Subcutaneous SC Dosing for Moderate to Severe RA | ORENCIA® (abatacept) (2023)

Important Safety Information
for ORENCIA® (abatacept)

Increased Risk of Infection with 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 moderate to severe rheumatoid arthritis (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 &lt0.9% 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. In addition, it is unknown if the immune response of an infant who was exposed in utero to abatacept and subsequently administered a live vaccine is impacted. Risks and benefits should be considered prior to vaccinating such infants.

Increased Risk of Adverse Reactions When Used 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.

Cytomegalovirus (CMV) and Epstein-Barr Virus (EBV) Reactivation in aGVHD Prophylaxis after Hematopoietic Stem Cell Transplant (HSCT): Post-Transplant Lymphoproliferative Disorder (PTLD) occurred in patients who received ORENCIA for aGVHD prophylaxis during unrelated HSCT. Of 116 patients who received ORENCIA, 4 patients (3.4%) experienced PTLD. All the PTLD events were associated with Epstein-Barr virus (EBV) infection. The range of time to onset of the event was 49 to 89 days post-transplant. Monitor patients for EBV reactivation in accordance with institutional practices. Before administering ORENCIA, provide recommended prophylaxis for EBV infection and continue for 6 months post-transplantation to prevent EBV-associated PTLD. Cytomegalovirus (CMV) invasive disease occurred in patients who received ORENCIA for aGVHD prophylaxis during unrelated HSCT. Of 116 patients who received ORENCIA, 7% (n=8) experienced CMV invasive diseases up to day 225 post-transplant. The median time to onset of the event was 91 days post-transplant. CMV invasive diseases predominantly involved the gastrointestinal tract. Monitor patients for CMV infection/reactivation for 6 months post-transplant regardless of the results of donor and recipient pre-transplant CMV serology. Consider prophylaxis for CMV infection/reactivation during treatment and for six months following HSCT.

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: In controlled clinical trials, adult RA patients experienced serious infections (3% ORENCIA vs 1.9% placebo) and malignancies (1.3% ORENCIA vs 1.1% placebo). In the GVHD-1 study, serious adverse reactions reported in >5% of patients who received ORENCIA in combination with a calcineurin inhibitor and methotrexate included pyrexia (20%), pneumonia (8%), acute kidney injury (7%), diarrhea (6%), hypoxia (5%), and nausea (5%).

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. The most frequent adverse reactions of all grades reported in ≥10% of patients with aGVHD who received ORENCIA with a difference of ≥2% for the 7/8 cohort, 8/8 cohort ORENCIA arm, and 8/8 cohort placebo arm, respectively, were anemia (56%, 69%, and 57%), CD4 lymphocytes decreased (14%, 14%, and 9%), hypertension (49%, 43%, and 38%), pyrexia (28%, 19%, and 20%), CMV reactivation/CMV infection (26%, 32%, and 22%), pneumonia (19%, 12%, and 10%), epistaxis (12%, 16%, and 10%), acute kidney injury (9%, 15%, and 10%), and hypermagnesemia (5%, 18%, 10%).

Incidence rates of grade 3 or 4 adverse reactions were the same as incidence rates of all grades, with the exception of grade 3 or 4 pyrexia in all arms (9% [7/8 cohort], 10% [8/8 cohort, ORENCIA arm], and 4% [8/8 cohort, placebo arm]), pneumonia in the 8/8 cohort placebo arm (9%) and acute kidney injury in the 7/8 cohort ORENCIA arm (7%). Clinically relevant adverse reactions in <10% of patients who received ORENCIA in combination with calcineurin inhibitor and methotrexate in Study GVHD-1 included EBV reactivation.

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. ORENCIA may only be administered as an intravenous (IV) infusion for the prophylaxis of aGVHD in patients undergoing HSCT. The safety and effectiveness of ORENCIA have not been established in pediatric patients younger than 2 years of age for prophylaxis of aGVHD.

