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Entyvio (Vedolizumab)

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Entyvio
Vedolizumab
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Prescription Required.Product of Canada.Shipped from Canada.

Entyvio, a groundbreaking medication, has emerged as a pivotal treatment option for individuals living with certain gastrointestinal conditions. This innovative therapy represents a significant advancement in the management of chronic inflammatory diseases, offering new hope and improved outcomes for patients who have struggled with conventional treatments. Entyvio’s introduction into the medical field marks a crucial development, especially for those suffering from debilitating conditions like Ulcerative Colitis and Crohn’s Disease, where effective treatment options are critically needed.

What is Entyvio (vedolizumab)?

Entyvio, scientifically known as vedolizumab, is a biologic medication designed to treat specific autoimmune conditions affecting the gastrointestinal tract. Its active ingredient, vedolizumab, is a monoclonal antibody, a type of protein made in the laboratory that can bind to substances in the body. Entyvio works by targeting a specific protein known as integrin.

The mechanism of action of Entyvio is centered around its interaction with the ?4?7 integrin. This integrin is a crucial component in the migration of white blood cells into the gut. By selectively binding to the ?4?7 integrin, Entyvio effectively blocks the movement of these cells into inflamed gut regions, thereby reducing inflammation and its associated symptoms. Unlike other treatments that have broader effects on the immune system, Entyvio’s targeted approach focuses specifically on the gut, minimizing systemic immunosuppression and potentially reducing the risk of adverse effects commonly associated with other immune therapies.

This targeted mechanism of action makes Entyvio a unique and valuable treatment option for patients with moderate to severe Ulcerative Colitis and Crohn’s Disease, offering a more focused approach to managing these complex and often challenging conditions.

How is Entyvio Used?

Entyvio is a specialized medication used in the treatment of certain chronic gastrointestinal disorders. It is administered through intravenous infusion, typically at a healthcare facility under the supervision of medical professionals. The infusion process for Entyvio usually takes about 30 minutes.

Conditions Treated with Entyvio

  • Ulcerative Colitis: Entyvio is prescribed for adults with moderate to severe Ulcerative Colitis (UC), a chronic inflammatory bowel disease characterized by inflammation and ulcers in the lining of the colon and rectum.
  • Crohn’s Disease: It is also used for treating adults with moderate to severe Crohn’s Disease, another type of inflammatory bowel disease that causes inflammation of the digestive tract, which can lead to abdominal pain, severe diarrhea, fatigue, weight loss, and malnutrition.

Storage

Proper storage of Entyvio is crucial to maintain its efficacy and safety. Entyvio vials should be stored in a refrigerator at 2°C to 8°C (36°F to 46°F). They should not be frozen or shaken. The vials should be kept in their original carton to protect them from light until the time of use. It’s important to check the medication visually for particulate matter and discoloration before administration.

Dosage

The dosage of Entyvio is tailored to the individual patient and the specific condition being treated.

Standard Dosage Regimen

  • The typical dosage for both Ulcerative Colitis and Crohn’s Disease starts with an initial dose, followed by additional doses at two weeks and six weeks after the first infusion.
  • After this initial period, a maintenance dose is usually given every eight weeks.
  • Each dose of Entyvio is 300 mg.

Dosage Adjustments

  • Dosage adjustments may be necessary based on the patient’s response to treatment and clinical condition.
  • In some cases, if a patient has not responded adequately to the initial treatment, an increased dosing frequency may be considered.

It is essential for patients to follow their healthcare provider’s instructions regarding the dosage and administration schedule of Entyvio. Regular monitoring and follow-up appointments are necessary to assess the effectiveness of the treatment and make any necessary adjustments.

Side Effects

Entyvio, like all medications, can cause side effects, although not everyone will experience them. Understanding these side effects is crucial for patients and healthcare providers to manage and monitor the treatment effectively.

