1-800-ORENCIAThis is a transcript for the “How to Use the Prefilled Syringe For Your Child with pJIA” video found on the ORENCIA resources page.
Narrator: ORENCIA (abatacept) is a prescription biologic medicine used to reduce signs and symptoms of moderate to severe polyarticular Juvenile Idiopathic Arthritis (pJIA) in patients two years of age and older. ORENCIA may be used alone or with methotrexate (MTX).
ORENCIA should not be used with other strong medicines that affect the immune system, such as biologic disease-modifying antirheumatic drugs (bDMARDs) and Janus kinase (JAK) inhibitors.
Please read the Important Safety Information for ORENCIA provided throughout and at the end of this video.
Guide to Injection With the Pre-filled Syringe
If you and your healthcare provider have decided that ORENCIA self-injection with a prefilled syringe is right for your child with polyarticular Juvenile Idiopathic Arthritis (pJIA), we would like you to meet Jennifer and her daughter Sarah.
When Sarah first started ORENCIA, her healthcare provider showed Jennifer how to inject Sarah with a hands-on demonstration in the doctor's office.
Now, they will show you how it's done, and how it can become part of your routine.
Jennifer: Hi, I'm Jennifer, and this is my 10-year-old daughter, Sarah.
Sarah: Hi!
Jennifer: Sarah has Juvenile Idiopathic Arthritis (JIA).
When Sarah's doctor spoke with us about biologic medications, we decided ORENCIA would be right for her and that she would have weekly injections. It was a good choice for Sarah.
(On-screen text: Sarah weighs 71 pounds, which is 32 kilograms. Her doctor prescribed her the 87.5 mg/0.7 mL dose. The patient's doctor will decide what is the best dosage.)
To train us, the nurse in Sarah's doctor's office took us through the process step-by-step.
(On-screen text: You should always receive your initial training at your healthcare provider's office.)
We were a little nervous at first about the injections.
It helps to think about the time of day you'll do this. You want to focus on the injection, not juggling other things.
Sarah: We do it on Saturday mornings.
Jennifer: By the way, what we're describing is an overview of how to inject.
Sarah: For detailed instructions, read the Instructions for Use manual that comes in the same box as your syringes.
Jennifer: Well said.
You can also call your doctor's office. And, if you still have questions, you can call 1-800-ORENCIA, and an ORENCIA nurse will be available to walk you through it.
Narrator: Infections. ORENCIA can make you more likely to get infections or make the infections that you have worse. In some cases, these infections have been fatal.
Symptoms of an infection include: fever; cough; warm, red, or painful skin; feeling very tired; flu-like symptoms.
Call your healthcare provider right away if you feel sick or have any of the symptoms of an infection.
Preparing for Your Injection
Jennifer: Okay, first, we'll go over how to prepare for your injection.
Think about the place in your home where you'd like to administer ORENCIA.
Sarah: We do almost everything in the kitchen.
Jennifer: So that was a natural fit for us. But just pick a place where you have a lot of light, and where you have a clean, flat space to spread out.
Gather all of your supplies and place them on a clean flat surface.
Sarah: We use the kitchen counter.
Jennifer: Alcohol swabs, cotton balls or gauze, your sharps container, adhesive bandages, should you need them, and your ORENCIA syringe.
Trust me, it helps to keep everything all tidy and organized.
Remove your syringe from the refrigerator and let it sit for 30 minutes before you inject.
(On-screen text: Keep them in the original package and out of the light. Do not freeze them.)
Sarah: That gives it a chance to warm up to room temperature.
Jennifer: Right. And don't try to speed up the warming process in any way, like putting it in the microwave, or placing the syringe in warm water.
ORENCIA is provided in a prefilled syringe.
Do not remove the needle cover until you are ready to inject ORENCIA.
Sarah: And don't forget to wash up before you inject.
Jennifer: I know, it sounds like a no-brainer, but really, before every injection, wash your hands thoroughly with soap and warm water. You want to minimize the amount of germs you carry to your injection site.
