Tresiba FlexTouch 100U/mL

TRESIBA is indicated to improve glycemic control in patients 1 year of age and older with diabetes mellitus. Limitations of Use • Not recommended for the treatment of diabetic ketoacidosis. TRESIBA is a long-acting human insulin analog indicated to improve glycemic control in patients 1 year of age and older with diabetes mellitus ( 1 ). Limitations of Use: • Not recommended for the treatment of diabetic ketoacidosis.

• See Full Prescribing Information for important administration instructions . • Inject TRESIBA subcutaneously into the thigh, upper arm, or abdomen . • Rotate injection sites to reduce risk of lipodystrophy and localized cutaneous amyloidosis . • For pediatric patients requiring less than 5 units of TRESIBA each day, use a TRESIBA U-100 vial . • In adults, inject subcutaneously once daily at any time of day . • In pediatric patients inject subcutaneously once daily at the same time every day . • Individualize dose based on type of diabetes, metabolic needs, blood glucose monitoring results and glycemic control goal . • The recommended days between dose increases are 3 to 4 days . • See Full Prescribing Information for recommended starting dose in insulin naïve patients and patients already on insulin therapy
• Important Administration Instructions • Always check insulin labels before administration [see Warnings and Precautions ] . • Inspect visually for particulate matter and discoloration
• Only use TRESIBA if the solution appears clear and colorless. • Inject TRESIBA subcutaneously into the thigh, upper arm, or abdomen. • Rotate injection sites within the same region from one injection to the next to reduce the risk of lipodystrophy and localized cutaneous amyloidosis
• Do not inject into areas of lipodystrophy or localized cutaneous amyloidosis [see Warnings and Precautions , Adverse Reactions ]. …

Injection: Available as a clear and colorless solution: • 100 units/mL (U-100): 3 mL single-patient-use FlexTouch prefilled pen • 100 units/mL (U-100): 10 mL multiple-dose vial • 200 units/mL (U-200): 3 mL single-patient-use FlexTouch prefilled pen Injection: Available as: • 100 units/mL (U-100): 3 mL single-patient-use FlexTouch ® prefilled pen ( 3 ). …

• The safety and effectiveness of TRESIBA to improve glycemic control
• In pediatric patients 1 year of age and older with diabetes mellitus have been established
• The use of TRESIBA for this indication is supported by evidence from an adequate and well-controlled trial and a pharmacokinetic study (trials included
• Pediatric patients 1 year of age and older with type 1 diabetes mellitus) [ see Clinical Pharmacology and Clinical Studies ]. …

In controlled clinical trials [see Clinical Studies ( 14 )] a total of 77 (7%) of the 1102 TRESIBA-treated patients with type 1 diabetes were 65 years or older and 9 (1%) were 75 years or older. A total of 670 (25%) of the 2713 TRESIBA-treated patients with type 2 diabetes were 65 years or older and 80 (3%) were 75 years or older. …

• Advise the patient and/or caregiver to read the FDA-approved patient labeling (Patient Information and Instructions for Use)
• There are separate Instructions for Use for the Vials and FlexTouch Pens
• Never Share a TRESIBA FlexTouch Pen, Needle, or Insulin Syringe Between Patients Advise patients that they should never share a TRESIBA FlexTouch pen device with another person, even if the needle is changed
• Advise patients using TRESIBA vials not to share needles or insulin syringes with another person
• Sharing poses a risk for transmission of blood-borne pathogens [see Warnings and Precautions ] . …

TRESIBA is contraindicated: • During episodes of hypoglycemia [see Warnings and Precautions ( 5.3 )] . • In patients with hypersensitivity to insulin degludec or any of the excipients in TRESIBA [see Warnings and Precautions ( 5.5 )] . • During episodes of hypoglycemia ( 4 ). • Hypersensitivity to insulin degludec or any of the excipients in TRESIBA ( 4 ).

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, salicylates, somatostatin analogs (e.g., octreotide), and sulfonamide antibiotics, GLP-1 receptor agonists, DPP-4 inhibitors, SGLT-2 inhibitors. Intervention: Dosage reductions and increased frequency of glucose monitoring may be required when TRESIBA is co-administered with these drugs. …

• Never share a TRESIBA FlexTouch pen, insulin syringe, or needle between patients, even if the needle is changed ( 5.1 ). • Hyperglycemia or hypoglycemia with changes in insulin regimen: Make changes to a patient’s insulin regimen (e.g., insulin strength, manufacturer, type, injection site or method of administration) under close medical supervision with increased frequency of blood glucose monitoring ( 5.2 ). • Hypoglycemia : May be life-threatening. Increase monitoring with changes to: insulin dosage, concomitant drugs, meal pattern, physical activity; and in patients with renal impairment or hepatic impairment or hypoglycemia unawareness ( 5.3 , 5.4 , 6.1 ). …

The following adverse reactions are also discussed elsewhere: • Hypoglycemia [see Warnings and Precautions ( 5.3 )] • Hypoglycemia due to Medication errors [see Warnings and Precautions ( 5.4 )] • Hypersensitivity reactions [see Warnings and Precautions ( 5.5 )] • Hypokalemia [see Warnings and Precautions ( 5.6 )] Adverse reactions commonly associated with TRESIBA are: • hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, edema and weight gain ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Novo Nordisk at 1-800-727-6500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …

8.1 Pregnancy Risk Summary Available data from one unpublished trial and the published literature with TRESIBA use during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. …

An excess of insulin relative to food intake, energy expenditure, or both may lead to severe and sometimes prolonged and life-threatening hypoglycemia and hypokalemia [see Warnings and Precautions ( 5.3 , 5.6 )] . Mild episodes of hypoglycemia usually can be treated with oral glucose. Lowering the insulin dosage, and adjustment in meal patterns or exercise may be needed. More severe episodes of hypoglycemia with coma, seizure, or neurologic impairment may be treated with a glucagon for emergency use or concentrated intravenous glucose. …

Tome assim que lembrar, a menos que esteja quase na hora da próxima dose. Nesse caso, pule a dose esquecida. Nunca tome duas doses de uma vez para compensar. Confira a bula, pois alguns medicamentos são diferentes.