FDA approves Fiasp for use in insulin infusion pumps for adults with type 1 or type 2 diabetes
[caption id="attachment_9277" align="aligncenter" width="747"] Press Release[/caption]
PLAINSBORO, N.J.,?Oct. 22, 2019?/PRNewswire/ -- Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) has expanded the label for Fiasp??(insulin aspart injection) 100 u/mL to include use in insulin infusion pumps for the improvement of glycemic control in adults with type 1 or type 2 diabetes.1?Fiasp?, a rapid-acting insulin, was approved by the FDA in 2017 for use by intravenous infusion under supervision by a healthcare professional or by subcutaneous multiple daily injection (MDI) in adults with diabetes.
There are estimated to be more than 350,000 insulin infusion pump users in the U.S.2,3,4?An insulin pump is a small, programmable, battery-operated device that delivers insulin under the skin. Fiasp??should be used in accordance with the insulin pump's instructions for use. Fiasp??is available in multiple dosing options for multiple daily injections (MDI) as well as continuous subcutaneous insulin infusion1:
Fiasp??is the first and only fast-acting mealtime insulin injection that does not have a pre-meal dosing recommendation. Fiasp??is administered at the beginning of a meal or within 20 minutes after starting a meal. About onset 5
The Fiasp??label expansion to include use in insulin infusion pumps for the improvement of glycemic control in adults with type 1 or type 2 diabetes was based on data from onset 5, a randomised, multicenter, multinational trial, which investigated the efficacy and safety of continuous subcutaneous insulin infusion of Fiasp??compared to NovoLog??in adults with type 1 diabetes.5 ? Indications and Usage What is Fiasp??(insulin aspart injection) 100 U/mL?
Who should not take Fiasp??
Do not take Fiasp??if:
How should I take Fiasp??
Serious side effects can lead to death, including:
Novo Nordisk is a global healthcare company that's been making innovative medicines to help people with diabetes lead longer, healthier lives for 95 years. This heritage has given us experience and capabilities that also enable us to help people defeat other serious diseases including obesity, hemophilia and growth disorders. We remain steadfast in our conviction that the formula for lasting success is to stay focused, think long-term and do business in a financially, socially and environmentally responsible way. With U.S. headquarters in?New Jersey?and production and research facilities in six states, Novo Nordisk employs nearly 6,000 people throughout the country. For more information, visit?novonordisk.us,?Facebook,?Instagram?and?Twitter.
References
Novo Nordisk is a registered trademark of Novo Nordisk A/S.?
? 2019 Novo Nordisk All rights reserved. US19FSP00188 October 2019 SOURCE Novo Nordisk
- 10 mL vial for use in insulin pumps or MDI
- 3 mL FlexTouch??for MDI
- 3 mL PenFill??Cartridge for NovoPen Echo for MDI
Fiasp??is the first and only fast-acting mealtime insulin injection that does not have a pre-meal dosing recommendation. Fiasp??is administered at the beginning of a meal or within 20 minutes after starting a meal. About onset 5
The Fiasp??label expansion to include use in insulin infusion pumps for the improvement of glycemic control in adults with type 1 or type 2 diabetes was based on data from onset 5, a randomised, multicenter, multinational trial, which investigated the efficacy and safety of continuous subcutaneous insulin infusion of Fiasp??compared to NovoLog??in adults with type 1 diabetes.5 ? Indications and Usage What is Fiasp??(insulin aspart injection) 100 U/mL?
- Fiasp??is a man-made insulin used to control high blood sugar in adults with diabetes mellitus. It is not known if Fiasp??is safe and effective in children.
Who should not take Fiasp??
Do not take Fiasp??if:
- your blood sugar is too low (hypoglycemia) or you are allergic to any of its ingredients.
- have kidney or liver problems
- are pregnant or breastfeeding or plan to become pregnant or breastfeed. It is not known if Fiasp??passes into your breast milk.
- are taking new prescription or over-the-counter medicines, including supplements.
How should I take Fiasp??
- Read the Instructions for Use?and take Fiasp??exactly as your health care provider tells you to.
- Fiasp??starts acting fast.?You should take your dose of Fiasp??at the beginning of the meal or within 20 minutes after starting a meal.
- Know the type and strength of your insulin.?Do not?change your insulin type unless your health care provider tells you to.
- Change (rotate) your injection sites within the area you choose with each injection?to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and amyloidosis (skin with lumps) at the injection sites.
- Do not?use the exact same spot for each injection.
- Do not?inject where the skin has pits, is thickened, or has lumps.
- Do not?inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin.
- If you miss a dose of Fiasp??monitor your blood sugar levels to decide if an insulin dose is needed. Continue with your regular dosing schedule at the next meal.
- Check your blood sugar levels.?Ask your health care provider what your blood sugar levels should be and when you should check them.
- Do not reuse or share your needles with other people. You may give other people a serious infection or get a serious infection from them.
- Do not?drive or operate heavy machinery, until you know how Fiasp??affects you.
- Do not?drink alcohol or use medicines that contain alcohol.
Serious side effects can lead to death, including:
- Low blood sugar (hypoglycemia).?Some signs and symptoms include: anxiety, irritability, mood changes, dizziness or light-headedness, sweating, confusion, and headache.
- low potassium in your blood (hypokalemia).
- serious allergic reactions (whole body reactions).?Get emergency medical help right away if you have a rash over your whole body; trouble breathing; a fast heartbeat; swelling of your face, tongue or throat; sweating; extreme drowsiness; dizziness, or confusion.
- heart failure.?Taking certain diabetes pills called TZDs (thiazolidinediones) with Fiasp??may cause heart failure in some people. This can happen even if you have never had heart failure or heart problems before. If you already have heart failure it may get worse while you take TZDs with Fiasp?. Your health care provider should monitor you closely while you are taking TZDs with Fiasp?. Tell your health care provider if you have any new or worse symptoms of heart failure including shortness of breath, swelling of your ankles or feet, or sudden weight gain.
- weight gain or loss, increased stress, illness, or change in diet or level of physical activity
- skin problems such as eczema, rash, itching, redness and swelling of your skin (dermatitis), reactions at the injection site such as itching, rash, skin thickening or pits at the injection site (lipodystrophy), or weight gain.
Novo Nordisk is a global healthcare company that's been making innovative medicines to help people with diabetes lead longer, healthier lives for 95 years. This heritage has given us experience and capabilities that also enable us to help people defeat other serious diseases including obesity, hemophilia and growth disorders. We remain steadfast in our conviction that the formula for lasting success is to stay focused, think long-term and do business in a financially, socially and environmentally responsible way. With U.S. headquarters in?New Jersey?and production and research facilities in six states, Novo Nordisk employs nearly 6,000 people throughout the country. For more information, visit?novonordisk.us,?Facebook,?Instagram?and?Twitter.
References
- Fiasp [package insert].?Plainsboro, NJ: Novo Nordisk Inc;?October 2019.
- Diabetes Care. 2015 Apr;38(4):716-22. doi: 10.2337/dc15-0168.
- J Clin Med. 2016 Jan; 5(1): 5. Published online 2016?Jan 4. doi: 10.3390/jcm5010005
- Diabetes Care. 2018 Aug;41(8):1579-1589. doi: 10.2337/dci18-0002. Epub 2018 Jun 23.
- Klonoff D, et al. Diabetes Obes Metab. 2019;21:961?967. doi: 10.1111/dom.13610
Novo Nordisk is a registered trademark of Novo Nordisk A/S.?
? 2019 Novo Nordisk All rights reserved. US19FSP00188 October 2019 SOURCE Novo Nordisk