For moderate to severe rheumatoid arthritis (RA)

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Indication/Usage

Adult Rheumatoid Arthritis (RA):
ORENCIA® (abatacept) is a prescription medicine that reduces signs and symptoms in adults with moderate to severe RA, including those who have not been helped enough by other medicines for RA. ORENCIA may prevent further damage to your bones and joints and may help your ability to perform daily activities. In adults, ORENCIA may be used alone or with other RA treatments other than tumor necrosis factor (TNF) antagonists.

Juvenile Idiopathic Arthritis (JIA): ORENCIA reduces signs and symptoms in patients 2 years of age and older with moderate to severe polyarticular JIA. ORENCIA may be used alone or with methotrexate (MTX).

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For Healthcare Professionals

ORENCIA ClickJect Autoinjector

The ORENCIA® (abatacept) ClickJect Autoinjector

The The ORENCIA ClickJect Autoinjector is a once-weekly self-injection that was designed with moderate to severe RA patients in mind.

The ClickJect Autoinjector's non-slip grip and lightweight design may make it easy to use, providing security during self-injection. The ClickJect Autoinjector's display features were designed to help give you an accurate dose of ORENCIA. The large viewing window and blue indicator help confirm the full dose has been injected. After training at your doctor's office, you can self-inject in your own home.

Common side effects with ORENCIA are headache, upper respiratory tract infection, sore throat, and nausea. Other side effects in children and adolescents may include diarrhea, cough, fever, abdominal pain, and injection site reactions.

ORENCIA ClickJect Autoinjector has not been studied in children under 18 years of age.


How to use the ClickJect Autoinjector

Watch the video below for the full instructions.

 

Video transcript

ORENCIA ClickJect Autoinjector

MALE VO: ORENCIA® (abatacept) is a prescription medicine that reduces signs and symptoms in adults with moderate to severe rheumatoid arthritis (RA), including those who have not been helped enough by other medicines for RA. ORENCIA may prevent further damage to your bones and joints and may help your ability to perform daily activities. In adults, ORENCIA may be used alone or with other RA treatments other than tumor necrosis factor (TNF) antagonists. Please read the Important Safety Information for ORENCIA provided at the end of this video.

NURSE: Hi, my name is Jeannie and I'm a nurse. As a nurse, I've had the experience of helping many people learn how to take their medication.

NURSE: If you and your healthcare provider have decided that the ClickJect Prefilled Autoinjector is right for you, I'd like you to meet my patient, Lisa, who along with her healthcare provider chose the ClickJect Autoinjector. When she first started ORENCIA, I gave her a hands-on demonstration, and helped her with her first injection in her healthcare provider's office. Now, she will show you how to use it, and how it can become routine for you too. So, let's meet Lisa.

PATIENT: Hi, I'm Lisa, and I have moderate to severe rheumatoid arthritis. When my healthcare provider talked to me about biologic medications, we decided that I would take ORENCIA through weekly self- injections with the ClickJect Autoinjector. It was a good choice for me.

PATIENT: I've given myself injections for a while now so I'm ready to show you how it's done.

PATIENT: To train me, Jeannie, my nurse, took me through the process step-by-step.

PATIENT: You however, could have been trained by your healthcare provider or another healthcare professional.

PATIENT: If you're not comfortable doing the injection yourself, a family member or friend, who's also been trained by your healthcare provider's office can do it for you.

PATIENT: You might feel a little nervous about giving yourself an injection. I know I was. But after a few times it becomes much more routine. Think about the time of day you'll self-inject. You want to focus on your injection, not juggling other things.

PATIENT: By the way, what I'm describing is an overview of how to inject. For detailed instructions, read the Instructions for Use included in the Full Prescribing Information located in the same box as your Autoinjectors came in. You can also call your healthcare provider's office.

PATIENT: And remember, if you still have questions, you can call 1-800-ORENCIA and an ORENCIA nurse will be available to walk you through it.

PATIENT: Ok, so the first step is to gather supplies for self-injection on a clean, flat surface and get a ClickJect ready for use. You will need an alcohol swab, a cotton ball or gauze, and a disposable sharps container to dispose of the used ClickJect. You may also choose to have a small adhesive bandage available, should you need it.

PATIENT: Next, carefully remove one Autoinjector from the carton kept in the refrigerator. Before you do anything else, check the expiration date on the side of the ClickJect. If the date has passed, do not use it. Dispose of it properly, which I will explain how to do later, and select a new ClickJect autoinjector. Call 1-800-ORENCIA about the expired date on the ClickJect.

PATIENT: Now check the liquid in the ClickJect by holding it by the grip, with the covered needle pointing downward, and looking through the viewing window. The liquid should be clear and colorless to pale yellow.

