TRESIBA 200 U/mL
insulin degludec · INJECTION, SOLUTION · A-S Medication Solutions
Tresiba (insulin degludec) is a long-acting insulin injection used to help control blood sugar levels in people with diabetes. It is administered under the skin and works by replacing insulin that the body cannot produce adequately on its own.
Key Facts
- Brand Name
- TRESIBA
- Generic Name
- insulin degludec
- NDC Code (Product)
50090-7094- Manufacturer
- A-S Medication Solutions
- Strength
- 200 U/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Marketing Status
- Application #
- BLA203314
- Drug Class
- Insulin Analog [EPC]
- Marketing Start
- 09/25/2015
Recall History
Novo Nordisk Inc
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
Novo Nordisk Inc
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
Novo Nordisk Inc
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE 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.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • See Full Prescribing Information for important administration instructions ( 2.1 ). • Inject TRESIBA subcutaneously into the thigh, upper arm, or abdomen ( 2.1 ). • Rotate injection sites to reduce risk of lipodystrophy and localized cutaneous amyloidosis ( 2.1 ). • For pediatric patients requiring less than 5 units of TRESIBA each day, use a TRESIBA U-100 vial ( 2.1 ). • In adults, inject subcutaneously once daily at any time of day ( 2.2 ). • In pediatric patients inject subcutaneously once daily at the same time every day ( 2.2 ). • Individualize dose based on type of diabetes, metabolic needs, blood glucose monitoring results and glycemic control goal ( 2.2 ). • The recommended days between dose increases are 3 to 4 days ( 2.2 ). • See Full Prescribing Information for recommended starting dose in insulin naïve patients and patients already on insulin therapy ( 2.3 , 2.4 ). 2.1 Important Administration Instructions • Always check insulin labels before administration [see Warnings and Precautions ( 5.4 ) ] . • Inspect visually for particulate matter and discoloration. Only use TRESIBA if the solution appears clear and colorless. • Inject TRESIBA subc…
Contraindications
4 CONTRAINDICATIONS 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 ).
Drug Interactions
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, 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. 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: Dosage increases and increased frequency of glucose monitoring may be required when TRESIBA is co…
Adverse Reactions
6 ADVERSE REACTIONS 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. 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 TRESIBA in subjects with type 1 diabetes or type 2 diabetes was evaluated in nine trials of 6-12 month duration in adults and in one trial of 12-month duration in pediatric patients 1 year of age and older with type 1 diabetes. The cardiovascular s…
Frequently Asked Questions
What is TRESIBA used for?
Tresiba (insulin degludec) is a long-acting insulin injection used to help control blood sugar levels in people with diabetes. It is administered under the skin and works by replacing insulin that the body cannot produce adequately on its own.
Is TRESIBA a controlled substance?
TRESIBA is not classified as a controlled substance by the DEA.
What is the generic name for TRESIBA?
The generic name for TRESIBA is insulin degludec. There are 10 other brand versions of insulin degludec.
What is the NDC code for TRESIBA 200 U/mL?
The NDC (National Drug Code) for TRESIBA 200 U/mL is 50090-7094, listed by A-S Medication Solutions.
Other TRESIBA Dosages
Other Insulin Brands
See all →- Insulin Degludec200 U/mL50090-7175
- Insulin Degludec100 U/mL73070-400
- Tresiba100 U/mL0169-2660
- Tresiba100 U/mL0169-2662
- Xultophy 100/3.6100 [iU]/mL0169-2911
- Insulin Degludec100 U/mL50090-7176
- Tresiba200 U/mL0169-2550
- Tresiba200 U/mL50090-3491
- Insulin Degludec100 U/mL73070-403
- Insulin Degludec200 U/mL73070-503
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)