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Indication  

Indication and Usage

Adult Rheumatoid Arthritis (RA): ORENCIA® (abatacept) is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA. ORENCIA may be used as monotherapy or concomitantly with disease-modifying, anti-rheumatic drugs (DMARDs) other than tumor necrosis factor (TNF) antagonists.

Important Limitations of Use: ORENCIA should not be administered concomitantly with TNF antagonists, and is not recommended for use concomitantly with other biologic RA therapy, such as anakinra.

ORENCIA is available as a lyophilized powder for intravenous (IV) infusion and as a solution for subcutaneous (SC) injection.

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Indication  

Indication and Usage

Juvenile Idiopathic Arthritis (JIA): ORENCIA® (abatacept) is indicated for reducing signs and symptoms in pediatric patients aged 6 years and older with moderately to severely active polyarticular JIA. ORENCIA may be used as monotherapy or concomitantly with methotrexate (MTX).

Important Limitations of Use: ORENCIA should not be administered concomitantly with TNF antagonists, and is not recommended for use concomitantly with other biologic RA therapy, such as anakinra.

Available formulation for JIA: ORENCIA is available as a lyophilized powder for intravenous (IV) infusion.

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IN MODERATE TO SEVERE RA
ORENCIA® (abatacept) is available in 2 formulations

  • ORENCIA SC
  • ORENCIA IV

ORENCIA SC is a once-weekly self-injection

ORENCIA SC (125 mg) should be administered once weekly and may be initiated with or without an ORENCIA IV loading dose.

For patients initiating therapy with an IV loading dose, ORENCIA should be initiated with a single IV infusion (as per body weight categories listed in the ORENCIA IV adult dosing by weight table), followed by the first 125-mg SC injection administered within a day of the IV infusion.

Patients transitioning from ORENCIA IV therapy to SC administration should administer the first SC dose instead of the next IV dose.

Note: ORENCIA SC is available for adults only and is intended for use under the guidance of a physician or health care practitioner. After proper training in SC injection technique, a patient may self-inject if a physician/healthcare practitioner determines that it is appropriate. Patients should be instructed to follow the directions provided in the Instructions for Use for additional details on medication administration.


ORENCIA PREFILLED SYRINGE WITH BD ULTRASAFE PASSIVE NEEDLE GUARD

Selected Important Safety Information

Concomitant Use with TNF Antagonists: Concurrent therapy with ORENCIA and a TNF antagonist is not recommended. In controlled clinical trials, adult patients receiving concomitant intravenous ORENCIA and TNF antagonist therapy experienced more infections (63%) and serious infections (4.4%) compared to patients treated with only TNF antagonists (43% and 0.8%, respectively), without an important enhancement of efficacy.

Self-injection guide

A printable, step-by-step guide designed to assist your patients
through the self-injection process

General injection instructions

For more detailed administration see the Instructions for Use.

PREPARATION AND SUPPLIES

  • Prefilled syringe with BD UltraSafe Passive Needle Guard
  • Alcohol swab
  • Adhesive bandage
  • Cotton ball or gauze
  • Sharps disposal container

Preparing for an ORENCIA injection

1. PREPARING FOR AN ORENCIA INJECTION

Remove 1 single-use ORENCIA prefilled syringe from the refrigerator and let it warm up for 30 to 60 minutes to allow it to reach room temperature.

Preparing for an ORENCIA injection

2. INSPECT

Look for cloudiness, particulate matter, or discoloration prior to administration; do not use if present; ORENCIA SC should be clear and colorless to pale yellow.

Preparing for an ORENCIA injection
Self-injection and caregiver injection
Caregiver
Caregiver injection only

3. CHOOSE AND PREPARE AN INJECTION SITE

Rotate injection sites and do not inject into areas where the skin is tender, bruised, red, scaly, or hard.

Preparing for an ORENCIA injection

4. INJECT ORENCIA

Inject the full amount in the syringe.

Preparing for an ORENCIA injection

5. DISPOSAL

Discard used syringes into biohazard containers.

Note: ORENCIA SC injection, 125 mg/syringe is not intended for IV infusion. For more detailed administration information, see the Instructions for Use.

