Novo Nordisk Launches Ozempic® and Fiasp®, Expanding Treatment Options for Adults with Diabetes

Ozempic®, a new once-weekly GLP-1 RA and Fiasp®, a new fast-acting mealtime insulin are now available in U.S. pharmacies

News provided by

Novo Nordisk

Feb 05, 2018, 08:35 ET

PLAINSBORO, N.J., Feb. 5, 2018 /PRNewswire/ -- Novo Nordisk today announced the availability of two new diabetes medications, Ozempic^® (semaglutide) injection 0.5 mg or 1 mg and Fiasp^® (insulin aspart injection) 100 Units/mL at pharmacies across the United States.

Ozempic^® is a once-weekly glucagon-like peptide (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.¹
Fiasp^® is a fast-acting mealtime insulin indicated to improve glycemic control in adults with type 1 and type 2 diabetes.²

Both medications received approval from the U.S. Food and Drug Administration (FDA) in 2017 and represent the latest advancements to Novo Nordisk's robust diabetes portfolio.

"With 1.5 million new patients diagnosed with diabetes each year,³ we must continue to innovate and bring to market new options to meet the diverse needs of patients," said David Moore, senior vice president, Commercial, Novo Nordisk. "There is no one-size-fits-all approach to effectively managing diabetes and we are proud to add Ozempic^® and Fiasp^® to our market-leading portfolio to give patients new treatment options. Our robust portfolio of diabetes products addresses the concerns and needs of people with diabetes, particularly around dosing and administration."

Ozempic^® is administered once weekly. In clinical trials, Ozempic^®demonstrated statistically significant A1C reductions. Ozempic^® is priced at parity to current market-leading weekly GLP-1 receptor agonists, and eligible patients with commercial insurance can use the Ozempic^®Instant Savings Card to reduce co-pays to as low as $25 per prescription fill for up to two years. For more information about the instant savings card, please visit www.OzempicSavings.com or call 877-304-6855. Please visit www.ozempic.com for more information about Ozempic^®.

Fiasp^® is the first fast-acting mealtime insulin injection that does not have a pre-meal dosing recommendation. Fiasp^®should be administered at the beginning of a meal or within 20 minutes after starting a meal due to its appearance in the blood in approximately 2.5 minutes.² The list price of Fiasp^® is the same as mealtime insulin NovoLog^® and eligible patients with commercial insurance can use the Novo Nordisk Instant Savings Card to reduce co-pays for Fiasp^®to as low as $25 per 30-day supply for up to two years. For more information about the instant savings card, please visit www.MyFiaspSavings.com or call 877-304-6852. Fiasp^® is also available to eligible patients through the Novo Nordisk Patient Assistance Program. More information on the Novo Nordisk Patient Assistance Program is available by calling 866-310-7549. Please visit www.MyFiasp.com for more information about Fiasp^®.

About Ozempic^®

What is Ozempic^®?
Ozempic^® (semaglutide) injection 0.5 mg or 1 mg is an injectable prescription medicine for adults with type 2 diabetes that along with diet and exercise may improve blood sugar.

Ozempic^® is not recommended as the first choice of medicine for treating diabetes.
It is not known if Ozempic^® can be used in people who have had pancreatitis.
Ozempic^® is not a substitute for insulin and is not for use in people with type 1 diabetes or people with diabetic ketoacidosis.
It is not known if Ozempic^® is safe and effective for use in children under 18 years of age.

Selected Important Safety Information for Ozempic^®

Do not share your Ozempic^® pen 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.

What is the most important information I should know about Ozempic^®?

Ozempic^® may cause serious side effects, including:

Possible thyroid tumors, including cancer. Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rodents, Ozempic^® and medicines that work like Ozempic^® caused thyroid tumors, including thyroid cancer. It is not known if Ozempic^® will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.
Do not use Ozempic^® if you or any of your family have ever had MTC, or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

Do not use Ozempic^®if:

you or any of your family have ever had MTC or if you have MEN 2.
you are allergic to semaglutide or any of the ingredients in Ozempic^®.

