Where can I find FDA label information for omacetaxine mepesuccinate?

Where can I find FDA label information for omacetaxine mepesuccinate?

FDA label information for this drug is available at DailyMed. Omacetaxine mepesuccinate is approved to treat: Chronic myelogenous leukemia. It is used in some patients who have been treated with at least two drugs called tyrosine kinase inhibitors and have not gotten better.

What is omacetaxine used to treat?

Use in Cancer. Omacetaxine mepesuccinate is approved to treat: Chronic myelogenous leukemia. It is used in some patients who have been treated with at least two drugs called tyrosine kinase inhibitors and have not gotten better. Omacetaxine mepesuccinate is also being studied in the treatment of other types of cancer.

Is Omacetaxine a Bcr-Abl inhibitor?

The activity of omacetaxine is independent of targeting the BCR-ABL oncogene. Omacetaxine is a reversible protein translation inhibitor first noted to have activity against CML in preclinical trials conducted in the 1990s (Kantarjian & Cortes, 2011; Visani et al., 1997).

Does omacetaxine cause hyperglycemia in diabetic patients?

Hyperglycemia (grade 1/2) was observed in nondiabetic patients, thus diabetic patients receiving omacetaxine should be monitored more closely for hyperglycemia (Legros et al., 2007). Evaluation of Treatment Response

How do you store Synribo (omacetaxine mepesuccinate) for injection?

SYNRIBO (omacetaxine mepesuccinate) for Injection is supplied in 8 mL clear glass single-dose vial in individual cartons. Each vial contains 3.5 mg of SYNRIBO (omacetaxine mepesuccinate) for Injection (NDC 63459-177-14). 16.2 Storage and Handling Store unopened vials at 20 o C to 25ºC (68 o

What are the possible adverse effects of omacetaxine mepesuccinate during pregnancy?

In an embryo-fetal development study, pregnant mice were administered omacetaxine mepesuccinate subcutaneously during the period of organogenesis at doses of 0.21 or 0.41 mg/kg/day. Drug-related adverse effects included embryonic death, an increase in unossified bones/reduced bone ossification and decreased fetal body weights.