FEMALE VO: If the liquid is cloudy, discolored or if you can see particles in it, do not use the ClickJect and call 1-800-ORENCIA to report it.

PATIENT: It is normal to see an air bubble in the liquid. There is no reason to remove it. Inspect the ClickJect for any damage. If the ClickJect is damaged, do not use it, and do not remove the needle cover. Call 1-800-ORENCIA.

PATIENT: After checking, let it rest at room temperature for 30 minutes. Do not remove the needle cover while allowing it to reach to room temperature.

MALE VO: Do not try to speed up the warming process in any way, such as using the microwave or placing the ClickJect in warm water. Do not leave the ClickJect unsupervised and do not shake it. Replace the box with the remaining Autoinjectors in the refrigerator.

SFX: DING!

PATIENT: Wash your hands thoroughly with soap and warm water.

SFX: water running, drying hands

PATIENT: Next, choose and clean the place on your body where you will administer the injection. The front of the thigh and the abdomen are the recommended injection sites, except for the two-inch area around the navel. I sometimes use the same thigh for weekly injections, since the same area of the body can be used each week, as long as a different injection site in that area is chosen. I always make sure the new site is at least an inch away from the previous injection site in that same area. Do not inject into areas where the skin is tender, bruised, red, scaly or hard. Do not inject in any areas with scars or stretch marks. The outer area of the upper arms may be used only if the injection is being given by a caregiver. Don't attempt to use the upper arm area yourself.

PATIENT: Clean the injection site with an alcohol swab and let the skin dry.

PATIENT: The next step is to administer the injection. To remove the needle cover—the orange cap—I hold the grip of the ClickJect in one hand and pull the cover straight off with my other hand.

SFX: Needle cover being removed

PATIENT: It is important to pull the needle cover straight off so you will not damage the ClickJect.

FEMALE VO: Do not put the needle cap back on. You can discard it in your household waste after injection. Do not use the ClickJect if dropped after removing the needle cover. It's normal to see a drop of fluid leaving the needle.

PATIENT: Continue to hold the grip of the ClickJect in one hand. Use your other hand to gently pinch the area of the skin that you cleaned and hold it firmly. Hold the ClickJect so you can see the viewing window and make sure to position it at a 90- degree angle to the injection site. Push the ClickJect down on the skin to unlock the Autoinjector. This unlocks the blue activation button on the top of the ClickJect.

PATIENT: Press the blue activation button while holding the ClickJect firmly against the skin. You will hear a click as the injection begins.

SFX: Click

PATIENT: Hold it in place for 15 seconds waiting for the blue indicator to stop moving in the viewing window.

FEMALE VO: When the blue indicator stops moving, the injection is complete.

SFX: Light music

PATIENT: Remove the ClickJect from the injection site by lifting it straight up. Once you remove it from your skin, the transparent tip will lock over the needle. Then release the pinched area of skin. If there is any bleeding, press a cotton ball over the injection site and hold it without rubbing the skin. Apply a small adhesive bandage if needed. If you have any pain, swelling or discoloration near the injection site, call your healthcare provider.

PATIENT: Dispose of the used ClickJect Autoinjector into an FDA-cleared sharps disposal container right after use.

FEMALE VO: Do not replace the cap on the used ClickJect. Instead, you can throw the cap in your household trash. Do not throw the ClickJect into household trash. Keep the autoinjectors and the sharps disposal container out of reach of children. If a caregiver is administering the injection, they should handle the ClickJect carefully afterwards as well, to avoid accidental needle stick injury and possibly spreading infection.

PATIENT: I find it helpful to keep a record of the date, time, and site, where I administered the injection, and any problems that I encountered, so that I can discuss them with my healthcare provider if needed. That's the procedure to use for the ORENCIA ClickJect Prefilled Autoinjector.

PATIENT: 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. When you call 1-800-ORENCIA, you can also sign up for ORENCIA On Call patient support program. ORENCIA On Call can help with the issues that matter to you, like living with moderate to severe rheumatoid arthritis, questions regarding health insurance coverage for ORENCIA, and how to take your medication. You can also get a sharps container and travel pack for your ClickJect autoinjectors. 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 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.

