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RoActemra is a brand name for Tocilizumab. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Rheumatoid arthritis (RA) RoActemra, in combination with methotrexate (MTX), is indicated for: the treatment of severe, active and progressive RA in adults not previously treated with MTX. the treatment of moderate to severe active RA in adult patients who have either responded inadequately to, or who were…
Verbatim from this product's EMA label. Tap a section to expand.
Treatment should be initiated by healthcare professionals experienced in the diagnosis and treatment of RA, COVID-19, sJIA, pJIA or CRS. All patients treated with RoActemra must be given the Patient Card. Posology RA patients The recommended posology is 8 mg/kg body weight, given once every four weeks.
2). 1). 4) Liver enzyme abnormalities Laboratory value Action > 1 to 3 × Upper Limit of Normal (ULN) Modify the dose of the concomitant MTX if appropriate. For persistent increases in this range, reduce tocilizumab dose to 4 mg/kg or interrupt treatment until alanine aminotransferase (ALT) or aspartate aminotransferase (AST) have normalised.
Restart with 4 mg/kg or 8 mg/kg, as clinically appropriate. 4). Interrupt tocilizumab dosing until < 3 × ULN and follow recommendations above for > 1 to 3 × ULN. For persistent increases > 3 × ULN, discontinue treatment. > 5 × ULN Discontinue treatment.
Low absolute neutrophil count (ANC) In patients not previously treated with tocilizumab, initiation is not recommended in patients with an absolute neutrophil count (ANC) below 2 × 109/L. 4 Laboratory Value (cells × 109/L) Action ANC > 1 Maintain dose.
5 to 1 Interrupt tocilizumab dosing. When ANC increases > 1 × 109/ L resume treatment at 4 mg/kg and increase to 8 mg/kg as clinically appropriate. 5 Discontinue treatment. Low platelet count Laboratory Value (cells × 103/μL) Action 50 to 100 Interrupt tocilizumab dosing.
When platelet count > 100 × 103/μL resume treatment at 4 mg/kg and increase to 8 mg/kg as clinically appropriate. < 50 Discontinue treatment. 1. If clinical signs or symptoms worsen or do not improve after the first dose, one additional infusion of tocilizumab 8 mg/kg may be administered.
The interval between the two infusions must be at least 8 hours. 2). Administration of tocilizumab is not recommended in patients with COVID-19 who have any of the following laboratory abnormalities: Laboratory test type Laboratory value Action Liver enzyme > 10 × ULN Administration of tocilizumab is not recommendedAbsolute neutrophil count < 1 × 109/L Platelet count < 50 × 103/μL Cytokine Release Syndrome (CRS) (adults and paediatrics) The recommended posology for treatment of CRS given as a 60-minute intravenous infusion is 8 mg/kg in patients weighing greater than or equal to 30 kg or 12 mg/kg in patients weighing less than 30 kg.
Summary of the safety profile RA, sJIA, pJIA and CRS The most commonly reported adverse reactions are upper respiratory tract infections, nasopharyngitis, headache, hypertension and increased ALT. 13 The most serious adverse reactions are serious infections, complications of diverticulitis, and hypersensitivity reactions.
COVID-19 The most commonly reported adverse reactions are hepatic transaminases increased, constipation, and urinary tract infection. Tabulated list of adverse reactions Adverse reactions from clinical trials and/or post-marketing experience with tocilizumab based on spontaneous case reports, literature cases and cases from non-interventional trial programs are listed in Table 1 and in Table 2 by MedDRA system organ class (SOC).
The corresponding frequency category for each adverse reaction is based on the following convention: very common ( ≥ 1/10); common ( ≥ 1/100 to < 1/10), uncommon ( ≥ 1/1 000 to < 1/100), rare ( ≥ 1/10 000 to < 1/1 000), very rare ( < 1/10 000), and frequency not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. RA patients Table 1. 4 3 This adverse reaction was identified through post-marketing surveillance but not observed in controlled clinical trials.
The frequency category was estimated as the upper limit of the 95 % confidence interval calculated on the basis of the total number of patients exposed to tocilizumab in clinical trials. Patients with COVID-19 The safety evaluation of this medicinal product in COVID-19 was based on 3 randomised, double-blind, placebo-controlled trials (Trials ML42528, WA42380, and WA42511).
