Hello. I'm here today to walk you through the specific steps needed for using the ENTYVIO Pen for subcutaneous use. But remember, your health care provider should show you how to use the ENTYVIO Pen before you use it for the first time.
What is ENTYVIO?
For adult patients with moderately to severely active ulcerative colitis (UC) when other therapies have not worked well enough or cannot be tolerated.
Safety Considerations
Do not receive ENTYVIO if you have had an allergic reaction to ENTVIO or any of its ingredients. Infusion-related and serious allergic reaction can happen while you are receiving ENTYVIO or several hours after treatment. ENTYVIO may increase your risk of getting a serious infection.
Please see additional Important Safety Information at the end of this video.
We’ll be visiting Sam's house, and Sam will be demonstrating the process while I lead you through the video. During this video, I'll cover these steps in three chapters, beginning with getting your supplies ready, then preparing to inject ENTYVIO, and lastly, injecting ENTYVIO. Okay, let’s get started.
So, what is the ENTYVIO Pen? It's a pre-filled pen designed to deliver an accurate, pre-measured dose of medication under the skin. Now let's get into the details on how to use the pen. Start by getting your supplies ready. The first thing you'll want to do is remove the ENTYVIO Pen box from its storage in your refrigerator.
ENTYVIO needs to be stored in a refrigerator, but if you're traveling, ENTYVIO can be kept safely in its box at room temperature for up to 7 days. Do not use the pen if it is past its expiration date.
After removing the pen from the box in the fridge, wait 30 minutes and let the pen come to room temperature. You may want to set a timer or use your phone to set a 30 minute reminder. Also, don't try to warm the pen quickly or let the pen sit in direct sunlight. And don't take the pen out of its tray until you're ready to inject.
You should gather these supplies on a clean, flat surface before your injection. You'll want some alcohol pads or cotton ball or gauze, and you'll also want a sharps container on hand to put your pen in after you've finished your injection.
Now you can get ready to inject ENTYVIO. First, you'll need to thoroughly wash your hands with soap and water. Now, take the pen from the box and remember, don't use the pen if any of the seals on the box are broken, or if the expiration date on the box has passed.
Next, peel off the paper on the tray, and then remove the pen. Don't shake the pen or remove the purple cap from the pen. Now you'll want to inspect the pen. The main things you're checking for here are the expiration date and the medicine in the pen window. The medicine should be colorless to pale yellow, and it is normal to see air bubbles. Don't use the pen if the expiration date on the pen has passed, or if the medicine is cloudy or has particles floating in it. And you don't want to use the pen if any part of it is damaged.
Now it's time to choose an injection site. If you're self-injecting, you can choose the front of your thigh, or a place on your stomach. Just don't inject too close to your belly button. If you have a caregiver, they can help by injecting into the back of your upper arm.
Be sure not to inject in the same spot of your last dose, and avoid injecting into moles, scars, bruises, or skin that's tender, hard, red, or damaged. It's now time to clean the injection site with the alcohol pad. Don’t touch or blow on the cleaned injection site before you inject. Be sure to let your skin dry before moving to the next step.
Let's review how to inject ENTYVIO. Note the purple cap. You want to pull it straight off and dispose of it in a sharps container right away. The needle is inside the yellow needle shield right there under the purple cap. Remember, do not put or press your thumb, fingers, or hand over the yellow needle shield. And don't put the purple cap back on, because this could accidentally start the injection.
Now you should hold the pen so you can see the viewing window. Then place the yellow end of the pen flat on your skin at 90 degrees to the injection site. And be sure not to push down on the pen until you're ready to inject.
Now you're ready to start injecting ENTYVIO. Push the pen straight down and hold for at least 10 seconds. You may hear a first click when the injection starts. You may also hear a second click. This is not the end of the injection. Continue holding the pen with constant pressure and watch the window fill with purple.
The injection is now complete. However, when you lift the pen from the skin, you will see a small amount of gray in the viewing window. But this is normal. If the viewing window did not fill with purple, you may not have received your full dose. If this happens, call your pharmacy or healthcare provider.
The yellow needle shield will drop down and lock over the needle. When you lift the pen, if the window has not turned purple, or it looks like medicine is still coming out of the pen, you may not have received a full dose. If this happens, call your pharmacy or healthcare provider. You may also see a small amount of blood at the injection site. If so, press on your skin with a cotton ball or gauze.
When it's time to throw away your ENTYVIO Pen, make sure you use an FDA-cleared sharps disposal container right after use. Do not recycle or toss the pen in your household trash. Throw the remaining supplies in your household trash or sharps disposal container.
Most specialty pharmacies have sharps programs that can help you access an FDA-cleared container, but you can also make your own safe disposal container. For instance, an empty laundry detergent bottle can be used. Just be sure to label it appropriately. Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this.
We've covered all of the steps, so you should be all set with instructions on how to use the ENTYVIO Pen for subcutaneous use. And remember, you can always watch this video again if you need a quick refresher. And if you'd like to find out more about resources and assistance that ENTYVIO offers to help manage your treatment, including in-home injection training, visit ENTYVIO.com/EntyvioConnect for more information.
Important Safety Information
- Do not receive ENTYVIO if you have had an allergic reaction to ENTYVIO or any of its ingredients.
- ENTYVIO may cause serious side effects, including:
- Infusion-related and serious allergic reactions can happen while you are receiving ENTYVIO or several hours after treatment. You may need treatment if you have an allergic reaction. Tell your healthcare provider or get immediate medical help if you get any of these symptoms during or after an infusion of ENTYVIO: rash, itching, swelling of your lips, tongue, throat or face, shortness of breath or trouble breathing, wheezing, dizziness, feeling hot, or palpitations (feel like your heart is racing).
- ENTYVIO may increase your risk of getting a serious infection. Before receiving and during treatment with ENTYVIO, tell your healthcare provider if you think you have an infection or symptoms of an infection, such as fever, chills, muscle aches, cough, shortness of breath, runny nose, sore throat, red or painful skin or sores on your body, tiredness, or pain during urination.
- People with weakened immune systems can get progressive multifocal leukoencephalopathy (PML) (a rare, serious brain infection caused by a virus). Although unlikely while receiving ENTYVIO, a risk of PML cannot be ruled out. PML can result in death or severe disability. There is no known treatment, prevention, or cure for PML. Tell your healthcare provider right away if you have any of the following symptoms: confusion or problems thinking, loss of balance, change in the way you walk or talk, decreased strength or weakness on one side of the body, blurred vision, or loss of vision.
- Liver problems can happen in people who receive ENTYVIO. Tell your healthcare provider right away if you have any of the following symptoms: tiredness, loss of appetite, pain on the right side of your abdomen, dark urine, or yellowing of the skin and eyes (jaundice).
- The most common side effects of ENTYVIO include common cold, headache, joint pain, nausea, fever, infections of the nose and throat, tiredness, cough, bronchitis, flu, back pain, rash, itching, sinus infection, throat pain, and pain in extremities. These are not all the possible side effects of ENTYVIO. Call your healthcare provider for medical advice about side effects.
- Before receiving ENTYVIO, tell your healthcare provider about all of your medical conditions, including if you: have or think you may have an infection or have infections that keep coming back; have liver problems; have tuberculosis (TB) or have been in close contact with someone with TB; have recently received or are scheduled to receive a vaccine; or if you are pregnant, breastfeeding, plan to become pregnant, or plan to breastfeed.
Please see accompanying full Prescribing Information, including the Medication Guide, for ENTYVIO at ENTYVIO.com/PI and talk with your healthcare provider.
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Uses of ENTYVIO® (vedolizumab)
ENTYVIO is a prescription medicine used in adults for the treatment of:
- moderately to severely active ulcerative colitis
- moderately to severely active Crohn's disease
It is not known if ENTYVIO is safe and effective in children under 18 years of age.
