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Brand Name :
Tofidence, Actemra
Synonyms :
tocilizumab-bavi, tocilizumab
Class :
DMARDs, Monoclonal Antibodies, Immunomodulators,
Brand Name :
Tofidence, Actemra
Synonyms :
tocilizumab-bavi, tocilizumab
Class :
DMARDs, Monoclonal Antibodies, Immunomodulators,
Dosage forms & Strengths
Injectable solutionÂ
20 mg/mlÂ
Single-use prefilled syringe:Â
162 mg/0.9mLÂ
Off-label:
tocilizumab (162 mg/0.9 mL) weekly injections were started, and daily oral prednisone (40 mg) was maintained
Given that individuals with VEXAS had higher levels of IL-6 and that tocilizumab is a competitive inhibitor of IL-6 binding to its receptor, tocilizumab was chosen as a treatment (IL-6R)
Intended for use in adults who have moderate-to-severe active rheumatoid arthritis and have not responded adequately to one or more disease-modifying antirheumatic drugs (DMARDs)
It can be used either by itself or in conjunction with methotrexate or other DMARDs
However, it is not advisable for patients whose ANC (absolute neutrophil count) is less than 1,000/mm3, those with a platelet count lower than 50,000/mm3, or those with ALT/AST levels exceeding 10 times the upper limit of normal
When administered through intravenous (IV) infusion, the initial dose is 4 mg/kg IV every 4 weeks
This dosage may be increased to 8 mg/kg every 4 weeks based on the patient's clinical response
It's important not to exceed a dose of 800 mg every 4 weeks
For subcutaneous (SC) injection, the dosage varies based on the patient's weight
For those weighing less than 100 kg, the recommended dose is 162 mg SC every other week, with the possibility of increasing to weekly injections depending on clinical response
Patients weighing 100 kg or more should receive 162 mg SC injections on a weekly basis
Recommended for the treatment of giant cell arteritis (GCA)
It is not recommended for patients with an ANC (absolute neutrophil count) less than 1,000/mm3, a platelet count below 50,000 mm3, or ALT/AST levels exceeding 10 times the upper limit of normal
When administered intravenously (IV), the recommended dosage is 6 mg/kg IV every 4 weeks, given alongside a tapering course of glucocorticoids
It can also be used as a standalone treatment after discontinuing glucocorticoids
If necessary, dosing may be paused to manage dose-related laboratory abnormalities, such as elevated liver enzymes, neutropenia, or thrombocytopenia
It's important not to exceed a dose of 600 mg per infusion
For subcutaneous (SC) injection, the recommended dosage is 162 mg SC weekly, alongside a tapering course of glucocorticoids
Depending on clinical considerations, it's possible to switch to 162 mg SC every other week while still following a tapering course of glucocorticoids
When transitioning from IV to SC administration, the first SC dose should replace the next scheduled IV dose
Dosage forms & Strengths
Injectable solutionÂ
20 mg/mlÂ
Single-use prefilled syringe:Â
162 mg/0.9mLÂ
Juvenile Idiopathic ArthritisÂ
Recommended for the treatment of active systemic juvenile idiopathic arthritis (SJIA) in patients who are 2 years of age or older
It can be administered intravenously (IV) or subcutaneously (SC) either as a standalone treatment or in combination with methotrexate
For patients <2 years old, the safety and effectiveness of this medication have not been established
It is also not advisable for patients with an ANC (absolute neutrophil count) less than 1,000/mm3, a platelet count below 50,000 mm3, or ALT/AST levels exceeding 10 times the upper limit of normal
The recommended dosages are as follows:
IV infusion for patients aged 2 years and older:
For those weighing less than 30 kg, the dosage is 12 mg/kg IV every 2 weeks
For those weighing 30 kg or more, the dosage is 8 mg/kg IV every 2 weeks
SC injection for patients aged 2 years and older:
For those weighing less than 30 kg, the recommended dose is 162 mg SC every 2 weeks
For those weighing 30 kg or more, the dosage is 162 mg SC weekly
Use caution, if used in elderly patientsÂ
may increase the immunosuppressive effect of other antirheumatic drugs
may increase the immunosuppressive effect of other antirheumatic drugs
may increase the immunosuppressive effect of other antirheumatic drugs
may increase the immunosuppressive effect of other antirheumatic drugs
may increase the immunosuppressive effect of other antirheumatic drugs
When tocilizumab is used in combination with rabies vaccine, this leads to a reduction in the rabies vaccine effects through the process of pharmacodynamic antagonism
When tocilizumab is used in combination with diphtheria & tetanus toxoids, this leads to a reduction in the effects of diphtheria & tetanus toxoids through pharmacodynamic antagonism
in combination with ofatumumab, tocilizumab increases the risk of adverse events
