Classified in: HealthSubject: FDA
FDA approves Fiasp® for use in insulin infusion pumps for adults with type 1 or type 2 diabetes
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:
- 10 mL vial for use in insulin pumps or MDI
- 3 mL FlexTouch® for MDI
- 3 mL PenFill® Cartridge for NovoPen Echo for MDI
"People living with diabetes are looking for treatment options that fit into their lifestyles and shifting schedules, and for many, an insulin pump is an important part of their regimen," said Todd Hobbs, vice president and U.S. chief medical officer of Novo Nordisk. "Since the launch of Fiasp®, we've heard time and again from the diabetes community about the need to make it available for adult insulin pump users. This label update will now enable adult patients to use Fiasp® in their pumps, which is an important part of our ongoing commitment to patient choice and meeting the needs of people living with type 1 and type 2 diabetes."
The label change is based on the FDA's review of data from the onset 5 clinical trial, which confirmed the efficacy and safety of Fiasp® when used in insulin infusion pumps in adults with diabetes. 5 Fiasp® has been shown to be well-tolerated and effective in pumps releasing steady doses throughout the day and mealtime doses during meals. The pump should be programmed based on guidance from healthcare providers and the pump maker's instructions. 1
For information on cost and savings offers, including co-pay and patient assistance programs, visit Novocare.com.
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.
Important Safety Information
Do not share your Fiasp® with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.
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.
Before taking Fiasp® tell your health care provider about all your medical conditions including, if you:
- 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.
Talk to your health care provider about low blood sugar and how to manage it.
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.
What should I avoid while taking Fiasp®?
- Do not drive or operate heavy machinery, until you know how Fiasp® affects you.
- Do not drink alcohol or use medicines that contain alcohol.
What are the possible side effects of Fiasp®?
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.
Your insulin dose may need to change because of:
- weight gain or loss, increased stress, illness, or change in diet or level of physical activity
Common side effects of Fiasp® may include:
- 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.
Please see Prescribing Information for Fiasp at http://www.novo-pi.com/fiasp.pdf
About Novo Nordisk
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.
- 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
Fiasp® is a registered trademark of Novo Nordisk A/S.
Novo Nordisk is a registered trademark of Novo Nordisk A/S.
© 2019 Novo Nordisk All rights reserved. US19FSP00188 October 2019
SOURCE Novo Nordisk
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