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Abatacept: Drug information

Abatacept: Drug information
(For additional information see "Abatacept: Patient drug information" and see "Abatacept: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Orencia;
  • Orencia ClickJect
Brand Names: Canada
  • Orencia
Pharmacologic Category
  • Antirheumatic, Disease Modifying;
  • Selective T-Cell Costimulation Blocker
Dosing: Adult

Note: Screen for tuberculosis and hepatitis prior to abatacept treatment initiation.

COVID-19, hospitalized patients

COVID-19, hospitalized patients (alternative agent) (off-label use):

Note: For use in patients who are hospitalized who require oxygen (eg, high-flow oxygen, noninvasive ventilation) and those with lower but increasing oxygen requirements and evidence of systemic inflammation who cannot use preferred agents (Ref).

IV: 10 mg/kg (maximum: 1 g/dose) as a single dose as part of an appropriate combination regimen (Ref).

Graft-versus-host disease, acute, prophylaxis

Graft-versus-host disease, acute, prophylaxis:

Note: Use in combination with a calcineurin inhibitor and methotrexate (Ref). Prior to administering abatacept, initiate antiviral prophylaxis for Epstein-Barr virus (EBV) reactivation, according to clinical/institutional practice guidelines; continue antiviral prophylaxis for 6 months following hematopoietic stem cell transplant (HSCT). Consider prophylactic antivirals for cytomegalovirus (CMV) infection/reactivation during abatacept treatment and for 6 months following HSCT.

IV: 10 mg/kg (maximum: 1 g/dose) on the day prior to transplant (day -1), followed by 10 mg/kg (maximum: 1 g/dose) on days 5, 14, and 28 post-transplant (Ref).

Psoriatic arthritis

Psoriatic arthritis:

Note: IV dosing is according to body weight. Following the initial IV infusion (using the weight-based dosing), repeat IV infusion (using the same weight-based dosing) at 2 weeks and 4 weeks after the initial infusion, and every 4 weeks thereafter.

IV:

<60 kg: 500 mg.

60 to 100 kg: 750 mg.

>100 kg: 1 g.

SUBQ: 125 mg once weekly. Note: Administer without an IV loading dose.

If transitioning from IV therapy to SUBQ therapy, administer the first SUBQ dose instead of the next scheduled IV dose.

Rheumatoid arthritis

Rheumatoid arthritis:

Note: For use as an alternative to methotrexate in disease-modifying antirheumatic drug–naive patients with moderate to high disease activity, or as adjunctive therapy in patients who have not met treatment goals despite maximally tolerated methotrexate therapy (Ref).

Note: IV dosing is according to body weight. Following the initial IV infusion (using the weight-based dosing), repeat IV infusion (using the same weight-based dosing) at 2 weeks and 4 weeks after the initial infusion, and every 4 weeks thereafter.

IV:

<60 kg: 500 mg.

60 to 100 kg: 750 mg.

>100 kg: 1 g.

SUBQ: 125 mg once weekly. Note: SUBQ dosing may be initiated with or without an IV loading dose.

If initiating with an IV loading dose, administer the initial IV infusion (using the weight-based dosing), then administer 125 mg subcutaneously within 24 hours of the infusion, followed by 125 mg subcutaneously once weekly thereafter.

If transitioning from IV therapy to SUBQ therapy, administer the first SUBQ dose instead of the next scheduled IV dose.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Dosing: Adjustment for Toxicity: Adult

Hypersensitivity reaction: If an anaphylactic or other serious allergic reaction occurs, immediately and permanently discontinue abatacept administration and manage as clinically appropriate.

Serious infection: Discontinue abatacept in patients who develop a serious infection.

Dosing: Older Adult

Refer to adult dosing. Due to potential for higher rates of infections and malignancies, use caution.

Dosing: Pediatric

(For additional information see "Abatacept: Pediatric drug information")

Dosage guidance:

Dosing: Dosing presented in mg/kg and fixed mg; use extra caution to ensure correct dosing units.

Graft-versus-host disease, acute; prophylaxis in patients receiving hematopoietic stem cell transplantation

Graft-versus-host disease, acute; prophylaxis in patients receiving hematopoietic stem cell transplantation (HSCT):

Note: Use in combination with calcineurin inhibitors and methotrexate. Prior to administering abatacept, initiate antiviral prophylaxis for Epstein-Barr virus reactivation according to clinical/institutional practice guidelines; continue antiviral prophylaxis for 6 months following HSCT. Consider prophylactic antivirals for cytomegalovirus infection/reactivation during abatacept treatment and for 6 months following HSCT. Efficacy shown in patients undergoing HSCT from a matched donor or 1 allele-mismatched unrelated donor.