Storage for ORENCIA SC

  • ORENCIA solution supplied in a prefilled syringe should be refrigerated at 2°C to 8°C (36°F to 46°F)
  • Do not use beyond the expiration date on the prefilled syringe*
  • Protect from light by storing in the original package until time of use
  • Do not allow the prefilled syringe to freeze

*If a patient receives a damaged syringe, or if the solution is cloudy, discolored, or has lumps or particles, call 1-800-ORENCIA.

ORENCIA IV is a 30-minute infusion

Following an initial intravenous dose, ORENCIA IV should be administered at 2 and 4 weeks and then every 4 weeks thereafter.

Month 1 Continue

Day 1 1st Dose

Day 15 2nd Dose

Day 29 3rd Dose

Every 4 Weeks thereafter Actual day of dosing may vary based on patient scheduling.

ORENCIA IV adult dosing by weight

Each vial of ORENCIA IV contains 250 mg of lyophilized powder. Based on your patient’s weight, the appropriate dose may require 2, 3, or 4 vials.

Body weight of patient* Dose (mg) Number of vials Billable units (abatacept per 10 mg)
<60 kg (<132 lbs) 500 mg 2 50
60 kg to 100 kg (132 lbs to 220 lbs) 750 mg 3 75
>100 kg (>220 lbs) 1000 mg 4 100

1 kg=2.2 lbs.
Each vial provides 250 mg of ORENCIA for administration.

Selected Important Safety Information

Hypersensitivity: Anaphylaxis or anaphylactoid reactions can occur during or after an infusion and can be life-threatening. There were 2 cases (<0.1%; n=2688) of anaphylaxis or anaphylactoid reactions in clinical trials with adult RA patients treated with intravenous ORENCIA. Other reactions potentially associated with drug hypersensitivity, such as hypotension, urticaria, and dyspnea, each occurred in <0.9% of patients. In postmarketing experience, a case of fatal anaphylaxis following the first infusion of ORENCIA was reported. Appropriate medical support measures for treating hypersensitivity reactions should be available for immediate use. If an anaphylactic or other serious allergic reaction occurs, administration of ORENCIA should be stopped immediately and permanently discontinued, with appropriate therapy instituted.

Infusing ORENCIA IV

A video guide to preparing and administering an ORENCIA IV infusion

ORENCIA IV dosing and administration guide

A printable, step-by-step guide to preparing and administering an ORENCIA IV infusion

General infusion instructions

For more detailed administration information, watch the ORENCIA IV infusion video above or see the Full Prescribing Information.

PREPARATION AND SUPPLIES

To complete an infusion you’ll need:

  • ORENCIA IV lyophilized powder in preservative-free, single-use vials (2, 3, or 4 vials based on patient body weight)
  • Sterile water for injection, USP
  • Sterile, nonpyrogenic, low-protein–binding filter (pore size of 0.2 to 1.2 μm)
  • 100-mL infusion bag or bottle of 0.9% Sodium Chloride Injection, USP
  • Silicone-free disposable syringe
  • 18- to 21-gauge needles
  • Sharps container
  • Alcohol swabs

Use aseptic technique throughout

1. USE ASEPTIC TECHNIQUE THROUGHOUT

Use aseptic technique throughout. Remove flip-top from ORENCIA vial and wipe the top with an alcohol swab.

Preparing for an ORENCIA injection

2. RECONSTITUTE

Reconstitute the ORENCIA powder in each vial with 10 mL of Sterile Water for Injection, USP, using only the silicone-free disposable syringe provided with each vial and an 18- to 21-gauge needle. If syringe is dropped or becomes contaminated, use a new one.

Discard any solution prepared using a siliconized syringe.

For information on obtaining additional syringes, contact Bristol-Myers Squibb at 1-800-ORENCIA.

Preparing for an ORENCIA injection

3. INSERT THE SYRINGE NEEDLE INTO THE VIAL

Insert the syringe needle into the vial through the center of the rubber stopper and direct the stream of Sterile Water for Injection, USP, to the glass wall of the vial. Do not use the vial if the vacuum is not present. Do not shake.

