Hospital Pharmacy - May 2017 - 326

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research-article2017

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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Table of Contents for the Digital Edition of Hospital Pharmacy - May 2017

Editorial, For Sale: FDA Priority Review Vouchers
Current FDA-Related Drug Information; Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals
Summaries of Safety Labeling Changes Approved by the FDA: Boxed Warnings
ISMP Adverse Drug Reactions: Levofloxacin-Induced Neuroexcitation and Hallucinations Statin-Induced Muscle Rupture Mefloquine-Induced Rhabdomyolysis Methimazole-Induced
Critical Care Pharmacist Market Perceptions: Comparison of Critical Care Program Directors and Directors of Pharmacy
Capecitabine, Oxaliplatin, and Bevacizumab (BCapOx) Regimen for Metastatic Colorectal Cancer
Clinical Pharmacy Discharge Counseling Service and the Impact on Readmission Rates in High-Risk Patients
Mannitol Prescribing Practices With Cisplatin Before and After an Educational Newsletter Intervention
Pharmacists’ Knowledge of the Cost of Laboratory Testing
Adverse Drug Reaction Reporting Practices Among United Arab Emirates Pharmacists and Prescribers
Postoperative Pain Management With Liposomal Bupivacaine in Patients Undergoing Orthopedic Knee and Hip Arthroplasty at a Community Hospital
Formulary Drug Reviews
Hospital Pharmacy - May 2017 - 317
Hospital Pharmacy - May 2017 - 318
Hospital Pharmacy - May 2017 - 319
Hospital Pharmacy - May 2017 - 320
Hospital Pharmacy - May 2017 - 321
Hospital Pharmacy - May 2017 - 322
Hospital Pharmacy - May 2017 - 323
Hospital Pharmacy - May 2017 - Editorial, For Sale: FDA Priority Review Vouchers
Hospital Pharmacy - May 2017 - 325
Hospital Pharmacy - May 2017 - Current FDA-Related Drug Information; Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals
Hospital Pharmacy - May 2017 - Summaries of Safety Labeling Changes Approved by the FDA: Boxed Warnings
Hospital Pharmacy - May 2017 - 328
Hospital Pharmacy - May 2017 - 329
Hospital Pharmacy - May 2017 - ISMP Adverse Drug Reactions: Levofloxacin-Induced Neuroexcitation and Hallucinations Statin-Induced Muscle Rupture Mefloquine-Induced Rhabdomyolysis Methimazole-Induced
Hospital Pharmacy - May 2017 - 331
Hospital Pharmacy - May 2017 - 332
Hospital Pharmacy - May 2017 - 333
Hospital Pharmacy - May 2017 - Critical Care Pharmacist Market Perceptions: Comparison of Critical Care Program Directors and Directors of Pharmacy
Hospital Pharmacy - May 2017 - 335
Hospital Pharmacy - May 2017 - 336
Hospital Pharmacy - May 2017 - 337
Hospital Pharmacy - May 2017 - 338
Hospital Pharmacy - May 2017 - 339
Hospital Pharmacy - May 2017 - 340
Hospital Pharmacy - May 2017 - Capecitabine, Oxaliplatin, and Bevacizumab (BCapOx) Regimen for Metastatic Colorectal Cancer
Hospital Pharmacy - May 2017 - 342
Hospital Pharmacy - May 2017 - 343
Hospital Pharmacy - May 2017 - 344
Hospital Pharmacy - May 2017 - 345
Hospital Pharmacy - May 2017 - 346
Hospital Pharmacy - May 2017 - 347
Hospital Pharmacy - May 2017 - Clinical Pharmacy Discharge Counseling Service and the Impact on Readmission Rates in High-Risk Patients
Hospital Pharmacy - May 2017 - 349
Hospital Pharmacy - May 2017 - 350
Hospital Pharmacy - May 2017 - 351
Hospital Pharmacy - May 2017 - 352
Hospital Pharmacy - May 2017 - Mannitol Prescribing Practices With Cisplatin Before and After an Educational Newsletter Intervention
Hospital Pharmacy - May 2017 - 354
Hospital Pharmacy - May 2017 - 355
Hospital Pharmacy - May 2017 - 356
Hospital Pharmacy - May 2017 - Pharmacists’ Knowledge of the Cost of Laboratory Testing
Hospital Pharmacy - May 2017 - 358
Hospital Pharmacy - May 2017 - 359
Hospital Pharmacy - May 2017 - 360
Hospital Pharmacy - May 2017 - Adverse Drug Reaction Reporting Practices Among United Arab Emirates Pharmacists and Prescribers
Hospital Pharmacy - May 2017 - 362
Hospital Pharmacy - May 2017 - 363
Hospital Pharmacy - May 2017 - 364
Hospital Pharmacy - May 2017 - 365
Hospital Pharmacy - May 2017 - 366
Hospital Pharmacy - May 2017 - Postoperative Pain Management With Liposomal Bupivacaine in Patients Undergoing Orthopedic Knee and Hip Arthroplasty at a Community Hospital
Hospital Pharmacy - May 2017 - 368
Hospital Pharmacy - May 2017 - 369
Hospital Pharmacy - May 2017 - 370
Hospital Pharmacy - May 2017 - 371
Hospital Pharmacy - May 2017 - 372
Hospital Pharmacy - May 2017 - 373
Hospital Pharmacy - May 2017 - Formulary Drug Reviews
Hospital Pharmacy - May 2017 - 375
Hospital Pharmacy - May 2017 - 376
Hospital Pharmacy - May 2017 - 377
Hospital Pharmacy - May 2017 - 378
Hospital Pharmacy - May 2017 - 379
Hospital Pharmacy - May 2017 - 380
Hospital Pharmacy - May 2017 - 381
Hospital Pharmacy - May 2017 - 382
Hospital Pharmacy - May 2017 - 383
Hospital Pharmacy - May 2017 - 384
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