Children 2 to <6 years: IV: 15 mg/kg on day −1 (day before transplantation) followed by 12 mg/kg on days 5, 14, and 28 post-transplant.

Children ≥6 years and Adolescents: IV: 10 mg/kg on day −1 (day before transplantation) followed by 10 mg/kg on days 5, 14, and 28 post-transplant; maximum dose: 1,000 mg/dose (Ref).

Juvenile idiopathic arthritis, polyarticular

Juvenile idiopathic arthritis, polyarticular: Note: Age and dosing vary by route of administration (IV or SUBQ); use caution. May be used as monotherapy or concomitantly with methotrexate.

IV:

Children ≥6 years and Adolescents: Following the initial IV infusion, repeat IV dose at 2 weeks and 4 weeks after the initial infusion, and every 4 weeks thereafter.

<75 kg: IV: 10 mg/kg.

75 to 100 kg: IV: 750 mg.

>100 kg: IV: 1,000 mg.

SUBQ: Note: Administer without an IV loading dose and use the following weight-based dosing.

Children ≥2 years and Adolescents:

10 to <25 kg: SUBQ: 50 mg once weekly.

≥25 to <50 kg: SUBQ: 87.5 mg once weekly.

≥50 kg: SUBQ: 125 mg once weekly.

Psoriatic arthritis, active

Psoriatic arthritis, active: Note: May be used as monotherapy or in combination with methotrexate.

Children ≥2 years and Adolescents:

10 to <25 kg: SUBQ: 50 mg once weekly.

≥25 to <50 kg: SUBQ: 87.5 mg once weekly.

≥50 kg: SUBQ: 125 mg once weekly.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling; has not been studied.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling; has not been studied.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported adverse reactions are for adults, unless otherwise noted. Reported adverse reactions are for infusion administration for rheumatoid arthritis (RA) unless noted to be for acute graft vs host disease (aGVHD) prophylaxis. Incidences may include concomitant therapies.

>10%:

Cardiovascular: Hypertension (aGVHD: 43%; RA: 7%)

Endocrine & metabolic: Hypermagnesemia (aGVHD: 18%)

Gastrointestinal: Nausea (RA: ≥10%; severe nausea: aGVHD: 5%)

Hematologic & oncologic: Anemia (aGVHD: 69%; grade 3/4: 69%), decreased CD-4 cell count (aGVHD: 14%; grade 3/4: 14%)

Immunologic: Antibody development (RA and aGVHD: 1% to 10%; neutralizing: 67%)

Infection: Cytomegalovirus disease (aGVHD: 32%, including reactivation; systemic cytomegalovirus disease: aGVHD: 7%), infection (54%; serious infection: 3%), influenza (5% to 13%)

Nervous system: Headache (18%)

Renal: Acute kidney injury (aGVHD: 15%)

Respiratory: Bronchitis (5% to 13%), epistaxis (aGVHD: 16%), nasopharyngitis (12%), pneumonia (aGVHD: 12%; RA: <5%), sinusitis (5% to 13%), upper respiratory tract infection (5% to 13%)

Miscellaneous: Fever (aGVHD: 19%)

1% to 10%:

Dermatologic: Skin rash (4%)

Gastrointestinal: Dyspepsia (6%), severe diarrhea (aGVHD: 6%)

Genitourinary: Urinary tract infection (6%)

Hematologic & oncologic: Lymphoproliferative disorder (aGVHD: Post-transplant: 3%)

Infection: Herpes simplex infection (<5%), reactivation of latent Epstein-Barr virus (aGVHD: <10%)

Nervous system: Dizziness (9%)

Neuromuscular & skeletal: Back pain (7%), limb pain (3%)

Respiratory: Cough (8%), rhinitis (<5%), severe hypoxia (aGVHD: 5%)

Miscellaneous: Infusion related reaction (including flushing, hypotension, and dyspnea: 9%)

<1%:

Dermatologic: Cellulitis (severe)

Gastrointestinal: Diverticulitis of the gastrointestinal tract (severe)

Hematologic & oncologic: Malignant lymphoma, malignant neoplasm of lung

Hypersensitivity: Anaphylaxis, hypersensitivity reaction

Renal: Pyelonephritis (severe)

Frequency not defined:

Genitourinary: Malignant neoplasm of cervix

Hematologic & oncologic: Endometrial carcinoma, malignant melanoma, malignant neoplasm of bladder, malignant neoplasm of breast, malignant neoplasm of kidney, malignant neoplasm of ovary, malignant neoplasm of prostate, malignant neoplasm of skin, malignant neoplasm of the bile duct, malignant neoplasm of thyroid, malignant neoplasm of uterus, myelodysplastic syndrome

Postmarketing:

Cardiovascular: Hypersensitivity angiitis, vasculitis

Dermatologic: Exacerbation of psoriasis, psoriasis

Hematologic & oncologic: Basal cell carcinoma of skin, squamous cell carcinoma of skin

Hypersensitivity: Angioedema

Infection: Sepsis

Contraindications

There are no contraindications listed within the manufacturer's US labeling.

