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Indications and Usage

Adult Rheumatoid Arthritis: ORENCIA® (abatacept) is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA).

Limitations of Use: The concomitant use of ORENCIA with other potent immunosuppressants [e.g., biologic disease-modifying antirheumatic drugs (bDMARDS), Janus kinase (JAK) inhibitors] is not recommended.

Polyarticular Juvenile Idiopathic Arthritis: ORENCIA is indicated for the treatment of patients 2 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA).

Limitations of Use: The concomitant use of ORENCIA with other potent immunosuppressants [e.g., biologic disease-modifying antirheumatic drugs (bDMARDS), Janus kinase (JAK) inhibitors] is not recommended.

Adult Psoriatic Arthritis: ORENCIA is indicated for the treatment of adult patients with active psoriatic arthritis (PsA).

Limitations of Use: The concomitant use of ORENCIA with other potent immunosuppressants [e.g., biologic disease-modifying antirheumatic drugs (bDMARDS), Janus kinase (JAK) inhibitors] is not recommended.

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Indications and Usage

Juvenile Idiopathic Arthritis (JIA): ORENCIA® (abatacept) is indicated for reducing signs and symptoms in patients 2 years of age 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.

  • INTRAVENOUS
  • PREFILLED SYRINGE
  • AUTOINJECTOR

ORENCIA IV is a 30-minute infusion—a long-standing treatment option for your patients1

ORENCIA® (abatacept) Intravenous Administration

ORENCIA may be used as monotherapy or concomitantly with disease modifying antirheumatic drugs (DMARDs) other than JAK inhibitors or bDMARDs (e.g., TNF antagonists).

*Includes Phase III and Phase IV studies for moderate to severe RA.

National Drug Code (NDC): 0003-2187-10

Selected Important Safety Information

Concomitant Use with TNF Antagonists, Other Biologic RA/PsA Therapy, or JAK Inhibitors: Concurrent therapy with ORENCIA and a TNF antagonist is not recommended. In controlled clinical trials, adult RA patients receiving concomitant intravenous ORENCIA and TNF antagonist therapy experienced more infections (63% vs 43%) and serious infections (4.4% vs 0.8%) compared to patients treated with only TNF antagonists, without an important enhancement of efficacy. Additionally, concomitant use of ORENCIA with other biologic RA/PsA therapy or JAK inhibitors is not recommended.

Infusing ORENCIA IV

A video guide to preparing and administering an ORENCIA IV infusion

 

Infusing ORENCIA ® (abatacept) IV Transcript

 

ORENCIA IV dosing and administration guide

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

Selected Important Safety Information

Hypersensitivity: There were 2 cases (<0.1%; n=2688) of anaphylaxis 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, fatal anaphylaxis following the first infusion of ORENCIA and life-threatening cases of angioedema have been reported. Angioedema has occurred as early as after the first dose of ORENCIA, but also has occurred with subsequent doses. Angioedema reactions have occurred within hours of administration and in some instances had a delayed onset (i.e., days). 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 intravenous or subcutaneous ORENCIA should be stopped immediately and permanently discontinued, with appropriate therapy instituted.

General infusion instructions2

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

PREPARATION AND SUPPLIES2

To complete an infusion you’ll need:

  • ORENCIA IV lyophilized powder in preservative-free, single-dose 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 each vial of supplied ORENCIA powder with 10 mL of Sterile Water for Injection, USP. Use only the provided silicone-free disposable syringe provided with each vial with an 18- to 21-gauge needle. If syringe is dropped or becomes contaminated, use a new one.

To obtain new syringes, contact Bristol Myers Squibb at 1-800-ORENCIA. Discard any solution prepared using siliconized syringes.

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, toward the inside wall of the vial. Use the vial only if the vacuum is present. Do not shake.

Preparing for an ORENCIA injection

4. ROTATE THE VIAL

Gently swirl the vial until contents completely dissolve. After mixing, each milliliter will contain 25 mg/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. Visually inspect the reconstituted solution. 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

Must 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(s) 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. Immediately discard any unused portion in the vials.

Prior to administration, visually inspect the ORENCIA solution for particulate matter and discoloration. Discard the diluted solution 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).

