Arthritis/rheumatic disorders:
Indications for: ORENCIA
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.
Adult Dosage:
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 Dosage:
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 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 Classification:
Selective costimulation modulator.
ORENCIA Interactions:
Concomitant TNF antagonists, other biologics (eg, anakinra), JAK inhibitors, live vaccines (or within 3 months of discontinuation): not recommended (see full labeling).
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.
Note:
Reconstitute with silicone-free disposable syringes only.
Generic Drug Availability:
NO
How Supplied:
Single-use vial—1 (w. silicone-free disposable syringe); Single-dose prefilled syringes—4; Single-dose ClickJect autoinjectors—4
Miscellaneous immune disorders:
Indications for: ORENCIA
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.
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 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 Classification:
Selective costimulation modulator.
ORENCIA Interactions:
Concomitant TNF antagonists, other biologics (eg, anakinra), JAK inhibitors, live vaccines (or within 3 months of discontinuation): not recommended (see full labeling).
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.
Note:
Reconstitute with silicone-free disposable syringes only.
Generic Drug Availability:
NO
How Supplied:
Single-use vial—1 (w. silicone-free disposable syringe); Single-dose prefilled syringes—4; Single-dose ClickJect autoinjectors—4
