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.

Adult:

RA: IV regimen: give as a 60-min single IV drip. 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. Rotate inj sites. Reduce IV dose to 4mg/kg or SC dose to every other week 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. Transitioning from IV to SC administration: give 1^st SC dose instead of next scheduled IV dose.

Children:

RA: not established. SJIA, PJIA: <2yrs or SC administration: not studied. ≥2yrs: Give once every 2 weeks (SJIA) or once every 4 weeks (PJIA) as a 60-min IV infusion. SJIA: <30kg: 12mg/kg. PJIA: <30kg: 10mg/kg. Both: ≥30kg: 8mg/kg. 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.

Pharmacological Class:

Interleukin-6 receptor inhibitor.

Warnings/Precautions:

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 2^nd infusion and then every 2–4 weeks; PJIA: at the time of the 2^nd 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. Immunosuppression. Malignancies. CNS demyelinating disorders; monitor. Discontinue permanently if anaphylaxis or hypersensitivity reactions occur. Elderly. Pregnancy (Cat. C). Nursing mothers: not recommended.

Interactions:

Avoid 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.

Adverse Reactions:

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.

REMS:

YES

Note:

Register pregnant patients in Actemra pregnancy exposure registry by calling (877) 311-8972.

How Supplied:

Single-use vial (80mg/4mL, 200mg/10mL, 400mg/20mL)—1; Single-use prefilled syringe—1