Must 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 and handling for ORENCIA IV

  • Refrigerate ORENCIA lyophilized powder 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

ORENCIA SC allows patients once-weekly self-injection1

ORENCIA SC MAY BE INITIATED WITH OR WITHOUT AN IV LOADING DOSE2

125-mg injection is supplied in a prefilled syringe with BD UltraSafe Passive Needle Guard.

ORENCIA® (abatacept) Safety Syringe

National Drug Code (NDC): 0003-2188-11

For patients switching from ORENCIA intravenous therapy to subcutaneous administration, administer the first subcutaneous dose instead of the next scheduled intravenous dose.

For patients initiating therapy with an IV loading dose, administer ORENCIA as a single IV infusion (as per IV body weight categories), followed by the first ORENCIA SC injection administered within 1 day of the IV infusion.

If an intravenous loading dose is used, administer the first subcutaneous injection within one day of the infusion. Administer ORENCIA 125 mg in prefilled syringes or in ORENCIA ClickJect™ Autoinjector by subcutaneous injection once weekly.

Dose of ORENCIA for Intravenous Infusion in Adult RA Patients

SCROLL FOR INJECTION INSTRUCTIONS

Selected Important Safety Information

Infections: Serious infections, including sepsis and pneumonia, were reported in 3% and 1.9% of RA patients treated with intravenous ORENCIA and placebo, respectively. 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.

Self-injection guide

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

General injection instructions2

For more detailed administration information, see the Full Prescribing Information

PREPARATION AND SUPPLIES2

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

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 particulate matter and discoloration prior to administration; do not use if either are present. ORENCIA SC should be clear to slightly opalescent and colorless to pale yellow.

ORENCIA® (abatacept) Safety Syringe Step 3

3. CHOOSE AND PREPARE AN INJECTION SITE

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

ORENCIA® (abatacept) Safety Syringe Step 4

4. INJECT ORENCIA

Inject the full amount in the syringe.

ORENCIA® (abatacept) Safety Syringe Step 5

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 Full Prescribing Information.

SCROLL FOR HANDLING INSTRUCTIONS

Selected Important Safety Information

Immunizations: Prior to initiating ORENCIA in adult patients, update vaccinations in accordance with current vaccination guidelines. Live vaccines should not be given concurrently with ORENCIA or within 3 months after discontinuation. ORENCIA may blunt the effectiveness of some immunizations.

Storage and handling for ORENCIA SC2

  • Refrigerate ORENCIA solution supplied in a prefilled syringe at 36°F to 46°F (2°C to 8°C)
  • 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 you find any product defects or the syringe is past its expiration date, call 1-800-ORENCIA for a replacement.

*If you find any product defects or the syringe is past its expiration date, call 1-800-ORENCIA for a replacement.

ORENCIA ClickJect Autoinjector:
Automatically delivers the full dose with one push of a button3

Push-button operation and injection confirmation may
reduce the possibility of user errors

ORENCIA® (abatacept) ClickJect AutoInjector

National Drug Code (NDC): 0003-2188-51 (pack of 4 injectors)2

For patients switching from ORENCIA intravenous therapy to subcutaneous administration, administer the first subcutaneous dose instead of the next scheduled intravenous dose.

SCROLL FOR AUTOINJECTOR INSTRUCTIONS

Selected Important Safety Information

Use in Patients with Chronic Obstructive Pulmonary Disease (COPD): In Study V, adult COPD patients treated with ORENCIA for RA developed adverse events more frequently than those treated with placebo, including COPD exacerbations, cough, rhonchi, and dyspnea. In the study, 97% of COPD patients treated with ORENCIA developed adverse events versus 88% treated with placebo. Respiratory disorders occurred more frequently in patients treated with ORENCIA compared to those on placebo (43% vs 24%, respectively), including COPD exacerbation, 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 COPD should be undertaken with caution, and such patients monitored for worsening of their respiratory status.

Recommendations for Subcutaneous Administration

ORENCIA ClickJectTM autoinjectors 125 mg/mL are intended for:

  • Subcutaneous use only and are not intended for intravenous infusion
  • Use under the guidance of a physician or healthcare practitioner

After proper training in subcutaneous injection technique, a patient or the patient’s caregiver may administer a subcutaneous injection of ORENCIA (ClickJect Autoinjector) if a physician/healthcare practitioner determines that it is appropriate.

Instruct patients and/or caregivers to follow the directions provided in the Instructions for Use for additional details on administration.

