Pricing
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Tolosa is indicated for:
Pharmacology
Tocilizumab is a recombinant humanized monoclonal antibody that targets the human interleukin 6 (IL-6) receptor. It belongs to the immunoglobulin IgG1K (gamma 1, kappa) subclass. The medicine binds to both soluble and membrane-bound IL-6 receptors, and it has been shown to block IL-6-mediated signaling through these receptors.
IL-6 is a pleiotropic pro-inflammatory cytokine, made by several cell types including T-cells, B-cells, lymphocytes, monocytes and fibroblasts. It has been shown to take part in many body processes, such as T-cell activation, induction of immunoglobulin secretion, initiation of hepatic acute phase protein synthesis, and stimulation of hematopoietic precursor cell proliferation and differentiation. Synovial and endothelial cells also produce IL-6, which leads to local production of IL-6 in joints affected by inflammatory processes such as rheumatoid arthritis.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Interrupting dosing may be needed to manage dose-related laboratory abnormalities, including elevated liver enzymes, neutropenia and thrombocytopenia.
Rheumatoid Arthritis: Tocilizumab may be used as monotherapy, or together with methotrexate or other non-biologic DMARDs, as an intravenous infusion.
Recommended Intravenous Dosage Regimen: For adults, the recommended dosage is given as a 60-minute single intravenous drip infusion. It starts at 4 mg per kg of body weight every 4 weeks, then goes up to 8 mg per kg of body weight every 4 weeks based on clinical response. Going back from 8 mg per kg to 4 mg per kg is recommended to manage certain dose-related laboratory changes, including elevated liver enzymes, neutropenia and thrombocytopenia. Doses exceeding 800 mg per infusion are not recommended in RA patients.
Polyarticular Juvenile Idiopathic Arthritis: Tocilizumab may be used as an intravenous infusion or as a subcutaneous injection, alone or in combination with methotrexate. Don't change the dose based on a single body weight measurement alone, as weight may fluctuate.
Recommended Intravenous Dosage Regimen: For PJIA patients, the recommended dosage is given once every 4 weeks as a 60-minute single intravenous drip infusion.
Patients less than 30 kg weight: 10 mg per kg of body weight.
Patients at or above 30 kg weight: 8 mg per kg of body weight.
Systemic Juvenile Idiopathic Arthritis: Tocilizumab may be used as an intravenous infusion or as a subcutaneous injection, alone or in combination with methotrexate. Again, don't change a dose based on a single body weight measurement alone, as weight may fluctuate.
Recommended Intravenous Dosage Regimen: For SJIA patients, the recommended dose is given once every 2 weeks as a 60-minute single intravenous drip infusion.
Patients less than 30 kg weight: 12 mg per kg of body weight.
Patients at or above 30 kg weight: 8 mg per kg of body weight.
Coronavirus Disease 2019: The recommended dosage is a single 60-minute intravenous infusion.
Patients less than 30 kg weight: 12 mg per kg of body weight.
Patients at or above 30 kg weight: 8 mg per kg of body weight.
If clinical signs or symptoms worsen or don't improve after the first dose, one more infusion may be given at least 8 hours after the first one. The maximum dosage in COVID-19 patients is 800 mg per infusion.
Cytokine Release Syndrome: Use only the intravenous route to treat CRS. The recommended dose is given as a 60-minute intravenous infusion.
Recommended Intravenous CRS Dosage
Patients less than 30 kg weight: 12 mg per kg of body weight, alone or in combination with corticosteroids.
Patients at or above 30 kg weight: 8 mg per kg of body weight, alone or in combination with corticosteroids.
If the signs and symptoms of CRS don't improve clinically after the first dose, up to 3 additional doses may be given. The interval between consecutive doses should be at least 8 hours. Doses exceeding 800 mg per infusion are not recommended in CRS patients.
Giant Cell Arteritis: For adults, the recommended dosage is 6 mg per kg of body weight every 4 weeks, given as a 60-minute single intravenous drip infusion in combination with a tapering course of glucocorticoids. Tocilizumab can be used alone after the glucocorticoids have been stopped. Doses exceeding 600 mg per infusion are not recommended in GCA patients.
Systemic Sclerosis-Associated Interstitial Lung Disease: For adults with SSc-ILD, the recommended dose is 162 mg once every week as a subcutaneous injection. Intravenous administration is not approved for SSc-ILD.
Administration of Intravenous Formulation:
For adults with RA, GCA, CRS, PJIA and SJIA patients at or above 30 kg, dilute to 100 mL in 0.9% or 0.45% Sodium Chloride Injection, USP, for intravenous infusion, using aseptic technique.
For PJIA, SJIA and CRS patients less than 30 kg, dilute to 50 mL in 0.9% or 0.45% Sodium Chloride Injection, USP, for intravenous infusion, using aseptic technique.
