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Tocilizumab STADA (Previously Tofidence) is a brand name for Tocilizumab. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Tocilizumab STADA, in combination with methotrexate (MTX), is indicated for: • the treatment of severe, active and progressive rheumatoid arthritis (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, or pJIA. All patients treated with tocilizumab should be given the Patient Alert 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 x 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 tocilizumab until alanine aminotransferase (ALT) or aspartate aminotransferase (AST) have normalized.
Restart with 4 mg/kg or 8 mg/kg, as clinically appropriate. 4). Interrupt tocilizumab dosing until < 3 x ULN and follow recommendations above for > 1 to 3 x ULN. For persistent increases > 3 x ULN, discontinue tocilizumab. > 5 x ULN Discontinue tocilizumab.
• 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 x 109/L. 4 Laboratory Value (cells x 109/L) Action ANC > 1 Maintain dose.
5 to 1 Interrupt tocilizumab dosing. When ANC increases > 1 x 109/L resume tocilizumab at 4 mg/kg and increase to 8 mg/kg as clinically appropriate. 5 Discontinue tocilizumab. • Low platelet count Laboratory Value (cells x 103/μL) Action 50 to 100 Interrupt tocilizumab dosing.
When platelet count > 100 x 103/μL resume tocilizumab at 4 mg/kg and increase to 8 mg/kg as clinically appropriate. < 50 Discontinue tocilizumab. 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 should 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 x ULN Administration of tocilizumab is not recommendedAbsolute neutrophil count < 1 x 109/L Platelet count < 50 x 103/μL Special populations Paediatric patients 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.
Summary of the safety profile The most commonly reported ADRs (occurring in ≥ 5% of patients treated with tocilizumab monotherapy or in combination with DMARDs for RA, sJIA and pJIA) were upper respiratory tract infections, nasopharyngitis, headache, hypertension and increased ALT.
The most serious ADRs were serious infections, complications of diverticulitis, and hypersensitivity reactions. The most commonly reported ADRs (occurring in ≥ 5% of patients treated with tocilizumab for COVID-19) were hepatic transaminases increased, constipation, and urinary tract infection.
13 ADRs from clinical studies and/or post marketing experience with tocilizumab based on spontaneous case reports, literature cases and cases from non-interventional study programs are listed in Table 1 and in Table 2 by MedDRA system organ class.
The corresponding frequency category for each ADR 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) or very rare (< 1/10 000). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
1). The double-blind controlled period was 6 months in four studies (studies I, III, IV and V) and was up to 2 years in one study (study II). In the double-blind controlled studies, 774 patients received tocilizumab 4 mg/kg in combination with MTX, 1 870 patients received tocilizumab 8 mg/kg in combination with MTX or other DMARDs and 288 patients received tocilizumab 8 mg/kg monotherapy.
The long-term exposure population includes all patients who received at least one dose of tocilizumab either in the double-blind control period or open label extension phase in the studies. Of the 4 009 patients in this population, 3 577 received treatment for at least 6 months, 3 296 for at least one year, 2 806 received treatment for at least 2 years and 1 222 for 3 years.
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, undesirable effects). 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 for moderate to severe RA, sJIA or pJIA 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 should 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.
Tuberculosis As recommended for other biological treatments, RA, sJIA and pJIA patients should be screened for latent tuberculosis (TB) infection prior to starting tocilizumab therapy. Patients with latent TB should be treated with standard anti-mycobacterial therapy before initiating tocilizumab.
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 tocilizumab.
g. hepatitis B virus) has been reported with biologic therapies for RA. In clinical studies with tocilizumab, patients who screened positive for hepatitis were excluded. 8). Tocilizumab 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.
Other brands of Tocilizumab in European Union.
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The dose should 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. 5 The safety and efficacy of intravenous tocilizumab in children below 2 years of age has not been established.
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 x ULN Modify the dose of the concomitant MTX if appropriate.
For persistent increases in this range, interrupt tocilizumab until ALT/AST have normalized. > 3 x ULN to 5 x ULN Modify the dose of the concomitant MTX if appropriate. Interrupt tocilizumab dosing until < 3 x ULN and follow recommendations above for > 1 to 3 x ULN.
> 5 x ULN Discontinue tocilizumab. The decision to discontinue tocilizumab in sJIA for a laboratory abnormality should be based on the medical assessment of the individual patient. • Low absolute neutrophil count (ANC) Laboratory Value (cells x 109/L) Action ANC > 1 Maintain dose.
5 to 1 Interrupt tocilizumab dosing. When ANC increases to > 1 x 109/L resume tocilizumab. 5 Discontinue tocilizumab. The decision to discontinue tocilizumab in sJIA for a laboratory abnormality should be based on the medical assessment of the individual patient.
• Low platelet count Laboratory Value (cells x 103/μL) Action 50 to 100 Modify the dose of the concomitant MTX if appropriate. Interrupt tocilizumab dosing. When platelet count is > 100 x 103/μL resume tocilizumab. 6 Laboratory Value (cells x 103/μL) Action < 50 Discontinue tocilizumab.
The decision to discontinue tocilizumab in sJIA for a laboratory abnormality should be based on the medical assessment of the individual patient. There are insufficient clinical data to assess the impact of a tocilizumab dose reduction in sJIA patients who have experienced laboratory abnormalities.
Available data suggest that clinical improvement is observed within 6 weeks of initiation of treatment with tocilizumab. Continued therapy should be carefully reconsidered in a patient exhibiting no improvement within this timeframe.
pJIA patients The recommended posology in patients above 2 years of age is 8 mg/kg once every 4 weeks in patients weighing greater than or equal to 30 kg or 10 mg/kg once every 4 weeks in patients weighing less than 30 kg. The dose should be calculated based on the […]
Table 1. 4 3 This adverse reaction was identified through post marketing surveillance but not observed in controlled clinical studies. 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 TCZ in clinical studies.
Infections In the 6-month controlled studies 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 patient years in the placebo plus DMARD group.
In the long-term exposure population, the overall rate of infections with tocilizumab was 108 events per 100 patient years exposure. 9 events per 100 patient years exposure in the placebo plus DMARD group. 5 events per 100 patient years of exposure in the MTX group.
7 events per 100 patient years. Reported serious infections, some with fatal outcome, included active tuberculosis, which may present with intrapulmonary or extrapulmonary disease, invasive pulmonary infections, including candidiasis, aspergillosis, coccidioidomycosis and pneumocystis jirovecii, pneumonia, cellulitis, herpes zoster, gastroenteritis, diverticulitis, sepsis and bacterial arthritis.
Cases of opportunistic infections have been reported. Interstitial lung disease Impaired lung function may increase the risk for developing infections. There have been post- marketing reports of interstitial lung disease (including pneumonitis and pulmonary fibrosis), some of which had fatal outcomes.
26 events per 100 patient years with tocilizumab therapy. 28 events per 100 patient years. […]
Patients presenting with symptoms potentially indicative of complicated diverticulitis, such as abdominal pain, haemorrhage and/or unexplained change in bowel habits with fever should 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 with tocilizumab.
If an anaphylactic reaction or other serious hypersensitivity / serious infusion related reaction occurs, administration of tocilizumab should be stopped immediately and tocilizumab 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 tocilizumab. Cases of liver failure resulting in liver transplantation have been reported.
Patients should be advised to immediately seek medical help if they experience signs and symptoms of hepatic injury. 5 x ULN. In RA, pJIA and sJIA patients with baseline ALT or AST > 5 x 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 x ULN, confirmed by repeat testing, tocilizumab treatment should be interrupted. 8). There may be an increased risk of neutropenia in patients […]