Before every injection, hold the syringe with the covered needle pointing down, and check the expiration date. If the date has passed, do not use it.
Throw it away, which we'll explain how to do later, and select a new syringe.
Then look at the ORENCIA liquid inside. The liquid should be clear and colorless to pale yellow.
Look closely at the amount of liquid in the syringe.
The placement of the fill line will be different depending on what dose you are prescribed.
So make sure the amount of liquid is at or just above the fill line for your prescribed dose.
Do not inject ORENCIA if the liquid is cloudy, discolored, or has lumps or particles in it.
Or if the syringe does not have the correct amount of liquid.
Call 1-800-ORENCIA to report it.
So remember, never inject without examining your syringe.
Sarah: But it is normal to see an air bubble in the liquid, and you don't need to remove it.
Jennifer: You've got this down.
The next step is to choose and prepare your injection site.
The nurse recommended the front of the thigh.
But she also suggested the belly, except for a two-inch area around the navel.
Now, since I typically administer Sarah's injections, it's okay to use the outer area of the upper arm.
Sarah: But don't try to inject there by yourself.
Jennifer: Every time you inject, change it up.
That means move away from your last injection site by at least one inch.
You can also switch the site altogether.
We did Sarah's thigh last time, so we're going to do her belly this time.
If you have a tender or bruised area, or your skin is red, scaly, or hard, don't inject there. Also avoid any areas with scars or stretch marks.
Write down the date, time, and specific part of your body where you injected.
I think it's also helpful to write down any questions about the injection so you can ask your doctor.
(On-screen text: How to Inject ORENCIA® [abatacept])
Sarah: Okay, I'm ready.
Jennifer: Alright.
First, wipe the area with an alcohol swab in a circular motion to clean the area, and let it dry naturally. Be sure not to touch the area after you've cleaned it.
Narrator: Allergic reactions.
Allergic reactions can happen with ORENCIA. Symptoms of an allergic reaction may include: hives; swollen face, eyelids, lips, or tongue; trouble breathing.
Seek urgent medical attention if you have any of the symptoms of an allergic reaction.
Jennifer: Remember, only remove the needle cover when you're ready to inject.
Sarah: And don't use the needle if it's damaged or bent.
Jennifer: Hold the housing of the syringe with one hand, and pull the needle cover straight off with your other hand.
Do not touch the plunger while you remove the needle cover.
And do not touch the needle or put the needle cover back on the needle once removed as this may damage the needle.
Be sure not to let the needle touch any surfaces.
And don't use the syringe if it's dropped with the needle exposed.
Sarah: You can throw away the needle cover in your household trash.
Jennifer: There may be a small air bubble in the syringe housing, and that's okay, you don't need to remove it.
You may also notice a drop of fluid leaving the needle. This is also normal and will not affect your dose.
You'll notice that the ORENCIA prefilled syringe with BD UltraSafe Passive Needle Guard has a square shape and extended finger grips.
Hold the housing of the syringe in one hand, between your thumb and your index finger, but don't pull back on the plunger of the syringe.
Use your other hand to gently pinch the area of skin that was cleaned.
Hold firmly. Insert the needle with a quick motion into the pinched skin at a 45-degree angle.
To inject all of the medicine, use your thumb to push the plunger until the plunger head is pushed in as far as it will go.
Slowly lift your thumb from the plunger head.
The needle is completely covered by the needle guard as it is removed from the skin.
You may hear a click.
Now, just remove the syringe, and let go of the surrounding skin.
Sarah: That's it.
Jennifer: If there's a little bleeding, grab a cotton ball, or gauze, and press on the area. You can even place a bandage on it.
Do not rub the injection site.
If you notice a little irritation around the site, that happens sometimes, and the discomfort should be mild to moderate. If you have any pain, swelling, or discoloration near the injection site, call your doctor.
Narrator: If you have the hepatitis B virus, talk to your healthcare provider as hepatitis B can become an active infection while you use ORENCIA. Your rheumatologist may do blood tests before treatment with ORENCIA to check if you have hepatitis B.