Administer as a single intravenous drip infusion over 1 hour; do not administer as bolus or push.
Side Effects
The most common side effects of Tocilizumab, seen in at least 5% of people, are upper respiratory tract infections, nasopharyngitis, headache, hypertension, increased ALT and injection site reactions. In people treated for COVID-19, the most common side effects (seen in more than 3%) are constipation, anxiety, diarrhea, insomnia, hypertension and nausea.
Cautions & Contraindications
Warnings & Precautions
Don't give Tocilizumab during an active infection, and that includes localized infections. If a serious infection develops, interrupt the treatment until the infection is controlled. For tuberculosis, check patients for risk factors and test for latent infection before starting Tocimab. Gastrointestinal perforation is another concern, so use the medicine with caution in patients who may be at increased risk. Hepatotoxicity needs watching too. Monitor patients for signs and symptoms of liver injury, and modify or stop Tocilizumab if abnormal liver tests persist or get worse, or if clinical signs and symptoms of liver disease develop. Laboratory monitoring is recommended because treatment can change neutrophils, platelets, lipids and liver function tests, and these changes can have consequences. Hypersensitivity reactions, including anaphylaxis and death, have occurred. Avoid live vaccines with Tocimab. Also avoid using Tocilizumab together with biological DMARDs. It is recommended that treatment not be started in patients with an absolute neutrophil count (ANC) below 2000 per mm3, a platelet count below 100,000 per mm3, or an ALT or AST above 1.5 times the upper limit of normal (ULN).
Contraindications
Don't give Tocilizumab to anyone who is already known to be hypersensitive to it.
Pregnancy & Breastfeeding
Animal data suggest that Tocilizumab may cause harm to the fetus. In COVID-19, it should be used during pregnancy only if the possible benefit to the mother justifies the possible risk to the mother and the fetus.
For breastfeeding, either the drug or nursing should be stopped, depending on how important the drug is to the mother. Mothers with COVID-19 who are breastfeeding should follow the practices set out in clinical guidelines, so the infant is not exposed to COVID-19.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Use in Special Populations
In pediatric patients, the safety and effectiveness of Tocilizumab have not been established for conditions other than PJIA, SJIA or CRS. For PJIA, SJIA and CRS, they have also not been established in patients below the age of 2. Tocilizumab is not authorized or approved for emergency use for the treatment of COVID-19 in pediatric patients less than 2 years of age.
Infections are more common in the elderly in general, so caution should be used when treating elderly patients.
In patients with hepatic impairment, safety and efficacy have not been studied. This includes patients with positive HBV and HCV serology.
No dose adjustment is required in mild or moderate renal impairment. The medicine has not been studied in patients with severe renal impairment.
Overdose
If someone takes too much Tocilizumab, they should be watched for any signs and symptoms of adverse reactions. If adverse reactions appear, the patient should be given suitable treatment for those symptoms.
⚠️ In an emergency call 999 or go to the nearest hospital emergency department.
Storage
Keep Tocilizumab at a temperature of 2°C to 8°C, in a dry place. Do not freeze it.
Drug Interactions
Common questions about Tolosa 80 mg/4 ml
What is Tolosa 80 mg/4 ml IV Infusion?
Tolosa 80 mg/4 ml IV Infusion is a medicine that contains Tocilizumab. It is made by Incepta Pharmaceuticals Ltd. It belongs to the Drugs used for Rheumatoid Arthritis group of medicines.
What is Tolosa used for?
Tolosa is used for: Rheumatoid Arthritis.
What are the side effects of Tolosa?
The most common side effects of Tocilizumab, seen in at least 5% of people, are upper respiratory tract infections, nasopharyngitis, headache, hypertension, increased ALT and injection site reactions. In people treated for COVID-19, the most common side effects (seen in more than 3%) are constipation, anxiety, diarrhea, insomnia, hypertension and nausea.
Can I take Tolosa during pregnancy or while breastfeeding?
Animal data suggest that Tocilizumab may cause harm to the fetus. In COVID-19, it should be used during pregnancy only if the possible benefit to the mother justifies the possible risk to the mother and the fetus. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
What happens if I take too much Tolosa?
If someone takes too much Tocilizumab, they should be watched for any signs and symptoms of adverse reactions. If adverse reactions appear, the patient should be given suitable treatment for those symptoms. In an emergency call 999 or go to the nearest hospital emergency department.
How should I store Tolosa?
Keep Tocilizumab at a temperature of 2°C to 8°C, in a dry place. Do not freeze it.
Can I take other medicines with Tolosa?
Some medicines can interact with Tocilizumab, for example: Atorvastatin, Lovastatin. Tell your doctor or pharmacist about every medicine you take.
Do I need a prescription for Tolosa?
Tolosa is a prescription (Rx) medicine. Take it as your doctor advises.