Canadian labeling: Additional contraindications (not in the US labeling): Hypersensitivity to abatacept or any component of the formulation; patients with or at risk of sepsis syndrome (eg, immunocompromised, HIV positive).

Warnings/Precautions

Concerns related to adverse effects:

• Hypersensitivity reactions: Rare cases of hypersensitivity, anaphylaxis, or anaphylactoid reactions, including fatalities, have been reported with IV administration; may occur with first infusion. Some reactions (angioedema, hypotension, urticaria, dyspnea) occurred within 24 hours of infusion, but may also have a delayed onset. Discontinue treatment if anaphylaxis or other serious allergic reaction occurs; medication for the treatment of hypersensitivity reactions should be available for immediate use.

• Infections: Serious and potentially fatal infections (including tuberculosis and sepsis) have been reported, particularly in patients receiving concomitant immunosuppressive therapy. Patients with rheumatoid arthritis (RA) receiving a concomitant tumor necrosis factor (TNF) antagonist experienced an even higher rate of serious infection; monitor for signs and symptoms of infection when transitioning from TNF-blocking agents to abatacept. Concomitant use of abatacept with TNF antagonists or Janus kinase inhibitors is not recommended. Caution should be exercised when considering the use in any patient with a history of new/recurrent infections, with conditions that predispose them to infections, or with chronic, latent, or localized infections. Patients who develop a new infection while undergoing treatment should be monitored closely. If a patient develops a serious infection, therapy should be discontinued.

• Malignancy: Use may affect defenses against malignancies (via T-cell inhibition); impact on the development and course of malignancies is not fully defined. As compared to the general population, an increased risk of lymphoma and lung cancer has been noted in clinical trials; however, RA has been previously associated with an increased rate of lymphoma. Malignancies, including skin cancer, have been reported with abatacept therapy; periodic skin examinations are recommended.

Disease-related concerns:

• Chronic obstructive pulmonary disease: Use caution with chronic obstructive pulmonary disease (COPD); higher incidences of adverse effects (COPD exacerbation, cough, rhonchi, dyspnea) have been observed; monitor closely.

Special populations:

• Hematopoietic stem cell transplantation: Posttransplant lymphoproliferative disorder (PTLD) has been reported in a small percentage of patients who received abatacept for acute graft-versus-host disease (aGVHD) prophylaxis following unrelated hematopoietic stem cell transplantation (HSCT). All PTLD cases were associated with Epstein-Barr virus (EBV) infection; the majority of patients were EBV serology positive at baseline, and most discontinued acyclovir prophylaxis at day 30 post-transplant. The time to PTLD onset ranged from 49 to 89 days post-transplant. Cytomegalovirus (CMV) invasive disease also occurred in some patients who received abatacept for aGVHD prophylaxis following unrelated HSCT; all patients who had CMV invasive disease were CMV serology positive at baseline. The median time to CMV onset was 91 days post-transplant (range: up to 225 days post-transplant). CMV invasive disease primarily involved the GI tract.

• Older age: Use with caution; higher incidences of infection and malignancy were observed in patients ≥65 years of age.

• Patients with rheumatic musculoskeletal disease undergoing hip or knee replacement surgery: Hold biologic disease-modifying antirheumatic drugs (DMARDs) prior to surgery and plan surgery after the next dose is due. Surgery can occur after holding medication for 1 full dosing cycle (eg, for medications administered every 4 weeks, schedule surgery 5 weeks from last administered dose); therapy can be restarted once surgical wound shows evidence of healing (eg, no swelling, erythema, or drainage), sutures/staples are removed, and no ongoing nonsurgical site infections (typically ~14 days to reduce infection risk). Decisions to withhold therapy should be based on shared decision making; ensure the patient and their provider weigh risks of interrupting therapy and disease control versus risks of continuing therapy and surgical complications (ACR/AAHKS [Goodman 2022]).

• Tuberculosis-positive patients: Safety has not been established in patients who are tuberculosis (TB)-positive; screen for TB infection (latent TB) prior to initiating therapy. Treat patients testing positive according to standard therapy prior to initiating abatacept.

Dosage form specific issues:

• Maltose: Powder for injection may contain maltose, which may result in falsely elevated serum glucose readings on the day of infusion.

