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Actemra 200mg/10ml is indicated for use alone or in combination with methotrexate or antirheumatic drugs for the treatment of moderate to severe progressive rheumatoid arthritis. So what is Actemra 200mg/10ml?
1. What is Actemra 200mg/10ml?
Actemra medicine 200mg / 10ml contains the main ingredient Tocilizumab with a strength of 20mg and a system of excipients: Polysorbate 80, sucrose, disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, water for injection. The product is prepared in the form of an infusion solution.
Tocilizumab is a recombinant humanized monoclonal antibody against the human Interleukin-6 receptor. This active ingredient binds to the soluble Interleukin-6 receptor and on the cell membrane to inhibit the activity of proinflammatory prodrugs mediated by Interleukin-6. In rheumatoid arthritis patients have elevated levels of Interleukin-6 in the blood and joint fluid, which gradually leads to the development of arthritis, joint pain, swelling, and joint damage. Tocilizumab inhibits Interleukin-6 and other receptors, thereby effective in treating inflammation, swelling and pain in joints, preventing joint damage.
2. Uses of actemra 200mg/10ml
Treatment of Rheumatoid Arthritis (RA): Tocilizumab plus methotrexate is indicated for the treatment of moderate to severe progressive rheumatoid arthritis (RA) in adult patients with inadequate or no response. tolerated prior therapy with 1 or more antirheumatic drugs or anti-tumor necrosis factor (TNF) agents. In these patients, Actemra 200mg/10ml may be used as monotherapy in cases of intolerance to methotrexate or if continuation of methotrexate therapy is inappropriate. Treatment of polyarticular idiopathic juvenile arthritis (pJIA): Tocilizumab contained in Actemra 200mg/10ml is indicated in polyarticular idiopathic juvenile arthritis in patients 2 years of age and older who have failed to respond adequately. enough with previous methotrexate. Actemra 200mg/10ml may also be indicated as monotherapy in cases where methotrexate is intolerant or continued therapy with methotrexate is no longer appropriate for this patient. Treatment of Systemic Idiopathic Juvenile Arthritis (sJIA): Tocilizumab is indicated for the treatment of systemic idiopathic juvenile arthritis in children 2 years of age and older, unresponsive to drug therapy. Non-steroidal anti-inflammatory drugs (NSAIDs) and systemic corticosteroids. Actemra 200mg/10ml can be used as monotherapy (in case of intolerance to Methotrexate or if continued treatment with Methotrexate is not appropriate) or in combination with Methotrexate.
3. Usage - Dosage of Actemra 200mg/10ml
Rheumatoid Arthritis in Adults: Actemra 200mg/10ml is administered at the recommended dose for adult patients by a 60-minute intravenous drip: 4 mg/kg every 4 weeks, then increased to 8 mg /kg every 4 weeks based on the patient's clinical response. Polyarticular juvenile idiopathic arthritis (pJIA): The recommended dose of Actemra 200mg/10ml for patients with polyarticular idiopathic juvenile arthritis is 10 mg/kg for patients < 30 kg and 8 mg/kg for patients < 30 kg. Patients ≥ 30 kg administered every 4 weeks by intravenous infusion. Changes in the dose of Actemra 200mg/10ml are based only on changes in body weight over time, and can be used alone or in combination with Methotrexate. Systemic idiopathic juvenile arthritis (sJIA): The recommended dose is 12 mg/kg for patients < 30 kg and 8 mg/kg for patients ≥ 30 kg administered every 2 weeks by intravenous infusion. The dose change of Actemra 200mg/10ml is only based on the change in body weight over time, the drug can be used alone or in combination with Methotrexate. The recommended dose of giant cell arteritis (GCA) is 162 mg once weekly as subcutaneous injection, in combination with a tapering course of glucocorticoids. Actemra 200mg/10ml can be used as monotherapy after stopping glucocorticoids. Special Precautions:The safety and efficacy of Tocilizumab have not been studied in children under 2 years of age. In patients over 65 years of age, there is no need to adjust the dose of Actemra 200mg/10ml. Renal Impairment: No dose adjustment of Actemra 200mg/10ml is required in patients with mild renal impairment however Tocilizumab has not been studied in patients with moderate to severe renal impairment. Hepatic impairment: The safety and efficacy of Actemra 200mg/10ml have not been studied in patients with hepatic impairment.
4. Contraindications of Actemra 200mg/10ml
Hypersensitivity to Actemra 200mg/10ml; Inactive arthritis; Severe infections; Women who are pregnant or breastfeeding.
5. Actemra 200mg/10ml side effects
The most common side effects of Actemra 200mg/10ml are:
Cough or sore throat; stuffy or runny nose; headache or dizziness; Mouth sores; High Blood Pressure ; Increased blood cholesterol; Allergic reactions including muscle pain, difficulty breathing, chest tightness, wheezing and high fever; Weight gain or ankle swelling; skin rash, infection, itching; Stomach irritation, abdominal pain.
6. Drug interactions of the drug Actemra 200mg/10ml
While using Actemra 200mg/10ml do not use drugs: anticoagulants such as Warfarin, Aspirin and non-steroidal anti-inflammatory drugs, Naproxen, statin cholesterol-lowering drugs such as Atorvastatin, Lovastatin.
Do not vaccinate during the infusion of Actemra 200mg/10ml because it can be harmful if used.
7. Pay attention when using Actemra 200mg/10ml
Tocilizumab has been shown to increase the risk of infections in patients with rheumatoid arthritis including:
Upper respiratory tract infections; Skin infections such as cellulitis; Pneumonia. If the patient is prescribed antibiotics, tocilizumab should be temporarily stopped until the infection has cleared up.
If the patient has HIV, hepatitis B or hepatitis C, it is important that the patient discuss any potential risks of taking Tocilizumab with the treating physician.
Tocilizumab may increase a patient's cholesterol levels and may affect liver function tests, so blood tests should be done every 4 weeks while taking Tocilizumab.
Patients may feel dizzy while taking Tocilizumab, which may affect their ability to drive and perform other activities.
Stop taking Tocilizumab 3 months before conception. While taking Actemra 200mg/10ml the patient should use contraception and for 3 months after stopping treatment.
Do not take Tocilizumab during pregnancy, however if the patient accidentally takes Actemra 200mg/10ml during the first 3 months of pregnancy, the drug is not likely to harm the baby.
8. Storing Actemra 200mg/10ml
Store Actemra 200mg/10ml in a place where the temperature is below 30 degrees Celsius, do not let sunlight shine directly on the medicine, do not leave the medicine in a place where the humidity or temperature is too high to cause the drug to be denatured. Pay attention to the appearance of Actemra 200mg/10ml, if you see any symptoms such as deformation, discoloration, mold, do not use it.
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