Orencia

— THERAPEUTIC CATEGORIES —
  • Arthritis/rheumatic disorders
  • Miscellaneous immune disorders
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Orencia Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Abatacept 250mg/vial; pwd for IV infusion after reconstitution and dilution; 50mg/0.4mL, 87.5mg/0.7mL, 125mg/mL prefilled syringe or 125mg/mL ClickJect autoinjector; soln for SC inj. All: preservative-free. IV form: contains maltose.

    Pharmacological Class

    Selective costimulation modulator.

    How Supplied

    Single-use vial—1 (w. silicone-free disposable syringe); Single-dose prefilled syringes—4; Single-dose ClickJect autoinjectors—4

    Storage

    Vials: 

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

    Prefilled syringes or ClickJect autoinjectors: 

    • Refrigerate at 2°C to 8°C (36°F to 46°F). 
    • Do not use beyond the expiration date on the prefilled syringe or autoinjector. 
    • Protect from light by storing in the original package until time of use. 
    • Do not allow the prefilled syringe or autoinjector to freeze. 

    Manufacturer

    Bristol Myers Squibb

    Generic Availability

    NO

    Mechanism of Action

    Abatacept, a selective costimulation modulator, inhibits T cell (T lymphocyte) activation by binding to CD80 and CD86, thereby blocking interaction with CD28. This interaction provides a costimulatory signal necessary for full activation of T lymphocytes. Activated T lymphocytes are implicated in the pathogenesis of RA, pJIA and PsA and are found in the synovium of patients with RA, pJIA and PsA.

    Orencia Indications

    Indications

    Moderately to severely active rheumatoid arthritis (RA) in adults; may be used alone or with DMARDS, other than JAK inhibitors or TNF antagonists. Moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA) in patients ≥2 years of age; may be used alone or with methotrexate. Active psoriatic arthritis (PsA) in patients ≥2 years of age; may be used alone or with methotrexate.

    Orencia Dosage and Administration

    Adult

    See full labeling. IV regimen (RA and PsA): give as IV infusion over 30mins at weeks 0, 2, and 4, then every 4 weeks thereafter. <60kg: 500mg. 60–100kg: 750mg. >100kg: 1g. SC regimen: For RA (may initiate with or without an IV loading dose): if using an IV loading dose, administer a single IV loading dose (based on body wt listed above), followed by the first 125mg SC inj given within one day, then subsequently 125mg SC inj once weekly; rotate inj sites. For PsA: administer once weekly SC inj without an IV loading dose. Switching from IV to SC regimen: give the first SC dose instead of the next scheduled IV dose.

    Children

    See full labeling. IV regimen (pJIA only): give as an IV infusion over 30mins at weeks 0, 2, and 4, then every 4 weeks thereafter. <6yrs: not studied. 6–17yrs: (<75kg): 10mg/kg; (≥75kg): use adult dose; max 1g. SC regimen (initiate without an IV loading dose): <2yrs: not established. ≥2yrs (pJIA and PsA): (10–<25kg): 50mg once weekly; (25–<50kg): 87.5mg once weekly; (≥50kg); 125mg once weekly. Rotate inj sites. ClickJect autoinjector: not studied in pediatrics.

    Orencia Contraindications

    Not Applicable

    Orencia Boxed Warnings

    Not Applicable

    Orencia Warnings/Precautions

    Warnings/Precautions

    Chronic, latent, localized, or history of recurring infections. Conditions that predispose to infection. Screen for latent tuberculosis (TB), hepatitis prior to initiation; treat TB if positive. Monitor closely if new infection develops; discontinue if serious infection occurs. COPD (monitor). In aGVHD prophylaxis after HSCT: monitor for Epstein-Barr Virus reactivation, cytomegalovirus (CMV) infection/reactivation for 6 months post-transplant (see Adults and Children). Update vaccinations according to current guidelines prior to initiation. Immunosuppression. Do periodic skin exams (esp. in those with risks for skin cancer). Elderly. Pregnancy. Infants exposed in utero: consider risks/benefits prior to administering live vaccines. Nursing mothers.

    Orencia Pharmacokinetics

    See Literature

    Orencia Interactions

    Interactions

    Concomitant TNF antagonists, other biologics (eg, anakinra), JAK inhibitors, live vaccines (or within 3 months of discontinuation): not recommended (see full labeling).

    Orencia Adverse Reactions

    Adverse Reactions

    Headache, upper respiratory tract infection, nasopharyngitis, nausea, infusion-related reactions; infections (may be serious), malignancies (eg, lymphoma, lung cancer), hypersensitivity reactions (permanently discontinue if occurs). Children: diarrhea, cough, pyrexia, abdominal pain. In aGVHD prophylaxis: anemia, hypertension, CMV reactivation/infection, pyrexia, pneumonia, epistaxis, CD4 lymphocytes decreased, hypermagnesemia, acute kidney injury.