Other warnings/precautions:

• Hepatitis screening: Patients should be screened for viral hepatitis prior to use; antirheumatic therapy may cause reactivation of hepatitis B.

• Immunizations: Patients should be brought up to date with all immunizations before initiating therapy. Live vaccines should not be given concurrently or within 3 months of discontinuation of therapy; there is no data available concerning secondary transmission of live vaccines in patients receiving therapy.

Warnings: Additional Pediatric Considerations

Reactivation of tuberculosis (TB) has been reported in pediatric patients receiving biologic response modifiers (infliximab and etanercept); prior to therapy, patients with no TB risk factors should be screened for latent TB infection (LTBI) with an age appropriate test (ie, <5 years of age: tuberculin skin test, and ≥5 years of age: IGRA [interferon gamma release assay]); if any TB risk factors are present or symptoms, both LTBI screening tests should be performed (AAP [Davies 2016]).

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Auto-injector, Subcutaneous [preservative free]:

Orencia ClickJect: 125 mg/mL (1 mL)

Solution Prefilled Syringe, Subcutaneous [preservative free]:

Orencia: 50 mg/0.4 mL (0.4 mL); 87.5 mg/0.7 mL (0.7 mL); 125 mg/mL (1 mL)

Solution Reconstituted, Intravenous [preservative free]:

Orencia: 250 mg (1 ea)

Generic Equivalent Available: US

No

Pricing: US

Solution (reconstituted) (Orencia Intravenous)

250 mg (per each): $1,713.84

Solution Auto-injector (Orencia ClickJect Subcutaneous)

125 mg/mL (per mL): $1,708.58

Solution Prefilled Syringe (Orencia Subcutaneous)

50 mg/0.4 mL (per 0.4 mL): $1,708.58

87.5 mg/0.7 mL (per 0.7 mL): $1,708.58

125 mg/mL (per mL): $1,708.58

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Prefilled Syringe, Subcutaneous:

Orencia: 125 mg/mL (1 mL)

Solution Reconstituted, Intravenous:

Orencia: 250 mg (1 ea)

Administration: Adult

Do not administer if solution is discolored or contains particulate matter.

IV: Infuse over 30 minutes (psoriatic arthritis and rheumatoid arthritis) or 60 minutes (acute graft-versus-host disease prophylaxis). Administer through a 0.2- to 1.2-micron sterile, nonpyrogenic, low protein-binding filter. Do not infuse other medications through the same IV line with abatacept.

SUBQ: Allow prefilled syringe and autoinjector to warm to room temperature (for 30 to 60 minutes and 30 minutes, respectively) prior to administration. Inject full amount into the front of the thigh (preferred), abdomen (except for 2-inch area around the navel), or the outer area of the upper arms (if administered by a caregiver). Rotate injection sites (≥1 inch apart); do not administer into tender, bruised, red, or hard skin.

Administration: Pediatric

IV: Administer through a 0.2 to 1.2 micron low protein-binding filter. Rate of administration varies by indication:

Graft-versus-host disease, acute; prophylaxis: Infuse over 60 minutes.

Juvenile idiopathic arthritis: Infuse over 30 minutes.

SUBQ: Allow prefilled syringe, autoinjector to warm to room temperature for 30 minutes prior to administration. Inject into the front of the thigh (preferred), abdomen (except for 2-inch area around the navel), or the outer area of the upper arms (if administered by a caregiver). Rotate injection sites (≥1 inch apart); do not administer into tender, bruised, red, or hard skin. Pediatric doses may be administered by a trained caregiver or pediatric patient; for self-administration, the health care provider and caregiver should determine it to be appropriate. Use of the autoinjector by pediatric patients has not been evaluated.

Use: Labeled Indications

Graft-versus-host disease, acute, prophylaxis: Prophylaxis of acute graft-versus-host disease (in combination with a calcineurin inhibitor and methotrexate) in adults and pediatric patients ≥2 years of age undergoing hematopoietic stem cell transplantation from a matched or 1 allele-mismatched unrelated donor.

Juvenile idiopathic arthritis: Treatment of moderately to severely active polyarticular juvenile idiopathic arthritis in patients ≥2 years of age; may be used as monotherapy or in combination with methotrexate.

Psoriatic arthritis: Treatment of active psoriatic arthritis in patients ≥2 years of age.

Rheumatoid arthritis: Treatment of moderately to severely active rheumatoid arthritis in adults; may be used as monotherapy or in combination with other disease-modifying antirheumatic drugs (DMARDs).

Limitations of use: The concomitant use of abatacept with other potent immunosuppressants (eg, biologic DMARDs, Janus kinase inhibitors) is not recommended.

