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Hypoglycemia: Omission of a meal or unplanned strenuous physical exercise may lead to hypoglycemia.
Hypoglycemia may occur if the insulin dose is too high in relation to the insulin requirement.
Patients whose blood-glucose control is greatly improved (eg, by intensified insulin therapy) may experience a change in their usual warning symptoms of hypoglycemia and must be advised accordingly. Usual warning symptoms may disappear in patients with long-standing diabetes.
Concomitant illness, especially infections and fever, usually increases the patient's insulin requirement. Concomitant diseases in the kidney, liver or diseases affecting the adrenal, pituitary or thyroid gland may require changes in the insulin dose. As with other basal insulin products, the prolonged effect of insulin degludec may delay recovery from hypoglycemia.
Hyperglycemia: Administration of rapid-acting insulin is recommended in situations with severe hyperglycemia.
Inadequate dosing and/or discontinuation of treatment in patients requiring insulin may lead to hyperglycemia and potentially to diabetic ketoacidosis. Furthermore, concomitant illness, especially infections, may lead to hyperglycemia and thereby cause an increased insulin requirement. Usually, the 1st symptoms of hyperglycemia develop gradually over a period of hours or days. They include thirst, increased frequency of urination, nausea, vomiting, drowsiness, flushed dry skin, dry mouth and loss of appetite as well as acetone odor of breath. In type 1 DM, untreated hyperglycemic events eventually lead to diabetic ketoacidosis, which is potentially lethal.
Transfer from Other Insulin Products: Transferring a patient to another type, brand or manufacturer of insulin must be done under medical supervision and may result in the need for a change in dosage.
Combination of Thiazolidinediones and Insulin Medicinal Products: Cases of cardiac failure have been reported when thiazolidinediones were used in combination with insulin, especially in patients with risk factors for development of cardiac failure. This should be kept in mind if treatment with the combination of thiazolidinediones and insulin degludec is considered. If the combination is used, patients should be observed for signs and symptoms of heart failure, weight gain and edema. Thiazolidinediones should be discontinued if any deterioration in cardiac symptoms occurs.
Eye Disorder: Intensification of insulin therapy with abrupt improvement in glycemic control may be associated with temporary worsening of diabetic retinopathy, while long-term improved glycemic control decreases the risk of progression of diabetic retinopathy.
Avoidance of Medication Errors: Patients must be instructed to always check the insulin label before each injection to avoid accidental mix-ups between the 2 different strengths of insulin degludec as well as other insulin products. Patients must visually verify the dialed units on the dose counter of the pen. Therefore, the requirement for patients to self-inject is that they can read the dose counter on the pen. Patients who are blind or have poor vision must be instructed to always get help/assistance from another person who has good vision and is trained in using the insulin device.
Insulin Antibodies: Insulin administration may cause insulin antibodies to form. In rare cases, the presence of such insulin antibodies may necessitate adjustment of the insulin dose in order to correct a tendency to hyperglycemia or hypoglycemia.
Effects on the Ability to Drive and Operate Machinery: The patient's ability to concentrate and react may be impaired as a result of hypoglycemia. This may constitute a risk in situations where these abilities are of special importance (eg, driving a car or operating machines).
Patients must be advised to take precautions to avoid hypoglycemia while driving. This is particularly important in those who have reduced or absent awareness of the warning signs of hypoglycemia or have frequent episodes of hypoglycemia. The advisability of driving should be considered in these circumstances.
Impairment of Fertility: Animal reproduction studies with insulin degludec have not revealed any adverse effects on fertility.
Use in Children: The safety and efficacy of insulin degludec in children and adolescents <18 years have not been established. Currently available data are described in Pharmacology: Pharmacokinetics, but no recommendation on a dosage can be made.
Insulin Degludec may be given to children ages 1 year old and above.
Use in Pregnancy & Lactation: The use of Insulin Degludec in pregnant women with diabetes has been investigated in an interventional trial (EXPECT Trial). A moderate amount of clinical trial and post-marketing data in pregnant women indicate no malformative or feto/neonatal toxicity. The treatment with Insulin Degludec may be considered during pregnancy, if clinically needed.
There is no clinical experience with Insulin Degludec during breast-feeding.
