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Pomalidomide, sold under the brand names Pomalyst and Imnovid, [7] [8] is an anti-cancer medication used for the treatment of multiple myeloma and AIDS-related Kaposi sarcoma. [ 7 ] Pomalidomide was approved for medical use in the United States in February 2013, [ 10 ] and in the European Union in August 2013. [ 8 ]
Acceptable daily intake or ADI is a measure of the amount of a specific substance (originally applied for a food additive, later also for a residue of a veterinary drug or pesticide) in food or drinking water that can be ingested (orally) daily over a lifetime without an appreciable health risk. [1]
The thalidomide molecule is a synthetic derivative of glutamic acid and consists of a glutarimide ring and a phthaloyl ring (Figure 5). [15] [16] Its IUPAC name is 2-(2,6-dioxopiperidin-3-yl)isoindole-1,3-dione and it has one chiral center [15] After thalidomide's selective inhibition of TNF-α had been reported, a renewed effort was put in thalidomide's clinical development.
The therapeutic index (TI; also referred to as therapeutic ratio) is a quantitative measurement of the relative safety of a drug with regard to risk of overdose.It is a comparison of the amount of a therapeutic agent that causes toxicity to the amount that causes the therapeutic effect. [1]
A virtually safe dose (VSD) may be determined for those carcinogens not assumed to have a threshold. Virtually safe doses are calculated by regulatory agencies to represent the level of exposure to such carcinogenic agents at which an excess of cancers greater than that level accepted by society is not expected. [1]
25–50 mg/day Enzalutamide: Xtandi: Antiandrogen: Oral: 160 mg/day GnRH analogue: Various: GnRH modulator: Various: Variable Elagolix: Orilissa: GnRH antagonist: Oral: 150 mg/day or 200 mg twice daily Finasteride: Propecia: 5αR inhibitor: Oral: 1–5 mg/day Dutasteride: Avodart: 5αR inhibitor: Oral: 0.25–0.5 mg/day Progesterone: Prometrium ...
Myelosuppression is the major dose-limiting toxicity, which is not the case with thalidomide. [26] Lenalidomide may be associated with adverse effects as second primary malignancy, severe cutaneous reactions, hypersensitivity reactions, tumor lysis syndrome, tumor flare reaction, hypothyroidism, and hyperthyroidism. [6]
Thalidomide taken on the 20th day of pregnancy caused central brain damage, day 21 would damage the eyes, day 22 the ears and face, day 24 the arms, and leg damage would occur if taken up to day 28. [citation needed] It is not known exactly how many worldwide victims of the drug there have been, although estimates range from 10,000 to 20,000. [76]