Insulin degludec

Serious side effects have been reported with insulin degludec 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. 
• Low potassium in your blood (hypokalemia). 
• Heart failure. Taking certain diabetes pills called thiazolidinediones or “TZDs” with insulin degludec 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. Your healthcare provider should monitor you closely while you are taking TZDs with insulin degludec. 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 may need to be adjusted or stopped by your healthcare provider if you have new or worse heart failure.

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 with other insulin products. 

Never share a insulin degludec FlexTouch pen between patients, even if the needle is changed.

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 

Drive or operate heavy machinery, until you know how this medication affects you.

Avoid alcohol while using insulin degludec. 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.

Do not use insulin degludec:

• if you are allergic to insulin degludec or any of its ingredients
• during episodes of low blood sugar

Insulin is a hormone that works by lowering levels of glucose (sugar) in the blood. Insulin degludec is a long-acting insulin that starts to work several hours after injection and keeps working evenly for 24 hours.

Insulin degludec is used to improve blood sugar control in adults with diabetes mellitus. This medicine may be used for type 1 or type 2 diabetes.

Insulin degludec may also be used for purposes not listed in this medication guide.

Insulin can cause low blood sugar. Avoid driving or operating machinery until you know how this medicine will affect you.

Avoid medication errors by always checking the medicine label before injecting your insulin.

Avoid drinking alcohol. It can cause low blood sugar and may interfere with your diabetes treatment.

Get emergency medical help if you have signs of an allergic reaction: hives, itching, skin rash; wheezing, tiredness, trouble breathing; feeling like you might pass out; nausea, diarrhea; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• fluid retention--weight gain, swelling in your hands or feet, feeling short of breath; or

• low potassium--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

Common side effects may include:

• low blood sugar;

• itching, mild skin rash; or

• thickening or hollowing of the skin where you injected the medicine.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Diabetes Type 1:

Dose should be individualized based on clinical response; this basal insulin should be used in regimens with short or rapid-acting insulin

Insulin-naive patients:
Initial dose: One-third to one-half the total daily insulin requirement subcutaneously once a day.
-The initial total daily insulin requirement in insulin naive patients is generally 0.2 to 0.4 units of insulin per kilogram of body weight.

Current insulin users:
Initiate at the same total daily dose of current long or intermediate-acting insulin subcutaneously once a day.

Comments:
-Adjust dosage according to metabolic needs, blood glucose measurements, and glycemic goals; dose increases should occur no sooner than every 3 to 4 days.
-Doses should be individualized based on clinical response; this basal insulin should be used in regimens with short or rapid-acting insulin
-When changing treatment regimens, the dose and frequency of short-acting insulin may need to be adjusted.
-To minimize hypoglycemia, closely monitor blood glucose, especially with changing regimens.

Use: To improve glycemic control in patients with type 1 diabetes mellitus.

Usual Adult Dose for Diabetes Type 2:

Initial dose: 10 units subcutaneously once a day

Current insulin users:
Initiate at the same total daily dose of current long or intermediate-acting insulin subcutaneously once a day.

Comments:
-Adjust dosage according to metabolic needs, blood glucose measurements, and glycemic goals; dose increases should occur no sooner than every 3 to 4 days.
-When changing treatment regimens, the dose and frequency of short-acting insulin or other anti-diabetic medications may need to be adjusted.
-To minimize hypoglycemia, closely monitor blood glucose, especially with changing regimens.

Use: To improve glycemic control in patients with type 2 diabetes mellitus.

Usual Pediatric Dose for Diabetes Type 1:

Age: 1 year or older:

Insulin-naive patients:
Initial dose: One-third to one-half the total daily insulin requirement subcutaneously once a day
-The initial total daily insulin requirement in insulin naive patients is generally 0.2 to 0.4 units of insulin per kilogram of body weight.

Current insulin users:
Initiate at 80% of the total daily dose of current long or intermediate-acting insulin subcutaneously once a day.