Use: Off-Label: Adult

COVID-19, hospitalized patients

Medication Safety Issues
Sound-alike/look-alike issues:

Abatacept may be confused with etanercept.

Orencia may be confused with Oracea.

High alert medication:

The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drugs that have a heightened risk of causing significant patient harm when used in error.

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Abrocitinib: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination

Anifrolumab: Biologic Disease-Modifying Antirheumatic Drugs (DMARDs) may enhance the immunosuppressive effect of Anifrolumab. Risk X: Avoid combination

Antithymocyte Globulin (Equine): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of immunosuppressive therapy is reduced. Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor therapy

Anti-TNF Agents: May enhance the immunosuppressive effect of Abatacept. Risk X: Avoid combination

Baricitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Baricitinib. Risk X: Avoid combination

BCG Products: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of BCG Products. Risk X: Avoid combination

Belimumab: May enhance the immunosuppressive effect of Biologic Disease-Modifying Antirheumatic Drugs (DMARDs). Management: Consider alternatives to the use of belimumab with other biologic therapies. Monitor closely for increased toxicities related to additive immunosuppression (ie, infection, malignancy) if combined. Risk D: Consider therapy modification

Biologic Disease-Modifying Antirheumatic Drugs (DMARDs): May enhance the immunosuppressive effect of other Biologic Disease-Modifying Antirheumatic Drugs (DMARDs). Risk X: Avoid combination

Brincidofovir: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Brincidofovir. Risk C: Monitor therapy

Brivudine: May enhance the adverse/toxic effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination

Chikungunya Vaccine (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Chikungunya Vaccine (Live). Risk X: Avoid combination

Cladribine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Cladribine. Risk X: Avoid combination

Coccidioides immitis Skin Test: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the diagnostic effect of Coccidioides immitis Skin Test. Management: Consider discontinuing therapeutic immunosuppressants several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider therapy modification

COVID-19 Vaccines: Abatacept may diminish the therapeutic effect of COVID-19 Vaccines. Management: Rheumatology guidelines recommend holding SQ abatacept for 1 to 2 weeks after each vaccine dose and timing vaccine dose so that it is given 1 week prior to the next IV abatacept dose. Risk D: Consider therapy modification

Dengue Tetravalent Vaccine (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Dengue Tetravalent Vaccine (Live). Risk X: Avoid combination

Denosumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Denosumab. Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and immunosuppressants. If combined, monitor for signs/symptoms of serious infections. Risk D: Consider therapy modification

Deucravacitinib: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination

Efgartigimod Alfa: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy

Etrasimod: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination

Filgotinib: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination

Inebilizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Inebilizumab. Risk C: Monitor therapy

Influenza Virus Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating immunosuppressants if possible. If vaccination occurs less than 2 weeks prior to or during therapy, revaccinate 2 to 3 months after therapy discontinued if immune competence restored. Risk D: Consider therapy modification

Leflunomide: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents. Risk D: Consider therapy modification

Mumps- Rubella- or Varicella-Containing Live Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Mumps- Rubella- or Varicella-Containing Live Vaccines. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Mumps- Rubella- or Varicella-Containing Live Vaccines. Risk X: Avoid combination

Nadofaragene Firadenovec: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid combination

Natalizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Natalizumab. Risk X: Avoid combination

Ocrelizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ocrelizumab. Risk C: Monitor therapy

Ofatumumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ofatumumab. Risk C: Monitor therapy

Pidotimod: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Pidotimod. Risk C: Monitor therapy

Pimecrolimus: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Pimecrolimus. Risk X: Avoid combination

Pneumococcal Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Pneumococcal Vaccines. Risk C: Monitor therapy

Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Risk X: Avoid combination

Polymethylmethacrylate: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the potential for allergic or hypersensitivity reactions to Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider therapy modification

Rabies Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider therapy modification

Ritlecitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ritlecitinib. Risk X: Avoid combination

Rozanolixizumab: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy

Ruxolitinib (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ruxolitinib (Topical). Risk X: Avoid combination

Sipuleucel-T: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants prior to initiating sipuleucel-T therapy. Risk D: Consider therapy modification

Sphingosine 1-Phosphate (S1P) Receptor Modulator: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk C: Monitor therapy

Tacrolimus (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Tacrolimus (Topical). Risk X: Avoid combination

Talimogene Laherparepvec: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid combination

Tertomotide: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Tertomotide. Risk X: Avoid combination

Tofacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Tofacitinib. Management: Coadministration of tofacitinib with potent immunosuppressants is not recommended. Use with non-biologic disease-modifying antirheumatic drugs (DMARDs) was permitted in psoriatic arthritis clinical trials. Risk X: Avoid combination