Please click here for Full Prescribing Information Subcutaneous SC Dosing for Moderate to Severe RA | ORENCIA® (abatacept) (1)

References: 1. ORENCIA [package insert]. Princeton, NJ: Bristol-Myers Squibb Company. 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

(Video) What is Abatacept? (Orencia)

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(Video) Evaluating drug-free remission with abatacept in early rheumatoid arthritis

Indications and Usage

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

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

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

Prophylaxis for Acute Graft versus Host Disease: ORENCIA® (abatacept) is indicated for the prophylaxis of acute graft versus host disease (aGVHD), in combination with a calcineurin inhibitor (CNI) and methotrexate (MTX), in adults and pediatric patients 2 years of age or older undergoing hematopoietic stem cell transplantation (HSCT) from a matched or 1 allele-mismatched unrelated-donor.

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.

Important Safety Information for ORENCIA® (abatacept)

Increased Risk of Infection with 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 moderate to severe rheumatoid arthritis (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. In addition, it is unknown if the immune response of an infant who was exposed in utero to abatacept and subsequently administered a live vaccine is impacted. Risks and benefits should be considered prior to vaccinating such infants.

Increased Risk of Adverse Reactions When Used 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.

Cytomegalovirus (CMV) and Epstein-Barr Virus (EBV) Reactivation in aGVHD Prophylaxis after Hematopoietic Stem Cell Transplant (HSCT): Post-Transplant Lymphoproliferative Disorder (PTLD) occurred in patients who received ORENCIA for aGVHD prophylaxis during unrelated HSCT. Of 116 patients who received ORENCIA, 4 patients (3.4%) experienced PTLD. All the PTLD events were associated with Epstein-Barr virus (EBV) infection. The range of time to onset of the event was 49 to 89 days post-transplant. Monitor patients for EBV reactivation in accordance with institutional practices. Before administering ORENCIA, provide recommended prophylaxis for EBV infection and continue for 6 months post-transplantation to prevent EBV-associated PTLD. Cytomegalovirus (CMV) invasive disease occurred in patients who received ORENCIA for aGVHD prophylaxis during unrelated HSCT. Of 116 patients who received ORENCIA, 7% (n=8) experienced CMV invasive diseases up to day 225 post-transplant. The median time to onset of the event was 91 days post-transplant. CMV invasive diseases predominantly involved the gastrointestinal tract. Monitor patients for CMV infection/reactivation for 6 months post-transplant regardless of the results of donor and recipient pre-transplant CMV serology. Consider prophylaxis for CMV infection/reactivation during treatment and for six months following HSCT.

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: In controlled clinical trials, adult RA patients experienced serious infections (3% ORENCIA vs 1.9% placebo) and malignancies (1.3% ORENCIA vs 1.1% placebo). In the GVHD-1 study, serious adverse reactions reported in >5% of patients who received ORENCIA in combination with a calcineurin inhibitor and methotrexate included pyrexia (20%), pneumonia (8%), acute kidney injury (7%), diarrhea (6%), hypoxia (5%), and nausea (5%).

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. The most frequent adverse reactions of all grades reported in ≥10% of patients with aGVHD who received ORENCIA with a difference of ≥2% for the 7/8 cohort, 8/8 cohort ORENCIA arm, and 8/8 cohort placebo arm, respectively, were anemia (56%, 69%, and 57%), CD4 lymphocytes decreased (14%, 14%, and 9%), hypertension (49%, 43%, and 38%), pyrexia (28%, 19%, and 20%), CMV reactivation/CMV infection (26%, 32%, and 22%), pneumonia (19%, 12%, and 10%), epistaxis (12%, 16%, and 10%), acute kidney injury (9%, 15%, and 10%), and hypermagnesemia (5%, 18%, 10%).