Common Side Effects

The most common side effects of Entyvio are usually mild to moderate and can include:

  • Headache: A frequent symptom experienced by patients, often manageable with standard pain relief medications.
  • Joint Pain: Discomfort or pain in the joints, which may require medical attention if persistent or severe.
  • Nausea: Feelings of sickness or discomfort in the stomach, which can sometimes be accompanied by vomiting.
  • Fever: A temporary increase in body temperature, often a sign of the body’s response to the medication.
  • Fatigue: A sense of tiredness or lack of energy, which may affect daily activities.
  • Common Cold Symptoms: Including sore throat, stuffy nose, or sneezing, which are usually mild.
  • Respiratory Infections: Such as bronchitis or sinus infections, which should be monitored and treated if they persist or worsen.

Serious Side Effects

While less common, some serious side effects may occur and require immediate medical attention:

  • Allergic Reactions: Symptoms such as rash, itching, swelling, severe dizziness, or trouble breathing.
  • Infections: Signs of serious infections include fever, chills, persistent sore throat, or other flu-like symptoms.
  • Liver Problems: Indicated by symptoms like yellowing eyes/skin, dark urine, severe stomach/abdominal pain, or persistent nausea/vomiting.
  • Heart Problems: Such as chest pain, shortness of breath, or irregular heartbeat.
  • Neurological Issues: Including vision changes, numbness/tingling of the extremities, or seizures.

Warnings and Precautions

Allergic Reactions

Patients may experience allergic reactions to Entyvio, which can range from mild to severe. Symptoms may include rash, itching, swelling of the face, lips, tongue, or throat, difficulty breathing, and dizziness. It is crucial to inform healthcare providers of any previous allergic reactions to vedolizumab or other biologic medications.

Risk of Infections

Entyvio can increase the risk of developing infections, including serious infections that could lead to hospitalization or death. Before starting treatment, patients should be screened for tuberculosis and other infections. Any signs of infection, such as fever, fatigue, cough, or flu-like symptoms, should be reported to a healthcare provider immediately.

Progressive Multifocal Leukoencephalopathy (PML)

Although rare, there is a risk of developing PML, a serious and potentially fatal brain infection caused by the John Cunningham (JC) virus. Symptoms of PML can include confusion, difficulty speaking or walking, vision problems, and weakness on one side of the body. Patients should be aware of these symptoms and report any neurological changes to their healthcare provider.

Liver Problems

Entyvio can cause liver injury, which may manifest as yellowing of the skin or eyes (jaundice), dark urine, abdominal pain, or elevated liver enzymes. Patients should undergo regular liver function tests, and any signs of liver problems should be promptly addressed.

Vaccinations

Live vaccines should be avoided during treatment with Entyvio, as the medication can impair the immune system’s response to the vaccine. Patients should ensure they are up to date on vaccinations before starting Entyvio, and any vaccination plans should be discussed with a healthcare provider.

Pregnancy and Breastfeeding

The effects of Entyvio on pregnant women and fetuses are not fully known. Women who are pregnant, planning to become pregnant, or breastfeeding should discuss the potential risks and benefits of Entyvio with their healthcare provider. A pregnancy registry exists for women who take Entyvio during pregnancy to monitor outcomes.

Drug Interactions

Entyvio can interact with other medications, including other immunosuppressants, which may increase the risk of infections or other side effects. Patients should provide their healthcare provider with a complete list of medications they are taking, including over-the-counter drugs and supplements.

Monitoring and Follow-up

Regular monitoring and follow-up appointments are essential to assess the effectiveness of Entyvio and to detect any adverse effects early. Patients should maintain open communication with their healthcare provider and report any new or worsening symptoms.

While Entyvio offers a promising treatment option for UC and Crohn’s Disease, it is accompanied by specific warnings and precautions that need careful consideration. Patients and healthcare providers must work closely together to ensure the safe and effective use of Entyvio, tailoring treatment plans to individual needs and monitoring for any potential risks.

Drug Interactions

Entyvio, as a targeted immunosuppressant, can interact with other medications, which may affect how it works or increase the risk of serious side effects. It’s crucial for patients to inform their healthcare providers about all the medications they are taking, including prescription drugs, over-the-counter medicines, and herbal supplements.

