ORENCIA® (Non-English)

1. Rheumatoid arthritis (RA):

   Reconstitute ORENCIA lyophilized powder and administer after dilution as a 30-minute intravenous infusion utilizing the weight range-based dosing recommended in Table below. Following the initial intravenous infusion, administer as an intravenous infusion at 2 and 4 weeks and every 4 weeks thereafter.

2. Juvenile Idiopathic Arthritis (Paediatric population):

   The recommended dose of ORENCIA for patients 6 to 17 years of age with juvenile idiopathic arthritis who weigh less than 75 kg is 10 mg/kg calculated based on the patient’s body weight at each administration. Paediatric patients weighing 75 kg or more should be administered ORENCIA following the adult dosing regimen, not to exceed a maximum dose of 1,000 mg. ORENCIA should be administered as a 30-minute intravenous infusion. Following the initial administration, ORENCIA should be given at 2 and 4 weeks after the first infusion and every 4 weeks thereafter.

   The safety and efficacy of ORENCIA in children below 6 years of age have not been studied and therefore, ORENCIA is not recommended for use in children under six years old.

3. Special population (Elderly patients):

   No dose adjustment is required.

4. Renal and hepatic impairment:

   ORENCIA has not been studied in these patient populations. No dose recommendations can be made.

• The treatment of adult patients with moderately to severely active rheumatoid arthritis (RA).
• The treatment of patients 2 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA).
• The treatment of patients 2 years of age and older with active psoriatic arthritis (PsA).
• The prophylaxis of acute graft versus host disease (aGVHD), in combination with a calcineurin inhibitor and methotrexate, in adults and pediatric patients 2 years of age and older undergoing hematopoietic stem cell transplantation (HSCT) from a matched or 1 allele-mismatched unrelated donor.

The properties of Orencia (abatacept) include its ability to reduce inflammatory symptoms such as swelling, pain, and stiffness. It is expected to stop joint deformities in the long term and maintain overall joint function. Studies have shown that Orencia can suppress inflammation, decrease the production of antibodies against collagen, and limit the production of antigens. Additionally, it is a selective costimulation modulator, inhibiting T-cell (T lymphocyte) activation by binding to CD80 and CD86.

• Treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis or JIA.
• If a response to abatacept is not present within 6 months of treatment, the continuation of the treatment should be reconsidered.

Step 1: Prepare for your injection

• Remove your syringe from the refrigerator and wait 30 minutes.
• Remove one prefilled syringe from the refrigerator and wait 30 minutes to allow it to reach room temperature.

Step 2: Examine your prefilled syringe

• Hold the prefilled syringe by the body with the needle cover pointing down as shown.
• Check the expiration date printed on the label. DO NOT use if the expiration date has passed.
• Check the prefilled syringe for damage. DO NOT use if it is cracked or broken.
• Check the liquid in the prefilled syringe through the viewing window. It should be clear and colorless to pale yellow. Do not inject if the liquid is cloudy, discolored, or has particles in it.
• It is normal to see an air bubble. Do not attempt to remove it.

Step 3: Check the dose on your prefilled syringe

• Hold the syringe at eye level.
• Look closely to make sure that the amount of liquid in the prefilled syringe is at or just above the fill line for your prescribed dose.

Step 4: Choose and prepare your injection site

• You can choose to inject in:
  • The stomach (abdomen)
  • Front of the thighs
  • Outer area of upper arm (only if your caregiver is administering your dose)
• Rotate your injection site: Each week you can use the same area of your body, but use a different injection site in that area.
• DO NOT inject into an area where the skin is tender, bruised, red, scaly, or hard.
• DO NOT give the injection in any areas with scars or stretch marks.
• Record the date, time, and site where you inject.
• Gently clean your injection site.
• Remove the needle cover.

Step 5: Inject your dose: You must pinch the skin during needle insertion

Contraindications

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.
• 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.
• 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.

After-care

• Care for the injection site:
  • There may be a little bleeding at the injection site. You can press a cotton ball or gauze over the injection site.
  • If needed, you may cover the injection site with an adhesive bandage.
• Dispose of your used prefilled syringe after injection:
  • Put your used ORENCIA prefilled syringes 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.