Incidence rates of grade 3 or 4 adverse reactions were the same as incidence rates of all grades, with the exception of grade 3 or 4 pyrexia in all arms (9% [7/8 cohort], 10% [8/8 cohort, ORENCIA arm], and 4% [8/8 cohort, placebo arm]), pneumonia in the 8/8 cohort placebo arm (9%) and acute kidney injury in the 7/8 cohort ORENCIA arm (7%). Clinically relevant adverse reactions in <10% of patients who received ORENCIA in combination with calcineurin inhibitor and methotrexate in Study GVHD-1 included EBV reactivation.

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. ORENCIA may only be administered as an intravenous (IV) infusion for the prophylaxis of aGVHD in patients undergoing HSCT. The safety and effectiveness of ORENCIA have not been established in pediatric patients younger than 2 years of age for prophylaxis of aGVHD.

Please click here for Full Prescribing Information Subcutaneous SC Dosing for Moderate to Severe RA | ORENCIA® (abatacept) (5)

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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).

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

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

Prophylaxis for Acute Graft versus Host Disease: ORENCIA® (abatacept) is indicated for the prophylaxis of acute graft versus host disease (aGVHD), in combination with a calcineurin inhibitor (CNI) and methotrexate (MTX), in adults and pediatric patients 2 years of age or older undergoing hematopoietic stem cell transplantation (HSCT) from a matched or 1 allele-mismatched unrelated-donor.

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.

Important Safety Information for ORENCIA® (abatacept)

Increased Risk of Infection with 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 moderate to severe rheumatoid arthritis (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. In addition, it is unknown if the immune response of an infant who was exposed in utero to abatacept and subsequently administered a live vaccine is impacted. Risks and benefits should be considered prior to vaccinating such infants.

Increased Risk of Adverse Reactions When Used 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.

Cytomegalovirus (CMV) and Epstein-Barr Virus (EBV) Reactivation in aGVHD Prophylaxis after Hematopoietic Stem Cell Transplant (HSCT): Post-Transplant Lymphoproliferative Disorder (PTLD) occurred in patients who received ORENCIA for aGVHD prophylaxis during unrelated HSCT. Of 116 patients who received ORENCIA, 4 patients (3.4%) experienced PTLD. All the PTLD events were associated with Epstein-Barr virus (EBV) infection. The range of time to onset of the event was 49 to 89 days post-transplant. Monitor patients for EBV reactivation in accordance with institutional practices. Before administering ORENCIA, provide recommended prophylaxis for EBV infection and continue for 6 months post-transplantation to prevent EBV-associated PTLD. Cytomegalovirus (CMV) invasive disease occurred in patients who received ORENCIA for aGVHD prophylaxis during unrelated HSCT. Of 116 patients who received ORENCIA, 7% (n=8) experienced CMV invasive diseases up to day 225 post-transplant. The median time to onset of the event was 91 days post-transplant. CMV invasive diseases predominantly involved the gastrointestinal tract. Monitor patients for CMV infection/reactivation for 6 months post-transplant regardless of the results of donor and recipient pre-transplant CMV serology. Consider prophylaxis for CMV infection/reactivation during treatment and for six months following HSCT.

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: In controlled clinical trials, adult RA patients experienced serious infections (3% ORENCIA vs 1.9% placebo) and malignancies (1.3% ORENCIA vs 1.1% placebo). In the GVHD-1 study, serious adverse reactions reported in >5% of patients who received ORENCIA in combination with a calcineurin inhibitor and methotrexate included pyrexia (20%), pneumonia (8%), acute kidney injury (7%), diarrhea (6%), hypoxia (5%), and nausea (5%).

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. The most frequent adverse reactions of all grades reported in ≥10% of patients with aGVHD who received ORENCIA with a difference of ≥2% for the 7/8 cohort, 8/8 cohort ORENCIA arm, and 8/8 cohort placebo arm, respectively, were anemia (56%, 69%, and 57%), CD4 lymphocytes decreased (14%, 14%, and 9%), hypertension (49%, 43%, and 38%), pyrexia (28%, 19%, and 20%), CMV reactivation/CMV infection (26%, 32%, and 22%), pneumonia (19%, 12%, and 10%), epistaxis (12%, 16%, and 10%), acute kidney injury (9%, 15%, and 10%), and hypermagnesemia (5%, 18%, 10%).

