Select therapeutic use:
Indications for ACTEMRA:
Moderately-to-severely active rheumatoid arthritis (RA) in patients who have had an inadequate response to ≥1 DMARDs; may be used as monotherapy or concomitantly with methotrexate or other non-biologic DMARDs. Active systemic juvenile idiopathic arthritis (SJIA) or active polyarticular juvenile idiopathic arthritis (PJIA) as monotherapy, or in combination with methotrexate. Giant cell arteritis (GCA) in combination with a tapering course of glucocorticoids.
RA: IV regimen: give as a 60-min single IV infusion. Initially 4mg/kg every 4 weeks, followed by an increase to 8mg/kg every 4 weeks based on clinical response. Doses >800mg per infusion: not recommended. SC regimen: <100kg: 162mg SC inj every other week, followed by an increase to once weekly based on clinical response. ≥100kg: 162mg SC inj once weekly. GCA: 162mg SC inj once weekly with a glucocorticoid taper. Rotate inj sites. Elevated liver enzymes, neutropenia, or thrombocytopenia: reduce IV dose to 4mg/kg or SC dose to every other week (see full labeling). Do not start if ANC <2000/mm3, platelets <100000/mm3, or ALT/AST >1.5xULN. Transitioning from IV to SC administration: give 1st SC dose instead of next scheduled IV dose.
<2yrs or SC administration: not studied. Give as a 60-min single IV infusion. ≥2yrs: SJIA (<30kg): 12mg/kg every 2wks; (≥30kg): 8mg/kg every 2wks. PJIA (<30kg): 10mg/kg every 4wks; (≥30kg): 8mg/kg every 4wks. May need to interrupt dose if elevated liver enzymes, neutropenia, or thrombocytopenia occur (see full labeling). Do not start if ANC <2000/mm3, platelets <100000/mm3, or ALT/AST >1.5xULN.
Increased risk of serious or fatal infections (eg, TB, bacterial, invasive fungal, viral, and other opportunistic infections); if develop, interrupt until controlled. Active infections: do not give therapy. Consider risks/benefits prior to initiating: chronic or recurrent, or history of opportunistic infections, exposed to TB, travel to, or residence in, areas with endemic TB or mycoses, conditions that predispose to infection. Monitor closely for signs/symptoms of infection during and after therapy; interrupt if serious or opportunistic infection or sepsis develop. Test for and treat latent TB prior to starting therapy. HBV or HCV infection. ANC <500mm3, platelets <50000mm3, or ALT/AST >5xULN: not recommended. Monitor neutrophils, platelets, liver function tests: RA: every 4–8 weeks, then every 3 months; SJIA: at the time of the 2nd infusion and then every 2–4 weeks; PJIA: at the time of the 2nd infusion and then every 4–8 weeks. Monitor lipids 4–8 weeks after initiation, then every 6 months. Increased risk of GI perforation. Active hepatic disease or impairment: not recommended. Severe renal impairment. Immunosuppression. Malignancies. CNS demyelinating disorders; monitor. Discontinue permanently if anaphylaxis or other hypersensitivity reactions occur. Elderly. Pregnancy. Nursing mothers.
Avoid concomitant live vaccines. Increased risk for infection with concomitant biological DMARDs (eg, TNF antagonists, IL-1R antagonists, anti-CD20 monoclonal antibodies, selective co-stimulation modulators); avoid. Caution with CYP3A4 substrate drugs (eg, oral contraceptives, lovastatin, atorvastatin, others). Monitor warfarin, cyclosporine, theophylline, other drugs that are CYP450 substrates with narrow therapeutic indices.
Upper respiratory tract infections, nasopharyngitis, headache, hypertension, increased ALT, inj site reactions; hypersensitivity reactions (may be severe and fatal), neutropenia, thrombocytopenia, GI perforation, increased lipids.
Register pregnant patients in Actemra pregnancy exposure registry by calling (877) 311-8972.
Single-use vial (80mg/4mL, 200mg/10mL, 400mg/20mL)—1; Single-use prefilled syringe—1