A total of 974 patients were exposed to tocilizumab in these trials. Collection of safety data from the RECOVERY trial was limited and is not presented here. The following adverse reactions, listed by MedDRA SOC in Table 2, have been adjudicated from events which occurred in at least 3 % of tocilizumab treated patients and more commonly than that in patients on placebo in the pooled safety-evaluable population from clinical Trials ML42528, WA42380, and WA42511.
Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. 8). 3). 8). g. diverticulitis, diabetes and interstitial lung disease) which may predispose patients to infections.
Vigilance for the timely detection of serious infection is recommended for patients receiving biological treatments as signs and symptoms of acute inflammation may be lessened, associated with suppression of the acute phase reaction.
The effects of tocilizumab on C-reactive protein (CRP), neutrophils and signs and symptoms of infection must be considered when evaluating a patient for a potential infection. Patients (which includes younger children with sJIA or pJIA who may be less able to communicate their symptoms) and parents/guardians of sJIA or pJIA patients should be instructed to contact their healthcare professional immediately when any symptoms suggesting infection appear, in order to assure rapid evaluation and appropriate treatment.
9 Tuberculosis (TB) As recommended for other biological treatments, RA, pJIA and sJIA patients should be screened for latent TB infection prior to starting tocilizumab therapy. Patients with latent TB must be treated with standard anti-mycobacterial therapy before initiating treatment.
Prescribers are reminded of the risk of false negative tuberculin skin and interferon-gamma TB blood test results, especially in patients who are severely ill or immunocompromised. , persistent cough, wasting/weight loss, low grade fever) suggestive of a tuberculosis infection occur during or after therapy with this medicinal product.
g. hepatitis B virus) has been reported with biologic therapies for RA. In clinical trials with tocilizumab, patients who screened positive for hepatitis were excluded. 8). This medicinal product should be used with caution in patients with previous history of intestinal ulceration or diverticulitis.
1. 4).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Tocilizumab can be given alone or in combination with corticosteroids. If no clinical improvement in the signs and symptoms of CRS occurs after the first dose, up to 3 additional doses of tocilizumab may be administered. The interval between consecutive doses must be at least 8 hours.
Doses exceeding 800 mg per infusion are not recommended in CRS patients. Patients with severe or life-threatening CRS frequently have cytopenias or elevated ALT or AST due to the underlying malignancy, preceding lymphodepleting chemotherapy or the CRS.
5 Special populations Elderly No dose adjustment is required in elderly patients > 65 years of age. Renal impairment No dose adjustment is required in patients with mild renal impairment. 2). Renal function must be monitored closely in these patients.
Hepatic impairment Tocilizumab has not been studied in patients with hepatic impairment. Therefore, no dose recommendations can be made. Paediatric population sJIA patients The recommended posology in patients above 2 years of age is 8 mg/kg once every 2 weeks in patients weighing greater than or equal to 30 kg or 12 mg/kg once every 2 weeks in patients weighing less than 30 kg.
The dose must be calculated based on the patient’s body weight at each administration. A change in dose should only be based on a consistent change in the patient’s body weight over time. The safety and efficacy of intravenous tocilizumab in children below 2 years of age has not been established.
2 but no recommendation on a posology can be made. Dose interruptions of tocilizumab for the following laboratory abnormalities are recommended in sJIA patients in the tables below. If appropriate, the dose of concomitant MTX and/or other medicinal products should be modified or dosing stopped and tocilizumab dosing interrupted until the clinical situation has been evaluated.
As there are many co-morbid conditions that may affect laboratory values in sJIA, the decision to discontinue tocilizumab for a laboratory abnormality should be based upon the medical assessment of the individual patient. Liver enzyme abnormalities Laboratory Value Action > 1 to 3 × ULN Modify the dose of the concomitant MTX if appropriate.
For persistent increases in this range, interrupt tocilizumab until ALT/AST have normalised. > 3 × ULN to 5 × ULN Modify the dose of the concomitant MTX if appropriate. Interrupt tocilizumab dosing until < 3 × ULN and follow recommendations above for > 1 to 3 × ULN.