Incidence rates of grade 3 or 4 adverse reactions were the same as incidence rates of all grades, with the exception of grade 3 or 4 pyrexia in all arms (9% [7/8 cohort], 10% [8/8 cohort, ORENCIA arm], and 4% [8/8 cohort, placebo arm]), pneumonia in the 8/8 cohort placebo arm (9%) and acute kidney injury in the 7/8 cohort ORENCIA arm (7%). Clinically relevant adverse reactions in <10% of patients who received ORENCIA in combination with calcineurin inhibitor and methotrexate in Study GVHD-1 included EBV reactivation.

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. ORENCIA may only be administered as an intravenous (IV) infusion for the prophylaxis of aGVHD in patients undergoing HSCT. The safety and effectiveness of ORENCIA have not been established in pediatric patients younger than 2 years of age for prophylaxis of aGVHD.

(Video) Head-to-Head Comparison of SC Abatacept Versus Adalimumab on Background Methotrexate in RA...

Please click here for Full Prescribing Information Subcutaneous SC Dosing for Moderate to Severe RA | ORENCIA® (abatacept) (6)

(Video) Prolonged Exposure to SC and IV Abatacept in Patients with Rheumatoid Arthritis...

FAQs

How do you administer abatacept? ›

ORENCIA subcutaneous (SC) may be initiated with or without an intravenous (IV) loading dose. ORENCIA SC should be administered weekly at a dose of 125 mg abatacept by subcutaneous injection regardless of weight (see section 5.1).

How is ORENCIA dosed? ›

For treating rheumatoid arthritis (RA), Orencia may be given as a subcutaneous injection or as an IV infusion. For treating RA by subcutaneous injection, the typical Orencia dosage is 125 mg. The dosing frequency for RA is once per week.

What is ORENCIA SUBQ? ›

ORENCIA prefilled syringe allows patients once-weekly self-injection at home1. Recommendations for Subcutaneous Administration1. ORENCIA prefilled syringes are intended for: Subcutaneous use only and are not intended for intravenous infusion. Use under the guidance of a physician or healthcare practitioner.

Is abatacept the same as ORENCIA? ›

Abatacept (Orencia) is often prescribed after failure of a disease-modifying anti-rheumatic agent (DMARD), like methotrexate but it can be used as first-line therapy. Abatacept is used to reduce inflammatory symptoms such as swelling, pain, and stiffness.

How often do you inject Orencia? ›

If you are prescribed ORENCIA self-injection, you should follow your doctor's instructions. The recommended dosage for this under-the-skin injection is 125 mg once weekly. Learn more about how to take ORENCIA and talk to your doctor for more information.

How long does it take for abatacept to work? ›

How long will it take to work? As with all of the biologics, you may not feel the effects of abatacept right away. Some people begin to feel the effects of the medication in six to eight weeks; however, it may take three to six months to feel its full effect.

Is Orencia a high risk medication? ›

You may have a higher risk of serious infections while you're taking Orencia. This is because the drug makes your immune system less able to protect you from infections. In clinical studies, 54% of people taking Orencia had infections. Infections were considered serious in 3% of people taking Orencia in the studies.

How long can you stay on Orencia? ›

Orencia treats long-lasting diseases. So you may need to take it long term. For graft-versus-host disease prevention, you'll only take Orencia for about 1 month. Talk with your doctor about how long you should use this drug.

How well does Orencia work in rheumatoid arthritis? ›

Orencia has an average rating of 6.1 out of 10 from a total of 48 ratings for the treatment of Rheumatoid Arthritis. 50% of reviewers reported a positive experience, while 33% reported a negative experience.