Specifically instruct patients to inject the full amount (which provides the proper dose of ORENCIA), rotate injection sites, and to avoid injections into areas where the skin is tender, bruised, red, or hard.

Visually inspect for particulate matter and discoloration prior to administration. Do not use ORENCIA prefilled syringes or ORENCIA ClickJectTM autoinjectors exhibiting particulate matter or discoloration. ORENCIA should be clear to slightly opalescent and colorless to pale yellow.

Injection instructions2

For more detailed administration information, see the Full Prescribing Information.

PREPARATION AND SUPPLIES2

  • ORENCIA ClickJect Autoinjector
  • Alcohol swab
  • Adhesive bandage
  • Cotton ball or gauze
  • Sharps disposal container

ORENCIA® (abatacept) ClickJect AutoInjector Step 1

1. PREPARING FOR AN ORENCIA INJECTION

Let the ClickJect Autoinjector rest at room temperature for 30 minutes.

ORENCIA® (abatacept) ClickJect AutoInjector Step 2

2. INSPECT

Check the expiration date on the label. Check for damage. Check that the liquid is clear to pale yellow. You may see a small air bubble; you do not need to remove it. Do not inject if the liquid is cloudy, discolored, or has particles in it.

ORENCIA® (abatacept) ClickJect AutoInjector Step 3

3. CHOOSE AND PREPARE AN INJECTION SITE

Each week, the patient can use the same area of the body but should use a different injection site in that area. Clean site with alcohol swab and let the skin dry. DO NOT inject into an area where the skin is tender, bruised, red, scaly, hard, scarred, or has stretch marks.

ORENCIA® (abatacept) ClickJect AutoInjector Step 4

4. PULL ORANGE NEEDLE COVER STRAIGHT OFF—DO NOT TWIST

DO NOT replace the cap on the Autoinjector. DO NOT use the Autoinjector if it is dropped after the cap is removed. It’s normal to see a drop of fluid leaving the needle. You can discard the cap in your household waste after injection.

ORENCIA® (abatacept) ClickJect AutoInjector Step 5 ORENCIA® (abatacept) ClickJect AutoInjector Step 5

5. INJECT ORENCIA

Position Autoinjector so you can see the viewing window and it's at a 90 degree angle to the injection site. Gently pinch the cleaned skin with your other hand. Press down on skin to unlock the Autoinjector. Press button, hold device in place for 15 seconds, AND wait until blue indicator stops moving in window. Remove from injection site by lifting straight up and release skin pinch. The transparent tip will extend and lock over the needle.

ORENCIA® (abatacept) ClickJect AutoInjector Step 6

6. After the injection

If there is bleeding at the injection site, a cotton ball, gauze, or an adhesive bandage can be placed on the injection site. The ClickJect Autoinjector should be disposed into a Sharps disposal container right away. DO NOT rub the injection site. If administered by a caregiver, they must handle the Autoinjector carefully to prevent accidental needle stick. Record the date, time, specific injection site, and questions or concerns about your injection.

Note: ORENCIA Autoinjector, 125 mg/syringe is not intended for IV infusion. For more detailed administration information, see the Full Prescribing Information.

 

Video Guide

A video guide on preparing and administering ORENCIA with the ClickJect Autoinjector

autoinjector video guide placeholder

 

SCROLL FOR STORAGE AND HANDLING INSTRUCTIONS

Selected Important Safety Information

Immunosuppression: In clinical trials in adult RA patients, a higher rate of infections was seen in ORENCIA-treated patients compared to placebo-treated patients. The impact of treatment with ORENCIA on the development and course of malignancies is not fully understood. There have been reports of malignancies, including skin cancer in patients receiving ORENCIA. Periodic skin examinations are recommended for all ORENCIA-treated patients, particularly those with risk factors for skin cancer.

 

Storage and handling for ORENCIA ClickJect Autoinjector2

  • Refrigerate ORENCIA solution supplied in a ClickJectTM Autoinjector at 36°F to 46°F (2°C to 8°C)
  • Do not use beyond the expiration date on the autoinjector
  • Protect from light by storing in the original package until time of use
  • Do not allow the autoinjector to freeze

*If you find any product defects or the autoinjector is past its expiration date, call 1-800-ORENCIA for a replacement.

