FDA Approves Levemir® Pregnancy Category Change For Women With Diabetes

Levemir® is the first and only basal insulin analog with pregnancy Category B classification

Princeton, N.J. /PRNewswire/ - Novo Nordisk, a world leader in diabetes care, announced today that the U.S. Food and Drug Administration (FDA) has approved Levemir® (insulin detemir [rDNA origin] injection) for a pregnancy Category B classification, indicating that Levemir®, when used in pregnant women with diabetes, did not increase the risk of harm to the unborn baby.

The label update makes Levemir® the first and only basal insulin analog to have this classification. Until this decision, NPH (human insulin) was considered the standard of care for diabetes in pregnancy. Now, Novo Nordisk is the only company that offers a complete portfolio of insulin analogs with a pregnancy Category B classification.

The FDA category change was based on a review of a large, randomized controlled trial examining Levemir® in pregnant women with type 1 diabetes. The study compared the safety and efficacy of Levemir® against NPH insulin in the treatment of 310 women. The study found that patients taking Levemir® had similar A1C reduction at gestational week 36 and lower fasting plasma glucose levels at gestational weeks 24 and 36 compared with NPH. Additionally, the study found no differences in the overall safety profile during pregnancy, on pregnancy outcomes or the health of the fetus and newborn.

"We are excited that the FDA has granted approval for this new category rating for Levemir®," said Lois Jovanovic, MD, MACE, Chief Scientific Officer, Sansum Diabetes Research Institute in Santa Barbara, California. "For women who are pregnant, diabetes can be extremely challenging; they must be even more diligent and careful when monitoring blood sugar levels than before they were pregnant. This approval provides patients with a long-acting insulin analog option that can help them manage their blood sugar."

In the U.S., there are approximately 1.85 million women of child-bearing age with diabetes. For those who want to get pregnant, this development gives them another option to manage their diabetes.

Novo Nordisk now offers its comprehensive line of insulin analog products with a pregnancy Category B classification for use with the FlexPen®, including Levemir® (insulin detemir [rDNA origin] injection) FlexPen®. FlexPen® is a discreet, prefilled insulin pen device that gives patients the ability to manage their diabetes while they're on-the-go. FlexPen® is covered on more than 90 percent of insurance plans.

For more information, visit www.levemir-us.com.

About Levemir® (insulin detemir [rDNA origin] injection)
Indications and Usage:
Levemir® (insulin detemir [rDNA origin] injection) is a man-made long-acting insulin that is used to control high blood sugar in adults and children with diabetes mellitus.

It is not recommended to use Levemir® to treat diabetic ketoacidosis.

Important Safety Information:
Do not take Levemir® if you are allergic to any of the ingredients in Levemir®.

If you take too much Levemir®, your blood sugar may fall too low (hypoglycemia). Check your blood sugar levels. Ask your health care provider what your blood sugar levels should be and when you should check them. Drinking alcohol may affect your blood sugar when you take Levemir®.

Before you take Levemir®, tell your health care provider about all of the medicines you take, and all of your medical conditions, including if you have liver or kidney problems, or if you are pregnant or breastfeeding or if you are planning to do so.

Do not make any changes to your dose or the type of insulin you use unless you are told to do so by your health care provider.

Do not dilute or mix Levemir® with any other insulin or solution. Do not use Levemir® in an insulin pump. Inject Levemir® under your skin (subcutaneously) in your upper arm, abdomen (stomach area) or thigh. Never inject Levemir® into a vein or muscle.

Do not share needles, insulin pens or syringes with others.

Common side effects of Levemir® include low blood sugar (hypoglycemia), local allergic reactions at the injection site (redness, swelling and itching), and weight gain. Serious side effects include low blood sugar (hypoglycemia), skin thickening or pits at the injection site (lipodystrophy), and allergic reactions. Serious allergic reactions can cause life-threatening symptoms. Get medical help right away if you have any symptoms of an allergic reaction such as body rash, itching, shortness of breath or wheezing, fast heartbeat, sweating, or feel faint. Ask your health care provider or pharmacist for more information.

Please see www.levemir-us.com for Levemir® complete Prescribing Information.

About NovoLog® (insulin aspart [rDNA origin] injection)
Indications and Usage:
NovoLog® is a man-made insulin that is used to control high blood sugar in adults and children with diabetes mellitus.

Important Safety Information:
Do not take NovoLog® if your blood sugar is too low (hypoglycemia) or if you are allergic to anything in NovoLog®. If you take too much NovoLog® your blood sugar may fall too low.