> 5 × ULN Discontinue tocilizumab. The decision to discontinue treatment in sJIA for a laboratory abnormality must be based on the medical assessment of the individual patient. 6 Low absolute neutrophil count (ANC) Laboratory Value (cells × 109/L) Action ANC > 1 Maintain […]
15 Table 2. List of adverse reactions1 identified from the pooled safety-evaluable population from tocilizumab clinical trials in COVID-19 patients2 MedDRA SOC Class Preferred Terms and frequency Common Infections and infestations Urinary tract infection Metabolism and nutrition disorders Hypokalaemia Psychiatric disorders Anxiety, Insomnia Vascular disorders Hypertension Gastrointestinal disorders Constipation, Diarrhoea, Nausea Hepatobiliary disorders Hepatic transaminases increased 1 Patients are counted once for each category regardless of the number of reactions 2 Includes adjudicated reactions reported in Trials WA42511, WA42380 and ML42528 Patients with sJIA or pJIA Adverse reactions in the sJIA and pJIA patients treated with tocilizumab are listed in the Table 3 and presented by MedDRA SOC.
The corresponding frequency category for each adverse reaction is based on the following convention: very common ( ≥ 1/10); common ( ≥ 1/100 to < 1/10) or uncommon ( ≥ 1/1 000 to < 1/100). Table 3. List of adverse reactions occurring in clinical trial patients with sJIA or pJIA receiving tocilizumab as monotherapy or in combination with MTX.
MedDRA SOC Preferrred term (PT) Frequency Infections and Infestations Very Common Common Uncommon Upper Respiratory Tract Infections pJIA, sJIA Nasopharyngitis pJIA, sJIA Nervous system disorders Headache pJIA sJIA Gastrointestinal Disorders Nausea pJIA Diarrhoea pJIA, sJIA General disorders and administration site conditions Infusion related reactions pJIA1, sJIA2 Investigations Hepatic transaminases increased pJIA Decrease in neutrophil count sJIA pJIA Platelet count decreased sJIA pJIA Cholesterol increased sJIA pJIA 1.
Infusion-related reaction events in pJIA patients included but were not limited to headache, nausea and hypotension 2. Infusion-related reaction events in sJIA patients included but were not limited to rash, urticaria, diarrhoea, epigastric discomfort, arthralgia and headache 16 Description of selected adverse reactions RA patients Infections In the 6-month controlled trials the rate of all infections reported with tocilizumab 8 mg/kg plus DMARD treatment was 127 events per 100 patient years compared to 112 events per 100 […]
Patients presenting with symptoms potentially indicative of complicated diverticulitis, such as abdominal pain, haemorrhage and/or unexplained change in bowel habits with fever must be evaluated promptly for early identification of diverticulitis, which can be associated with gastrointestinal perforation.
8). Such reactions may be more severe, and potentially fatal in patients who have experienced hypersensitivity reactions during previous infusions even if they have received premedication with steroids and antihistamines. Appropriate treatment should be available for immediate use in the event of an anaphylactic reaction during treatment.
If an anaphylactic reaction or other serious hypersensitivity / serious infusion-related reaction occurs, administration of tocilizumab must be stopped immediately and treatment should be permanently discontinued. 8). 8). g. MTX) were used in combination with tocilizumab.
When clinically indicated, other liver function tests including bilirubin should be considered. 8). Serious hepatic injury occurred between 2 weeks to more than 5 years after initiation of treatment. Cases of liver failure resulting in liver transplantation have been reported.
Patients must be advised to immediately seek medical help if they experience signs and symptoms of hepatic injury. 5 × ULN. In RA, pJIA and sJIA patients with baseline ALT or AST > 5 × ULN, treatment is not recommended. In RA, pJIA and sJIA patients, ALT/AST should be monitored every 4 to 8 weeks for the first 6 months of treatment followed by every 12 weeks thereafter.
2. For ALT or AST elevations > 3-5 × ULN, confirmed by repeat testing, treatment must be interrupted. 8). There may be an increased risk of neutropenia in patients who have previously been treated with a TNF antagonist. In patients not previously treated with tocilizumab, […]