interaction raises immunosuppressive effects and risk of infection
may increase the immunosuppressive effect of other antirheumatic drugs
may increase the immunosuppressive effect of other antirheumatic drugs
may increase the immunosuppressive effect of other antirheumatic drugs
may increase the immunosuppressive effect of other antirheumatic drugs
may increase the immunosuppressive effect of other antirheumatic drugs
It may enhance and diminish the immunosuppressive effects when combined with maitake
it may enhance the adverse effects when combined with aducanumab
when both drugs are combined, there may be an increased metabolism of paclitaxel  
may increase the risk or severity of toxic effects when combined
may diminish the serum concentration of CYP3A4 substrates
Action and Spectrum:Â
tocilizumab is a monoclonal antibody medication that targets interleukin-6 (IL-6) receptor. It is used to treat a range of inflammatory conditions, including rheumatoid arthritis, giant cell arteritis, systemic juvenile idiopathic arthritis, and cytokine release syndrome (CRS) associated with cancer treatments. Tocilizumab works by blocking the action of IL-6, a protein that plays a role in inflammation and the immune response. By blocking the IL-6 receptor, tocilizumab reduces inflammation and helps to control symptoms in individuals with the conditions mentioned above.Â
Frequency defined
10%
Reaction at the injection siteÂ
1-10%
Upper respiratory tract infectionÂ
Nasopharyngitis Â
Headache Â
Hypertension Â
ALT increased Â
Bronchitis Â
Rash Â
Dizziness Â
Mouth ulceration Â
Upper abdominal pain Â
GastritisÂ
Oral herpes simplex Â
Stomatitis Â
Gastric ulcer Â
Increased weightÂ
Black Box Warning:Â
The black box warning for tocilizumab, a medication used to treat rheumatoid arthritis and systemic juvenile idiopathic arthritis, states that it may increase the risk of serious infections, including tuberculosis, which can lead to death.Â
tocilizumab is contraindicated in patients hypersensitive to the active ingredient.Â
Pregnancy consideration:Â Â
Insufficient data is unavailable regarding the use of the drug during pregnancy.Â
Breastfeeding warnings:Â Â
No data is available regarding the secretion of the drug in breast milk.Â
Pregnancy category:Â
Pharmacology:Â
tocilizumab is a humanized monoclonal antibody that targets the interleukin-6 (IL-6) receptor. IL-6 is a cytokine that plays a crucial role in the immune system and is involved in the regulation of inflammation. Â
Pharmacodynamics:Â
tocilizumab binds to the IL-6 receptor and blocks the signaling of IL-6, thereby reducing the inflammation in the body.Â
tocilizumab is used in the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, giant cell arteritis, and systemic juvenile idiopathic arthritis. It is also used in the treatment of cytokine release syndrome (CRS), a condition associated with the treatment of certain types of cancer.Â
Pharmacokinetics:Â
AbsorptionÂ
tocilizumab is administered intravenously and reaches peak plasma concentration within 2 hours after administration.Â
DistributionÂ
tocilizumab has a large volume of distribution and distributes primarily in the extracellular fluid.Â
MetabolismÂ
It is not metabolized and is excreted mainly through the kidneys.Â
Elimination and excretion
The elimination half-life of tocilizumab is approximately 25-30 hours. The drug is cleared primarily by the kidneys and a small portion by the liverÂ
Administration:Â
tocilizumab is administered intravenously, either as a single dose or as multiple doses, depending on the condition being treated. The therapeutic effects of tocilizumab typically occur within 1-2 hours of administration, with the maximum effect observed within 4-8 hours. The half-life of tocilizumab is approximately 25 days, allowing for long-lasting therapeutic effects.Â
Patient information leafletÂ
Generic Name: tocilizumabÂ
Pronounced: to-cil-izu-mabÂ
Why do we use tocilizumab?Â
Tofidence, also known as tocilizumab-bavi, is a biosimilar of Actemra and functions as an antagonist for the interleukin-6 (IL-6) receptor. It is prescribed for the treatment of moderately to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.
tocilizumab is used in the treatment of vasculitis with extrapulmonary involvement (VEXAS syndrome) because of its ability to target and block the interleukin-6 (IL-6) receptor, which plays a key role in the development and progression of the disease. VEXAS syndrome is a rare autoimmune disorder that causes inflammation and damage to the blood vessels, leading to various symptoms such as joint pain, fever, skin rashes, and other organ involvement. tocilizumab works by inhibiting the action of IL-6, which is a pro-inflammatory cytokine involved in the pathogenesis of VEXAS syndrome.
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