Does Orencia cause nerve damage? ›

Neurological side effects weren't seen in studies of Orencia. During your Orencia treatment, call your doctor right away if you experience seizures, changes in vision or hearing, or feelings of numbness or weakness. Your doctor may order tests to find the cause.

Does Orencia cause hair loss? ›

People using Orencia in clinical studies didn't note hair loss as a side effect. In rare cases, hair loss can be a symptom of RA, which Orencia is used to treat. Also, other medications that treat some of the same conditions as Orencia may cause hair loss.

How do you give yourself subcutaneous injections? ›

Hold the syringe in your dominant (stronger) hand, as if holding a pencil, one inch above the injection site at a 90 degree angle to the skin. Quickly dart (stab) the needle through the skin into the fat tissue. 4. Use your non-dominant (weaker) hand to slowly push down on the plunger to inject the medication.

Can Orencia cause heart problems? ›

Acute infusion-related events that were reported in >0.1% and ≤1% of patients treated with ORENCIA included cardiopulmonary symptoms, such as hypotension, increased blood pressure, and dyspnea; other symptoms included nausea, flushing, urticaria, cough, hypersensitivity, pruritus, rash, and wheezing.

How often is abatacept given? ›

The abatacept subcutaneous injections (shots) are available as a 125mg prefilled syringe or auto-injector (pen). It is given once a week.

Does Orencia raise blood sugar? ›

ORENCIA for intravenous infusion (given through a needle placed in a vein) contains maltose, a type of sugar, that can give false high blood sugar readings with certain types of blood glucose monitors on the day of ORENCIA infusion.

Can Orencia cause lung problems? ›

You may experience breathing problems more often while taking ORENCIA. Call your healthcare provider if you experience any of the following: Worsened COPD. Cough.

Is Orencia better than Enbrel? ›

Enbrel has an average rating of 7.8 out of 10 from a total of 267 ratings on Drugs.com. 72% of reviewers reported a positive effect, while 13% reported a negative effect. Orencia has an average rating of 6.1 out of 10 from a total of 57 ratings on Drugs.com.

Does Orencia lower your immune system? ›

Many people using this medication do not have serious side effects. Because abatacept works by weakening the immune system, it may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse.

What is the best biologic for rheumatoid arthritis? ›

Also called TNF blockers or anti-TNFs, these include: adalimumab (Humira), certolizumab pegol (Cimzia), etanercept (Enbrel), golimumab (Simponi, Simponi Aria) and infliximab (Remicade). Benefits: These are the most widely used biologics for inflammatory autoimmune arthritis.

Can Orencia cause kidney problems? ›

Examples of long-term side effects that can happen with Orencia include: an increased risk of cancers, such as lung cancer and lymphoma (a type of blood cancer) serious infection, such as pneumonia. kidney problems, such as acute (sudden) kidney failure.

What happens when you stop taking Orencia? ›

Not taking the medication on schedule could cause your condition and symptoms to get worse. If you stop taking it: If you stop taking this medication, your condition and symptoms could get worse.

What is the safest RA treatment? ›

The RA drug with the least side effects is hydroxychloroquine (Plaquenil). “We don't consider it immunosuppressive, and it doesn't cause elevated liver markers or kidney issues like some of the other drugs,” says Dr. Sharmeen.

Is Orencia safer than Humira? ›

Overall rates of side effects were also similar in the two groups. Autoimmune side effects were more common with Orencia (3.1% with Orencia versus 0.9% with Humira). Withdrawal from the study because of side effects was more common with Humira (6.1% with Humira versus 3.5% with Orencia).

Does Orencia cause sun sensitivity? ›

Photosensitivity may also be a serious side-effect of anti-TNF drugs such as Cimzia, Enbrel, Humira, Remicade, and Simponi, as well as sulfasalazine. It is not considered a side-effect of Actemra, Arava, Kineret, Orencia, or Rituxan.

