Hospital Pharmacy - February 2018 - 2

and 4800 mg/kg/day by continuous intravenous infusion over
24 hours or at 60, 120, and 240 mg/kg/day by 2-hour infusions
4 times per day. Pregnant rabbits were administered defibrotide
sodium at 0, 30, 60, or 120  mg/kg/day from GD 6 to 18 by
2-hour infusions 4 times per day.
In another study in pregnant rabbits, 3 separate subgroups of
animals were treated with doses of 80 mg/kg/day defibrotide
sodium administered by 2-hour infusions 4  times per day for
5 days each in a staggered manner during the organogenesis
period. The dose of 80 mg/kg/day is approximately equivalent
to the recommended clinical dose on a mg/m2 basis. Subgroup
1 was dosed from GD 6 to 10, subgroup 2 was dosed from GD
10 to 14, and subgroup 3 was dosed from GD 14 to 18. An
increased incidence of unilateral implantation was observed in
defibrotide sodium-treated animals. Treatment with defibrotide
sodium resulted in a decreased number of implantations and
viable fetuses.
Lactation
Risk Summary
There is no information regarding the presence of Defitelio in
human milk, the effects on the breastfed infant, or the effects
on milk production. Because of the potential for serious
adverse reactions, including bleeding in a breastfed infant,
advise patients that breastfeeding is not recommended during
treatment with Defitelio.
Pediatric Use
The safety and effectiveness of Defitelio have been established
in pediatric patients. Use of Defitelio is supported by evidence
from an adequate and well-controlled study and a dose finding
study of Defitelio in adult and pediatric patients with VOD with
evidence of renal or pulmonary dysfunction following HSCT. The
clinical trials enrolled 66 pediatric patients in the following age
groups: 22 infants (1 month up to less than 2 years), 30 children
(2 years up to less than 12 years), and 14 adolescents (12 years
to less than 17 years). The efficacy and safety outcomes were
consistent across pediatric and adult patients in the clinical trials
[see Adverse Reactions].
Juvenile Animal Toxicity Data
A juvenile toxicity study in 21-day-old rats was conducted with
intravenous bolus administration of defibrotide sodium at 40,
150, or 320 mg/kg/day for 4 weeks. A delayed mean age of
preputial separation was observed at all doses, suggesting a
delay in onset of male puberty. The dose of 40 mg/kg/day is
approximately 0.4 times the clinical dose on a mg/m2 basis for a
child. The relevance of this finding for the onset of male puberty
in humans is unknown.
Geriatric Use
Clinical studies of Defitelio did not include sufficient numbers of
subjects aged 65 and over to determine whether they respond
differently from younger subjects. Other reported clinical
experience has not identified differences in responses between
the elderly and younger patients.
OVERDOSAGE
There are no known cases of overdose with Defitelio. There is
no known antidote for Defitelio, and Defitelio is not dialyzable.
If an overdose occurs, institute general supportive measures.
PATIENT COUNSELING INFORMATION
* Hemorrhage: Advise patients and caregivers that Defitelio
may increase the risk of bleeding (hemorrhage). Instruct
patients to immediately report any signs or symptoms
suggestive of hemorrhage (unusual bleeding, easy bruising,
blood in urine or stool, headache, confusion, slurred speech,
or altered vision) [see Warnings and Precautions].
* Hypersensitivity Reactions: Ask patients if they have been
treated with defibrotide sodium previously. Instruct patients
on the risk of allergic reactions, including anaphylaxis.
Describe the symptoms of allergic reactions, including
anaphylaxis, and instruct the patient to seek medical
attention immediately if they experience such symptoms [see
Warnings and Precautions].

Distributed By:
Jazz Pharmaceuticals, Inc.
Palo Alto, CA 94304
©2016 Jazz Pharmaceuticals plc or its subsidiaries
DEF-0023

