1.RETEVMO selpercatinib (short answer 2-3 pages)
Obtain the label (prescribing information) of selpercatinib in pdf form from the web. If necessary, always say that you are a US healthcare provider, which is the truth. The purpose of this presentation request is to familiarize you with reading labels from the point of view of a Pharma scientist.
summarizing specific characteristics of the drug as listed below:
· Commercial name, international nonproprietary name (INN), structure, molecular weight, and sponsor company name
· Show the three indications of selpercatinib (omit less essential details)
· What is the general pharmacological action of the drug?
· What is the intended molecular target*?
· List all the other kinases it inhibits.
· In what form is the drug provided?
· What is the dose and frequency of administration? (For body weight > 50 kg)
· How does selpercatinib affect QTc interval in healthy subjects (Section 12.2)? What should the physician do with patients at risk of developing QTc prolongation (few words)?
· What are the bioavailability and half-life of selpercatinib?
· What was the Cmax (at 160 mg BID) in ng/ml and nM ? What was the PPB and the concentration of free drug (in nM) at Cmax at this dose?
· Which CYP450 is responsible for most of selpercatinib metabolism?
· What was the effect of coadministration of strong CYP3A inhibitors? (Assume they mean CYP3A4)