Altebrel™ is a biosimilar product with the generic name of Etanercept. Etanercept is a fusion protein consisting of FC part of antibodies and two TNF receptors. Etanercept belongs to a group of medicines called Tumor Necrosis Factor (TNF) Blocking Agents which can inhibit the activity of TNF-α in the body and therefore prevent its attachment on the cell surface receptors; as a result, it reduces inflammation in the body. That is the reason why it is known as one the most important medicines used in Rheumatoid Arthritis. Altebrel is produced by recombinant DNA technology in a Chinese Hamster Ovary (CHO), mammalian expression system. The other indications of Altebrel are; Psoriasis Arthritis, Axial Spondyloarthritis (Ankylosing Spondylitis and non-radiographic axial Spondyloarthritis, Juvenile Idiopathic Arthritis, Enthesitis-related Arthritis and Plaque Psoriasis.
This medicine is produced as prefilled syringes containing solution for injection for subcutaneous injection in two different doses of 25 mg and 50 mg. The concentration of Etanercept in the prefilled syringe is 50 milligram in 1 milliliter. The 25 mg syringe of Altebrel contains 0.5 ml solution and the 50 mg syringe of Altebrel contains 1 ml of solution. Each small box of Altebrel contains 4 prefilled syringes, 8 alcohol swabs and a patient information leaflet. The recommended dose of Altebrel in treatment of Rheumatoid Arthritis, Psoriasis Arthritis and Axial Spondyloarthritis is 50 mg per week and in case of Plaque Psoriasis the recommended dose for adults is 50 mg twice weekly for 3 months which can be reduced to 50 mg per week after 3 months.
Active Raw Material (API) of Altebrel with the name of Etanercept is being purified via several pre-purification and purification steps by chromatography methods for use in final formulation.
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