MALE VO: Important Safety Information
Inform your healthcare provider of the following, before you receive treatment with ORENCIA®:
Infections: If you have any kind of infection even if it is small (such as an open cut or sore), an infection that is in your whole body (such as the flu), an infection that will not go away, or a history of infections that keep coming back. ORENCIA may make your immune system less able to fight infections, so you may be more likely to get infections or any infection you have may get worse.
Tuberculosis: If you have had tuberculosis (TB), a positive skin test for TB, or if you recently have been in close contact with someone who has had TB. If you get any of the symptoms of TB (a cough that does not go away, weight loss, fever, night sweats), call your healthcare provider right away. Before you start ORENCIA, your healthcare provider may examine you for TB or perform a skin test.
If you have or have had Viral Hepatitis. Before you use ORENCIA, your healthcare provider may examine you for hepatitis.
If you have a history of Chronic Obstructive Pulmonary (lung) Disease (COPD).
If you are scheduled to have Surgery.
Allergies to the Ingredients of ORENCIA: The ingredients of intravenous (IV) ORENCIA are: abatacept, maltose, monobasic sodium phosphate, and sodium chloride for administration. The ingredients of subcutaneous (SC) ORENCIA are: abatacept, sucrose, poloxamer 188, monobasic sodium phosphate monohydrate, dibasic sodium phosphate anhydrous, and water for injection.
Vaccinations: If you have recently received a vaccination or are scheduled for any vaccination. If you are receiving ORENCIA, and for 3 months after you stop receiving ORENCIA, you should not take live vaccines.
Diabetes: If you have diabetes and use a blood glucose monitor to check your sugar levels. The infusion of ORENCIA contains maltose, a sugar that can give falsely high blood glucose readings with some monitors on the day you receive your infusion. Your healthcare provider may tell you to use a different way to monitor your blood sugar levels. ORENCIA for SC injection does not contain maltose; therefore, you do not need to change the way you monitor your blood sugar if you are taking ORENCIA® (abatacept) subcutaneously.
Pregnancy: If you are pregnant, planning to become pregnant, or are thinking about becoming pregnant. It is not known if ORENCIA can harm your unborn baby.
Breastfeeding: You will need to decide to either breastfeed or receive treatment with ORENCIA, but not both.
If you Take Any Other Kinds of Medicine, including prescription and nonprescription medicines, vitamins, and herbal supplements.
If you are Taking Other Biologic Medicines to Treat RA such as: Enbrel® (etanercept), Humira® (adalimumab), Remicade® (infliximab), Kineret® (anakinra), Rituxan® (rituximab), Simponi® (golimumab), Cimzia® (certolizumab pegol), or Actemra® (tocilizumab). You may have a higher chance of getting a serious infection if you take ORENCIA with other biologic medicines.
Possible Side Effects of ORENCIA (abatacept)
ORENCIA can cause serious side effects including:
• Serious infections. ORENCIA can make you more likely to get infections or make the infection that you have get worse. Some patients have died from these infections. Call your healthcare provider immediately if you feel sick or get any of the following signs of infection: fever; feel very tired; cough; feel flu-like; or warm, red or painful skin.
• Allergic reactions. Allergic reactions can happen to people who use ORENCIA. Call your healthcare provider or get emergency medical help right away if you have any symptoms of an allergic reaction, which may include hives; swollen face, eyelids, lips, or tongue; or trouble breathing.
• Hepatitis B infection. If you are a carrier of the hepatitis B virus (a virus that affects the liver), the virus can become active while you use ORENCIA. Your healthcare provider may do a blood test before you start or while using ORENCIA.
• Vaccinations. You should not receive ORENCIA with certain types of vaccines. ORENCIA may cause some vaccinations to be less effective.
• Respiratory problems in patients with COPD. You may get certain respiratory problems more often if you receive ORENCIA and have COPD, including: worsened COPD, cough, or trouble breathing.
Please read the Patient Information and Full Prescribing information found on ORENCIA.com

ORENCIA ClickJect Autoinjector
Administration Guide

This guide features step-by-step instructions to help you use your autoinjector properly.

Download the ORENCIA ClickJect Autoinjector Administration Guide

 

Selected Important Safety Information

ORENCIA can cause serious side effects including:

Important Safety Information

Serious infections. ORENCIA can make you more likely to get infections or make the infection that you have get worse. Some patients have died from these infections. Call your healthcare provider immediately if you feel sick or get any of the following signs of infection: fever; feel very tired; cough; feel flu-like; or warm, red or painful skin.

Allergic reactions. Allergic reactions can happen to people who use ORENCIA. Call your healthcare provider or get emergency medical help right away if you have any symptoms of an allergic reaction, which may include hives; swollen face, eyelids, lips, or tongue; or trouble breathing.

Vaccinations. You should not receive ORENCIA with certain types of vaccines. ORENCIA may cause some vaccinations to be less effective.

Hepatitis B infection. If you are a carrier of the hepatitis B virus (a virus that affects the liver), the virus can become active while you use ORENCIA. Your healthcare provider may do a blood test before you start or while using ORENCIA.

Cancer (malignancies). Certain kinds of cancer have been reported in patients receiving ORENCIA. It is not known if ORENCIA increases your chance of getting certain kinds of cancer.

Inform your healthcare provider of the following, before you receive treatment with ORENCIA® (abatacept):

Infections: If you have any kind of infection, even if it is small (such as an open cut or sore), an infection that is in your whole body (such as the flu), an infection that will not go away, or a history of infections that keep coming back. ORENCIA may make your immune system less able to fight infections, so you may be more likely to get infections or any infection you have may get worse.