  • Immunosuppressants: Concurrent use of Entyvio with other immunosuppressants (like azathioprine, 6-mercaptopurine, or corticosteroids) may increase the risk of infections or other immune-related side effects.
  • Live Vaccines: Patients receiving Entyvio should avoid live vaccines, as the drug can impair the immune response to the vaccine, potentially leading to infections.
  • Biologic Therapies: Using Entyvio in combination with other biologic therapies that target the immune system (such as TNF blockers) is generally not recommended due to the increased risk of infections and other complications.
  • Antibiotics: While specific interactions with antibiotics are not well-documented, it’s important to monitor for any signs of infection, as Entyvio can affect the immune system’s ability to fight infections.

Overdose

An overdose of Entyvio is unlikely due to its administration in a controlled healthcare setting. However, in the event of an overdose, patients may experience exacerbated side effects or adverse reactions.

  • Symptoms: Overdose symptoms might include intensified common side effects or new adverse reactions.
  • Immediate Steps: If an overdose is suspected, immediate medical attention is necessary. Healthcare providers will monitor the patient for any adverse reactions and provide supportive care as needed.

Alternative Medications

For patients who cannot use Entyvio or for whom it is ineffective, there are alternative medications available for the treatment of Ulcerative Colitis and Crohn’s Disease:

  • TNF Blockers: Medications like infliximab, adalimumab, and certolizumab pegol, which work by blocking the tumor necrosis factor (TNF) protein involved in systemic inflammation.
  • Immunomodulators: Such as azathioprine and 6-mercaptopurine, which modify the immune system’s response to reduce inflammation.
  • JAK Inhibitors: A newer class of medication, like tofacitinib, which works by inhibiting Janus kinase enzymes involved in the inflammatory process.
  • 5-ASA Medications: For milder forms of Ulcerative Colitis, drugs like mesalamine can be effective in reducing inflammation in the colon lining.

Each of these alternatives has its own set of benefits and risks, and the choice of medication should be tailored to the individual patient’s condition and medical history.

Medication Price & Coupons

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For patients in the US, the cost of Entyvio, a leading medication for the treatment of Ulcerative Colitis and Crohn’s Disease, can pose a significant financial challenge, especially for those without medical insurance coverage. The price of Entyvio in the US can be prohibitively expensive, with 1 vial potentially costing as much as $8,666, making it difficult for many patients to access this essential treatment.

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Frequently Asked Questions

What exactly is Entyvio and how does it work?

Entyvio, known scientifically as vedolizumab, is a biologic medication used to treat certain inflammatory bowel diseases, specifically moderate to severe Ulcerative Colitis and Crohn’s Disease. It works by targeting a protein called integrin, found on the surface of certain white blood cells. By binding to this protein, Entyvio prevents these cells from entering the gut’s lining, reducing inflammation. This targeted action makes it effective in managing symptoms and inducing remission in these conditions.

Entyvio is administered through intravenous infusion at a healthcare facility. The first three doses are given at the start, two weeks, and six weeks, followed by maintenance doses every eight weeks. The duration of treatment varies based on individual response and disease severity. Some patients may require long-term treatment, while others might achieve remission and discontinue use under medical guidance.

Common side effects of Entyvio include headache, joint pain, nausea, fever, fatigue, and respiratory infections like the common cold or sinusitis. These side effects are generally mild to moderate and manageable. However, patients should report persistent or severe symptoms to their healthcare provider for appropriate management.

Entyvio can be used with certain other medications, but it’s important to discuss potential interactions with your healthcare provider. Caution is advised when combining Entyvio with other immunosuppressants, as this may increase the risk of infections. Each patient’s medication regimen should be tailored to their specific needs and medical history.

The safety of Entyvio during pregnancy and breastfeeding isn’t fully established. It’s crucial for pregnant or breastfeeding patients to discuss the risks and benefits with their healthcare provider. Decisions regarding the use of Entyvio during pregnancy or breastfeeding should be made based on the patient’s specific condition and the potential risks to the fetus or infant.

