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packages containing 5 pens, but needles are not included; a
new NovoFine or NovoTwist needle is needed.1
Prior to first use, the pen should be stored in the refrigerator at 2°C to 8°C (36°F-46°F). Freezing should be avoided; if
contents freeze, the pen should be discarded. After first use,
the pen can be stored at room temperature (15°C-30°C
[59°F-86°F]) but must be discarded after 21 days. The pens
should be protected from light. The needle should be removed
after each use. New needles (eg, NovoFine or NovoTwist
needles) should be used for each injection.1

Drug Safety/Risk Evaluation and
Mitigation Strategy (REMS)
A communication plan REMS is required for insulin
degludec/liraglutide.1,14

Conclusion
Insulin degludec/liraglutide is a combination of a long-acting
basal insulin and a GLP-1 receptor agonist approved as an
adjunct to diet and exercise to improve glycemic control in
adults with type 2 diabetes mellitus inadequately controlled
on basal insulin (less than 50 units daily) or liraglutide (less
than or equal to 1.8 mg daily). A factor influencing the decision to add the combination agent to the formulary will be
whether the individual ingredients are already on the formulary. This convenient combination produces better glucose
lowering and related changes in laboratory values than either
agent alone and is more convenient for patient use because it
requires 1 injection instead of 2 separate injections. There are
no head-to-head comparison studies with insulin degludec/
liraglutide and insulin glargine/lixisenatide (another longacting insulin/GLP-1 receptor agonist combination). The
role of various diabetes drugs in the treatment of patients
with established cardiovascular disease also needs to be considered; 2017 treatment guidelines indicate that empagliflozin or liraglutide therapy should be considered for these
patients.
Declaration of Conflicting Interests
The author(s) declared no potential conflicts of interest with respect
to the research, authorship, and/or publication of this article.

Funding
The author(s) received no financial support for the research, authorship, and/or publication of this article.

References
1. Xultophy (insulin degludec/liraglutide) [prescribing information]. Plainsboro, NJ: Novo Nordisk; November 2016.
2. Soliqua (insulin glargine/lixisenatide) [prescribing information]. Bridgewater, NJ: Sanofi-Aventis; November 2016.

Hospital Pharmacy 52(5)
3. Kapitza C, Bode B, Ingwersen SH, Jacbosen LV, Poulsen
P. Preserved pharmacokinetic exposure and distinct glycemic effects of insulin degludec and liraglutide in IDegLira,
a fixed-ratio combination therapy. J Clin Pharmacol.
2015;55(12):1369-1377.
4. American Diabetes Association. Standards of medical care
in diabetes-2017: summary of revisions. Diabetes Care.
2017;40(suppl 1):S4-S5.
5. American Diabetes Association. Pharmacologic approaches
to glycemic treatment. Diabetes Care. 2017;40(suppl 1):
S64-S74.
6. Qaseem A, Barry MJ, Humphrey LL, Forciea MA, Clinical
Guidelines Committee of the American College of Physicians.
Oral pharmacologic treatment of type 2 diabetes mellitus: a
clinical practice guideline update from the American College
of Physicians. Ann Intern Med. 2017;166(4):279-290.
7. Gough SC, Bode B, Woo V, et al; NN9068-3697 (DUAL-I)
Trial Investigators. Efficacy and safety of a fixed-ratio combination of insulin degludec and liraglutide (IDegLira) compared with its components given alone: results of a phase
3, open-label, randomised, 26-week, treat-to-target trial in
insulin-naive patients with type 2 diabetes. Lancet Diabetes
Endocrinol. 2014;2(11):885-893.
8. Gough SC, Bode BW, Woo VC, et al. One-year efficacy and
safety of a fixed combination of insulin degludec and liraglutide in patients with type 2 diabetes: results of a 26-week
extension to a 26-week main trial. Diabetes Obes Metab.
2015;17(10):965-973.
9. Buse JB, Vilsbøll T, Thurman J, et al; NN9068-3912
(DUAL-II) Trial Investigators. Contribution of liraglutide in
the fixed-ratio combination of insulin degludec and liraglutide
(IDegLira). Diabetes Care. 2014;37(11):2926-2933.
10. Vilsbøll T, Vora J, Jarlov H, Kvist K, Blonde L. Type 2 diabetes patients reach target glycemic control faster using IDegLira
than either insulin degludec or liraglutide given alone. Clin
Drug Investig. 2016;36(4):293-303.
11. Rodbard HW, Buse JB, Woo V, et al. Benefits of combination
of insulin degludec and liraglutide are independent of baseline
glycated haemoglobin level and duration of type 2 diabetes.
Diabetes Obes Metab. 2016;18(1):40-48.
12. Linjawi S, Bode BW, Chaykin LB, et al. The efficacy of
IDegLira (insulin degludec/liraglutide combination) in adults
with type 2 diabetes inadequately controlled with a GLP-1
receptor agonist and oral therapy: DUAL III randomized clinical trial [published online ahead of print December 10. 2016].
Diabetes Ther. doi:10.1007/s13300-016-0218-3.
13. Rodbard HW, Bode BW, Harris SB, et al; Dual Action
of Liraglutide and Insulin Degludec (DUAL) IV Trial
Investigators. Safety and efficacy of insulin degludec/liraglutide (IDegLira) added to sulphonylurea alone or to sulphonylurea and metformin in insulin-naïve people with type
2 diabetes: the DUAL IV trial. Diabet Med. 2017;34(2):
189-196.
14. Guettier JM. NDA approval letter: Xultophy (insulin degludec/
liraglutide NDA 208583). U.S. Food & Drug Administration.
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/20
16/208583Orig1s000ltr.pdf. Published November 21, 2016.
Accessed December 20, 2016.


http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208583Orig1s000ltr.pdf http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208583Orig1s000ltr.pdf

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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