Product Description
1. Technical Specifications
| Attribute |
Details |
| Brand Name |
Actemra 162mg Injection |
| Generic Name |
Tocilizumab |
| Strength |
162 mg / 0.9 ml prefilled syringe or autoinjector |
| Dosage Form |
Subcutaneous Injection (SC) |
| Packaging Size |
Single-use prefilled syringe/autoinjector |
| Packaging Type |
Prefilled glass syringe with needle guard |
| Medicine Type |
Biologic / Monoclonal Antibody (IL-6 receptor antagonist) |
| Manufacturer |
Roche / Chugai Pharmaceutical |
| Distributed By |
Roche / Authorized biotechnology distributors |
2. Product Description
Actemra 162mg Injection contains Tocilizumab, a recombinant humanized monoclonal antibody that blocks the interleukin-6 (IL-6) receptor.
IL-6 is a key cytokine involved in inflammation and immune response. By inhibiting IL-6 signaling, Actemra reduces inflammation and prevents joint and tissue damage.
It is used in autoimmune and inflammatory disorders, including rheumatoid arthritis, juvenile idiopathic arthritis, giant cell arteritis, and cytokine release syndrome (CRS).
3. Product Highlights
| Attribute |
Details |
| Therapeutic Category |
Immunosuppressive / Biologic DMARD (Disease-Modifying Anti-Rheumatic Drug) |
| Application Area |
Autoimmune disorders (RA, JIA, GCA), CRS, COVID-19 complications (severe cytokine storm, off-label) |
| Mechanism of Action |
Monoclonal antibody binds to IL-6 receptors blocks IL-6 mediated signaling reduces inflammation & tissue damage |
| Administration |
Subcutaneous injection (every 12 weeks depending on condition and patient weight) |
| Storage Conditions |
Refrigerate at 28 C; do not freeze; protect from light |
4. Therapeutic Uses
-
Rheumatoid Arthritis (RA): For adults with moderate to severe RA, alone or with methotrexate.
-
Polyarticular Juvenile Idiopathic Arthritis (pJIA): For children 2 years.
-
Systemic Juvenile Idiopathic Arthritis (sJIA): For children 2 years.
-
Giant Cell Arteritis (GCA): Used in adults, with tapering corticosteroids.
-
Cytokine Release Syndrome (CRS): Severe or life-threatening CRS caused by CAR-T cell therapy.
-
COVID-19 (off-label/emergency use): For hospitalized patients with severe systemic inflammation and cytokine storm.
5. Side Effects
Common:
-
Injection site reactions (redness, swelling, itching)
-
Headache, dizziness
-
Upper respiratory tract infections (cold, cough, sore throat)
-
Increased cholesterol levels
-
Elevated liver enzymes
Serious / Severe:
-
Serious infections: tuberculosis, bacterial, viral, fungal (due to immune suppression)
-
Neutropenia, thrombocytopenia (low blood counts)
-
Gastrointestinal perforation (rare, especially in diverticulitis patients)
-
Hepatotoxicity: elevated liver enzymes, potential liver injury
-
Hypersensitivity reactions / anaphylaxis
-
Increased risk of malignancy with long-term use (rare, but monitored)
6. Precautions
-
Screening before therapy: Test for latent TB, hepatitis B, hepatitis C before starting.
-
Blood Monitoring: CBC, LFTs, and lipid profile regularly.
-
Vaccinations: Avoid live vaccines during therapy.
-
Infections: Discontinue if serious infection develops.
-
Liver Disease: Use with caution; contraindicated in severe hepatic impairment.
-
Pregnancy & Breastfeeding: Limited safety data use only if clearly needed.
-
Drug Interactions: May affect CYP450 enzyme activity, altering metabolism of drugs such as warfarin, cyclosporine, simvastatin.
Precise Dosage and AdministrationTocilizumab 162mg injection should always be administered as per a doctors instructions. Medical professionals determine the appropriate dosage and schedule based on the patients specific medical needs and response to the drug, ensuring safety and optimal therapeutic effect.
Safe Storage and HandlingThis injection requires storage in a cool and dry environment to maintain its stability and potency. Healthcare professionals should ensure that the injection is unused past its expiration date and is always kept away from direct sunlight or heat sources.
FAQs of Tocilizumab 162mg injection:
Q: How should Tocilizumab 162mg injection be administered?
A: Tocilizumab 162mg injection must be administered by a healthcare professional under strict medical supervision. The dosage and frequency are decided by the doctor based on the patients condition and response to treatment.
Q: What conditions is Tocilizumab 162mg injection recommended for?
A: This injection is typically prescribed for adults with certain inflammatory diseases or autoimmune disorders, as determined by a doctor. The specific indications should be confirmed with a healthcare provider.
Q: When can patients expect to see the benefits of Tocilizumab 162mg injection?
A: The time to observe improvement varies depending on the condition being treated, but patients may begin to notice benefits within several weeks of starting therapy, as assessed by their doctor.
Q: Where is Tocilizumab 162mg injection available in India?
A: Tocilizumab 162mg injection can be procured through authorized distributors, exporters, suppliers, traders, and wholesalers throughout India, ensuring broad access for medical facilities and professionals.
Q: What is the correct process for storing Tocilizumab 162mg injection?
A: Store the injection in a cool and dry place, away from direct sunlight and heat. Always check the expiration date before use, and discard any unused or expired medicine as per medical waste guidelines.
Q: How does Tocilizumab 162mg injection benefit adult patients?
A: The injection can help manage symptoms of specific inflammatory or autoimmune conditions, reducing inflammation and potentially improving overall quality of life for adult patients under medical care.
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