Typhoid Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Typhoid Vaccine. Risk X: Avoid combination

Ublituximab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ublituximab. Risk C: Monitor therapy

Upadacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Upadacitinib. Risk X: Avoid combination

Vaccines (Inactivated/Non-Replicating): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before initiating or during therapy should be revaccinated at least 2 to 3 months after therapy is complete. Risk D: Consider therapy modification

Vaccines (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination

Yellow Fever Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Yellow Fever Vaccine. Risk X: Avoid combination

Reproductive Considerations

Based on limited data, use of abatacept may be continued through conception in patients with rheumatic and musculoskeletal diseases who are planning to become pregnant and not able to use alternative therapies; use should be discontinued once pregnancy is confirmed. Conception should be planned during a period of quiescent/low disease activity (ACR [Sammaritano 2020]).

Recommendations for use of abatacept to treat rheumatic and musculoskeletal diseases in patients who are planning to father a child are not available due to limited data (ACR [Sammaritano 2020]).

Pregnancy Considerations

Outcome data related to the use of abatacept in pregnancy are limited (Dernoncourt 2023; Ghalandari 2022; Kumar 2015; Ojeda-Uribe 2013).

Until additional data are available, abatacept is not currently recommended for the treatment of rheumatic and musculoskeletal diseases during pregnancy. Abatacept should be discontinued once pregnancy is confirmed (ACR [Sammaritano 2020]).

Breastfeeding Considerations

Abatacept is present in human milk.

Breast milk concentrations were measured in one patient administered abatacept 2.5 mg/kg (125 mg) SUBQ weekly, restarted 2 days postpartum for rheumatoid arthritis. Maternal serum and breast milk were sampled 63 and 71 days after delivery, after doses 9 and 10, respectively. Breast milk concentrations peaked ~3 days after the injection (256.2 ng/mL) then declined gradually (169.5 ng/mL prior to next treatment). Authors of the report calculated the relative infant dose of abatacept to be 1.02% to 1.54% of the weight adjusted maternal dose, providing an estimated infant dose via breast milk of 0.025 to 0.038 mg/kg/day. Adverse events were not observed in the infant exclusively breastfed for 12 months (Saito 2019).

Concentrations of abatacept are expected to be limited in breast milk due to large molecular weight. Also, because abatacept is unlikely to be absorbed by the infant GI tract following exposure via breast milk, treatment with abatacept may be continued or initiated in breastfeeding patients with rheumatic and musculoskeletal diseases (ACR [Sammaritano 2020]).

Monitoring Parameters

Monitor for signs/symptoms of infection and/or hypersensitivity reaction. Conduct hepatitis and tuberculosis screening prior to therapy initiation. Perform periodic skin examinations. In patients receiving abatacept for prophylaxis of acute graft-versus-host disease following hematopoietic stem cell transplant, monitor for cytomegalovirus infection/reactivation for 6 months post-transplant; monitor for Epstein-Barr virus reactivation and for posttransplant lymphoproliferative disorder.

For prophylaxis of acute graft-versus-host disease: The American Society of Clinical Oncology hepatitis B virus (HBV) screening and management provisional clinical opinion (ASCO [Hwang 2020]) recommends HBV screening with hepatitis B surface antigen, hepatitis B core antibody, total Ig or IgG, and antibody to hepatitis B surface antigen prior to beginning (or at the beginning of) systemic anticancer therapy; do not delay treatment for screening/results. Detection of chronic or past HBV infection requires a risk assessment to determine antiviral prophylaxis requirements, monitoring, and follow-up.

Mechanism of Action

Abatacept is a selective costimulation modulator; it inhibits T-cell (T-lymphocyte) activation by binding to CD80 and CD86 on antigen presenting cells (APC), thus blocking the required CD28 interaction between APCs and T cells. Activated T lymphocytes are found in the synovium of patients with rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and psoriatic arthritis. Costimulation blockade has a role in preventing graft-versus-host disease (Watkins 2021).

Pharmacokinetics (Adult Data Unless Noted)

Distribution: Vss: Rheumatoid arthritis (RA): IV: 0.07 L/kg (range: 0.02 to 0.13 L/kg); acute graft-versus-host disease (aGVHD) prophylaxis: 0.13 to 0.17 L/kg

Bioavailability: SUBQ: 78.6% (relative to IV administration).

Half-life elimination: RA: IV: 13.1 days (range: 8 to 25 days); aGVHD prophylaxis: ~21 days.

Clearance: Note: Clearance increases with increasing body weight. Population pharmacokinetic analyses in patients receiving abatacept for aGVHD prophylaxis showed that 7 of 8 HLA-matched hematopoietic stem cell transplant (HSCT) recipients had 29% lower clearance compared to 8 of 8 HLA-matched HSCT recipients.