*If you find any product defects or the autoinjector is past its expiration date, call 1-800-ORENCIA for a replacement.

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More Important
Safety Information

Important Safety Information for ORENCIA® (abatacept)

Concomitant Use with TNF Antagonists, Other Biologic RA/PsA Therapy, or JAK Inhibitors: Concurrent therapy with ORENCIA and a TNF antagonist is not recommended. In controlled clinical trials, adult RA patients receiving concomitant intravenous ORENCIA and TNF antagonist therapy experienced more infections (63% vs 43%) and serious infections (4.4% vs 0.8%) compared to patients treated with only TNF antagonists, without an important enhancement of efficacy. Additionally, concomitant use of ORENCIA with other biologic RA/PsA therapy or JAK inhibitors is not recommended.

Hypersensitivity: There were 2 cases (<0.1%; n=2688) of anaphylaxis 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. There was one case of a hypersensitivity reaction with ORENCIA in pJIA clinical trials (0.5%; n=190). In postmarketing experience, fatal anaphylaxis following the first infusion of ORENCIA and life-threatening cases of angioedema have been reported. Angioedema has occurred as early as after the first dose of ORENCIA, but also has occurred with subsequent doses. Angioedema reactions have occurred within hours of administration and in some instances had a delayed onset (i.e., days). 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 intravenous or subcutaneous ORENCIA should be stopped immediately and permanently discontinued, with appropriate therapy instituted.

Infections: Serious infections, including sepsis and pneumonia, were reported in 3% and 1.9% of RA patients treated with intravenous ORENCIA and placebo, respectively. 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: Prior to initiating ORENCIA in pediatric and adult patients, update vaccinations in accordance with current vaccination guidelines. Live vaccines should not be given concurrently with ORENCIA or within 3 months after discontinuation. ORENCIA may blunt the effectiveness of some immunizations.

Use in Patients with Chronic Obstructive Pulmonary Disease (COPD): In Study V, adult COPD patients treated with ORENCIA for RA developed adverse events more frequently than those treated with placebo, including COPD exacerbations, cough, rhonchi, and dyspnea. In the study, 97% of COPD patients treated with ORENCIA developed adverse events versus 88% treated with placebo. Respiratory disorders occurred more frequently in patients treated with ORENCIA compared to those on placebo (43% vs 24%, respectively), including COPD exacerbation, 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 COPD should be undertaken with caution, and such patients monitored for worsening of their respiratory status.

Immunosuppression: In clinical trials in adult RA patients, a higher rate of infections was seen in ORENCIA-treated patients compared to placebo-treated patients. The impact of treatment with ORENCIA on the development and course of malignancies is not fully understood. There have been reports of malignancies, including skin cancer in patients receiving ORENCIA. Periodic skin examinations are recommended for all ORENCIA-treated patients, particularly those with risk factors for skin cancer.

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.

Pregnancy: There are no adequate and well-controlled studies of ORENCIA use in pregnant women and the data with ORENCIA use in pregnant women are insufficient to inform on drug-associated risk. A pregnancy registry has been established to monitor pregnancy outcomes in women exposed to ORENCIA during pregnancy. Healthcare professionals are encouraged to register patients by calling
1-877-311-8972.

Lactation: There is no information regarding the presence of abatacept in human milk, the effects on the breastfed infant, or the effects on milk production. However, abatacept was present in the milk of lactating rats dosed with abatacept.

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 RA 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 pJIA patients were diarrhea, cough, pyrexia, and abdominal pain. In general, the adverse events in pediatric pJIA and adult PsA patients were similar in frequency and type to those seen in adult RA patients.

Note concerning ORENCIA administration options: ORENCIA may be administered as an intravenous infusion only for patients 6 years of age and older. PJIA patients may self-inject with ORENCIA or the patient’s caregiver may administer ORENCIA if both the healthcare practitioner and the parent/legal guardian determines it is appropriate. The ability of pediatric patients to self-inject with the autoinjector has not been tested.

