Tocilizumab is used in the treatment of ankylosing spondylitis, rheumatoid arthritis, psoriasis, Ulcerative colitis, and Crohn’s disease.
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Actemra 162mg/0.9ml SC Injection contains Tocilizumab which belongs to the group of medicines called interleukin-6 (IL-6) receptor inhibitors. It is used to manage adults with moderate to severely active rheumatoid arthritis (an inflammatory disease affecting the joints).
It is also used in children aged 2 years and above to manage active systemic juvenile idiopathic arthritis and polyarticular juvenile idiopathic arthritis (inflammatory disease that causes pain and swelling in one or more joints).
Actemra 162mg/0.9ml SC Injection is also used to manage adults and children aged 2 years and over with severe cytokine release syndrome (a side-effect in patients managed with chimeric antigen receptor (CAR) T-cell therapies used to manage certain types of cancer) and to manage adults with coronavirus disease 2019 (COVID-19), receiving systemic corticosteroids and requiring supplemental oxygen or mechanical ventilation.
Actemra 162mg/0.9ml SC injection is not recommended in patients with active, severe infection, active liver disease, or liver impairment. It should be used with caution in patients with tuberculosis, mild to moderate kidney disease, intestinal ulcers or diverticulitis, and cancer. Consult your doctor before receiving it.
Actemra 162mg/0.9ml SC Injection is not recommended for use in pregnant women, breastfeeding mothers, and children under 2 years of age. Consult your doctor before receiving it.
You are recommended to avoid alcohol consumption if you are being treated with Actemra 162mg/0.9ml SC Injection. Alcohol intake, along with Actemra 162mg/0.9ml SC Injection, may cause increased dizziness and risk of stomach bleeding/ulcers.
Actemra 162mg/0.9ml SC Injection is not recommended for use in pregnant women unless clearly necessary. Women of childbearing potential must use effective contraception during and up to 3 months after> management. Contact your doctor before receiving Actemra 162mg/0.9ml SC Injection.
Actemra 162mg/0.9ml SC Injection is not recommended for use in breastfeeding mothers as it is not known if it is excreted in the breast milk. Leave a gap of at least 3 months after your last management before starting breastfeeding. Consult your doctor before receiving Actemra 162mg/0.9ml SC Injection.
Do not drive or operate any machines if you feel dizzy after receiving an Actemra 162mg/0.9ml SC Injection.
Actemra 162mg/0.9ml SC Injection should be used with caution in patients with mild to moderate kidney disease with no dose adjustment. There is no information available on the use of this medicine in severe kidney disease. Consult your doctor before receiving Actemra 162mg/0.9ml SC Injection.
Actemra 162mg/0.9ml SC Injection is not recommended in patients with active liver disease or liver impairment. Consult your doctor before receiving Actemra 162mg/0.9ml SC Injection.
To manage:
Actemra 162mg/0.9ml SC Injection works by blocking the activity of a specific protein (cytokine) called interleukin 6, which is involved in inflammatory processes of the body, and blocking it can reduce the pain and swelling in your joints.
Common adverse reactions (≥5%) include upper respiratory tract infections, nasopharyngitis, headache, hypertension, increased ALT, and injection site reactions. In COVID-19 patients, common adverse reactions (≥3%) include constipation, anxiety, diarrhea, insomnia, hypertension, and nausea.
Tocilizumab is a recombinant humanized monoclonal antibody against the human interleukin-6 (IL-6) receptor, belonging to the immunoglobulin IgG1K subclass. Tocilizumab binds to both soluble and membrane-bound IL-6 receptors, inhibiting IL-6-mediated signaling. IL-6 is a multifunctional pro-inflammatory cytokine produced by various cell types, including T-cells, B-cells, lymphocytes, monocytes, and fibroblasts. It plays a role in several physiological processes such as T-cell activation, immunoglobulin secretion, hepatic acute phase protein synthesis initiation, and stimulation of hematopoietic precursor cell proliferation and differentiation. IL-6 is also produced by synovial and endothelial cells in joints affected by inflammatory conditions like rheumatoid arthritis.
Dosing may need to be interrupted to manage laboratory abnormalities related to dosage, including elevated liver enzymes, neutropenia, and thrombocytopenia.
Rheumatoid Arthritis: Tocilizumab can be used alone or with methotrexate or other non-biologic DMARDs and can be administered as an intravenous infusion.
Recommended Intravenous Dosage:
- Initial dose: 4 mg per kg of body weight every 4 weeks via a 60-minute intravenous infusion.
- Dose increase: Can be increased to 8 mg per kg of body weight every 4 weeks, depending on clinical response.
- Dose reduction: In cases of certain dose-related laboratory changes, reducing the dose from 8 mg/kg to 4 mg/kg is recommended.
Polyarticular Juvenile Idiopathic Arthritis: Tocilizumab can be administered intravenously or subcutaneously, alone or with methotrexate.
Recommended Intravenous Dosage:
Systemic Juvenile Idiopathic Arthritis: Tocilizumab can be administered intravenously or subcutaneously, alone or with methotrexate.
Recommended Intravenous Dosage:
COVID-19:
Recommended Dosage:
- Patients under 30 kg: 12 mg/kg via a single 60-minute intravenous infusion.
- Patients 30 kg or more: 8 mg/kg via a single 60-minute intravenous infusion.
- If symptoms worsen or do not improve after the first dose, a second infusion may be given at least 8 hours after the initial infusion. The maximum dosage is 800 mg per infusion.
Cytokine Release Syndrome: Administer only via the intravenous route for CRS treatment.
Recommended Dosage:
Giant Cell Arteritis:
Recommended Dosage:
Systemic Sclerosis-Associated Interstitial Lung Disease:
Recommended Dosage:
Pediatric Use: The safety and effectiveness of Actemra for conditions other than PJIA, SJIA, or CRS have not been established in pediatric patients. The safety and effectiveness of PJIA, SJIA, or CRS in children under 2 years of age have also not been established. Actemra is not authorized for emergency use in COVID-19 treatment for pediatric patients under 2 years old.
Geriatric Use: Use caution when treating elderly patients, as they have a higher incidence of infections.
Hepatic Impairment: The safety and efficacy of Actemra have not been studied in patients with hepatic impairment, including those with positive HBV and HCV serology.
Renal Impairment: No dose adjustment is required for patients with mild or moderate renal impairment. Actemra has not been studied in patients with severe renal impairment.
Administration of Intravenous Formulation:
Use caution when co-administering Actemra with CYP3A4 substrate drugs where decreased effectiveness is undesirable, such as oral contraceptives, lovastatin, and atorvastatin. The effect on CYP450 enzyme activity may persist for several weeks after stopping therapy.
Actemra is contraindicated in patients with known hypersensitivity to Tocilizumab.
Based on animal studies, Actemra may cause fetal harm. In the case of COVID-19, use during pregnancy should be considered only if the potential benefits outweigh the potential risks for the mother and fetus. Discontinue the drug or nursing, taking into account the drug's importance to the mother. Breastfeeding individuals with COVID-19 should follow clinical guidelines to avoid exposing the infant to COVID-19.
Actemra should not be started in patients with an absolute neutrophil count (ANC) below 2000/mm³, a platelet count below 100,000/mm³, or ALT or AST levels above 1.5 times the upper limit of normal (ULN).
Store at a temperature of 2°C to 8°C in a dry place. Do not freeze.
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