    Orencia Clinical Trials

    See Literature

    Orencia Note

    Notes

    Reconstitute with silicone-free disposable syringes only.

    Orencia Patient Counseling

    See Literature

    Orencia Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Abatacept 250mg/vial; pwd for IV infusion after reconstitution and dilution; 50mg/0.4mL, 87.5mg/0.7mL, 125mg/mL prefilled syringe or 125mg/mL ClickJect autoinjector; soln for SC inj. All: preservative-free. IV form: contains maltose.

    Pharmacological Class

    Selective costimulation modulator.

    How Supplied

    Single-use vial—1 (w. silicone-free disposable syringe); Single-dose prefilled syringes—4; Single-dose ClickJect autoinjectors—4

    Storage

    Vials: 

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

    Prefilled syringes or ClickJect autoinjectors: 

    • Refrigerate at 2°C to 8°C (36°F to 46°F). 
    • Do not use beyond the expiration date on the prefilled syringe or autoinjector. 
    • Protect from light by storing in the original package until time of use. 
    • Do not allow the prefilled syringe or autoinjector to freeze. 

    Manufacturer

    Bristol Myers Squibb

    Generic Availability

    NO

    Mechanism of Action

    Abatacept, a selective costimulation modulator, inhibits T cell (T lymphocyte) activation by binding to CD80 and CD86, thereby blocking interaction with CD28. This interaction provides a costimulatory signal necessary for full activation of T lymphocytes. Activated T lymphocytes are implicated in the pathogenesis of RA, pJIA and PsA and are found in the synovium of patients with RA, pJIA and PsA.

    Orencia Indications

    Indications

    Prevention of acute graft versus host disease (aGVHD), in combination with a calcineurin inhibitor and methotrexate, in patients aged ≥2yrs undergoing hematopoietic stem cell transplantation (HSCT) from a matched or 1 allele-mismatched unrelated-donor.

    Orencia Dosage and Administration

    Adults and Children

    <2yrs: not established. See full labeling. Prior to initiation, give antiviral prophylaxis for EBV reactivation; continue for 6 months after HSCT; also, consider antiviral prophylaxis for CMV infection/reactivation during and for 6 months after HSCT. Give Orencia as IV infusion over 60mins. 2–<6yrs: 15mg/kg on the day before transplantation (Day 1), followed by 12mg/kg on Days 5, 14, and 28 after transplantation. ≥6yrs: 10mg/kg (max 1000mg) on Day 1, and then on Days 5, 14, and 28 after transplantation.

    Orencia Contraindications

    Not Applicable

    Orencia Boxed Warnings

    Not Applicable

    Orencia Warnings/Precautions

    Warnings/Precautions

    Chronic, latent, localized, or history of recurring infections. Conditions that predispose to infection. Screen for latent tuberculosis (TB), hepatitis prior to initiation; treat TB if positive. Monitor closely if new infection develops; discontinue if serious infection occurs. COPD (monitor). In aGVHD prophylaxis after HSCT: monitor for Epstein-Barr Virus reactivation, cytomegalovirus (CMV) infection/reactivation for 6 months post-transplant (see Adults and Children). Update vaccinations according to current guidelines prior to initiation. Immunosuppression. Do periodic skin exams (esp. in those with risks for skin cancer). Elderly. Pregnancy. Infants exposed in utero: consider risks/benefits prior to administering live vaccines. Nursing mothers.

    Orencia Pharmacokinetics

    See Literature

    Orencia Interactions

    Interactions

    Concomitant TNF antagonists, other biologics (eg, anakinra), JAK inhibitors, live vaccines (or within 3 months of discontinuation): not recommended (see full labeling).

    Orencia Adverse Reactions

    Adverse Reactions

    Headache, upper respiratory tract infection, nasopharyngitis, nausea, infusion-related reactions; infections (may be serious), malignancies (eg, lymphoma, lung cancer), hypersensitivity reactions (permanently discontinue if occurs). Children: diarrhea, cough, pyrexia, abdominal pain. In aGVHD prophylaxis: anemia, hypertension, CMV reactivation/infection, pyrexia, pneumonia, epistaxis, CD4 lymphocytes decreased, hypermagnesemia, acute kidney injury.

    Orencia Clinical Trials

    See Literature

    Orencia Note

    Notes

    Reconstitute with silicone-free disposable syringes only.

    Orencia Patient Counseling

    See Literature

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