VEDOLIZUMAB - INJECTION

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VEDOLIZUMAB - INJECTION

PHONETIC PRONUNCIATION: (VE-doe-LIZ-ue-mab)

COMMON BRAND NAME(S): Entyvio

GENERIC NAME(S): vedolizumab

Uses

USES: This medication is used to treat certain bowel disorders (ulcerative colitis, Crohn's disease). In these conditions, the body's defense system (immune system) attacks healthy tissues in the gut, causing symptoms such as abdominal pain, blood in the stool, and diarrhea. Vedolizumab belongs to a class of drugs known as monoclonal antibodies. It works by blocking the actions of a certain natural substance (integrin) in the body. This helps to decrease swelling (inflammation) in the gut, which lessens symptoms and may slow or stop damage from these bowel disorders.


How to use VEDOLIZUMAB - INJECTION

HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using vedolizumab and each time you get a treatment. If you have any questions, ask your doctor or pharmacist. Discuss the risks and benefits of vedolizumab treatment. Before starting treatment with vedolizumab, you should be up to date with all your vaccinations. Ask your doctor if you need to receive any vaccines before starting vedolizumab. This medication is given by injection into a vein by a health care professional. It should be injected slowly over 30 minutes. After the first dose, you will usually receive the next two doses 2 weeks and 6 weeks later. After the third dose, this medication is given as directed by your doctor, usually every 8 weeks. Serious allergic reactions can happen during or even several hours after your treatment. Careful monitoring by your doctor may decrease your risk. If you have a serious reaction, your treatment will be temporarily stopped. Get medical help right away if you have shortness of breath, fast heartbeat, flushing, or rash/itching. Use this medication regularly to get the most benefit from it. It may help to mark your calendar with a reminder. Tell your doctor if your condition does not improve or if it worsens.

Side Effects

SIDE EFFECTS: See also How to Use section. Nausea, headache, flu/common cold symptoms, or tiredness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: mouth/throat pain, pain in your arms/legs, symptoms of liver damage (such as persistent nausea/vomiting, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine). This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as fever, chills, persistent sore throat, cough). This medication may increase your risk of getting a rare but very serious (possibly fatal) brain infection (progressive multifocal leukoencephalopathy-PML). Get medical help right away if you have any of these side effects: clumsiness, loss of coordination/balance, weakness, sudden change in your thinking (such as confusion, difficulty concentrating, memory loss), difficulty talking/walking, seizure, vision changes. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

PRECAUTIONS: Before using vedolizumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: symptoms of infection (such as fever, chills, sore throat, cough, runny nose), current/past/returning infections (such as tuberculosis), cancer. Vedolizumab can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details. Do not have immunizations/vaccinations without the consent of your doctor. Tell your doctor if you have had any recent immunizations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose). Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Interactions

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug include: other drugs that weaken the immune system/increase the risk of infection (such as natalizumab, rituximab, TNF blockers such as adalimumab/infliximab).

Overdose

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

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Faq for VEDOLIZUMAB - INJECTION

Vedolizumab injection is used to treat adults with moderate to severe ulcerative colitis or Crohn's disease when other treatments have not been successful.

Vedolizumab is a type of medication called an integrin receptor antagonist. It works by blocking specific proteins in the body that cause inflammation in the intestines, helping to reduce the symptoms of ulcerative colitis or Crohn's disease.

Vedolizumab injection is given as an intravenous infusion, which means it is injected directly into a vein. It is typically administered by a healthcare professional in a clinic or hospital setting.

Common side effects of vedolizumab injection may include headache, fever, nausea, cold symptoms, joint pain, or rashes. It is important to inform your healthcare provider if you experience any side effects or if they persist or worsen.

The dosing frequency of vedolizumab injection varies depending on the condition being treated. For ulcerative colitis, it is typically administered as an infusion every 8 weeks. For Crohn's disease, the initial dose is given as an infusion, followed by additional infusions at 2 and 6 weeks after the initial dose, and then every 8 weeks thereafter.

The use of vedolizumab injection during pregnancy or breastfeeding should be discussed with a healthcare provider. Limited data is available on its safety in these situations, and the potential risks and benefits must be carefully considered.

Vedolizumab injection does not have significant interactions with other medications. However, it is important to inform your healthcare provider about all the medications you are taking, including over-the-counter drugs and supplements, to ensure there are no potential interactions.

Vedolizumab can increase the risk of infections, including serious ones. You should inform your healthcare provider if you have a history of chronic infections or any current infections before starting treatment. It is important to follow your healthcare provider's instructions and report any signs of infection immediately.

The response to vedolizumab injection can vary among individuals. Some people may experience an improvement in symptoms within weeks, while others may take several months to respond. It is important to continue the prescribed treatment and have regular follow-up visits with your healthcare provider.

Vedolizumab is a medication that is used to treat inflammatory bowel disease (IBD), specifically ulcerative colitis and Crohn's disease.

Vedolizumab is given as an intravenous injection. It is usually administered by a healthcare professional in a clinic or hospital setting.

The recommended dosing schedule for vedolizumab is every 8 weeks for ulcerative colitis and every 4 or 8 weeks for Crohn's disease, depending on your response to treatment.

Some common side effects of vedolizumab include headache, nausea, upper respiratory tract infections, and joint pain. Serious side effects may occur in rare cases, such as allergic reactions or infection.

While on vedolizumab, live vaccines should be avoided. However, non-live vaccines can be administered.

The timeframe for vedolizumab to start working can vary from person to person. Some individuals may experience improvement within weeks, while others may take several months to see the full benefit.

Data on the use of vedolizumab during pregnancy is limited. It is recommended to discuss the risks and benefits with your healthcare provider if you are pregnant or planning to become pregnant.

Vedolizumab is approved for use in children aged 6 years and older with ulcerative colitis. However, the use of vedolizumab in children with Crohn's disease is limited and should be considered on a case-by-case basis.

It is important to follow the recommended dosing schedule for vedolizumab. If you miss a dose, contact your healthcare provider to determine the best course of action.

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Disclaimer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.