Who should not take Orencia? ›

a bad infection. cancer or malignancy. a reduction in the body's resistance to infection. chronic obstructive pulmonary disease.

What drugs interact with Orencia? ›

Most frequently checked interactions
  • aspirin.
  • atorvastatin.
  • Cymbalta (duloxetine)
  • folic acid.
  • gabapentin.
  • hydroxychloroquine.
  • leflunomide.
  • levothyroxine.

Do you have to take methotrexate with Orencia? ›

Concomitant therapy It is important to continue taking methotrexate to get the maximum benefit from ORENCIA. Concomitant therapies including corticosteroids, salicylates, non-steroidal anti- inflammatory drugs (NSAIDs) or analgesics may be used during treatment with ORENCIA.

What is the most effective RA treatment? ›

Methotrexate is usually the first medicine given for rheumatoid arthritis, often with another DMARD and a short course of steroids (corticosteroids) to relieve any pain. These may be combined with biological treatments.

What is the most successful treatment for rheumatoid arthritis? ›

Conventional DMARDs .

These drugs can slow the progression of rheumatoid arthritis and save the joints and other tissues from permanent damage. Common DMARDs include methotrexate (Trexall, Otrexup, others), leflunomide (Arava), hydroxychloroquine (Plaquenil) and sulfasalazine (Azulfidine).

What is the new breakthrough for rheumatoid arthritis? ›

The new drug olokizumab is a humanised monoclonal antibody that directly targets the interleukin-6 cytokine. This is a messenger molecule that, like TNF, activates inflammatory responses in the body and is involved in the progression of joint damage in rheumatoid arthritis.

What organs does RA effect? ›

Rheumatoid arthritis is a chronic inflammatory disorder that can affect more than just your joints. In some people, the condition can damage a wide variety of body systems, including the skin, eyes, lungs, heart and blood vessels.

Can rheumatoid affect the brain? ›



People with RA are more likely to have narrowed or blocked arteries in the brain – the result of systemic inflammation. This can cause problems with memory, thinking and reasoning.

Does RA cause anxiety? ›

RA patients are more prone to have anxiety, depression and cognitive impairment compared to the general healthy population. Those mental health conditions contribute to less responsiveness to treatment and higher disease activity in RA mainly due to fatigue and bodily pain.

How can I stop hair loss from rheumatoid arthritis? ›

People taking methotrexate or leflunomide may benefit from taking folic acid and biotin supplements. These B vitamins can help protect against hair loss. Folic acid can also help relieve some of the other side effects that can occur with methotrexate.

Can Orencia cause low blood pressure? ›

Acute infusion-related events that were uncommon included cardiopulmonary symptoms (e.g., hypotension, decreased blood pressure, tachycardia, bronchospasm, dyspnea); other symptoms included myalgia, nausea, erythema, flushing, urticaria, cough, hypersensitivity, pruritus, throat tightness, chest discomfort, chills, ...

What are the side effects of abatacept? ›

Abatacept may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
  • headache.
  • runny nose.
  • nausea.
  • diarrhea.
  • stomach pain.
  • dizziness.
  • heartburn.
  • back pain.
15 Aug 2022

What is a safe amount of medication to inject subcutaneously? ›

The maximum volume generally accepted for an SC injection is around 1.5 ml [29], although higher volumes (of up to 4 ml) can be administered if necessary [30].

How far do you insert a subcutaneous injection? ›

Inject the Medicine

With the hand that is not holding the syringe, pinch an inch (2.5 centimeters) of skin and fatty tissue (not the muscle) between your fingers. Quickly insert the needle all the way into the pinched skin at a 90-degree angle (45-degree angle if there is not much fatty tissue).