Tuberculosis: If you have had tuberculosis (TB), a positive skin test for TB, or if you recently have been in close contact with someone who has had TB. If you get any of the symptoms of TB (a cough that does not go away, weight loss, fever, night sweats), call your healthcare provider right away. Before you start ORENCIA, your healthcare provider may examine you for TB or perform a skin test.

If you have or have had Viral Hepatitis. Before you use ORENCIA, your healthcare provider may examine you for hepatitis.

If you have a history of Chronic Obstructive Pulmonary (lung) Disease (COPD).

If you are scheduled to have Surgery.

Allergies to the Ingredients of ORENCIA: The ingredients of intravenous (IV) ORENCIA are: abatacept, maltose, monobasic sodium phosphate, and sodium chloride for administration. The ingredients of subcutaneous (SC) ORENCIA are: abatacept, sucrose, poloxamer 188, monobasic sodium phosphate monohydrate, dibasic sodium phosphate anhydrous, and water for injection.

Vaccinations: If you have recently received a vaccination or are scheduled for any vaccination. If you are receiving ORENCIA, and for 3 months after you stop receiving ORENCIA, you should not take live vaccines.

Diabetes: If you have diabetes and use a blood glucose monitor to check your sugar levels. The infusion of ORENCIA® (abatacept) contains maltose, a sugar that can give falsely high blood glucose readings with some monitors on the day you receive your infusion. Your healthcare provider may tell you to use a different way to monitor your blood sugar levels. ORENCIA for SC injection does not contain maltose; therefore, you do not need to change the way you monitor your blood sugar if you are taking ORENCIA subcutaneously.

Pregnancy: If you are pregnant, or plan to become pregnant. It is not known if ORENCIA can harm your unborn baby. If you took ORENCIA during pregnancy, talk to your healthcare provider before your baby receives any vaccines.

Breastfeeding: It is not known if ORENCIA passes into your breastmilk. Talk to your healthcare provider about the best way to feed your baby if you use ORENCIA.

If you Take Any Other Kinds of Medicine, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

If you are Taking Other Biologic Medicines to Treat RA or JIA such as: Enbrel® (etanercept), Humira® (adalimumab), Remicade® (infliximab), Kineret® (anakinra), Rituxan® (rituximab), Simponi® (golimumab), Cimzia® (certolizumab pegol), or Actemra® (tocilizumab). You may have a higher chance of getting a serious infection if you take ORENCIA with other biologic medicines.

Possible Side Effects of ORENCIA

ORENCIA can cause serious side effects including:

  • Serious infections. ORENCIA can make you more likely to get infections or make the infection that you have get worse. Some people have died from these infections. Call your healthcare provider immediately if you feel sick or get any of the following signs of infection: fever; feel very tired; cough; feel flu-like; or warm, red or painful skin.
  • Allergic reactions. Allergic reactions can happen to people who use ORENCIA. Call your healthcare provider or get emergency medical help right away if you have any symptoms of an allergic reaction, which may include hives; swollen face, eyelids, lips, or tongue; or trouble breathing.
  • Hepatitis B infection. If you are a carrier of the hepatitis B virus (a virus that affects the liver), the virus can become active while you use ORENCIA. Your healthcare provider may do a blood test before you start treatment with ORENCIA.
  • Vaccinations. You should not receive ORENCIA with certain types of vaccines. ORENCIA may cause some vaccinations to be less effective.
  • Respiratory problems in people with COPD. You may get certain respiratory problems more often if you receive ORENCIA and have COPD, including: worsened COPD, cough, or trouble breathing.
  • Cancer (malignancies). Certain kinds of cancer have been reported in people receiving ORENCIA. It is not known if ORENCIA increases your chance of getting certain kinds of cancer.

Common side effects with ORENCIA® (abatacept) are headache, upper respiratory tract infection, sore throat, and nausea. Other side effects in children and adolescents may include diarrhea, cough, fever, and abdominal pain.

These are not all the possible side effects of ORENCIA.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

There are three ways to receive your dose of ORENCIA, and each way is approved for different ages:

  • ORENCIA prefilled SC syringe is approved for patients 2 years and older
  • ORENCIA IV is approved for patients 6 years and older. ORENCIA IV has not been studied in children younger than 6 years of age.
  • ORENCIA ClickJect Autoinjector has not been studied in children under 18 years of age.

Please talk to your child’s healthcare provider about the best way for your child to receive ORENCIA.

Please click here to read the Patient Information in the Full Prescribing Information.

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ORENCIA® (abatacept) ClickJect Autoinjector
Administration Guide (PDF).

Full Prescribing Information (PDF).

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