Children 6 to 17 years of age: Juvenile idiopathic arthritis: 0.4 mL/hour/kg (0.2 to 1.12 mL/hour/kg).

Adults: RA: 0.22 mL/hour/kg (0.13 to 0.47 mL/hour/kg); aGVHD prophylaxis: 0.26 to 0.32 mL/hour/kg.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Orencia;
  • (AR) Argentina: Orencia;
  • (AT) Austria: Orencia;
  • (AU) Australia: Orencia;
  • (BE) Belgium: Orencia;
  • (BR) Brazil: Orencia;
  • (CH) Switzerland: Orencia;
  • (CL) Chile: Orencia;
  • (CO) Colombia: Orencia;
  • (CZ) Czech Republic: Orencia;
  • (DE) Germany: Orencia;
  • (EE) Estonia: Orencia;
  • (EG) Egypt: Orencia;
  • (ES) Spain: Orencia;
  • (FI) Finland: Orencia;
  • (FR) France: Orencia;
  • (GB) United Kingdom: Orencia;
  • (GR) Greece: Orencia;
  • (HK) Hong Kong: Orencia;
  • (HU) Hungary: Orencia;
  • (IE) Ireland: Orencia;
  • (IN) India: Orencia;
  • (IT) Italy: Orencia;
  • (JP) Japan: Orencia;
  • (KR) Korea, Republic of: Orencia;
  • (KW) Kuwait: Orencia;
  • (LT) Lithuania: Orencia;
  • (LU) Luxembourg: Orencia;
  • (LV) Latvia: Orencia;
  • (MX) Mexico: Ohrencia | Orencia;
  • (NL) Netherlands: Orencia;
  • (NO) Norway: Orencia;
  • (NZ) New Zealand: Orencia;
  • (PE) Peru: Orencia;
  • (PL) Poland: Orencia;
  • (PR) Puerto Rico: Orencia;
  • (PT) Portugal: Orencia;
  • (RO) Romania: Orencia;
  • (RU) Russian Federation: Orencia | Orensia;
  • (SA) Saudi Arabia: Orencia;
  • (SE) Sweden: Orencia;
  • (SG) Singapore: Orencia;
  • (SI) Slovenia: Orencia;
  • (SK) Slovakia: Orencia;
  • (TH) Thailand: Orencia;
  • (TR) Turkey: Orencia;
  • (TW) Taiwan: Orencia;
  • (ZA) South Africa: Orencia
  1. Bruce SP and Boyce EG, "Update on Abatacept: A Selective Costimulation Modulator for Rheumatoid Arthritis," Ann Pharmacother, 2007, 41(7):1153-62. [PubMed 17609234]
  2. Davies HD, Committee on Infectious Disease. Infectious complications with the use of biologic response modifiers in infants and children. Pediatrics. 2016;138(2):e20161209. [PubMed 27432853]
  3. Dernoncourt A, Liabeuf S, Bennis Y, et al. Fetal and neonatal adverse drug reactions associated with biologics taken during pregnancy by women with autoimmune diseases: insights from an analysis of the World Health Organization Pharmacovigilance Database (VigiBase®). BioDrugs. 2023;37(1):73-87. doi:10.1007/s40259-022-00564-4 [PubMed 36401769]
  4. Doan T and Massarotti E, “Rheumatoid Arthritis: An Overview of New and Emerging Therapies,” J Clin Pharmacol, 2005, 45(7):751-62. [PubMed 15951465]
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  7. Genovese MC, Becker JC, Schiff M, et al, “Abatacept for Rheumatoid Arthritis Refractory to Tumor Necrosis Factor Alpha Inhibition,” N Engl J Med, 2005, 353(11):1114-23. [PubMed 16162882]
  8. Ghalandari N, Crijns HJMJ, Bergman JEH, Dolhain RJEM, van Puijenbroek EP, Hazes JMW. Reported congenital malformations after exposure to non-tumour necrosis factor inhibitor biologics: a retrospective comparative study in EudraVigilance. Br J Clin Pharmacol. 2022;88(12):5378-5388. doi:10.1111/bcp.15471 [PubMed 35894810]
  9. Goodman SM, Springer BD, Chen AF, et al. 2022 American College of Rheumatology/American Association of Hip and Knee Surgeons guideline for the perioperative management of antirheumatic medication in patients with rheumatic diseases undergoing elective total hip or total knee arthroplasty. Arthritis Care Res (Hoboken). 2022;74(9):1399-1408. doi:10.1002/acr.24893 [PubMed 35718887]
  10. Hwang JP, Feld JJ, Hammond SP, et al. Hepatitis B virus screening and management for patients with cancer prior to therapy: ASCO provisional clinical opinion update. J Clin Oncol. 2020;38(31):3698-3715. doi:10.1200/JCO.20.01757 [PubMed 32716741]