Preparing for an ORENCIA injection

4. ROTATE THE VIAL

Rotate the vial with a gentle swirling motion until contents completely dissolve. After mixing, each milliliter will contain 25 mg (250 mg/10 mL) of ORENCIA

Preparing for an ORENCIA injection

5. VENT THE VIAL

Vent the vial with a needle to dissipate any foam that may be present. The solution should be clear and colorless to pale yellow. Do not use if opaque particles, discoloration, or other foreign particles are present.

Preparing for an ORENCIA injection

6. FURTHER DILUTE THE RECONSTITUTED ORENCIA SOLUTION

Further dilute the reconstituted ORENCIA solution to 100 mL as follows: from a 100-mL infusion bag or bottle, withdraw a volume of 0.9% Sodium Chloride Injection, USP, equal to the volume of the reconstituted ORENCIA solution (for 2 vials remove 20 mL, for 3 vials remove 30 mL, for 4 vials remove 40 mL).

Slowly add the reconstituted ORENCIA solution from each vial to the infusion bag or bottle using the same silicone-free disposable syringe provided with each vial.

Preparing for an ORENCIA injection

7. GENTLY MIX

Gently mix. Do not shake the bag or bottle. The concentration of the fully diluted ORENCIA solution in the infusion bag or bottle will be approximately 5, 7.5, or 10 mg of ORENCIA per mL of solution depending on whether 2, 3, or 4 vials of ORENCIA are used. Discard any unused portion in the vials.

Prior to administration, visually inspect the ORENCIA solution for particulate matter and discoloration. Discard if any particulate matter or discoloration is observed.

Preparing for an ORENCIA injection

8. ADMINISTER

Administer the entire, fully diluted ORENCIA solution over a period of 30 minutes with an infusion set and a sterile, nonpyrogenic, low-protein–binding filter (pore size of 0.2 μm to 1.2 μm).

Complete the infusion within 24 hours of reconstitution of the ORENCIA vials. The fully diluted ORENCIA solution may be stored at room temperature or refrigerated at 36°F to 46°F (2°C to 8°C) before use.

Storage for ORENCIA IV

  • ORENCIA lyophilized powder must be refrigerated at 36°F to 46°F (2°C to 8°C)
  • Do not use beyond the expiration date on the vial
  • Protect the vials from light by storing in the original package until time of use

In moderate to severe RA
What is early rapidly progressing RA?


More Important Safety Information

Important Safety Information for ORENCIA® (abatacept)

Concomitant Use with TNF Antagonists: Concurrent therapy with ORENCIA and a TNF antagonist is not recommended. In controlled clinical trials, adult patients receiving concomitant intravenous ORENCIA and TNF antagonist therapy experienced more infections (63%) and serious infections (4.4%) compared to patients treated with only TNF antagonists (43% and 0.8%, respectively), without an important enhancement of efficacy.

Hypersensitivity: Anaphylaxis or anaphylactoid reactions can occur during or after an infusion and can be life-threatening. There were 2 cases (<0.1%; n=2688) of anaphylaxis or anaphylactoid reactions in clinical trials with adult RA patients treated with intravenous ORENCIA. Other reactions potentially associated with drug hypersensitivity, such as hypotension, urticaria, and dyspnea, each occured in <0.9% of patients. There was one case of a hypersensitivity reaction with ORENCIA in JIA clinical trials (0.5%; n=190). In postmarketing experience, a case of fatal anaphylaxis following the first infusion of ORENCIA was reported. Appropriate medical support measures for treating hypersensitivity reactions should be available for immediate use. If an anaphylactic or other serious allergic reaction occurs, administration of ORENCIA should be stopped immediately and permanently discontinued, with appropriate therapy instituted.

Infections: Serious infections, including sepsis and pneumonia, have been reported in patients receiving ORENCIA. Some of these infections have been fatal. Many of the serious infections have occurred in patients on concomitant immunosuppressive therapy which in addition to their underlying disease, could further predispose them to infection. Caution should be exercised in patients with a history of infection or underlying conditions which may predispose them to infections. Treatment with ORENCIA should be discontinued if a patient develops a serious infection. Patients should be screened for tuberculosis and viral hepatitis in accordance with published guidelines, and if positive, treated according to standard medical practice prior to therapy with ORENCIA.

