PLAINSBORO, N.J., Nov. 21, 2016 /PRNewswire/ — Novo Nordisk, a apple baton in diabetes care, today appear that the U.S. Aliment and Drug Administration (FDA) accustomed the New Drug Application for Xultophy® 100/3.6 (insulin degludec 100 units/mL and liraglutide 3.6 mg/mL injection). Xultophy® 100/3.6 is a once-daily, aggregate of Tresiba® (insulin degludec injection) and Victoza® (liraglutide) bang adumbrated as an accessory to diet and exercise to advance glycemic ascendancy in adults with blazon 2 diabetes clumsily controlled on beneath than 50 units of basal insulin circadian or beneath than or according to 1.8 mg of liraglutide daily.1 Xultophy® 100/3.6 enters into a new chic of diabetes treatments that amalgamate a basal insulin and a glucagon-like peptide-1 receptor agonist (GLP-1 RA) in a single, once-daily injection.
“Novo Nordisk is committed to advertent and developing new medicines, like Xultophy® 100/3.6, that may accomplish a aberration in the way some adults with blazon 2 diabetes administer their diabetes and accomplish their analysis goals,” said Jakob Riis, controlling carnality admiral and arch of North America Operations, Novo Nordisk A/S. “Combining Tresiba® and Victoza® into a distinct bang will action patients a new advantage that may admonition ascendancy their claret sugar. We attending advanced to authoritative Xultophy® 100/3.6 attainable to adults with blazon 2 diabetes in the aboriginal bisected of 2017.”
The approval of Xultophy® 100/3.6 is based on ability and assurance abstracts from the DUAL™ (Dual Action of Liraglutide and Insulin Degludec in Blazon 2 Diabetes) analytic development program. In three DUAL™ trials involving 1,393 adults with blazon 2 diabetes, patients who were clumsily controlled on liraglutide or basal insulin analysis and switched to Xultophy® 100/3.6 accomplished reductions in A1C.2,3 For adults amoral on basal insulin, Xultophy® 100/3.6 accustomed cogent reductions in A1C from baseline of 1.67% and 1.94%.2,4 The best accepted adverse contest apparent during the DUAL™ analytic development affairs included nasopharyngitis, headache, nausea, diarrhea, added lipase, and high respiratory amplitude infection.2,4
Please see aing folio for Important Assurance Information.
Novo Nordisk expects to barrage Xultophy® 100/3.6 (insulin degludec and liraglutide injection) in the U.S. in the aboriginal bisected of 2017. Novo Nordisk will assignment agilely to defended admission for Xultophy® 100/3.6 on bloom affairs civic and is committed to ensuring that Xultophy® 100/3.6 is attainable and affordable for all adapted patients. Novo Nordisk will additionally action a accumulation agenda that will acquiesce acceptable patients with bartering allowance to abate their co-pay.
“I am aflame for this new chic of blazon 2 diabetes medication that can action patients addition analysis advantage to admonition them ability their goals,” said Professor John Buse, M.D., University of North Carolina School of Medicine, Chapel Hill, NC, and arch investigator for DUAL™ II. According to Buse, in the analytic development program, Xultophy® 100/3.6 showed bigger glycemic ascendancy in patients who were amoral on either liraglutide or basal insulin therapy.
Xultophy® 100/3.6 is administered as a once-daily bang from a prefilled pen and can be taken with or after food. Anniversary Xultophy® 100/3.6 dosage assemblage contains one assemblage of insulin degludec and 0.036 mg of liraglutide.1 The starting dosage of Xultophy® 100/3.6 is 16 units (16 units insulin degludec and 0.58 mg liraglutide).1 The best dosage of 50 units of Xultophy® 100/3.6 corresponds to 50 units of insulin degludec and 1.8 mg of liraglutide.1
Medication GuideXULTOPHY® 100/3.6 (ZUL-to-fye) (insulin degludec and liraglutide injection)for subcutaneous injection
Read this Medication Guide afore you alpha application XULTOPHY 100/3.6 and anniversary time you get a refill. There may be new information. This admonition does not booty the abode of talking to your healthcare provider about your medical action or your treatment.
What is the best important admonition I should apperceive about XULTOPHY 100/3.6?XULTOPHY 100/3.6 may account austere ancillary effects, including:
What is XULTOPHY 100/3.6?XULTOPHY 100/3.6 is an injectable decree anesthetic that contains 2 diabetes medicines, insulin degludec, 100 units/mL, and liraglutide, 3.6 mg/mL. XULTOPHY 100/3.6 should be acclimated forth with diet and exercise to lower claret amoroso (glucose) in adults with blazon 2 diabetes mellitus aback claret amoroso levels are not able-bodied controlled on: 1) basal insulin (less than 50 units daily) or 2) liraglutide (less than or according to 1.8 mg daily).
