Insulin Degludec & Insulin Aspart

Insulin degludec/insulin aspart is a prescription medication used to treat adults with type 1 and type 2 diabetes. This medication combines an "ultra-long acting" and a rapid-acting insulin that together help keep blood glucose at consistent levels for long periods of time.

Insulin degludec/insulin aspart comes as a solution to be injected subcutaneously (just under the skin) once or twice daily, at mealtimes.

The most frequently reported side effect is low blood sugar. Insulin degludec/insulin aspart should not be used in those who have increased ketones in their blood or urine (diabetic ketoacidosis).

Insulin degludec/insulin aspart is a prescription medication used to treat adults with type 1 and type 2 diabetes. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Insulin Degludec & Insulin Aspart may be found in some form under the following brand names:

• Ryzodeg

Serious side effects have been reported with Insulin degludec/insulin aspart. See the “Insulin degludec/insulin aspart Precautions” section.

Common side effects of Insulin degludec/insulin aspart include the following:

• low blood sugar
• local reactions at the place you inject yourself may occur. The signs may include: pain, redness, hives, swelling and itching. The reactions usually disappear after a few days. See your doctor if they do not disappear after a few weeks. Stop using this medication and see a doctor right away if the reactions become serious. 
• skin changes where you use the injection (lipodystrophy). It is not known if insulin degludec/insulin aspart may cause lipodystrophy but such skin changes have been seen with other types of insulin. Fatty tissue under the skin may shrink (lipoatrophy) or get thicker (lipohypertrophy). Changing where you inject each time may reduce the risk of developing these skin changes. If you notice these skin changes, tell your doctor. If you keep injecting in the same place, these reactions can become more severe and affect the amount of medicine your body gets from the pen.

This is not a complete list of side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• other medicines for diabetes (oral and injectable)
• sulfonamides
• anabolic steroids such as testosterone
• beta-blockers. They may make it harder to recognize the warning signs of too low blood sugar.
• acetylsalicylic acid (and other salicylates)
• monoamine oxidase (MAO) inhibitors
• angiotensin converting enzyme (ACE) inhibitors

Some medications can increase your blood sugar levels and can affect your insulin treatment such as the following:

• danazol
• oral contraceptives
• thyroid hormones
• growth hormone
• glucocorticoids such as ‘cortisone’
• sympathomimetics such as epinephrine (adrenaline), salbutamol or terbutaline
• thiazides
• antifungal medications

This is not a complete list of drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with insulin degludec/insulin aspart including the following:

• Low blood sugar (hypoglycemia). If you get too low blood sugar, eat glucose tablets or another high sugar snack, like sweets, biscuits or fruit juice (always carry glucose tablets or a high sugar snack, just in case). Signs of low blood sugar include:
  • headache
  • slurred speech
  • fast heartbeat
  • cold sweat
  • cool pale skin
  • feeling sick
  • feeling very hungry
  • tremor
  • feeling nervous or worried
  • feeling unusually tired, weak and sleepy
  • feeling confused
  • difficulty in concentrating
  • short-lasting changes in your sight
• High blood sugar (hyperglycemia). This can occur if you eat more or exercise less than usual, drink alcohol, get an infection or a fever, have not used enough insulin, keep using less insulin than you need, forget to use your insulin or stop using insulin without talking to your doctor. Signs of very high blood sugar include:
  • flushed, dry skin
  • feeling sleepy or tired
  • dry mouth
  • fruity (acetone) breath
  • urinating more often
  • feeling thirsty
  • losing your appetite
  • feeling or being sick (nausea or vomiting)

These may be signs of a very serious condition called ketoacidosis. This is a build-up of acid in the blood because the body is breaking down fat instead of sugar. If not treated, this could lead to diabetic coma and eventually death. If you have very high blood sugar, get medical help immediately. 

