Hospital Pharmacy - November 2017 - 662
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 - November 2017
AKD—The Time Between AKI and CKD: What Is the Role of the Pharmacist?
Letter to the Editor
Antithrombotic Therapy Post Endovascular Stenting for Superior Vena Cava Syndrome
Pharmaceutical Pipeline Update
Janus Kinase Inhibitors for the Treatment of Rheumatoid Arthritis
Formulary Drug Reviews
Etelcalcetide
Treatment of Hypertriglyceridemia-Induced Acute Pancreatitis With Insulin, Heparin, and Gemfibrozil: A Case Series
Evaluation of Antimicrobial Stewardship–Related Alerts Using a Clinical Decision Support System
Compatibility, Stability, and Efficacy of Vancomycin Combined With Gentamicin or Ethanol in Sodium Citrate as a Catheter Lock Solution
Development of Institutional Guidelines for Management of Gram-Negative Bloodstream Infections: Incorporating Local Evidence
Underutilization of Aldosterone Antagonists in Heart Failure
Stability of Procainamide Injection in Clear Glass Vials and Polyvinyl Chloride Bags
Development of a Local Health-System Pharmacy Resident Society
Challenges and Solutions to New Manager Onboarding
Hospital Pharmacy - November 2017 - 649
Hospital Pharmacy - November 2017 - 650
Hospital Pharmacy - November 2017 - 651
Hospital Pharmacy - November 2017 - 652
Hospital Pharmacy - November 2017 - 653
Hospital Pharmacy - November 2017 - 654
Hospital Pharmacy - November 2017 - 655
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Hospital Pharmacy - November 2017 - 659
Hospital Pharmacy - November 2017 - 660
Hospital Pharmacy - November 2017 - AKD—The Time Between AKI and CKD: What Is the Role of the Pharmacist?
Hospital Pharmacy - November 2017 - 662
Hospital Pharmacy - November 2017 - Letter to the Editor
Hospital Pharmacy - November 2017 - Pharmaceutical Pipeline Update
Hospital Pharmacy - November 2017 - Janus Kinase Inhibitors for the Treatment of Rheumatoid Arthritis
Hospital Pharmacy - November 2017 - Formulary Drug Reviews
Hospital Pharmacy - November 2017 - Etelcalcetide
Hospital Pharmacy - November 2017 - 668
Hospital Pharmacy - November 2017 - 669
Hospital Pharmacy - November 2017 - 670
Hospital Pharmacy - November 2017 - 671
Hospital Pharmacy - November 2017 - 672
Hospital Pharmacy - November 2017 - Treatment of Hypertriglyceridemia-Induced Acute Pancreatitis With Insulin, Heparin, and Gemfibrozil: A Case Series
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Hospital Pharmacy - November 2017 - Evaluation of Antimicrobial Stewardship–Related Alerts Using a Clinical Decision Support System
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Hospital Pharmacy - November 2017 - Compatibility, Stability, and Efficacy of Vancomycin Combined With Gentamicin or Ethanol in Sodium Citrate as a Catheter Lock Solution
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Hospital Pharmacy - November 2017 - Development of Institutional Guidelines for Management of Gram-Negative Bloodstream Infections: Incorporating Local Evidence
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Hospital Pharmacy - November 2017 - Underutilization of Aldosterone Antagonists in Heart Failure
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Hospital Pharmacy - November 2017 - Stability of Procainamide Injection in Clear Glass Vials and Polyvinyl Chloride Bags
Hospital Pharmacy - November 2017 - 703
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Hospital Pharmacy - November 2017 - 705
Hospital Pharmacy - November 2017 - 706
Hospital Pharmacy - November 2017 - Development of a Local Health-System Pharmacy Resident Society
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Hospital Pharmacy - November 2017 - Challenges and Solutions to New Manager Onboarding
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