If you are receiving or are scheduled to receive vaccinations, it is important to know that:
You should not receive live vaccines while taking ORENCIA.
You can receive non-live vaccines, such as pneumococcal and inactivated influenza (flu) vaccines.
ORENCIA may also cause some other vaccinations to be less effective. Talk to your rheumatologist about your vaccination plans.
Jennifer: Now, for the last part.
Sarah: Disposal.
Jennifer: Do not try to put the needle cover back on the needle.
If your injection is administered by a caregiver, this person must also be careful handling the syringe to prevent accidental needle stick injury and possibly spreading infection.
Check with your healthcare provider or pharmacist for instructions about the right way to throw away used syringes.
There may be special local or state laws about how to dispose of used syringes.
Put the used syringe into an FDA-cleared container made specifically for disposing of used syringes, called a Sharps container.
You can also use a heavy duty plastic container with a tight-fitting, puncture-resistant lid, such as an empty detergent bottle.
Sarah: Or a metal container with a plastic lid, like this coffee can.
Jennifer: Make sure that whatever you use is upright and stable during use and is leak resistant.
Sarah: And make sure you label your container "hazardous waste."
Sharps containers can be purchased at your local pharmacy and many retail outlets.
You can also sign up to get free Sharps containers from the makers of ORENCIA.
When the container is full, tape around the cap or lid to make sure the cap or lid does not come off.
You will need to follow your community guidelines for the right way to dispose of your sharps container.
There may be state or local laws about how you should throw away used needles and syringes.
For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at www.fda.gov/safesharpsdisposal
Do not throw away your used sharps container in your household trash unless your community guidelines permit this. Do not recycle your used sharps container.
Sarah: And never, ever reuse a syringe.
Jennifer: Also, keep your syringes and the disposal container out of the reach of children and pets.
Guess what?
Sarah: We're done.
Jennifer: We hope this helped you feel more comfortable with your ORENCIA injections. Remember, if you have any questions, talk to your doctor.
For any questions or concerns about your ORENCIA syringe, call an ORENCIA nurse at 1-800-ORENCIA.
I know this process may seem like a lot to take in, but you're not alone.
Sarah: Don't worry, you'll get the hang of it. We did.
Narrator: And now, for a brief review.
First, get ready for the injection.
Then choose and prepare an injection site.
Inject ORENCIA.
And finally, dispose of your syringe properly.
And remember, if you still have questions, talk to your healthcare provider, or you can call 1-800-ORENCIA, and an ORENCIA nurse will be available to walk you through it.
ORENCIA nurses are available for assistance Monday through Friday, 8 AM to 8 PM, Eastern Standard Time.
At all other times, nurses will usually return your calls within 30 to 60 minutes.
When you call 1-800-ORENCIA, you can also sign up for the ORENCIA On Call patient support program.
ORENCIA On Call can help with the issues that matter to you, like living with polyarticular Juvenile Idiopathic Arthritis, questions regarding health insurance coverage for ORENCIA.
You can also get a Sharps container and travel pack for your prefilled syringe.
When you sign up for ORENCIA On Call, personal ORENCIA care counselors will be available 24/7 to provide answers and support.
No matter where you are in your treatment journey, your care counselor is just a phone call or a click away with the resources you need.
Please know that neither the care counselor nor the nurse can provide medical advice. Your doctor is the best source of information about your health.
Important Facts About ORENCIA (abatacept).
This is a summary of important information that you need to know in order to take ORENCIA safely. Work with the rheumatologist to make the treatment suitable and safe for you or your loved one.
Keep this information, so you can refer to it before and during your treatment.
Look out for the following icons as you read:
talk to your rheumatologist;
call a healthcare provider right away;
helpful information to remember.
What is ORENCIA?
ORENCIA (abatacept) is a prescription biologic medicine used to reduce signs and symptoms of moderate to severe polyarticular Juvenile Idiopathic Arthritis (pJIA) in patients two years of age and older.
ORENCIA may be used alone or with methotrexate (MTX).