• Hypersensitivity reactions: Severe, life-threatening, generalized allergy, including anaphylaxis, can occur. Seek immediate attention if you develop an allergic reaction. 
• Heart failure. Taking certain diabetes pills called thiazolidinediones or “TZDs” with insulin degludec/insulin aspart 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 insulin degludec/insulin aspart. Your healthcare provider should monitor you closely while you are taking TZDs with insulin degludec/insulin aspart. Tell your healthcare provider if you have any new or worse symptoms of heart failure including shortness of breath, tiredness, swelling of your ankles or feet and sudden weight gain. Treatment with TZDs and insulin degludec/insulin aspart may need to be adjusted or stopped by your healthcare provider if you have new or worse heart failure. 
• Eye disorder. Fast improvements in blood sugar control may lead to a temporary worsening of diabetic eye disorder. If you experience eye problems talk to your doctor.

If you are switching from other insulin products, the insulin dose may need to be changed. Talk to your doctor.

Always check the insulin label before each injection to avoid accidentally confusing insulin degludec/insulin aspart with other insulin products. 

Avoid alcohol while using insulin degludec/insulin aspart. If you drink alcohol, your need for insulin may change. Your blood sugar level may either rise or fall. You should therefore monitor your blood sugar level more often than usual.

Your insulin dose may need to change because of:

• change in level of physical activity or exercise
• increased stress 
• change in diet
• weight gain or loss
• illness 

Do not take insulin degludec/insulin aspart if you:

• are allergic to insulin degludec, insulin aspart or any of the other ingredients of this medicine 

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of insulin degludec/insulin aspart, there are no specific foods that you must exclude from your diet when receiving this medication.

Before using Insulin degludec/insulin aspart, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to insulin degludec/insulin aspart or to any of its ingredients
• have liver problems
• have kidney problems
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant. 

It is not known if insulin degludec/insulin aspart affects the baby in pregnancy. 

Your insulin dose may need to be changed during pregnancy and after delivery. Careful control of your diabetes is needed in pregnancy. Avoiding too low blood sugar (hypoglycemia) is particularly important for the health of your baby.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is unknown whether insulin degludec/insulin aspart is excreted in human milk. No metabolic effects are anticipated in the breastfed newborn/infant. Because many drugs, including human insulin, are excreted in human milk, caution should be exercised when insulin degludec is administered to a nursing mother. Women with diabetes who are lactating may require adjustments in insulin dose, meal plan, or both.

Use insulin degludec/insulin aspart exactly as prescribed.

Insulin degludec/insulin aspart can either be used once or twice each day.

Use with the main meal(s). You can change the time of dosing as long as insulin degludec/insulin aspart is dosed with the largest meal(s).

This medication is given as an injection under the skin in stomach area, upper arm or thigh.

The place within the chosen area should be altered with each injection to reduce the risk of lipodystrophy (changes in the distribution of body fat) under the skin that can affect the amount of insulin degludec/insulin aspart absorbed.

Always follow your doctor’s recommendation for dose.

If you want to change your usual diet, check with your doctor or pharmacist first as a change in diet may alter your need for insulin.

Based on your blood sugar level your doctor may change your dose. When using other medicines, ask your doctor if your treatment needs to be adjusted.

If you forget a dose, inject the missed dose with your next large meal on that day and thereafter resume your usual dosing schedule. Do not take a double dose to make up for a forgotten dose. 

Do not stop using your insulin without speaking to your doctor. If you stop using your insulin this could lead to a very high blood sugar level and ketoacidosis (a condition with too much acid in the blood).

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your age

The correct dose is determined individually for each patient.

In type-1 diabetes, this medication is used in combination with rapid-acting insulin, which is injected at other mealtimes.

If you use too much insulin degludec/insulin aspart, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the pen label and carton, after ‘EXP’. The expiry date refers to the last day of that month.

Before first use:

• Store in a refrigerator (2°C to 8°C). Keep away from the freezing element. Do not freeze.
• Keep the cap on the pen in order to protect from light.

After first opening or if carried as a spare:

• Do not refrigerate. You can carry your insulin degludec/insulin aspart pre-filled pen (FlexTouch) with you and keep it at room temperature (not above 30°C) for up to 4 weeks.
• Always keep the cap on the pen when you are not using it in order to protect from light.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment