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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.

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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.

  • INTRAVENOUS
  • PREFILLED SYRINGE
  • AUTOINJECTOR

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

ORENCIA® (abatacept) Intravenous Administration
National Drug Code (NDC): 0003-2187-10

ORENCIA® (abatacept) Intravenous Administration

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.

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: 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.

General infusion instructions1

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

PREPARATION AND SUPPLIES1

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.

For information on obtaining additional 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, 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 and handling 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

ORENCIA SC allows patients once-weekly self-injection at home

ORENCIA SC MAY BE INITIATED WITH OR WITHOUT AN IV LOADING DOSE1

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

SCROLL FOR INJECTION INSTRUCTIONS

Selected Important Safety Information

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.

Self-injection guide

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

General injection instructions1

For more detailed administration information, see the Full Prescribing Information

PREPARATION AND SUPPLIES1

  • 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 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: 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.

Storage and handling for ORENCIA SC1

  • ORENCIA solution supplied in a prefilled syringe should be refrigerated 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 button2

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)1

SCROLL FOR AUTOINJECTOR INSTRUCTIONS

Selected Important Safety Information

Use in Patients with Chronic Obstructive Pulmonary Disease (COPD): SAdult 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 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 RA and COPD should be undertaken with caution, and such patients monitored for worsening of their respiratory status.

General injection instructions for subcutaneous injection1

ORENCIA injection, 125 mg/mL is not intended for intravenous infusion.

ORENCIA Injection for subcutaneous use is intended for use under the guidance of a physician or health care practitioner. After proper training in subcutaneous injection technique, a patient may self-inject with ORENCIA if a physician/health care 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. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Patients using ORENCIA for subcutaneous administration should be instructed to inject the full amount in the syringe or Autoinjector (1 mL), which provides 125 mg of ORENCIA, according to the directions provided in the Instructions for Use.

Injection instructions1

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

PREPARATION AND SUPPLIES1

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

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

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.

 

Storage and handling for ORENCIA ClickJect Autoinjector1

  • ORENCIA solution supplied in a prefilled syringe should be refrigerated 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.

In moderate to severe RA
Treating the patient with rapidly progressing RA

LEARN MORE

Model—not an actual patient.

 


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 occurred 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 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 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.

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 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 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.

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 »

References: 1. ORENCIA (abatacept) [package insert]. Princeton, NJ: Bristol-Myers Squibb. 2. 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.