Hospital Pharmacy - May 2017 - 327

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HPXXXX10.1177/0018578717715385Hospital PharmacyCurrent FDA-Related Drug Information

Current FDA-Related Drug Information

Summaries of Safety Labeling Changes
Approved by the FDA: Boxed Warnings
Highlights January - March 2017

The FDA's MedWatch program safety labeling changes for
boxed warnings are compiled quarterly for drugs and therapeutic biologics where important changes have been made
to the safety information. Search of Drug Safety Labeling
Changes (SLC) database was conducted on 3/28/20174/19/2017 for date range 1/1/2017 to 3/31/2017 labeling
section "Boxed Warning". These and other label changes
are searchable in the Drug Safety Labeling Changes (SLC)
database, where data are available to the public in downloadable and searchable formats. (Drug Safety Labeling
Changes are available at: http://www.accessdata.fda.gov/

Hospital Pharmacy
2017, Vol. 52(5) 327-329
© The Author(s) 2017
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https://doi.org/10.1177/0018578717715385
DOI: 10.1177/0018578717715385
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scripts/cder/safetylabelingchanges/?source=govdelivery&
utm_medium=email&utm_source=govdelivery) Boxed
warnings are ordinarily used to highlight either: adverse
reactions so serious in proportion to the potential benefit
from the drug that it is essential that it be considered in
assessing the risks and benefits of using the drug; OR serious adverse reactions that can be prevented/reduced in frequency or severity by appropriate use of the drug; OR FDA
approved the drug with restrictions to ensure safe use
because FDA concluded that the drug can be safely used
only if distribution or use is restricted.

Bicnu (carmustine) for injection, for intravenous use (application number 017422)
Edited Boxed Warning (additions/revisions are underlined)
WARNING: MYELOSUPPRESSION and PULMONARY TOXICITY
Myelosuppression
** Bicnu causes suppression of marrow function (including thrombocytopenia and leukopenia), which may contribute to bleeding and
overwhelming infections.
** Monitor blood counts weekly for at least 6 weeks after each dose. Adjust dosage based on nadir blood counts from the prior
dose. Do not administer a repeat course of Bicnu until blood counts recover.
Pulmonary Toxicity
** Bicnu causes dose-related pulmonary toxicity...

Cerebyx (fosphenytoin sodium) injection, for intravenous or intramuscular use (application number 020450)
Edited Boxed Warning (PLR conversion; additions and/or revisions underlined)
WARNING: CARDIOVASCULAR RISK ASSOCIATED WITH RAPID INFUSION RATES
The rate of intravenous Cerebyx administration should not exceed 150 mg phenytoin sodium equivalents (PE) per minute in adults and
2 mg PE/kg/min (or 150 mg PE/min, whichever is slower) in pediatric patients because of the risk of severe hypotension and cardiac
arrhythmias. Careful cardiac monitoring is needed during and after administering intravenous Cerebyx ...
Class of Direct-acting Antiviral (DAA) Medicines for Hepatitis C Virus
Daklinza (daclatasvir) tablets, for oral use (application number 206843); Epclusa (sofosbuvir and velpatasvir) tablets, for oral use
(application number 208341); Harvoni (ledipasvir and sofosbuvir) tablets, for oral use (application number 205834); Olysio (simeprevir)
capsules, for oral use (application number 205123); Sovaldi (sofosbuvir) tablets, for oral use (application number 204671); Technivie
(ombitasvir, paritaprevir, and ritonavir) tablets, for oral use (application number 207931); Viekira Pak (ombitasvir, paritaprevir,
and ritonavir tablets; dasabuvir tablets), co-packaged for oral use (application number 206619); Viekira XR (dasabuvir, ombitasvir,
paritaprevir, and ritonavir) extended-release tablets, for oral use (application number 208624); Zepatier (elbasvir and grazoprevir)
tablets, for oral use (application number 208261)
Added Section to Boxed Warning
WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV
Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with {PRODUCT}. HBV
reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV directacting antivirals and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and
death. Monitor HCV/HBV coinfected patients for hepatitis flare or HBV reactivation during HCV treatment and post-treatment followup. Initiate appropriate patient management for HBV infection as clinically indicated.

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