Company Information
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Contact SupplierGeneric Name | Thalidomide |
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Brand Name | Thaloda Capsule |
Strength Available | 50 MG. and 100 MG. |
Packing | 10 Capsule |
Name of Company | Alkem Laboratories Ltd. |
Classification | Immunomodulatory agent, Antiangiogenic agent |
Mechanism of Action |
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Mechanism of Resistance | None known |
Absorption | Oral bioavailability of thalidomide is not known due to poor aqueous solubility. Slowly absorbed from the GI tract with peak plasma levels reached 3-6 hours after oral administration. |
Distribution | The apparent volume of distribution varies by dose level - 67 L and 166 L at doses of 200 and 1,200 mg/ day. Remains unclear whether thalidomide is present in the ejaculate of males. The extent of binding to plasma proteins is not known. |
Metabolism | Nonenzymatic hydrolysis appears to be the principal mechanism of thalidomide breakdown. However, the exact metabolic pathway(s) has not been fully characterized. The precise route of drug excretion is not well defined. |
Indications & Usage | Currently, thalidomide is FDA-approved only for the treatment of the cutaneous manifestations of erythema nodosurn leprosum (ENL). However, the drug has been extensively used in patients with advanced malignancies for which no therapy is available. Several phase I and phase II trials have been undertaken using thalidomide in the treatment of multiple myeloma, breast cancer, primary eNS cancers, prostate cancer, colorectal cancer, pancreatic cancer, melanoma, hepatocellular cancer, ovarian cancer, renal cell cancer, lung cancer, myelodysplastic syndrome (MDS), and Kaposi's sarcoma. This agent is especially active in multiple myeloma and MOS. |
Dosage Range | No standard dose recommendations for oncologic use have been established. When used in combination with chemotherapy, doses are typically titrated up to 400 mg PO daily given as a single bedtime dose. As a single agent, doses have been in the range of 100 mg to 1,200 mg daily. |
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