Entyvio has been shown to be effective in reducing symptoms and inducing remission in many patients with moderate to severe Ulcerative Colitis and Crohn’s Disease. Its effectiveness can vary among individuals, and some may respond better than others. Clinical trials have demonstrated its ability to improve quality of life and reduce the need for steroids and surgery in many cases.

Weight gain is not a commonly reported side effect of Entyvio. However, as patients’ symptoms improve and their condition stabilizes, they may experience weight normalization, which can sometimes be perceived as weight gain. Any significant changes in weight should be discussed with a healthcare provider.

There are no specific dietary restrictions while taking Entyvio. However, patients with Ulcerative Colitis or Crohn’s Disease may benefit from a balanced diet tailored to their individual needs and tolerances. It’s advisable to discuss dietary considerations with a healthcare provider or a dietitian.

While there is no direct interaction between Entyvio and alcohol, it’s important to consider the overall health of the liver and the potential effects of alcohol on inflammatory bowel diseases. Patients should discuss alcohol consumption with their healthcare provider to make an informed decision based on their individual health status and treatment plan.

The response time to Entyvio can vary among individuals. Some patients may notice symptom improvement within a few weeks, while for others, it may take several months to observe the full therapeutic effects. Consistent treatment and regular monitoring are important to assess the effectiveness of Entyvio.

Before starting Entyvio, inform your healthcare provider about any allergies, current medications, and your complete medical history, especially regarding infections, liver disease, and heart conditions. It’s also important to ensure all vaccinations are up to date, as live vaccines should be avoided during treatment with Entyvio.

Currently, Entyvio is approved for use in adults with Ulcerative Colitis and Crohn’s Disease. Its safety and effectiveness in children have not been fully established. Clinical trials and research are ongoing to determine its potential use in pediatric patients.

Serious side effects of Entyvio include allergic reactions, severe infections, liver problems, heart issues, and neurological symptoms. These side effects are rare but require immediate medical attention. Patients should be aware of the symptoms and contact their healthcare provider if they experience any concerning signs.

As an immunosuppressant, Entyvio can increase the risk of infections. Patients should report any signs of infection, such as fever, chills, or flu-like symptoms, to their healthcare provider. Preventive measures, such as avoiding close contact with sick individuals and practicing good hygiene, are recommended.

Entyvio is not considered a permanent cure for Ulcerative Colitis or Crohn’s Disease, but it can be a long-term treatment option. The duration of treatment depends on the patient’s response and the course of the disease. Some patients may require ongoing treatment to maintain remission.

Travel is generally possible while receiving Entyvio treatment. However, it’s important to plan around your infusion schedule and consider the health risks of your destination. Discuss travel plans with your healthcare provider to ensure continuity of care and access to medical services if needed.

An Entyvio overdose is unlikely due to its administration in a controlled setting. However, if an overdose occurs, seek immediate medical attention. Symptoms of an overdose may include exacerbated side effects, and treatment will involve supportive care and monitoring.

Yes, there are several alternative medications for treating Ulcerative Colitis and Crohn’s Disease, including TNF blockers, immunomodulators, and JAK inhibitors. The choice of alternative medication depends on the individual’s specific condition, treatment history, and overall health.

Do not stop taking Entyvio without consulting your healthcare provider. Decisions to discontinue or adjust treatment should be based on a thorough medical evaluation and consideration of the risks and benefits.

Entyvio should be stored in a refrigerator at 2°C to 8°C (36°F to 46°F) and protected from light. It should not be frozen or shaken. Always check the medication for particulate matter or discoloration before use.

Liver problems are a rare but possible side effect of Entyvio. Symptoms of liver issues include yellowing of the skin or eyes, dark urine, and severe abdominal pain. Patients experiencing these symptoms should seek immediate medical attention.

No, Entyvio is not a chemotherapy drug. It is a biologic medication specifically designed to target the immune system’s activity in the gastrointestinal tract.

Entyvio infusions are typically administered in a healthcare facility. Home infusion services may be available in some cases, but this requires coordination with healthcare providers and insurance companies.

If Entyvio is not effective, your healthcare provider may consider alternative treatments or adjust the treatment regimen. It’s important to communicate openly with your healthcare provider about your symptoms and response to treatment.