose, start a new schedule based on the time the dose was administered. If you are unsure about how to proceed, consult with your doctor. If you have any questions or concerns about missed doses, contact your doctor for guidance.
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered via injection into the fatty tissue of the skin, typically on the top of the thigh or in the belly area. If someone else is giving you the injection, it may be administered into the outer area of the upper arm.
If you will be self-administering the injection, your doctor or nurse will provide guidance on the proper technique. Before and after handling the medication, wash your hands thoroughly.
Preparing the Medication for Use
If the medication has been stored in the refrigerator, allow it to come to room temperature for 30 minutes before use. Do not heat the medication or expose it to direct sunlight.
Important Administration Guidelines
Rotate the injection site with each use to avoid damaging the skin.
Do not shake the medication.
The solution should be colorless to faintly yellow; do not use if it has changed color or appears cloudy, leaking, or contains particles.
Avoid injecting into skin within 2 inches (5 cm) of the belly button or into moles, scars, or irritated, tender, bruised, red, hard, or broken skin.
* Do not use the medication if it has been dropped or damaged.
Device Malfunction or Uncertainty
If your injection device is not functioning properly or you are unsure if you received the full dose, contact your doctor or pharmacist for assistance.
Disposal of Used Devices
Each prefilled pen or syringe is for single use only; discard the used device after administration. Dispose of needles in a designated needle/sharp disposal box and do not reuse needles or other items. When the box is full, follow local regulations for proper disposal. If you have any questions, consult with your doctor or pharmacist.
Storage and Disposal
Store the medication in the refrigerator, but do not freeze. Keep it in the original container to protect it from light. Do not use the medication if it has been frozen.
Missed Dose
If you miss a dose, take it as soon as you remember. After taking the missed dose, start a new schedule based on the time the dose was administered. If you are unsure about how to proceed, consult with your doctor. If you have any questions or concerns about missed doses, contact your doctor for guidance.
Lifestyle & Tips
- Avoid live vaccines while taking Entyvio and for a period after stopping, as your immune system may be weakened.
- Report any signs of infection (fever, chills, persistent cough, fatigue) to your doctor immediately.
- Maintain good hygiene to reduce the risk of infection.
- Inform all healthcare providers that you are taking Entyvio before any medical procedures or vaccinations.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
108 mg subcutaneously every 2 weeks, after completing at least 2 doses of Entyvio IV induction therapy.
Dose Range:
108 - 108 mg
Condition-Specific Dosing:
Ulcerative Colitis:
108 mg SC every 2 weeks (maintenance)
Crohn's Disease:
108 mg SC every 2 weeks (maintenance)
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (SC formulation)
Adolescent:
Not established (SC formulation)
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment needed
Moderate:
No dose adjustment needed
Severe:
No dose adjustment needed
Dialysis:
No specific recommendations; not expected to be dialyzable due to large molecular weight.
Hepatic Impairment:
Mild:
No dose adjustment needed
Moderate:
No dose adjustment needed
Severe:
No dose adjustment needed
Pharmacology
Mechanism of Action
Vedolizumab is a humanized monoclonal antibody that specifically binds to the ι4β7 integrin, which is expressed on the surface of a subset of gut-homing T lymphocytes. By binding to ι4β7 integrin, vedolizumab blocks the interaction of ι4β7 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 T lymphocytes across the endothelium into the inflamed gut tissue, thereby reducing inflammation. It does not block ι4β1 integrin, which is involved in brain immune surveillance, contributing to its gut-selective nature.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 80%
Tmax:
3 to 7 days
FoodEffect:
Not applicable (subcutaneous injection)
Distribution:
Vd:
Approximately 5.1 to 7.2 L
ProteinBinding:
Not applicable (monoclonal antibody)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 25 days (SC)
Clearance:
Approximately 0.15 L/day
ExcretionRoute:
Catabolism
Unchanged:
Not applicable (catabolized)
Pharmacodynamics
OnsetOfAction:
Clinical response typically observed within 6-10 weeks (after IV induction)
PeakEffect:
Steady-state concentrations achieved after approximately 3 doses (6 weeks) of SC maintenance therapy.