ORENCIA should not be used with other strong medicines that affect the immune system, such as biologic disease-modifying antirheumatic drugs (bDMARDs) and Janus kinase (JAK) inhibitors.
ORENCIA is available in two forms. ORENCIA intravenous (IV) infusion is given by your healthcare provider through a vein in your arm. ORENCIA IV is approved for children six years and older. ORENCIA IV has not been studied in children under the age of six. Or ORENCIA subcutaneous (SC) injection is a shot that is given just under your skin. It is available as a prefilled syringe, or a ClickJect Autoinjector. ORENCIA SC prefilled syringe is available for patients two years and older.
PJIA patients may self-inject with ORENCIA or the patient's caregiver may administer ORENCIA if both the healthcare practitioner and the parent/legal guardian determines it is appropriate.
The ability of pediatric patients to self-inject with the autoinjector has not been tested.
Talk to your rheumatologist about the best way to receive ORENCIA.
What should I discuss with my rheumatologist before starting ORENCIA?
Talk to your rheumatologist about all of your medical conditions, including:
You have any kind of infection, as you may have a higher chance of getting serious side effects from an infection while taking ORENCIA.
Infections include: small infections—such as an open cut or sore—to whole body infections (such as the flu). Any infection that will not go away, or a history of infections that keep coming back.
Viral hepatitis, a viral infection that affects the liver. Tell your rheumatologist if you have or have ever had viral hepatitis. Before starting ORENCIA, your rheumatologist may examine you for hepatitis.
Tuberculosis (TB), a type of lung infection. Tell your rheumatologist if you have ever had TB, or a positive skin test for TB, or have recently been in close contact with someone who has ever had TB.
Before starting ORENCIA, your rheumatologist may check you for TB, or do a skin test. Call your rheumatologist if you notice any symptoms of TB, including: a cough that does not go away, weight loss, fever, or night sweats.
You have allergies to the ingredients of ORENCIA.
For a list of ingredients, see: What are the ingredients in ORENCIA? in the Patient Information section of the Full Prescribing Information
You have Chronic Obstructive Pulmonary Disease (COPD), a type of lung disease.
You have diabetes. Your healthcare provider may tell you to use a different way to monitor your blood sugar levels on the day that you receive ORENCIA IV infusion.
ORENCIA IV contains maltose, which can alter the blood sugar readings with certain types of blood glucose monitors.
You have a family or personal history of skin cancer, or see any growths or changes in the appearance of your skin during or after treatment with ORENCIA.
Some people treated with ORENCIA have developed skin cancer.
Tell your rheumatologist about all of your medical treatments, including if: you are scheduled to have surgery.
You recently received, or are scheduled to receive vaccinations.
If you are receiving ORENCIA, and for three months after you stop receiving ORENCIA, you should not take live vaccines.
You are taking: other medications for pJIA; prescription medications or over-the-counter medications; vitamins or herbal supplements.
Let your rheumatologist know if you are a woman who is: pregnant or considering pregnancy. It is not known if ORENCIA can harm an unborn baby.
If ORENCIA is taken during pregnancy, talk to your healthcare provider before your baby receives any vaccines. There is a registry for pregnant women exposed to ORENCIA.
The purpose of this registry is to check the health of the pregnant mother and her child. Women are encouraged to call the registry themselves or ask their healthcare provider to contact the registry for them by calling 1-877-311-8972.
Breastfeeding or planning to breastfeed. It is not known if ORENCIA passes into breast milk. Talk to your healthcare provider about the best way to feed your baby if you use ORENCIA.
What should I avoid while I am on ORENCIA?
ORENCIA and other medicines may affect each other, which could cause serious side effects.
You should avoid taking ORENCIA with other biologics for your pJIA that may affect your immune system. Doing so may increase your chances of getting a serious infection.
Tell your rheumatologist if you are taking other biologic medicines to treat pJIA, such as:
Enbrel (etanercept), Humira (adalimumab), Remicade (infliximab), Kineret (anakinra), Rituxan (rituximab), Simponi (golimumab), Cimzia (certolizumab pegol), Actemra (tocilizumab).