Immunizations: Live vaccines should not be given concurrently with ORENCIA or within 3 months of its discontinuation. The efficacy of vaccination in patients receiving ORENCIA is not known. ORENCIA may blunt the effectiveness of some immunizations. It is recommended that JIA patients be brought up to date with all immunizations in agreement with current immunization guidelines prior to initiating therapy with ORENCIA.

Use in Patients with Chronic Obstructive Pulmonary Disease (COPD): Adult COPD patients treated with ORENCIA developed adverse events more frequently than those treated with placebo (97% vs 88%, respectively). Respiratory disorders occurred more frequently in patients treated with ORENCIA compared to those on placebo (43% vs 24%, respectively), including COPD exacerbations, cough, rhonchi, and dyspnea. A greater percentage of patients treated with ORENCIA developed a serious adverse event compared to those on placebo (27% vs 6%), including COPD exacerbation [3 of 37 patients (8%)] and pneumonia [1 of 37 patients (3%)]. Use of ORENCIA in patients with RA and COPD should be undertaken with caution, and such patients monitored for worsening of their respiratory status.

Blood Glucose Testing: ORENCIA for intravenous administration contains maltose, which may result in falsely elevated blood glucose readings on the day of infusion when using blood glucose monitors with test strips utilizing glucose dehydrogenase pyrroloquinoline quinone (GDH-PQQ). Consider using monitors and advising patients to use monitors that do not react with maltose, such as those based on glucose dehydrogenase nicotine adenine dinucleotide (GDH-NAD), glucose oxidase or glucose hexokinase test methods. ORENCIA for subcutaneous (SC) administration does not contain maltose; therefore, patients do not need to alter their glucose monitoring.

Pregnant and Nursing Mothers: ORENCIA should be used during pregnancy only if clearly needed. The risk for development of autoimmune diseases in humans exposed in utero to abatacept has not been determined. Nursing mothers should be informed of the risk/benefit of continued breast-feeding or discontinuation of the drug. A pregnancy registry has been established to monitor fetal outcomes. Healthcare professionals are encouraged to register pregnant patients exposed to ORENCIA by calling 1-877-311-8972.

Most Serious Adverse Reactions: Serious infections (3% ORENCIA vs 1.9% placebo) and malignancies (1.3% ORENCIA vs 1.1% placebo).

Malignancies: The overall frequency of malignancies was similar between adult patients treated with ORENCIA or placebo. However, more cases of lung cancer were observed in patients treated with ORENCIA (0.2%) than those on placebo (0%). A higher rate of lymphoma was seen compared to the general population; however, patients with RA, particularly those with highly active disease, are at a higher risk for the development of lymphoma. The potential role of ORENCIA in the development of malignancies in humans is unknown.

Most Frequent Adverse Events (≥10%): Headache, upper respiratory tract infection, nasopharyngitis, and nausea were the most commonly reported adverse events in the adult RA clinical studies. Other events reported in ≥5% of JIA patients were diarrhea, cough, pyrexia, and abdominal pain. In general, the adverse events in pediatric patients were similar in frequency and type to those seen in adult patients.

Note concerning SC ORENCIA: The safety and efficacy of SC ORENCIA have not been studied in patients under 18 years of age.

Please see Full Prescribing Information »

 More Important Safety Information

Important Safety Information for ORENCIA® (abatacept)

Concomitant Use with TNF Antagonists: Concurrent therapy with ORENCIA and a TNF antagonist is not recommended. In controlled clinical trials, adult patients receiving concomitant intravenous ORENCIA and TNF antagonist therapy experienced more infections (63%) and serious infections (4.4%) compared to patients treated with only TNF antagonists (43% and 0.8%, respectively), without an important enhancement of efficacy.

Hypersensitivity: Anaphylaxis or anaphylactoid reactions can occur during or after an infusion and can be life-threatening. There were 2 cases (<0.1%; n=2688) of anaphylaxis or anaphylactoid reactions in clinical trials with adult RA patients treated with intravenous ORENCIA. Other reactions potentially associated with drug hypersensitivity, such as hypotension, urticaria, and dyspnea, each occured in <0.9% of patients. In postmarketing experience, a case of fatal anaphylaxis following the first infusion of ORENCIA was reported. Appropriate medical support measures for treating hypersensitivity reactions should be available for immediate use. If an anaphylactic or other serious allergic reaction occurs, administration of ORENCIA should be stopped immediately and permanently discontinued, with appropriate therapy instituted.