DurationOfAction:
Maintained with every 2-week dosing.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
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 immediately or seek emergency medical attention:
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
Abnormal or rapid heartbeat
Progressive multifocal leukoencephalopathy (PML), a rare but serious brain condition that can cause:
+ Confusion
+ Memory problems
+ Depression
+ Changes in behavior
+ Weakness on one side of the body
+ Speech or thinking difficulties
+ Balance problems
+ Vision changes
Other Possible Side Effects
Most people taking this medication will not experience severe side effects, and some may have only minor issues. However, if you notice any of the following side effects or if they persist or bother you, contact your doctor:
Back pain
Common cold symptoms
Headache
Joint pain
Upset stomach
Nose or throat irritation
Arm or leg pain
Fatigue or weakness
Injection site reactions, such as bruising, itching, pain, redness, swelling, or other irritation
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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 immediately or seek emergency medical attention:
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
Abnormal or rapid heartbeat
Progressive multifocal leukoencephalopathy (PML), a rare but serious brain condition that can cause:
+ Confusion
+ Memory problems
+ Depression
+ Changes in behavior
+ Weakness on one side of the body
+ Speech or thinking difficulties
+ Balance problems
+ Vision changes
Other Possible Side Effects
Most people taking this medication will not experience severe side effects, and some may have only minor issues. However, if you notice any of the following side effects or if they persist or bother you, contact your doctor:
Back pain
Common cold symptoms
Headache
Joint pain
Upset stomach
Nose or throat irritation
Arm or leg pain
Fatigue or weakness
Injection site reactions, such as bruising, itching, pain, redness, swelling, or other irritation
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Signs of serious infection (e.g., fever, chills, persistent cough, flu-like symptoms, skin redness/swelling)
- Signs of allergic reaction (e.g., rash, hives, itching, swelling of the face/lips/tongue/throat, difficulty breathing or swallowing, dizziness)
- Signs of liver problems (e.g., yellowing of skin/eyes, dark urine, severe stomach pain, unusual tiredness)
- New or worsening neurological symptoms (e.g., confusion, memory problems, vision changes, weakness on one side of the body, difficulty speaking or walking - these could be signs of a rare but serious brain infection called PML)
Before Using This Medicine
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 allergic reaction and its symptoms.
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 disclose all of your:
Prescription and over-the-counter (OTC) medications
Natural products
Vitamins
* Health problems
Your doctor and pharmacist need this information to assess the safety of taking this medication with your other treatments and health conditions. Never start, stop, or adjust the dose of any medication without first consulting 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 allergic reaction and its symptoms.
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 disclose all of your:
Prescription and over-the-counter (OTC) medications
Natural products
Vitamins
* Health problems
Your doctor and pharmacist need this information to assess the safety of taking this medication with your other treatments and health conditions. Never start, stop, or adjust the dose of any medication without first consulting your doctor.
Precautions & Cautions
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. Frequent handwashing and avoiding close contact with individuals who have infections, colds, or flu can help minimize this risk.
Before starting treatment with this drug, you may need to undergo a tuberculosis (TB) test to ensure you do not have a latent TB infection. Additionally, make sure you are up to date with all recommended vaccinations before beginning treatment. However, it is essential to consult with your doctor before receiving any vaccines, as some vaccines 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 within several hours after the infusion is completed. 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 vital to discuss the potential benefits and risks of this medication with your doctor to ensure the best possible outcome for you and your baby. If you have used this medication during pregnancy, be sure to inform your baby's doctor to ensure they are aware of any potential risks and can provide appropriate care.
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. Frequent handwashing and avoiding close contact with individuals who have infections, colds, or flu can help minimize this risk.
Before starting treatment with this drug, you may need to undergo a tuberculosis (TB) test to ensure you do not have a latent TB infection. Additionally, make sure you are up to date with all recommended vaccinations before beginning treatment. However, it is essential to consult with your doctor before receiving any vaccines, as some vaccines 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 within several hours after the infusion is completed. 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 vital to discuss the potential benefits and risks of this medication with your doctor to ensure the best possible outcome for you and your baby. If you have used this medication during pregnancy, be sure to inform your baby's doctor to ensure they are aware of any potential risks and can provide appropriate care.
Overdose Information
Overdose Symptoms:
- No specific symptoms of overdose have been reported in clinical trials. High doses may increase the risk of adverse effects, particularly infections.
What to Do:
In case of suspected overdose, contact a poison control center (e.g., 1-800-222-1222 in the US) or seek emergency medical attention. Management should be supportive and directed at treating any clinical symptoms.
Drug Interactions
Contraindicated Interactions
- Live vaccines (while on vedolizumab therapy)
Major Interactions
- Other immunosuppressants (e.g., TNF blockers, natalizumab, rituximab, cyclosporine, azathioprine, 6-mercaptopurine) - increased risk of serious infections and PML (Progressive Multifocal Leukoencephalopathy) with natalizumab.
Monitoring
Baseline Monitoring
Tuberculosis (TB) screening
Rationale: To rule out latent or active TB before initiating immunosuppressive therapy.
Timing: Prior to initiation of therapy
Hepatitis B virus (HBV) screening
Rationale: To assess for active or chronic HBV infection, as reactivation can occur with immunosuppression.