NovoLog® is a fast-acting insulin. You should eat a meal within 5 to 10 minutes after using NovoLog® to avoid low blood sugar. Do not inject NovoLog® if you do not plan to eat right after using NovoLog®. Check your blood sugar levels. Ask your health care provider what your blood sugars should be and when you should check your blood sugar levels. Alcohol, including beer and wine, may affect your blood sugar when you take NovoLog®.

Do not change the type of insulin you use unless told to do so by your health care provider. The amount of insulin you take as well as the best time for you to take your insulin may need to change if you take a different type of insulin.

Do not mix NovoLog® with any other insulins when used in a pump or with any insulins other than NPH when used with injections by syringe.

Needles and NovoLog® FlexPen® must not be shared.

Tell your health care provider about all medicines you take and all of your medical conditions, including if you are pregnant or breastfeeding. Your NovoLog® dose may change if you take other medicines.

NovoLog® has not been studied in children with type 2 diabetes or in children with type 1 diabetes under the age of two.

The most common side effects of NovoLog® Mix 70/30 include skin thickening or pits at the injection site (lipodystrophy), weight gain, swelling of your hands and feet, and vision changes. Serious adverse events may include low blood sugar (hypoglycemia), low potassium in your blood (hypokalemia), local allergic reactions at the injection site (like redness, swelling, and itching), and whole body reactions. Get medical help right away if you have any of these symptoms of an allergic reaction: a rash over the whole body, have trouble breathing, fast heart rate, sweating or if you feel faint. Ask your health care provider or pharmacist for more information.

Please see www.novolog.com for NovoLog® complete Prescribing Information.

About NovoLog® Mix 70/30 (70% insulin aspart protamine suspension and 30% insulin aspart injection, [rDNA origin])
Indications and Usage: NovoLog® Mix 70/30 (70% insulin aspart protamine suspension and 30% insulin aspart injection, [rDNA origin]) is a man-made insulin that is used to control high blood sugar in adults with diabetes mellitus.

It is not known if NovoLog® Mix 70/30 is safe or effective in children.

Important Safety Information:
Do not take NovoLog® Mix 70/30 if your blood sugar is too low (hypoglycemia) or if you are allergic to any of the ingredients in NovoLog® Mix 70/30. If you take too much NovoLog® Mix 70/30, your blood sugar may fall too low (hypoglycemia).

NovoLog® Mix 70/30 starts acting fast. If you have Type 1 diabetes, inject it up to 15 minutes before you eat a meal. If you have Type 2 diabetes, you may inject NovoLog® Mix 70/30 up to 15 minutes before or after starting your meal.

Check your blood sugar levels regularly. Ask your healthcare provider what your blood sugars should be and when you should check your blood sugar levels. Do not make any changes to your dose or type of insulin unless your healthcare provider tells you to. Alcohol, including beer and wine, may affect your blood sugar when you take NovoLog® Mix 70/30.

Before using NovoLog® Mix 70/30, tell your health care provider about all medicines you take and all of your medical conditions, including if you have kidney or liver problems or if you are pregnant or breastfeeding. It is not known if NovoLog® Mix 70/30 will harm your unborn baby or pass into breast milk. Your NovoLog® Mix 70/30 dose may change if you take other medicines.

Do not inject NovoLog® Mix 70/30 with any other insulin products or use in an insulin pump.

Do not share needles, insulin pens or syringes with others.

The most common side effects of NovoLog® Mix 70/30 include skin thickening or pits at the injection site (lipodystrophy), weight gain, swelling of your hands and feet, and vision changes. Serious adverse events may include low blood sugar (hypoglycemia), low potassium in your blood (hypokalemia), local allergic reactions at the injection site (like redness, swelling, and itching), and whole body reactions. Get medical help right away if you have any of these symptoms of an allergic reaction: a rash over the whole body, have trouble breathing, fast heart rate, sweating or if you feel faint. Ask your health care provider or pharmacist for more information.

Please see www.novologmix70-30.com for complete NovoLog® Mix 70/30 Prescribing Information.

About Novo Nordisk
Headquartered in Denmark, Novo Nordisk is a global healthcare company with 89 years of innovation and leadership in diabetes care. The company also has leading positions within hemophilia care, growth hormone therapy and hormone replacement therapy. For more information, visit novonordisk-us.com.

About Diabetes
In the United States, 25.8 million people have diabetes, a condition in which the body does not produce enough or properly use insulin, the hormone needed to convert sugar, starches and other food into energy needed for daily life.

SOURCE: Novo Nordisk