FDA approves Ryzodeg 70/30

The U.S. Food and Drug Administration (FDA) has approved Ryzodeg 70/30 (insulin degludec/insulin aspart), a long-acting basal insulin analogue and rapid-acting human insulin analog combination indicated to improve glycemic control in adults with type 1 and 2 diabetes mellitus.
Ryzodeg 70/30 is a man-made insulin that is used to control high blood sugar in adults with diabetes mellitus.
Ryzodeg 70/30 is not for people with diabetic ketoacidosis (increased ketones in the blood or urine).
It is not known if this medicine is safe and effective in children under 18 years of age.
Do not take Ryzodeg 70/30 if you:
are having an episode of low blood sugar (hypoglycemia).
have an allergy to any of the active or inactive ingredients in Ryzodeg 70/30.
Before you start treatment:
tell your healthcare provider about all your medical conditions including, if you are:
pregnant, planning to become pregnant, or are breastfeeding.
taking new prescription or over-the-counter medicines, vitamins, or herbal supplements.
you should talk to your healthcare provider about low blood sugar and how to manage it.
Ryzodeg 70/30 side effects
Ryzodeg 70/30 may cause serious side effects that can lead to death, including:
Low blood sugar (hypoglycemia).
Signs and symptoms that may indicate low blood sugar include:
dizziness or light-headedness
sweating
confusion
fast heart beat
blurred vision
slurred speech
shakiness
anxiety, irritability, or mood changes
hunger
headache
Low potassium in your blood (hypokalemia).
Heart failure. Taking certain diabetes pills called thiazolidinediones or "TZDs" with Ryzodeg 70/30 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 Ryzodeg 70/30.  Tell your healthcare provider if you have any new or worse symptoms of heart failure including shortness of breath, swelling of your ankles or feet, tiredness, sudden weight gain.
Treatment with TZDs and Ryzodeg 70/30 may need to be adjusted or stopped by your healthcare provider if you have new or worse heart failure.
Your insulin dose may need to change because of:
change in level of physical activity or exercise
weight gain or loss
increased stress
illness
change in diet
Common side effects may include:
serious allergic reactions (whole body reactions), reactions at the injection site, skin thickening or pits at the injection site (lipodystrophy), itching, rash, swelling of your hands and feet, and weight gain.
Get emergency medical help if you have:
trouble breathing, shortness of breath, fast heartbeat, swelling of your face, tongue, or throat, sweating, extreme drowsiness, dizziness, confusion.
Th is is not a complete list of all the possible side effects.
Source: drugs.com

FDA approves Ryzodeg 70/30

The U.S. Food and Drug Administration (FDA) has approved Ryzodeg 70/30 (insulin degludec/insulin aspart), a long-acting basal insulin analogue and rapid-acting human insulin analog combination indicated to improve glycemic control in adults with type 1 and 2 diabetes mellitus. Ryzodeg 70/30 is a man-made insulin that is used to control high blood sugar in adults with diabetes mellitus. Ryzodeg 70/30 is not for people with diabetic ketoacidosis (increased ketones in the blood or urine). It is not known if this medicine is safe and effective in children under 18 years of age. Do not take Ryzodeg 70/30 if you: are having an episode of low blood sugar (hypoglycemia). have an allergy to any of the active or inactive ingredients in Ryzodeg 70/30. Before you start treatment: tell your healthcare provider about all your medical conditions including, if you are: pregnant, planning to become pregnant, or are breastfeeding. taking new prescription or over-the-counter medicines, vitamins, or herbal supplements. you should talk to your healthcare provider about low blood sugar and how to manage it. Ryzodeg 70/30 side effects Ryzodeg 70/30 may cause serious side effects that can lead to death, including: Low blood sugar (hypoglycemia). Signs and symptoms that may indicate low blood sugar include: dizziness or light-headedness sweating confusion fast heart beat blurred vision slurred speech shakiness anxiety, irritability, or mood changes hunger headache Low potassium in your blood (hypokalemia). Heart failure. Taking certain diabetes pills called thiazolidinediones or TZDs with Ryzodeg 70/30 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 Ryzodeg 70/30. Tell your healthcare provider if you have any new or worse symptoms of heart failure including shortness of breath, swelling of your ankles or feet, tiredness, sudden weight gain. Treatment with TZDs and Ryzodeg 70/30 may need to be adjusted or stopped by your healthcare provider if you have new or worse heart failure. Your insulin dose may need to change because of: change in level of physical activity or exercise weight gain or loss increased stress illness change in diet Common side effects may include: serious allergic reactions (whole body reactions), reactions at the injection site, skin thickening or pits at the injection site (lipodystrophy), itching, rash, swelling of your hands and feet, and weight gain. Get emergency medical help if you have: trouble breathing, shortness of breath, fast heartbeat, swelling of your face, tongue, or throat, sweating, extreme drowsiness, dizziness, confusion. Th is is not a complete list of all the possible side effects. Source: drugs.com