Revised: 3/2016



Table of Contents for the Digital Edition of Hospital Pharmacy - February 2018

Ed Board
TOC
Editorial
The Evolving Frontier of Digital Health: Opportunities for Pharmacists on the Horizon
Letter to the Editor
Immediate Attention Required: Another Shortage
ISMP Adverse Drug Reactions
ISMP Adverse Drug Reactions
Current FDA-Related Drug Information
Summaries of Safety Labeling Changes Approved By FDA: Boxed Warnings Highlights July-September 2017
ISMP Medication Error Report Analysis
Common Missteps With Medication Safety: Rolling a Single Dice, Ineffective Strategies, and Unexecuted Action Plans
Formulary Drug Reviews
Betrixaban
Pharmaceutical Pipeline Update
Antibiotics in Development for the Treatment of Resistant Bacterial Disease
Articles
Evaluation of the Incidence of Ibuprofen Administration in Alcohol and Opioid Detoxification Patients With Concomitant Thrombocytopenia
Antimicrobial Utilization Pattern in Pediatric Patients in Tertiary Care Hospital, Eastern Ethiopia: The Need for Antimicrobial Stewardship
Acute Hepatocellular Jaundice After Dofetilide Initiation: A Case Report
Outcomes From a Pharmacist: Led Proton Pump Inhibitor Stewardship Program at a Single Institution
Corrigendum
Hospital Pharmacy - February 2018 - Cover1
Hospital Pharmacy - February 2018 - Cover2
Hospital Pharmacy - February 2018 - 1
Hospital Pharmacy - February 2018 - 2
Hospital Pharmacy - February 2018 - 3
Hospital Pharmacy - February 2018 - Ed Board
Hospital Pharmacy - February 2018 - TOC
Hospital Pharmacy - February 2018 - Editorial
Hospital Pharmacy - February 2018 - The Evolving Frontier of Digital Health: Opportunities for Pharmacists on the Horizon
Hospital Pharmacy - February 2018 - 8
Hospital Pharmacy - February 2018 - 9
Hospital Pharmacy - February 2018 - 10
Hospital Pharmacy - February 2018 - Letter to the Editor
Hospital Pharmacy - February 2018 - Immediate Attention Required: Another Shortage
Hospital Pharmacy - February 2018 - 13
Hospital Pharmacy - February 2018 - ISMP Adverse Drug Reactions
Hospital Pharmacy - February 2018 - ISMP Adverse Drug Reactions
Hospital Pharmacy - February 2018 - 16
Hospital Pharmacy - February 2018 - Current FDA-Related Drug Information
Hospital Pharmacy - February 2018 - Summaries of Safety Labeling Changes Approved By FDA: Boxed Warnings Highlights July-September 2017
Hospital Pharmacy - February 2018 - 19
Hospital Pharmacy - February 2018 - 20
Hospital Pharmacy - February 2018 - 21
Hospital Pharmacy - February 2018 - 22
Hospital Pharmacy - February 2018 - 23
Hospital Pharmacy - February 2018 - ISMP Medication Error Report Analysis
Hospital Pharmacy - February 2018 - Common Missteps With Medication Safety: Rolling a Single Dice, Ineffective Strategies, and Unexecuted Action Plans
Hospital Pharmacy - February 2018 - 26
Hospital Pharmacy - February 2018 - 27
Hospital Pharmacy - February 2018 - Formulary Drug Reviews
Hospital Pharmacy - February 2018 - Betrixaban
Hospital Pharmacy - February 2018 - 30
Hospital Pharmacy - February 2018 - 31
Hospital Pharmacy - February 2018 - 32
Hospital Pharmacy - February 2018 - 33
Hospital Pharmacy - February 2018 - 34
Hospital Pharmacy - February 2018 - 35
Hospital Pharmacy - February 2018 - 36
Hospital Pharmacy - February 2018 - Pharmaceutical Pipeline Update
Hospital Pharmacy - February 2018 - Antibiotics in Development for the Treatment of Resistant Bacterial Disease
Hospital Pharmacy - February 2018 - 39
Hospital Pharmacy - February 2018 - Articles
Hospital Pharmacy - February 2018 - Evaluation of the Incidence of Ibuprofen Administration in Alcohol and Opioid Detoxification Patients With Concomitant Thrombocytopenia
Hospital Pharmacy - February 2018 - 42
Hospital Pharmacy - February 2018 - 43
Hospital Pharmacy - February 2018 - Antimicrobial Utilization Pattern in Pediatric Patients in Tertiary Care Hospital, Eastern Ethiopia: The Need for Antimicrobial Stewardship
Hospital Pharmacy - February 2018 - 45
Hospital Pharmacy - February 2018 - 46
Hospital Pharmacy - February 2018 - 47
Hospital Pharmacy - February 2018 - 48
Hospital Pharmacy - February 2018 - 49
Hospital Pharmacy - February 2018 - 50
Hospital Pharmacy - February 2018 - 51
Hospital Pharmacy - February 2018 - 52
Hospital Pharmacy - February 2018 - 53
Hospital Pharmacy - February 2018 - 54
Hospital Pharmacy - February 2018 - Acute Hepatocellular Jaundice After Dofetilide Initiation: A Case Report
Hospital Pharmacy - February 2018 - 56
Hospital Pharmacy - February 2018 - 57
Hospital Pharmacy - February 2018 - 58
Hospital Pharmacy - February 2018 - Outcomes From a Pharmacist: Led Proton Pump Inhibitor Stewardship Program at a Single Institution
Hospital Pharmacy - February 2018 - 60
Hospital Pharmacy - February 2018 - 61
Hospital Pharmacy - February 2018 - 62
Hospital Pharmacy - February 2018 - 63
Hospital Pharmacy - February 2018 - 64
Hospital Pharmacy - February 2018 - 65
Hospital Pharmacy - February 2018 - 66
Hospital Pharmacy - February 2018 - 67
Hospital Pharmacy - February 2018 - Corrigendum
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