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AVTOZMA is a brand name for Tocilizumab. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Avtozma, 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 intolerant…
Verbatim from this product's MHRA label. Tap a section to expand.
Tocilizumab SC formulation is administered with a single-use pre-filled syringe with needle safety device. Treatment should be initiated by healthcare professionals experienced in the diagnosis and treatment of RA, sJIA, pJIA and/or GCA.
The pre- filled pen should not be used to treat paediatric patients < 12 years of age since there is a potential risk of intramuscular injection due to thinner subcutaneous tissue layer. The first injection should be performed under the supervision of a qualified health care professional.
A patient or parent/guardian can self-inject Avtozma only if the physician determines that it is appropriate and the patient or parent/guardian agrees to medical follow-up as necessary and has been trained in proper injection technique.
Patients who transition from tocilizumab IV therapy to SC administration should administer the first SC dose at the time of the next scheduled IV dose under the supervision of a qualified health care professional. All patients treated with Avtozma should be given the Patient Alert Card.
Suitability of the patient or parent/guardian for subcutaneous home use should be assessed and patients or parent/guardian instructed to inform a healthcare professional before administering the next dose if they experience symptoms of an allergic reaction.
4). Posology RA The recommended posology is subcutaneous 162 mg once every week. Limited information is available regarding switching patients from Avtozma intravenous formulation to Avtozma subcutaneous fixed dose formulation. The once every week dosing interval should be followed.
Patients transitioning from intravenous to subcutaneous formulation should administer their first subcutaneous dose instead of the next scheduled intravenous dose under the supervision of a qualified healthcare professional. GCA The recommended posology is subcutaneous 162 mg once every week in combination with a tapering course of glucocorticoids.
Avtozma can be used alone following discontinuation of glucocorticoids. 4). Based upon the chronic nature of GCA, treatment beyond 52 weeks should be guided by disease activity, physician discretion, and patient choice. 4). • Liver enzyme abnormalities Laboratory Value Action > 1 to 3 x Upper Limit of Normal (ULN) Dose modify concomitant DMARDs (RA) or immunomodulatory agents (GCA) if appropriate.
Summary of the safety profile The safety profile comes from 4510 patients exposed to tocilizumab in clinical trials; the majority of these patients were participating in adult RA studies (n=4009), while the remaining experience comes from GCA (n=149), pJIA (n=240) and sJIA (n=112) studies.
The safety profile of tocilizumab across these indications remains similar and undifferentiated. The most commonly reported Adverse Drug Reactions (ADRs) were upper respiratory tract infections, nasopharyngitis, headache, hypertension and increased ALT.
The most serious ADRs were serious infections, complications of diverticulitis, and hypersensitivity reactions. Tabulated list of adverse reactions ADRs from clinical trials 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 are presented by MedDRA system organ class.
The corresponding frequency category for each AR 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, undesirable effects are presented in order of decreasing seriousness.
Table 1. List of ADRs occurring in patients treated with tocilizumab. 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 TCZ in clinical trials.
Subcutaneous use RA The safety of subcutaneous tocilizumab in RA includes a double-blind, controlled, multicenter study, SC-I. SC-I was a non-inferiority study that compared the efficacy and safety of tocilizumab162 mg administered every week versus 8 mg/kg intravenous in 1262 patients with RA.
1. 4). 4 Special warnings and precautions for use Avtozma subcutaneous formulation is not intended for intravenous administration. Avtozma subcutaneous formulation is not intended to be given to children with sJIA weighing less than 10 kg.
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). ) 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 immunosuppressive agents such as Avtozma as signs and symptoms of acute inflammation may be lessened, due to suppression of the acute phase reactants.
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, all patients should be screened for latent tuberculosis (TB) infection prior to starting Avtozma therapy. Patients with latent TB should be treated with standard anti-mycobacterial therapy before initiating Avtozma.
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 Avtozma.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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For persistent increases in this range, reduce Avtozma dose frequency to every other week injection or interrupt Avtozma until alanine aminotransferase (ALT) or aspartate aminotransferase (AST) have normalised. Restart with weekly or every other week injection, as clinically appropriate.
> 3 to 5 x ULN Interrupt Avtozma dosing until < 3 x ULN and follow recommendations above for > 1 to 3 x ULN. ), discontinue Avtozma. > 5 x ULN Discontinue Avtozma. • 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 Laboratory Value (cells x 109/ L ) Action ANC > 1 Maintain dose.