  11. Kremer JM, Dougados M, Emery P, et al, “Treatment of Rheumatoid Arthritis With the Selective Costimulation Modulator Abatacept: Twelve-Month Results of a Phase IIb, Double-Blind, Randomized, Placebo-Controlled Trial,” Arthritis Rheum, 2005, 52(8):2263-71. [PubMed 16052582]
  12. Kremer JM, Genant HK, Moreland LW, et al, “Effects of Abatacept in Patients With Methotrexate-Resistant Active Rheumatoid Arthritis: A Randomized Trial,” Ann Intern Med, 2006, 144(12):865-76. [PubMed 16785475]
  13. Kremer JM, Westhovens R, Leon M, et al, “Treatment of Rheumatoid Arthritis by Selective Inhibition of T-Cell Activation With Fusion Protein CTLA4Ig,” N Engl J Med, 2003, 349(20):1907-15. [PubMed 14614165]
  14. Kumar M, Ray L, Vemuri S, Simon TA. Pregnancy outcomes following exposure to abatacept during pregnancy. Semin Arthritis Rheum. 2015;45(3):351-356. doi: 10.1016/j.semarthrit.2015.06.016. [PubMed 26210783]
  15. National Institutes of Health (NIH). COVID-19 Treatment Guidelines Panel. Coronavirus disease 2019 (COVID-19) treatment guidelines. https://www.covid19treatmentguidelines.nih.gov/. Accessed October 13, 2023.
  16. O'Halloran JA, Ko ER, Anstrom KJ, et al; ACTIV-1 IM Study Group Members. Abatacept, cenicriviroc, or infliximab for treatment of adults hospitalized with COVID-19 pneumonia: a randomized clinical trial. JAMA. 2023;330(4):328-339. doi:10.1001/jama.2023.11043 [PubMed 37428480]
  17. Ojeda-Uribe M, Afif N, Dahan E, et al. Exposure to abatacept or rituximab in the first trimester of pregnancy in three women with autoimmune diseases. Clin Rheumatol. 2013;32(5):695-700. doi:10.1007/s10067-012-2156-4 [PubMed 23292481]
  18. Orencia (abatacept) [prescribing information]. Princeton, NJ: Bristol-Myers Squibb; October 2023.
  19. Orencia (abatacept) [product monograph]. Montreal, Quebec, Canada: Bristol-Meyers Squibb Canada; May 2023.
  20. Refer to manufacturer's labeling.
  21. Saito J, Yakuwa N, Takai C, et al. Abatacept concentrations in maternal serum and breast milk during breastfeeding and an infant safety assessment: a case study. Rheumatology (Oxford). 2019;58(9):1692-1694. doi:10.1093/rheumatology/kez135 [PubMed 31323087]
  22. Sammaritano LR, Bermas BL, Chakravarty EE, et al. 2020 American College of Rheumatology guideline for the management of reproductive health in rheumatic and musculoskeletal diseases. Arthritis Rheumatol. 2020;72(4):529-556. doi:10.1002/art.41191 [PubMed 32090480]
  23. Singh JA, Furst DE, Bharat A, et al, “2012 Update of the 2008 American College of Rheumatology Recommendations for the Use of Disease-Modifying Antirheumatic Drugs and Biologic Agents in the Treatment of Rheumatoid Arthritis,” Arthritis Care Res (Hoboken), 2012, 64(5):625-39. [PubMed 22473917]
  24. Tay L, Leon F, Vratsanos G, et al, “Vaccination Response to Tetanus Toxoid and 23-Valent Pneumococcal Vaccines Following Administration of a Single Dose of Abatacept: A Randomized, Open-Label, Parallel Group Study in Healthy Subjects,” Arthritis Res Ther, 2007, 9(2): R38. [PubMed 17425783]
  25. Watkins B, Qayed M, McCracken C, et al. Phase II trial of costimulation blockade with abatacept for prevention of acute GVHD. J Clin Oncol. 2021;39(17):1865-1877. doi:10.1200/JCO.20.01086 [PubMed 33449816]
  26. Weinblatt M, Combe B, Covucci A, et al, “Safety of the Selective Costimulation Modulator Abatacept in Rheumatoid Arthritis Patients Receiving Background Biologic and Nonbiologic Disease-Modifying Antirheumatic Drugs: A One-Year Randomized, Placebo-Controlled Study,” Arthritis Rheum, 2006, 54(9):2807-16. [PubMed 16947384]
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