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
Manufacturer
Generic Availability
NO
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 adults.
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: 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: (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 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 (EBV) 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
Manufacturer
Generic Availability
NO
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 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 (EBV) 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