Hospital Pharmacy - May 2017 - 326

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HPXXXX10.1177/0018578717715384Hospital PharmacyCurrent FDA-Related Drug Information

Current FDA-Related Drug Information

Approvals, Submission, and Important
Labeling Changes for US Marketed
Pharmaceuticals

Hospital Pharmacy
2017, Vol. 52(5) 326
© The Author(s) 2017
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https://doi.org/10.1177/0018578717715384
DOI: 10.1177/0018578717715384
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This monthly feature will help readers keep current on new drug, new indications, dosage forms and safety-related changes
in labeling or use. Efforts have been made to assure the accuracy of this information; however, if there are any questions,
please let us know at jgeneral@ku.edu.
Table 1. New drugs and biologicals approved by the US Food and Drug Administration: February 18, 2017 through March 17, 2017.
Telotristat etiprate - Xermelo (Lexicon Pharms Inc.).
Indication:
Mechanism of action:
Common adverse effects:
Dosage form & strength:
Product labeling:

Treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in
adults inadequately controlled by SSA therapy
Through inhibition of tryptophan hydroxylase, telotristat and telotristat ethyl reduce the production of
peripheral serotonin, and the frequency of carcinoid syndrome diarrhea.
Nausea, headache, increased GGT, depression, flatulence, decreased appetite, peripheral edema, and
pyrexia
Tablets: 250 mg telotristat ethyl
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208794s000lbl.pdf

Ribociclib succinate - Kisqali (Novartis Pharms Corp.)
Indication:
Mechanism of action:
Common adverse effects:
Dosage form & strength:
Product labeling:

In combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of
postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor
2 (HER2)-negative advanced or metastatic breast cancer
Ribociclib is an inhibitor of cyclin-dependent kinase (CKA) 4 and 6.
Neutropenia, nausea, fatigue, diarrhea, leukopenia, alopecia, vomiting, constipation, headache, and back
pain
Tablets: 200 mg
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209092s000lbl.pdf

Table 2. Selected FDA safety communications: February 18, 2017 through March 17, 2017.
Generic name (brand name)
Eluxadoline (Viberzi)

Safety communication
March 15, 2017. FDA alerted health professionals regarding an increased risk for developing serious
pancreatitis associated with the use of eluxadoline in patients with irritable bowel syndrome with
diarrhea (IBS-D) who do not have a gallbladder. FDA received reports of 120 serious cases of
pancreatitis or death via their reporting database. Of these, 75 cases resulted in hospitalization and
2 cases were fatal. In the cases that reported time to onset of event (n=84), more than half (n=48)
occurred after 1 or 2 doses, and the remaining cases occurred with prolonged use.
https://www.fda.gov/Drugs/DrugSafety/ucm546154.htm

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