Insulin Icodec: uses, dosing, side effects & brands

The following adverse reactions are also discussed elsewhere: • Hypoglycemia Due to Medication Errors and Accidental Overdose [see Warnings and Precautions ( 5.1 )] • Hypoglycemia [see Warnings and Precautions ( 5.2 )] • Hypersensitivity reactions [see Warnings and Precautions ( 5.4 )] • Hypokalemia [see Warnings and Precautions ( 5.5 )] Adverse reactions commonly associated with Awiqli are: • hypoglycemia, hypersensitivity reactions (e.g., urticaria, swelling face and lips), injection site reactions, lipodystrophy, pruritus, rash, edema, and weight gain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novo Nordisk at 1-844-668-6463 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of Awiqli in patients with type 2 diabetes was evaluated in five clinical trials involving 1,880 adults with type 2 diabetes exposed to Awiqli, with a mean exposure duration of 26 to 52 weeks across the five trials [see Clinical Studies ( 14 )] . The type 2 diabetes population had the following characteristics: mean age was 59 years and 5% were older than 75 years, 59% were male, 71% were…

Awiqli is contraindicated: • During episodes of hypoglycemia [see Warnings and Precautions ( 5.2 )] . • In patients with hypersensitivity to insulin icodec-abae or any of the excipients in Awiqli FlexTouch. Serious hypersensitivity reactions have included anaphylaxis [see Warnings and Precautions ( 5.4 )] . • During episodes of hypoglycemia ( 4 ) • Hypersensitivity to insulin icodec-abae or any of the excipients in Awiqli ( 4 )

Table 3 includes clinically significant drug interactions with Awiqli. Table 3: Clinically Significant Drug Interactions with Awiqli Drugs That May Increase the Risk of Hypoglycemia Drugs: Antidiabetic agents, angiotensin converting enzyme (ACE) inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analogs (e.g., octreotide), and sulfonamide antibiotics, glucagon-like peptide-1 (GLP-1) receptor agonists, dipeptidyl peptidase-4 (DPP-4) inhibitors, sodium-glucose co-transporter 2 (SGLT-2) inhibitors. Intervention: Dose reductions and increased frequency of glucose monitoring may be required when Awiqli is co-administered with these drugs. Drugs That May Decrease the Blood Glucose Lowering Effect of Awiqli 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 Awiqli is co-administered with these drugs. Drugs That May Increase or Decrease the Blood Glucose Lowering Effect of Awiqli 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 Awiqli 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 Awiqli is co-administered with these drugs. • Drugs that may increase the risk of hypoglycemia : antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analog (e.g., octreotide), sulfonamide antibiotics, GLP-1 receptor agonists, DPP-4 inhibitors, and SGLT-2 inhibitors. ( 7 ) • Drugs that may decrease the blood glucose lowering effect : atypical antipsychotics, 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. ( 7 ) • Drugs that may increase or decrease the blood glucose lowering effect : Alcohol, beta-blockers, clonidine, lithium salts, and pentamidine. ( 7 ) • Drugs that may blunt the signs and symptoms of hypoglycemia : beta-blockers, clonidine, guanethidine, and reserpine. ( 7 )