Infections: Serious infections, including sepsis and pneumonia, have been reported in patients receiving ORENCIA. Some of these infections have been fatal. Many of the serious infections have occurred in patients on concomitant immunosuppressive therapy which in addition to their underlying disease, could further predispose them to infection. Caution should be exercised in patients with a history of infection or underlying conditions which may predispose them to infections. Treatment with ORENCIA should be discontinued if a patient develops a serious infection. Patients should be screened for tuberculosis and viral hepatitis in accordance with published guidelines, and if positive, treated according to standard medical practice prior to therapy with ORENCIA.

Immunizations: Live vaccines should not be given concurrently with ORENCIA or within 3 months of its discontinuation.It is recommended that JIA patients be brought up to date with all immunizations in agreement with current immunization guidelines prior to initiating therapy with ORENCIA.

Use in Patients with Chronic Obstructive Pulmonary Disease (COPD): Adult COPD patients treated with ORENCIA developed adverse events more frequently than those treated with placebo (97% vs 88%, respectively). Respiratory disorders occurred more frequently in patients treated with ORENCIA compared to those on placebo (43% vs 24%, respectively), including COPD exacerbations, cough, rhonchi, and dyspnea. A greater percentage of patients treated with ORENCIA developed a serious adverse event compared to those on placebo (27% vs 6%), including COPD exacerbation [3 of 37 patients (8%)] and pneumonia [1 of 37 patients (3%)]. Use of ORENCIA in patients with RA and COPD should be undertaken with caution, and such patients monitored for worsening of their respiratory status.

Blood Glucose Testing: ORENCIA for intravenous administration contains maltose, which may result in falsely elevated blood glucose readings on the day of infusion when using blood glucose monitors with test strips utilizing glucose dehydrogenase pyrroloquinoline quinone (GDH-PQQ). Consider using monitors and advising patients to use monitors that do not react with maltose, such as those based on glucose dehydrogenase nicotine adenine dinucleotide (GDH-NAD), glucose oxidase or glucose hexokinase test methods. ORENCIA for subcutaneous (SC) administration does not contain maltose; therefore, patients do not need to alter their glucose monitoring.

Pregnant and Nursing Mothers: ORENCIA should be used during pregnancy only if clearly needed. The risk for development of autoimmune diseases in humans exposed in utero to abatacept has not been determined. Nursing mothers should be informed of the risk/benefit of continued breast-feeding or discontinuation of the drug. A pregnancy registry has been established to monitor fetal outcomes. Healthcare professionals are encouraged to register pregnant patients exposed to ORENCIA by calling 1-877-311-8972.

Most Serious Adverse Reactions: Serious infections (3% ORENCIA vs 1.9% placebo) and malignancies (1.3% ORENCIA vs 1.1% placebo).

Malignancies: The overall frequency of malignancies was similar between adult patients treated with ORENCIA or placebo. However, more cases of lung cancer were observed in patients treated with ORENCIA (0.2%) than those on placebo (0%). A higher rate of lymphoma was seen compared to the general population; however, patients with RA, particularly those with highly active disease, are at a higher risk for the development of lymphoma. The potential role of ORENCIA in the development of malignancies in humans is unknown.

Most Frequent Adverse Events (≥10%): Headache, upper respiratory tract infection, nasopharyngitis, and nausea were the most commonly reported adverse events in the adult RA clinical studies. Other events reported in ≥5% of JIA patients were diarrhea, cough, pyrexia, and abdominal pain. In general, the adverse events in pediatric patients were similar in frequency and type to those seen in adult patients.

Note concerning SC ORENCIA: The safety and efficacy of SC ORENCIA have not been studied in patients under 18 years of age.

Please see Full Prescribing Information »

All individuals are models used for illustrative purposes only and not actual patients.

Reference: ORENCIA (abatacept) [package insert]. Princeton, NJ: Bristol-Myers Squibb.