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INSTRUCTIONS FOR USE
ORENCIA
ClickJect
®
™
(abatacept) Injection
125 mg/mL, Single-Dose Autoinjector, For Subcutaneous Use Only
Read these instructions before you use the ClickJect Autoinjector
and each time you get a refill. There may be new information. Before you use the Autoinjector for the first time,
make sure your healthcare provider shows you the right way to use it.
Important:
• Keep the ClickJect Autoinjector in the refrigerator until ready to use.
• Do not freeze.
Indication/Usage
Adult Rheumatoid Arthritis (RA): ORENCIA
(abatacept) is a prescription medicine that reduces signs and
®
symptoms in adults 18 years or older 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.
Adult Psoriatic Arthritis (PsA): ORENCIA is a prescription medicine that reduces signs and symptoms in adults
with active psoriatic arthritis (PsA). In adults, ORENCIA may be used alone or with other PsA treatments.
Please read Important Safety Information on pages 16-18.
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Table of Contents
Summary of Contents for ORENCIA ClickJect
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Page 1: Instructions For Use
18 years or older 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. -
Page 2: Before You Begin
Before You Begin Get to know the ClickJect Autoinjector • The Autoinjector automatically delivers the medicine. The transparent tip locks over the needle once the injection is complete and the Autoinjector is removed from the skin. • Do not remove the orange needle cover until you are ready to inject. -
Page 3: After Use
Blue Indicator After Use Transparent Tip Gather supplies for your injection on a clean, flat surface (only the ClickJect Autoinjector is included in the package): • Alcohol • ClickJect swab Autoinjector • Adhesive bandage • Sharps disposal • Cotton ball or gauze... - Page 4 Step 1: Prepare Your Autoinjector WAIT Let your ClickJect Autoinjector warm up. Remove one Autoinjector from the refrigerator and let it rest at room temperature for 30 minutes. Do not remove the Autoinjector needle cover while allowing it to reach room temperature.
- Page 5 Wash your hands well with soap and water. Examine the ClickJect Autoinjector: Expiration Date • Check expiration date printed on the label. Do not use if past the expiration date. Liquid • Check the Autoinjector for damage. Do not use if it is cracked or broken.
- Page 6 Step 2: Prepare for Injection Choose your injection site Injection Areas Self-Injection in either the stomach (abdomen), front of and Caregiver the thighs, or outer area of upper arm (only if caregiver administered). Abdomen, avoid 2 inches around navel Rotate injection site. Front of thighs •...
- Page 7 Gently clean injection site: • Wipe the injection site with an alcohol swab and let it air dry. • Do not touch the injection site again before giving the injection. • Do not fan or blow on the clean area. Pull orange needle cover Remove Needle Cover...
- Page 8 Step 3: Inject Your Dose 90° Position the Autoinjector so you can see the viewing window and it is at a 90 º angle to the injection site. With Window Skin Pinch your other hand, gently pinch the cleaned skin. Complete all steps to deliver your full dose of medicine: WAIT PUSH...
- Page 9 • To deliver the full dose of medicine, hold the Autoinjector in place for 15 seconds AND wait until the blue indicator stops moving in window. Remove the ClickJect Autoinjector from the injection site by lifting it straight up. After you remove it from your skin, the transparent tip will lock over the needle.
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Page 10: After The Injection
Disposing of used ClickJect Autoinjectors: • Put your used ClickJect Autoinjector in an FDA-cleared Sharps disposal container right away after use. Do not throw away (dispose of) loose needles and prefilled syringes in your household trash. • If you do not have an FDA-cleared Sharps disposal container, you may use a household container that is: º... - Page 11 Keep Autoinjector and the disposal container out of the reach of children. container How to store ORENCIA ClickJect Autoinjector • Store ORENCIA in the refrigerator at 36°F to 46°F (2°C to 8°C). • Keep ORENCIA in the original package and out of the light. • Do not freeze ORENCIA.
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Page 12: Frequently Asked Questions
Frequently Asked Questions Q. Why do I need to allow the Autoinjector to warm up at room temperature for 30 minutes prior to injecting? A. This step is primarily for your comfort. If the medicine is cold, the injection may take longer than 15 seconds. - Page 13 Q. I feel a little bit of burning and/or pain during injection. Is this normal? A. When giving an injection, you may feel a prick from the needle. Sometimes, the medicine can cause slight irritation near the injection site. If this occurs, the discomfort should be mild to moderate. If you experience any side effects, including pain, swelling, or discoloration near the injection site, contact your healthcare provider or pharmacist immediately.
- Page 14 Frequently Asked Questions Q. How should I dispose of a used Autoinjector? A. Place used Autoinjector into an FDA-cleared Sharps disposal container right away after use. • If you do not have one, you may use a household container that is: •...
- Page 15 Q. Can I take my Autoinjector on board an aircraft? A. Generally, this is allowed. Be sure to pack your Autoinjector in your carry-on, and do not put it in your checked luggage. You should carry it with you in your travel cooler at a temperature of 36°F to 46°F (2°C to 8°C) until you are ready to use it.
- Page 16 If away. Before you start ORENCIA, your healthcare you are receiving ORENCIA, and for 3 months after provider may examine you for TB or perform you stop receiving ORENCIA, you should not take a skin test.
- Page 17 ORENCIA subcutaneously. effects including: Pregnancy: If you are pregnant, or plan to become pregnant. It is not known if ORENCIA can harm • Serious infections. ORENCIA can make you more your unborn baby. If you took ORENCIA during...
- Page 18 • Cancer (malignancies). Certain kinds of cancer have been reported in people receiving • Allergic reactions. Allergic reactions can ORENCIA. It is not known if ORENCIA increases happen to people who use ORENCIA. Call your your chance of getting certain kinds of cancer.
- Page 19 1-800-ORENCIA (1-800-673-6242). Click here for the Patient Information in the Full Prescribing Information. © 2017 Bristol-Myers Squibb Company ORENCIA is a registered trademark and ClickJect is a trademark of Bristol-Myers Squibb Company. All other trademarks are property Injection for Intravenous Use of their respective owners.
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