Rapamune® [Sirolimus]
Vaet Lederle
1557 Items
2019-09-19
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Clinical Pharmacology
Immunosuppressant. The action of Rapamuna is due to the suppression of T-cell activation by blocking Ca2 + -mediated and Ca2 + -independent intracellular signal transduction; binding with a specific cytosolic protein - immunophilin. Reduces the activity of T-and B-lymphocytes and suppresses the rejection of allogeneic transplant.
Indications
Prevention of transplant rejection (in adult patients with low and moderate immunological risk after kidney transplantation, in combination with GCS and cyclosporin).
Composition
1 tablet contains Sirolimus 1 mg
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Dosage and Administration
Rapamun is taken orally. It is recommended to use in combination with corticosteroids and cyclosporine for 2-3 months. Supportive therapy, if necessary, can be continued in combination with the corticosteroids without cyclosporine.
Initial therapy (within 2-3 months after transplantation): saturating dose - 6 mg once within 48 hours after transplantation, then maintenance dose of 2 mg / day. In the future, the dose should be chosen so that Cmin in the blood is in the range of 4-12 ng / ml (chromatographic method). Cmin of cyclosporine in the blood during the first 2-3 months after transplantation should be maintained at the level of 150-400 ng / ml (monoclonal concentration method).
Adverse reactions
From the lymphatic system: very often (10%) - lymphocele.
On the part of the body as a whole: often (1-10%) - impaired wound healing, edema, development or aggravation of fungal, viral and bacterial infections (including those caused by mycobacteria and Epstein-Barr virus).
On the part of the liver: possibly - hepatotoxicity, including fatal liver necrosis.
These side effects were observed with combination therapy with sirolimus and cyclosporine.
Contraindications
Pregnancy, lactation, childhood and adolescence, hypersensitivity to sirolimus.
Special instructions
Therapy should be carried out by a doctor who has relevant experience in transplantology.
- Brand name: Rapamune
- Active ingredient: Sirolimus
- Dosage form: coated pills
- Manufacturer: Vaet Lederle
- Country of Origin: USA
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