About Fiasp^®

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.

Selected Important Safety Information for Fiasp^®

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.

Important Safety Information for Ozempic^®(continued)

Before using Ozempic^®, tell your health care provider if you have any other medical conditions, including if you:

have or have had problems with your pancreas or kidneys.
have a history of diabetic retinopathy.
are pregnant or breastfeeding or plan to become pregnant or breastfeed. It is not known if Ozempic^® will harm your unborn baby or passes into your breast milk. You should stop using Ozempic^® 2 months before you plan to become pregnant.

Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements, and other medicines to treat diabetes, including insulin or sulfonylureas.

How should I use Ozempic^®?

Ozempic^® is injected under the skin (subcutaneously) of your stomach (abdomen), thigh, or upper arm. Do not inject Ozempic^® into a muscle (intramuscularly) or vein (intravenously).
Do not mix insulin and Ozempic^® together in the same injection.
Change (rotate) your injection site with each injection. Do not use the same site for each injection.
Talk to your healthcare provider about how to prevent, recognize and manage low blood sugar (hypoglycemia), high blood sugar (hyperglycemia), and problems you have because of your diabetes.

What are the possible side effects of Ozempic^®?
Ozempic^® may cause serious side effects, including:

inflammation of your pancreas (pancreatitis). Stop using Ozempic^® and call your health care provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back.
changes in vision. Tell your healthcare provider if you have changes in vision during treatment with Ozempic^®.
low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Ozempic^®with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include: dizziness or lightheadedness, blurred vision, anxiety, irritability or mood changes, sweating, slurred speech, hunger, confusion or drowsiness, shakiness, weakness, headache, fast heartbeat, and feeling jittery.
kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems to get worse. It is important for you to drink fluids to help reduce your chance of dehydration.
serious allergic reactions. Stop using Ozempic^® and get medical help right away if you have any symptoms of a serious allergic reaction, including itching, rash, or difficulty breathing.

The most common side effects of Ozempic^® may include nausea, vomiting, diarrhea, stomach (abdominal) pain, and constipation.

Please see Medication Guide and Prescribing Information, including Boxed Warning for Ozempic, at http://www.novo-pi.com/ozempic.pdf

Important Safety Information for Fiasp^® (continued)

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.
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.

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.
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.

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 Type 2 Diabetes
Type 2 diabetes is a serious condition that affects more than 28 million people in the United States (9.4 percent of the population).³ The diagnosis is most common in adults and occurs when the body no longer produces enough of the blood sugar-regulating hormone, insulin, or is no longer able to use the insulin the body produces properly. Additionally, people with type 2 diabetes are two to four times more likely to have cardiovascular disease than those without diabetes.⁴ Type 2 diabetes is a life-long condition once diagnosed, but can be managed through a combination of lifestyle modifications like eating healthy, physical activity and oral and/or injectable medications as prescribed by a physician.⁵

About Novo Nordisk
Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: hemophilia, growth disorders and obesity. With U.S. headquarters in Plainsboro, N.J., Novo Nordisk Inc. has nearly 5,000 employees in the United States. For more information, visit novonordisk.us or follow us on Twitter: @novonordiskus.

References

Ozempic^® [package insert]. Plainsboro, NJ: Novo Nordisk Inc; December 2017.
Fiasp^® [package insert]. Plainsboro, NJ: Novo Nordisk Inc; September 2017.
Centers for Disease Control and Prevention. National Diabetes Statistics Report, 2017. https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf. Updated 2017. Accessed January 2018.
World Heart Federation. Risk Factors. https://www.world-heart-federation.org/resources/risk-factors/. Updated 2017. Accessed January 2018.
Centers for Disease Control and Prevention. Type 2 Diabetes. https://www.cdc.gov/diabetes/basics/type2.html. Updated July 25, 2017. Accessed January 2018.