AIA) at least once during the studies, including 89.7% that were positive at baseline. In studies of type 2 diabetes patients, 31.5% of patients who received TRESIBA once daily were positive for AIA at least once during the studies, including 14.5% that were positive at baseline. The antibody incidence rates for type 2 diabetes may be underreported due to potential assay interference by endogenous insulin in samples in these patients. The presence of antibodies that affect clinical efficacy may necessitate dose adjustments to correct for tendencies toward hyper or hypoglycemia.
The incidence of anti-insulin degludec antibodies has not been established.
7 DRUG INTERACTIONS
Table 5 includes clinically significant drug interactions with TRESIBA.
Table 5: Clinically Significant Drug Interactions with TRESIBA
Drugs That May Increase the Risk of Hypoglycemia
Drugs:
Antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, propoxyphene, salicylates, somatostatin analogs (e.g., octreotide), and sulfonamide antibiotics, GLP-1 receptor agonists, DPP-4 inhibitors, SGLT-2 inhibitors.
Intervention:
Dose reductions and increased frequency of glucose monitoring may be required when TRESIBA is co-administered with these drugs.
Drugs That May Decrease the Blood Glucose Lowering Effect of TRESIBA
Drugs:
Atypical antipsychotics (e.g., olanzapine and clozapine), corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline), and thyroid hormones.
Intervention:
Dose increases and increased frequency of glucose monitoring may be required when TRESIBA is co-administered with these drugs.
Drugs That May Increase or Decrease the Blood Glucose Lowering Effect of TRESIBA
Drugs:
Alcohol, beta-blockers, clonidine, and lithium salts. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia.
Intervention:
Dose adjustment and increased frequency of glucose monitoring may be required when TRESIBA is co-administered with these drugs.
Drugs That May Blunt Signs and Symptoms of Hypoglycemia
Drugs:
Beta-blockers, clonidine, guanethidine, and reserpine
Intervention:
Increased frequency of glucose monitoring may be required when TRESIBA is co-administered with these drugs.
8 USE IN SPECIFIC POPULATIONS
8.1 PregnancyPregnancy Category C
There are no well-controlled clinical studies of the use of insulin degludec in pregnant women. Patients should be advised to discuss with their health care provider if they intend to or if they become pregnant. Because animal reproduction studies are not always predictive of human response, insulin degludec should be used during pregnancy only if the potential benefit justifies the potential risk to the
