How to use Vedolizumab Solution, Reconstituted (Recon Soln)
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.
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.
See also How to Use section.
Remember that this medication has been prescribed because your doctor 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 nausea/vomiting that doesn't stop, 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 sore throat that doesn't go away, fever, chills, 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.
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 make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.
Tell your doctor your vaccine history and ask if you need to get any vaccines before starting treatment with this medication. Tell your health care professional that you are using vedolizumab before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
This drug passes into breast milk. Consult your doctor before breast-feeding.
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).
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.
Not applicable. This medication is given in a clinic and will not be stored at home.