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ORENCIA ClickJect - User Manual

ORENCIA ClickJect
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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.
INSTRUCTIONS FOR USE
ORENCIA
®
ClickJect
(abatacept) Injection
125 mg/mL, Single-Dose Autoinjector, For Subcutaneous Use Only
eyers Squibb Company
n, NJ 08543 USA
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EXP:
For Position Only
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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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Do you have a question about the ORENCIA ClickJect and is the answer not in the manual?

Summary

Indication and Usage

Adult Rheumatoid Arthritis (RA)

ORENCIA is for adults 18+ with moderate to severe RA, alone or with other RA treatments except TNF antagonists.

Adult Psoriatic Arthritis (PsA)

ORENCIA is for adults with active psoriatic arthritis, alone or with other PsA treatments.

Before You Begin

Get to know the ClickJect Autoinjector

Describes the ClickJect Autoinjector features and automatic delivery mechanism. Do not remove the needle cover until ready.

Step 1: Prepare Your Autoinjector

Examine the ClickJect Autoinjector

Check expiration date, for damage, and liquid clarity. Do not use if cloudy or discolored.

Step 2: Prepare for Injection

Choose your injection site

Select abdomen, front of thighs, or outer upper arm. Avoid tender, bruised, or scarred areas.

Rotate injection site

Use a different site within the same area each week. Record date, time, and site.

Gently clean injection site

Wipe with alcohol swab, let air dry. Do not touch or fan the clean area.

Pull orange needle cover

Pull straight off. Do not recap. Discard cover in household trash.

Step 3: Inject Your Dose

Step 4: After the Injection

Care of injection site

Press cotton ball/gauze on site if bleeding. Do not rub. Cover with bandage if needed.

Disposing of used ClickJect Autoinjectors

Place in FDA-cleared sharps container. Do not throw in household trash. Follow local guidelines.

How to store ORENCIA ClickJect Autoinjector

Store in refrigerator (36-46°F), in original package, out of light. Do not freeze.

Important Safety Information

Infections

ORENCIA may increase risk or worsen existing infections. Consult doctor if symptoms appear.

Tuberculosis

Inform doctor if you have or had TB, or close contact with someone with TB.

Viral Hepatitis

Doctor may examine you for hepatitis if you have or had it.

Chronic Obstructive Pulmonary Disease (COPD)

May increase risk of respiratory problems if you have COPD.

Surgery

Inform doctor if scheduled for surgery.

Allergies to Ingredients

Lists ingredients for IV and SC ORENCIA. Consult doctor for any known allergies.

Vaccinations

Do not take live vaccines while receiving ORENCIA or for 3 months after.

Diabetes

Infusion may affect glucose readings. SC injection does not contain maltose.

Pregnancy

Effect on unborn baby unknown. Consult doctor before baby receives vaccines if you used ORENCIA during pregnancy.

Breastfeeding

Unknown if ORENCIA passes into breastmilk. Consult doctor.

Taking Other Medicine

Inform doctor about all medications, vitamins, and supplements.

Taking Other Biologic Medicines

May increase risk of serious infection when taken with other biologics.

Possible Side Effects

Includes serious infections, headache, respiratory infection, sore throat, nausea. Call doctor for side effects.

Allergic Reactions

May include hives, swollen face, or trouble breathing. Seek emergency medical help.

Hepatitis B Infection

Hepatitis B virus can become active. Doctor may perform blood test before treatment.

Vaccinations

ORENCIA may affect vaccine effectiveness. Avoid certain vaccines.

Respiratory Problems in COPD

May increase frequency of worsened COPD, cough, or trouble breathing.

Cancer (Malignancies)

Certain cancers reported. Not known if ORENCIA increases cancer risk.

Common Side Effects

Headache, upper respiratory infection, sore throat, nausea. Children may have diarrhea, cough, fever, abdominal pain.

ORENCIA ClickJect Specifications

General IconGeneral
Brand NameORENCIA ClickJect
Generic Nameabatacept
FormulationSolution for subcutaneous injection
Concentration125 mg/mL
Administration RouteSubcutaneous
ManufacturerBristol-Myers Squibb
Drug ClassSelective T-cell costimulation modulator
IndicationRheumatoid arthritis