Drug Detail:Insulin degludec (Insulin degludec)
Drug Class: Insulin
Usual Adult Dose for Diabetes Type 1
Insulin-naive patients:
Initial dose: One-third to one-half the total daily insulin requirement subcutaneously once a day
- Initial total daily insulin requirement in insulin naive patients is generally 0.2 to 0.4 units/kg
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
- Initial total daily insulin requirement in insulin naive patients is generally 0.2 to 0.4 units/kg
Current insulin users:
To minimize the risk of hypoglycemia: Initiate at 80% of the total daily long or intermediate-acting insulin dose subcutaneously once a day
Comments:
- For pediatric patients who require less than 5 units/day, use the U-100 vial.
- 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.
Use: To improve glycemic control in patients 1 year or older 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:
To minimize the risk of hypoglycemia: Initiate at 80% of the total daily long or intermediate-acting insulin dose subcutaneously once a day
Comments:
- For pediatric patients who require less than 5 units/day, use the U-100 vial.
- 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.
- 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 1 year or older with type 2 diabetes mellitus.
Renal Dose Adjustments
Use caution; glucose-monitoring should be intensified and the insulin dose adjusted on an individual basis.
Liver Dose Adjustments
Use caution; glucose-monitoring should be intensified and the insulin dose adjusted on an individual basis.
Dose Adjustments
Elderly: Glucose-monitoring should be intensified in patients 65 years or older.
Dose adjustments may be necessary with changes in daily insulin requirements:
- Daily insulin requirements may be higher during illness, stress, pregnancy, in obese patients, trauma, during concurrent use with medications having hyperglycemic effects, or after surgery
- Daily insulin requirements may be lower with exercise, weight loss, calorie restricted diets, or during concurrent use of medications having hypoglycemic effects.
Dosage adjustments may be required when the brand, type, or species of insulin is changed; oral antidiabetic treatment may need to be adjusted as well.
Missed doses:
- Adult patients: Ensure at least 8 hours between consecutive doses
- Pediatric patients: Contact health care professional for guidance; more frequent blood glucose monitoring should be performed until next scheduled dose.
Precautions
CONTRAINDICATIONS:
- Hypersensitivity to this product or any of its excipients
- During episodes of hypoglycemia
Safety and efficacy have not been established in patients younger than 1 years.
Consult WARNINGS section for additional precautions.
Dialysis
Data not available
Other Comments
Administration advice:
- Always check insulin labels before administration
- Never share an insulin pen between patients, even if the needle is changed; do not reuse or share needles or syringes between patients as this presents a risk for transmission of blood-borne pathogens
- Inject subcutaneously into thigh, upper arm, or abdomen; rotate sites to reduce the risk of lipodystrophy
Adults:
- Administer subcutaneously once a day at any time of the day
- Ensure a minimum of 8 hours between consecutive injections
- Administer subcutaneously once a day at the same time every day; if a dose is missed, contact healthcare provider for guidance
- For patients requiring less than 5 units/day, use the U-100 vial
- Do not administer IV or IM or use in insulin infusion pumps
- The dose window for both strengths (U-100 and U-200) shows the number of insulin units to be delivered; no dose conversion should be done
- Do not transfer insulin from the pen to an insulin syringe as the markings on the insulin syringe will not measure the dose correctly.
Preparation and Instructions for Use:
- All patients should receive instruction on proper injection technique prior to first use
- Inspect insulin; inject only if solution appears clear and colorless
- Place new needle on pen; prime the pen (turn dose selector to 2 units; with needle pointing up, tap the pen to allow any air bubbles to rise to top, then press and hold dose button until the dose counter shows "0" [the dose pointer should line up with the 0])
- Select dose and inject subcutaneously as instructed; keep needle in skin after dose counter has returned to "0" and slowly count to 6
- If insulin is seen coming from the needle tip when pulled from skin, a full dose may not have been delivered and blood sugar levels should be checked frequently to see if more insulin may be needed
- If blood is seen when needle tip is pulled from the skin, press injection site lightly but do not rub
- Dispose of properly
- Complete instructions are available in manufacturer's labeling.
Storage requirements:
- Not in use (unopened): Store in the refrigerator at 36F to 46F (2C to 8C); do not freeze, if frozen do not use
- In-use (opened): Store below 86F [30C]; discard after 8 weeks
- Unopened pens that are stored at room temperature (below 86F [30C]) should be discarded after 8 weeks
- Keep pen away from direct heat and protect from light
Compatibility:
- Do not dilute or mix with any other insulin products or solutions
General:
- Not recommended for the treatment of diabetic ketoacidosis.
- Insulin requirements may be altered during stress, major illness, or with changes in exercise, meal patterns, or coadministered drugs.
- Hypoglycemia is the most common adverse reaction of insulin therapy; the timing generally reflects the time-action profile of the administered insulin.
Monitoring:
- Blood glucose monitoring is essential for patients receiving insulin therapy.
- Urine ketone testing is recommended for patients with type I diabetes if they develop symptoms of colds, influenza, nausea, vomiting, or other illnesses, polyuria, or if blood glucose levels are unexpectedly high or inconsistent.
- Glycosylated hemoglobin measurements are recommended every 3 months.
Patient advice:
- Read the US FDA-approved patient labeling (Patient Information and Instructions for Use).
- Patients should be advised to never share an insulin pen with another person, even if the needle is changed; patients should understand that sharing needles or syringes with another person carries a risk for transmission of blood-borne pathogens.
- Patients should be reminded to always check insulin labels before injection, especially if using more than 1 type of insulin.
- Patients should be instructed on glucose monitoring, proper injection technique, and the management of hypoglycemia and hyperglycemia.
- Patients should be instructed on how to handle situations which may affect their insulin requirements.
- Patients should check blood sugar prior to driving a car or operating machinery.
- Advise patient to speak to physician or health care professional if pregnant or if they intend to become pregnant.
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