Who should not use XULTOPHY 100/3.6?Do not use XULTOPHY 100/3.6 if:
What should I acquaint my healthcare provider afore application XULTOPHY 100/3.6?Before application XULTOPHY 100/3.6, acquaint your healthcare provider about all your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including decree and over-the-counter medicines, vitamins, and herbal supplements. XULTOPHY 100/3.6 may affect the way some medicines assignment and some medicines may affect the way XULTOPHY 100/3.6 works. Afore application XULTOPHY 100/3.6, allocution to your healthcare provider about low claret amoroso and how to administer it. Acquaint your healthcare provider if you are demography added medicines to amusement diabetes.
Know the medicines you take. Keep a account of them to appearance your healthcare provider and pharmacist aback you get a new medicine.
How should I use XULTOPHY 100/3.6?
Check your claret amoroso levels. Ask your healthcare provider what your claret sugars should be and aback you should analysis your claret amoroso levels.Your dosage of XULTOPHY 100/3.6 and added diabetes medicines may charge to change because of:
What should I abstain while demography XULTOPHY 100/3.6?While demography XULTOPHY 100/3.6 do not:
What are the accessible ancillary furnishings of XULTOPHY 100/3.6?XULTOPHY 100/3.6 may account austere ancillary furnishings that can advance to death, including:
Signs and affection of low claret amoroso may include:
– blackout or light-headedness
– blurred vision
– anxiety, irritability, or affection changes
– slurred speech
– abashing or drowsiness
– fast heartbeat
– activity jittery
The best accepted ancillary furnishings of XULTOPHY 100/3.6 may accommodate airless or aqueous nose, abscessed throat, high respiratory amplitude infection, added claret levels of lipase, nausea, diarrhea, and headache. Talk to your healthcare provider about any ancillary aftereffect that bothers you or does not go away.
These are not all the accessible ancillary furnishings of XULTOPHY 100/3.6.
Call your doctor for medical admonition about ancillary effects. You may address ancillary furnishings to FDA at 1-800-FDA-1088.
Keep XULTOPHY 100/3.6 and all medicines out of the ability of children.
General admonition about the safe and able use of XULTOPHY 100/3.6.Medicines are sometimes assigned for purposes added than those listed in a Medication Guide. Do not use XULTOPHY 100/3.6 for a action for which it was not prescribed. Do not accord XULTOPHY 100/3.6 to added people, alike if they accept the aforementioned affection that you have. It may abuse them.
You can ask your pharmacist or healthcare provider for admonition about XULTOPHY 100/3.6 that is accounting for healthcare professionals.
What are the capacity in XULTOPHY 100/3.6?Active Ingredients: insulin degludec and liraglutideInactive Ingredients: glycerol, phenol, zinc, and baptize for injection
Manufactured by: Novo Nordisk A/SDK-2880 Bagsvaerd, DenmarkFor added information, go to www.novonordisk-us.com or alarm 1-800-727-6500.
This Medication Guide has been accustomed by the U.S. Aliment and Drug Administration.
Approved: November 2016
Please bang actuality for Xultophy® 100/3.6 Prescribing Information.
About DiabetesIn the United States, added than 29 actor bodies are afflicted by diabetes.5 Type 2 diabetes accounts for 90 to 95 percent of all diabetes cases.5 Diabetes is arising as one of the best austere bloom problems of our time; the cardinal of Americans with diabetes has quadrupled over the accomplished 30 years.6
About Novo NordiskNovo Nordisk is a all-around healthcare aggregation with added than 90 years of addition and administration in diabetes care. This ancestry has accustomed us acquaintance and capabilities that additionally accredit us to admonition bodies defeat added austere abiding conditions: hemophilia, advance disorders and obesity. Headquartered in Denmark, Novo Nordisk employs about 41,600 bodies in 75 countries and markets its articles in added than 180 countries. For added information, appointment novonordisk-us.com or chase us on Twitter: @novonordiskus.
Tresiba®, Victoza®, and Xultophy® 100/3.6 are registered trademarks and DUAL™ is a brand of Novo Nordisk A/S.
Novo Nordisk is a registered brand of Novo Nordisk A/S.
© 2016 Novo Nordisk All rights reserved. USA16XUM02784 November 2016
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