Please click here for Full Prescribing Information »

 More Important
Safety Information

Important Safety Information for ORENCIA® (abatacept)

Concomitant Use with TNF Antagonists, Other Biologic RA/PsA Therapy, or JAK Inhibitors: Concurrent therapy with ORENCIA and a TNF antagonist is not recommended. In controlled clinical trials, adult RA patients receiving concomitant intravenous ORENCIA and TNF antagonist therapy experienced more infections (63% vs 43%) and serious infections (4.4% vs 0.8%) compared to patients treated with only TNF antagonists, without an important enhancement of efficacy. Additionally, concomitant use of ORENCIA with other biologic RA/PsA therapy or JAK inhibitors is not recommended.

Hypersensitivity: There were 2 cases (<0.1%; n=2688) of anaphylaxis 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. There was one case of a hypersensitivity reaction with ORENCIA in pJIA clinical trials (0.5%; n=190). In postmarketing experience, fatal anaphylaxis following the first infusion of ORENCIA and life-threatening cases of angioedema have been reported. Angioedema has occurred as early as after the first dose of ORENCIA, but also has occurred with subsequent doses. Angioedema reactions have occurred within hours of administration and in some instances had a delayed onset (i.e., days). 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 intravenous or subcutaneous ORENCIA should be stopped immediately and permanently discontinued, with appropriate therapy instituted.

Infections: Serious infections, including sepsis and pneumonia, were reported in 3% and 1.9% of RA patients treated with intravenous ORENCIA and placebo, respectively. 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: Prior to initiating ORENCIA in pediatric and adult patients, update vaccinations in accordance with current vaccination guidelines. Live vaccines should not be given concurrently with ORENCIA or within 3 months after discontinuation. ORENCIA may blunt the effectiveness of some immunizations.

Use in Patients with Chronic Obstructive Pulmonary Disease (COPD): In Study V, adult COPD patients treated with ORENCIA for RA developed adverse events more frequently than those treated with placebo, including COPD exacerbations, cough, rhonchi, and dyspnea. In the study, 97% of COPD patients treated with ORENCIA developed adverse events versus 88% treated with placebo. Respiratory disorders occurred more frequently in patients treated with ORENCIA compared to those on placebo (43% vs 24%, respectively), including COPD exacerbation, 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 COPD should be undertaken with caution, and such patients monitored for worsening of their respiratory status.

Immunosuppression: In clinical trials in adult RA patients, a higher rate of infections was seen in ORENCIA-treated patients compared to placebo-treated patients. The impact of treatment with ORENCIA on the development and course of malignancies is not fully understood. There have been reports of malignancies, including skin cancer in patients receiving ORENCIA. Periodic skin examinations are recommended for all ORENCIA-treated patients, particularly those with risk factors for skin cancer.

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.

Pregnancy: There are no adequate and well-controlled studies of ORENCIA use in pregnant women and the data with ORENCIA use in pregnant women are insufficient to inform on drug-associated risk. A pregnancy registry has been established to monitor pregnancy outcomes in women exposed to ORENCIA during pregnancy. Healthcare professionals are encouraged to register patients by calling 1-877-311-8972.

Lactation: There is no information regarding the presence of abatacept in human milk, the effects on the breastfed infant, or the effects on milk production. However, abatacept was present in the milk of lactating rats dosed with abatacept.

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 RA 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 pJIA patients were diarrhea, cough, pyrexia, and abdominal pain. In general, the adverse events in pediatric pJIA and adult PsA patients were similar in frequency and type to those seen in adult RA patients.

Note concerning ORENCIA administration options: ORENCIA may be administered as an intravenous infusion only for patients 6 years of age and older. PJIA patients may self-inject with ORENCIA or the patient’s caregiver may administer ORENCIA if both the healthcare practitioner and the parent/legal guardian determines it is appropriate. The ability of pediatric patients to self-inject with the autoinjector has not been tested.

Please see Full Prescribing Information »

References:

  • ORENCIA (abatacept) [package insert]. Princeton, NJ: Bristol-Myers Squibb.
  • A Phase III study of BMS-188667 in subjects with active rheumatoid arthritis. NIH/US National Library of Medicine registry. Available from: https://clinicaltrials.gov [identifier: NCT00048932]. Originally posted November 13, 2002. Updated November 24, 2011. Accessed February 19, 2019.
  • Schiff M, Koo J, Jin E, et al. Usability and acceptability of the abatacept pre-filled autoinjector for the subcutaneous treatment of rheumatoid arthritis. Adv Ther. 2016;33(2):199-213. doi:10.1007/S12325-016-0286-9.