Timing: Prior to initiation of therapy
Hepatitis C virus (HCV) screening
Rationale: To assess for HCV infection.
Timing: Prior to initiation of therapy
Liver function tests (LFTs)
Rationale: To establish baseline liver function.
Timing: Prior to initiation of therapy
Routine Monitoring
Signs and symptoms of infection
Frequency: Continuously
Target: Absence of fever, chills, persistent cough, fatigue, malaise
Action Threshold: Any new or worsening signs/symptoms of infection; consider holding therapy and investigating.
Signs and symptoms of Progressive Multifocal Leukoencephalopathy (PML)
Frequency: Continuously
Target: Absence of new neurological symptoms (e.g., progressive weakness, vision changes, cognitive deficits)
Action Threshold: Any new neurological symptoms; discontinue therapy and refer for neurological evaluation.
Liver function tests (LFTs)
Frequency: Periodically, or as clinically indicated
Target: Within normal limits
Action Threshold: Significant elevations (e.g., >3x ULN); investigate and consider holding therapy.
Symptom Monitoring
- Fever
- Chills
- Persistent cough
- Fatigue
- Unusual bruising or bleeding
- Skin rash
- Swelling of face, lips, tongue, or throat
- Difficulty breathing or swallowing
- New or worsening neurological symptoms (e.g., confusion, dizziness, vision changes, weakness on one side of the body, difficulty speaking or walking)
Special Patient Groups
Pregnancy
Limited data on vedolizumab use in pregnant women. Human IgG1 antibodies are known to cross the placental barrier, particularly during the third trimester. Use during pregnancy only if the potential benefit outweighs the potential risk to the fetus. Consider the potential for altered immune response in infants exposed in utero.
Trimester-Specific Risks:
First Trimester:
Limited data; theoretical risk of immune system development interference.
Second Trimester:
Limited data; increasing placental transfer.
Third Trimester:
Significant placental transfer; potential for altered immune response in neonate (e.g., reduced vaccine response, increased infection risk).
Lactation
Vedolizumab is present in human milk at low levels. The risk to a breastfed infant appears to be low due to the drug's large molecular weight and likely degradation in the infant's gastrointestinal tract. Monitor breastfed infants for signs of infection or adverse effects.
Infant Risk:
Low
Pediatric Use
The subcutaneous formulation of Entyvio is not approved for pediatric patients. The intravenous formulation is approved for moderately to severely active ulcerative colitis and Crohn's disease in pediatric patients 2 years of age and older.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly and younger patients. However, the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy in elderly patients should be considered. Monitor for increased risk of infections.
Clinical Information
Clinical Pearls
- Vedolizumab is a gut-selective biologic, meaning it primarily targets inflammation in the gastrointestinal tract, potentially leading to a lower risk of systemic immunosuppression compared to non-gut-selective biologics.
- The subcutaneous formulation is for maintenance therapy only, following at least two doses of intravenous (IV) Entyvio induction therapy.
- Patients should be screened for tuberculosis (TB) and hepatitis B virus (HBV) before initiating therapy.
- Live vaccines should be avoided during treatment with vedolizumab.
- While the risk is very low, clinicians should be vigilant for signs and symptoms of Progressive Multifocal Leukoencephalopathy (PML), especially in patients with prior immunosuppressive therapy or other risk factors.
Alternative Therapies
- TNF inhibitors (e.g., infliximab, adalimumab, golimumab)
- Ustekinumab (IL-12/23 inhibitor)
- Tofacitinib (JAK inhibitor)
- Ozanimod (S1P receptor modulator)
- Corticosteroids (e.g., prednisone, budesonide)
- Conventional immunosuppressants (e.g., azathioprine, 6-mercaptopurine, methotrexate)
- Aminosalicylates (e.g., mesalamine, sulfasalazine)
Cost & Coverage
Average Cost:
Highly variable, typically several thousand USD per dose per 108 mg/0.68 mL prefilled syringe/pen
Insurance Coverage:
Specialty Tier (requires prior authorization, often step therapy)
General Drug Facts
If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about your treatment. It is crucial to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about your medication, do not hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, it is vital to seek immediate medical attention. Call your local poison control center or visit the emergency room right away. When seeking help, be prepared to provide detailed information about the overdose, including the name of the medication taken, the amount consumed, and the time it occurred. This information will help healthcare professionals provide you with the most appropriate care and treatment.
This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about your treatment. It is crucial to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about your medication, do not hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, it is vital to seek immediate medical attention. Call your local poison control center or visit the emergency room right away. When seeking help, be prepared to provide detailed information about the overdose, including the name of the medication taken, the amount consumed, and the time it occurred. This information will help healthcare professionals provide you with the most appropriate care and treatment.