Where is the best place to give a subcutaneous injection? ›

Choose Your Injection Site
  • Upper arms. At least 3 inches (7.5 centimeters) below your shoulder and 3 inches (7.5 centimeters) above your elbow, on the side or back.
  • Outer side of upper thighs.
  • Belly area. Below your ribs and above your hip bones, at least 2 inches (5 centimeters) away from your belly button.
23 Oct 2021

Does Orencia cause COPD? ›

A greater percentage of adult RA 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%)].

How long has Orencia been on the market? ›

Orencia was first approved in the United States in December 2005 for the treatment of rheumatoid arthritis, and has been marketed in more than 50 countries around the world. The manufacturing and marketing approval for intravenous infusion was granted in Japan in July 2010.

Is abatacept the same as Orencia? ›

Abatacept (Orencia) is often prescribed after failure of a disease-modifying anti-rheumatic agent (DMARD), like methotrexate but it can be used as first-line therapy. Abatacept is used to reduce inflammatory symptoms such as swelling, pain, and stiffness.

How is Orencia dosed? ›

For treating rheumatoid arthritis (RA), Orencia may be given as a subcutaneous injection or as an IV infusion. For treating RA by subcutaneous injection, the typical Orencia dosage is 125 mg. The dosing frequency for RA is once per week.

Does Orencia cause diabetes? ›

In a 2017 study published in the Annals of the Rheumatic Diseases, the DMARD plaquenil and the biologic abatacept (Orencia) both reduced diabetes risk, while steroids increased it. Higher steroid doses and longer use compound increases in blood sugar.

Can you take antibiotics with Orencia? ›

Combining these medications may seriously suppress your immune system and raise your chances of developing life-threatening infections. Notify your health care provider if you are experiencing symptoms of an infection or taking antibiotics for an infection.

Can you take prednisone with Orencia? ›

Interactions between your drugs

No interactions were found between Orencia and prednisone.

What is abatacept infusion? ›

Abatacept is in a class of medications called selective costimulation modulators (immunomodulators). It works by blocking the activity of T-cells, a type of immune cell in the body that causes swelling and joint damage in people who have arthritis.

How do you administer an Orencia prefilled syringe? ›

Inject your dose

Remove the prefilled syringe and let go of the pinched skin. Complete all steps to deliver your full dose of the medicine. Inject: Push the plunger with your thumb as far as it will go. Insert: Gently insert the needle into the pinched skin at a 45º angle.

How do you administer DMARDs? ›

DMARDs (biologics and non-biologics) can be administered orally, subcutaneously (SC), or intravenously (IV).

How do you give a subcutaneous injection? ›

Pinch a 2-inch fold of skin between your thumb and index finger. Hold the syringe the way you would a pencil or dart. Insert the needle at a 45 to 90 degree angle to the pinched-up skin. The needle should be completely covered by skin.

Do Orencia infusions make you tired? ›

Some medications that treat conditions Orencia is used for can cause neurological side effects. For example, methotrexate can cause dizziness, drowsiness, and mood changes. Remicade (infliximab) is known to cause seizures in very rare cases.

How long is ORENCIA good out of the fridge? ›

Abatacept (Orencia®) is stable for up to eight hours if left out of the fridge provided that it has been kept in normal light and at a temperature not exceeding 25°C.

Do ORENCIA injections hurt? ›

A caregiver may inject into your upper arm. Injection site reactions are more common when Orencia is given by subcutaneous injection than by infusion. These side effects can be mild to moderate and may include: pain.

How do you administer subcutaneous methotrexate? ›

The medicine is given as a shot under your skin, usually on the stomach or thigh. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems from the injection.

What is the initial drug of choice for a patient with rheumatoid arthritis? ›

NSAIDs. NSAIDs, salicylates, or cyclooxygenase-2 inhibitors are used for initial treatment of rheumatoid arthritis to reduce joint pain and swelling.

Is methotrexate injection IM or SUBQ? ›

The usual dose is 7.5mg to 25mg per week. Methotrexate may be injected just under the skin or intramuscularly.

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