Comments:
-Not recommended for pediatric patients who require less than 5 units of this insulin daily.
-Inject subcutaneously once a day at the same time every day; if a dose is missed, consult health care professional for guidance.
-Adjust dosage according to metabolic needs, blood glucose measurements, and glycemic goals; dose increases should occur no sooner than every 3 to 4 days.
-Doses should be individualized based on clinical response; this basal insulin should be used in regimens with short or rapid-acting insulin
-When changing treatment regimens, the dose and frequency of short-acting insulin may need to be adjusted.
-For pediatric patients already on insulin therapy, dosing should start at 80% of current therapy in order to minimize hypoglycemia, closely monitor blood glucose with changing regimens.

Use: To improve glycemic control in patients with type 1 diabetes mellitus.

Usual Pediatric Dose for Diabetes Type 2:

Age: 1 year or older:
Initial dose: 10 units subcutaneously once a day

Current insulin users:
Initiate at 80% of the total daily dose of current long or intermediate-acting insulin subcutaneously once a day.

Comments:
-Not recommended for pediatric patients who require less than 5 units of this insulin daily.
-Inject subcutaneously once a day at the same time every day; if a dose is missed, consult health care professional for guidance
-Adjust dosage according to metabolic needs, blood glucose measurements, and glycemic goals; dose increases should occur no sooner than every 3 to 4 days.
-For pediatric patients already on insulin therapy, dosing should start at 80% of current therapy in order to minimize hypoglycemia, closely monitor blood glucose with changing regimens.
-When changing treatment regimens, the dose and frequency of short-acting insulin or other anti-diabetic medications may need to be adjusted.

Use: To improve glycemic control in patients with type 2 diabetes mellitus.

Many other medicines can affect your blood sugar, and some medicines can increase or decrease the effects of insulin. Some drugs can also cause you to have fewer symptoms of hypoglycemia, making it harder to tell when your blood sugar is low. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products.

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

(IN su lin de GLOO dek)

~1 hour

Time to Peak

9 hours

Half-Life Elimination

~25 hours (independent of dose)

Protein Binding

>99% (albumin)

Hypersensitivity to insulin degludec or any component of the formulation; during episodes of hypoglycemia

Documentation of allergenic cross-reactivity for insulin is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.

Adverse events were observed in animal reproduction studies secondary to maternal hypoglycemia.

In women with diabetes, maternal hyperglycemia can be associated with congenital malformations as well as adverse effects in the fetus, neonate, and the mother (ACOG 2005; ADA 2017c; Kitzmiller 2008; Metzger 2007). To prevent adverse outcomes, prior to conception and throughout pregnancy maternal blood glucose and HbA1c should be kept as close to target goals as possible but without causing significant hypoglycemia (ACOG 2013; ADA 2017c; Blumer 2013; Kitzmiller 2008; Lambert 2013).

Insulin therapy is the preferred treatment of type 1 and type 2 diabetes in pregnant women, as well as GDM when pharmacologic therapy is needed (ADA 2017c). Information specific to insulin degludec use in pregnant women has not been located. Insulin requirements tend to fall during the first trimester of pregnancy and increase in the later trimesters, peaking at 28 to 32 weeks' gestation. Following delivery, insulin requirements decrease rapidly (ACOG 2005).

Applies to insulin degludec: subcutaneous solution

Along with its needed effects, insulin degludec may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking insulin degludec:

• Bloating or swelling of the face, arms, hands, lower legs, or feet
• rapid weight gain
• tingling of the hands or feet
• unusual weight gain or loss

• Anxiety
• blurred vision
• chills
• cold sweats
• confusion
• convulsions
• cool, pale skin
• cough
• decreased urine
• depression
• difficulty with swallowing
• dizziness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• dry mouth
• fast heartbeat
• headache
• hives, itching, or skin rash
• increased hunger
• increased thirst
• irregular heartbeat
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• loss of appetite
• muscle pain or cramps
• nausea or vomiting
• nightmares
• numbness or tingling in the hands, feet, or lips puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• shakiness
• slurred speech
• sweating
• tightness in the chest
• unusual tiredness or weakness

Some side effects of insulin degludec may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Abdominal or stomach pain
• body aches or pain
• diarrhea
• dry mouth
• ear congestion
• fever
• headache
• loss of voice
• nasal congestion
• nausea or vomiting
• runny nose
• sneezing
• sore throat

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• redistribution or accumulation of body fat

Use caution; glucose-monitoring should be intensified and the insulin dose adjusted on an individual basis.

Use caution; glucose-monitoring should be intensified and the insulin dose adjusted on an individual basis.