5 to 1 Interrupt Avtozma dosing. When ANC increases > 1 x 109/ L resume Avtozma dosing every other week and increase to every week injection, as clinically appropriate. 5 Discontinue Avtozma. • Low platelet count Laboratory Value (cells x 103/ μL) Action 50 to 100 Interrupt Avtozma dosing.
When platelet count > 100 x 103/ μL resume Avtozma dosing every other week and increase to every week injection as clinically appropriate. < 50 Discontinue Avtozma. RA and GCA Missed dose If a patient misses a subcutaneous weekly injection of Avtozma within 7 days of the scheduled dose, he/she should be instructed to take the missed dose on the next scheduled day.
If a patient misses a subcutaneous once every other week injection of Avtozma 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.
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 or moderate renal impairment. 2). Renal function should be monitored closely in these patients.
Hepatic impairment:
Avtozma has not been studied in patients with hepatic impairment. Therefore, no dose recommendations can be made. Paediatric patients The safety and efficacy of Avtozma subcutaneous formulation in children from birth to less than 1 year have not been established.
No data are available. A change in dose should only be based on a consistent change in the patient’s body weight over time. Avtozma can be used alone or in combination with MTX. sJIA Patients The recommended posology in patients above 1 year of age is subcutaneous 162 mg once every week in patients weighing greater than or equal to 30 kg or subcutaneous 162 mg once every 2 weeks in patients weighing less than 30 kg.
Patients must have a minimum body weight of 10 kg when receiving Avtozma subcutaneously. pJIA Patients: The recommended posology in patients above 2 years of age is subcutaneous 162 mg once every 2 weeks in patients weighing greater than or equal to 30 kg or subcutaneous 162 mg once every 3 weeks in patients weighing less than 30 kg.
Dose adjustments due to laboratory abnormalities (sJIA and pJIA) If appropriate, the dose of concomitant MTX and/or other medications 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 […]
All patients received background non-biologic DMARD(s). The safety and immunogenicity observed for tocilizumab administered subcutaneous was consistent with the known safety profile of intravenous tocilizumab and no new or unexpected adverse drug reactions were observed (see Table 1).
A higher frequency of injection site reactions was observed in the subcutaneous arms compared with placebo subcutaneous injections in the intravenous arms. 4% (15/631) for the subcutaneous tocilizumab and the subcutaneous placebo (intravenous group) weekly injections, respectively.
These injection site reactions (including erythema, pruritus, pain and haematoma) were mild to moderate in severity. The majority was resolved without any treatment and none necessitated drug discontinuation. 9% of patients on the subcutaneous weekly dose.
There was no clear relationship between decreases in neutrophils below 1 x 109/L and the occurrence of serious infections. Platelets During routine laboratory monitoring in the tocilizumab 6 month clinical trial SC-I, none of the patients on the SC weekly dose had a decrease in platelet count to ≤50 × 103/μL.
4% of patients, respectively on the subcutaneous weekly dose. 1 mmol/L (160 mg/dL) on the subcutaneous weekly dose. Subcutaneous Use sJIA The safety profile of subcutaneous tocilizumab was evaluated in 51 paediatric patients (1 to 17 years of age) with sJIA.
In general, the adverse drug reactions in patients with sJIA were similar in type to those seen in RA patients (see Undesirable Effects section above). Infections The rate of infection in sJIA patients treated with SC tocilizumab was comparable to sJIA patients treated with IV tocilizumab.
2% (21/51) sJIA patients experienced ISRs to tocilizumab SC. The most common ISRs were erythema, pruritus, pain, and swelling at the injection site. The majority of ISRs reported were Grade 1 events […]
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). Avtozma should be used with caution in patients with previous history of intestinal ulceration or diverticulitis.
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 treatment with Avtozma even if they have received premedication with steroids and antihistamines.
If an anaphylactic reaction or other serious hypersensitivity reaction occurs, administration of Avtozma should be stopped immediately, appropriate therapy initiated and tocilizumab should be permanently discontinued. 8). 8). g. MTX) were used in combination with Avtozma.
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 patients with baseline ALT or AST > 5 x ULN, treatment is not recommended. In RA, GCA, 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, Avtozma treatment should be interrupted. Haematological abnormalities Decreases in neutrophil and platelet counts have occurred […]