These ISRs occurred in a 44% of patients In the SC Study 5.8% [3/52] developed positive neutralizing anti-tocilizumab antibodies without developing a serious or clinically significant hypersensitivity reaction. No adverse reactions were observed. MTX) to RoActemra monotherapy resulted in increased frequency of these elevations. RoActemra in combination with methotrexate (MTX) is indicated for the treatment of juvenile idiopathic polyarthritis (pJIA; rheumatoid factor positive or negative and extended oligoarthritis) in patients 12 years of age and older, who have responded inadequately to previous therapy with MTX (see Section 4.2).RoActemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.RoActemra is indicated for the treatment of Giant Cell Arteritis (GCA) in adult patients.Tocilizumab SC formulation is administered with a single-use pre-filled pen. At week 24, inhibition of structural damage was shown, with significantly less radiographic progression in patients receiving RoActemra subcutaneous compared to placebo (mean mTSS of 0.62 vs. 1.23, p=0.0149 (van Elteren). No correlation between antibody development and clinical response or adverse events was observedDuring routine laboratory monitoring in the RoActemra all exposure population, a decrease in neutrophil count below 1 × 10In the SC Study, 14.3% and 12.8% of patients experienced a post-baseline elevation of their LDL-cholesterol value to ≥ 130 mg/dL and total cholesterol value to ≥ 200 mg/dL at any time during study treatment, respectively.The rate of infection/serious infection events was balanced between the RoActemra weekly group (200.2/9.7 events per 100 patient years) vs. placebo plus 26 weeks prednisone taper (156.0/4.2 events per 100 patient years) and placebo plus 52 weeks taper (210.2/12.5 events per 100 patient years) groups. In the long-term exposure population, the overall rate of infections with RoActemra was 108 events per 100 patient years exposure.In 6-month controlled clinical studies, the rate of serious infections with RoActemra8 mg/kg plus DMARDs was 5.3 events per 100 patient years exposure compared to 3.9 events per 100 patient years exposure in the placebo plus DMARD group. RoActemra, in combination with methotrexate (MTX), is indicated for

Cases of opportunistic infections have been reported.Impaired lung function may increase the risk for developing infections. The safety and efficacy of RoActemra subcutaneous formulation in children from birth to less than 1 year have not been established. In patients treated with RoActemra 8 mg/kg, significant improvements were noted on all individual components of the ACR response including: tender and swollen joint counts; patients and physician global assessment; disability index scores; pain assessment and CRP compared to patients receiving placebo plus MTX or other DMARDs in all studies. However, a slight increase in abortion/embryonal-foetal death was observed with high systemic exposure (> 100 x human exposure) in the 50 mg/kg/day high-dose group compared to placebo and other low-dose groups. As there are many co-morbid conditions that may effect laboratory values in sJIA or pJIA, the decision to discontinue tocilizumab for a laboratory abnormality should be based upon the medical assessment of the individual patient.Modify the dose of the concomitant MTX if appropriateFor persistent increases in this range, interrupt RoActemra until ALT/AST have normalized. The cumulative prednisone dose at week 52 was significantly lower in the two RoActemra dose groups compared to the two placebo groups (Table 4). Consistent with the effect on acute phase reactants, treatment with RoActemra was associated with reduction in platelet count within the normal range. If a patient misses a subcutaneous once every 2 week injection of RoActemra within 7 days of the scheduled dose, he/she should be instructed to take the missed dose immediately and the next dose on the next scheduled day.

The syringe is closed by a rigid needle shield (elastomer seal with a polypropylene shell) and a plunger stopper (butyl rubber with a fluororesin coating).RoActemra is supplied in a single use pre-filled pen.


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