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To aid in the interpretation of the bowel movement reduction results, the proportion of patients reporting any particular level of reduction in overall average bowel movement frequency is depicted in Figure 1 below. For example, 33% of patients randomized to Xermelo and 4% of patients randomized to placebo experienced a reduction in overall average bowel movements from baseline of at least 2 bowel movements per day. Figure 1: Cumulative Proportion of Patients with Carcinoid Syndrome Diarrhea Reporting Change in Overall Average Bowel Movement Frequency. Other symptoms of carcinoid syndrome (abdominal pain or flushing) did not show improvement in the comparison of Xermelo to placebo. The average number of daily short-acting octreotide injections used for rescue therapy over the 12-week double-blind treatment period was 0. In the subgroup of patients who received short-acting octreotide injections, observed reductions in the number of bowel movements per day and treatment differences were generally consistent with the reductions and differences observed in patients who did not receive rescue therapy, and were similar to the overall data presented in Table 2 above [see Dosage and Administration (2), Drug Interactions (7. A third randomized treatment arm of Xermelo 500 mg three times daily did not demonstrate additional treatment benefit on the primary endpoint and had a greater incidence of adverse reactions than Xermelo 250 mg three times daily. Therefore, Xermelo 500 mg three times daily is not recommended [see Dosage and Administration (2)]. How Supplied/Storage and Handling. Xermelo is dispensed in a monthly case for a total of 28 days of therapy. Each monthly case contains four weekly packs. Each weekly pack contains 21 tablets, tb 500 2 mg peptides $28.00. NDC 70183-125-85: Monthly case of 84 tablets. Each child resistant weekly pack contains twenty one 250 mg tablets. Store at 25’C (77’F); excursions permitted to 15’C to 30’C (59’F to 86’F) [see USP Controlled Room Temperature]. If they experience severe constipation or severe persistent or worsening abdominal pain, to discontinue Xermelo and contact their healthcare provider [see Warnings and Precautions (5. To take Xermelo with food [see Clinical Pharmacology (12. When short-acting octreotide is used in combination with Xermelo, administer short-acting octreotide at least 30 minutes after administering Xermelo [see Clinical Pharmacology (12. If a dose is missed, take the next dose at the regular time. Do not take 2 doses at the same time to make up for a missed dose. Distributed by: Lexicon Pharmaceuticals, Inc. The Woodlands, TX 77381. Principal Display Panel — 3×7 weekly pack. WEEKLY PACK 21 TABLETS Rx Only. Xermelo ‘ (telotristat ethyl) tablets.
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