Talk to your rheumatologist and your other healthcare providers before you begin to take anything new or if you have any changes to your medication during your treatment with ORENCIA.
It is a good idea to keep an up-to-date list of all your medicines, vitamins, and herbal supplements on hand to show your doctors and pharmacists.
What are the possible side effects of ORENCIA?
This is a list of some of the possible side effects of ORENCIA for your reference. Talk to your rheumatologist about any side effect that may be bothering you.
Your rheumatologist can work with you to manage side effects throughout your treatment.
Serious side effects. Serious side effects are those that may require medical treatment or hospitalization, cause permanent damage, or be life-threatening, or sometimes even fatal. Talk to your healthcare provider about any concerns you may have.
Infections. ORENCIA can make you more likely to get infections, or make the infections that you have worse. In some cases, these infections have been fatal.
Symptoms of an infection include: fever; cough; warm, red, or painful skin; feeling very tired; flu-like symptoms.
Call your healthcare provider right away if you feel sick or have any of the symptoms of an infection.
Allergic reactions. Allergic reactions can happen with ORENCIA. Symptoms of an allergic reaction may include: hives; swollen face, eyelids, lips, or tongue; trouble breathing.
Seek urgent medical attention if you have any of the symptoms of an allergic reaction.
If you have the hepatitis B virus, talk to your healthcare provider as hepatitis B can become an active infection while you use ORENCIA.
Your rheumatologist may do blood tests before treatment with ORENCIA to check if you have hepatitis B.
If you are receiving or are scheduled to receive vaccinations, it is important to know that: you should not receive live vaccines while taking ORENCIA; you can receive non-live vaccines, such as pneumococcal and inactivated influenza (flu) vaccines.
ORENCIA may also cause some other vaccinations to be less effective. Talk to your rheumatologist about your vaccination plans.
If you have Chronic Obstructive Pulmonary Disease (COPD), you may experience breathing problems more often while taking ORENCIA. Call your healthcare provider if you experience any of the following: worsened COPD; cough; trouble breathing.
Certain kinds of cancer (malignancies) have been reported in people using ORENCIA. It is not known if ORENCIA increases your chances of developing certain kinds of cancer.
Most common side effects.
The most common side effects of ORENCIA include: Headache; upper respiratory tract infection; sore throat; nausea. In children and adolescents, other side effects may include: diarrhea; cough; fever; abdominal pain.
These are not all the possible side effects of ORENCIA.
If you have any questions, or want more information about side effects, ask your rheumatologist or healthcare provider.
If you experience any side effects and would like to report them to the FDA, you can call 1-800-FDA-1088.
How will I receive ORENCIA?
ORENCIA is available in two forms, as intravenous (IV) infusions and as subcutaneous (SC) injections.
Work with your rheumatologist to determine the right treatment plan for you or your child.
ORENCIA IV infusion is given by a healthcare provider through a vein in your arm.
You will receive your first three infusions two weeks apart from each other (weeks zero, two, and four). After that, you will receive an infusion every four weeks. Each infusion takes about 30 minutes, though actual time in the clinic will be longer.
ORENCIA SC injection is a shot that is given just under your skin. It is available as a prefilled syringe.
ORENCIA SC prefilled syringe is available for patients two years and older. PJIA patients may self-inject with ORENCIA or the patient's caregiver may administer ORENCIA if both the healthcare practitioner and the parent/legal guardian determines it is appropriate.
The ability of pediatric patients to self-inject with the autoinjector has not been tested.
If your rheumatologist decides that your injections can be given at home, you or your caregiver will receive training on how to prepare and inject ORENCIA.
Do not try to inject ORENCIA until you have been shown the right way by your rheumatologist or healthcare provider.
You will use ORENCIA SC injection once weekly.
For more information about preparing and giving ORENCIA SC injections at home, see Instructions for Use in the Patient Information Section of the Full Prescribing Information on ORENCIA.com.