TOUJEO 300 U/mL

insulin glargine · INJECTION, SOLUTION · Sanofi-Aventis U.S. LLC

No Recall HistoryCurrently in Shortage

Plain English

TOUJEO is a injection, solution containing insulin glargine at 300 U/mL, taken subcutaneous. Manufactured by Sanofi-Aventis U.S. LLC.

Key Facts

Brand Name: TOUJEO
Generic Name: insulin glargine
NDC Code (Product): 0024-5869
Manufacturer: Sanofi-Aventis U.S. LLC
Strength: 300 U/mL
Dosage Form: INJECTION, SOLUTION
Route: SUBCUTANEOUS
Marketing Status
Application #: BLA206538
Drug Class: Insulin Analog [EPC]
Marketing Start: 02/15/2015

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE TOUJEO is indicated to improve glycemic control in adults and pediatric patients 6 years of age and older with diabetes mellitus. TOUJEO is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients 6 years and older with diabetes mellitus. ( 1 ) Limitations of Use : Not recommended for the treatment of diabetic ketoacidosis. ( 1 ) Limitations of Use: TOUJEO is not recommended for the treatment of diabetic ketoacidosis.

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Individualize dose based on type of diabetes, metabolic needs, blood glucose monitoring results and glycemic control goal. ( 2.1 , 2.2 , 2.3 ) Administer subcutaneously into the abdominal area, thigh, or deltoid once daily at any time during the day, at the same time every day. ( 2.1 ) Rotate injection sites to reduce risk of lipodystrophy and localized cutaneous amyloidosis. ( 2.1 ) Do not dilute or mix with any other insulin or solution. ( 2.1 ) See Full Prescribing Information for the recommended starting dosage in patients with type 2 diabetes and how to switch to TOUJEO from other insulins ( 2.3 , 2.4 ) Closely monitor glucose when changing switching to TOUJEO and during initial weeks thereafter. ( 2.4 ) 2.1 Important Administration Instructions Always check insulin labels before administration [see Warnings and Precautions (5.4) ] . Visually inspect the TOUJEO solution for particulate matter and discoloration prior to administration and only use if the solution is clear and colorless with no visible particles. Inject TOUJEO subcutaneously into the abdominal area, thigh, or deltoid. Rotate injection sites within the same region from one injection to…

Contraindications

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

Drug Interactions

7 DRUG INTERACTIONS Table 3 includes clinically significant drug interactions with TOUJEO. Table 3: Clinically Significant Drug Interactions with TOUJEO 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, and SGLT-2 inhibitors. Intervention: Dosage reductions and increased frequency of glucose monitoring may be required when TOUJEO is coadministered with these drugs. Drugs That May Decrease the Blood Glucose Lowering Effect of TOUJEO 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 TOUJEO is coad…

Adverse Reactions

6 ADVERSE REACTIONS The following adverse reactions are 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 TOUJEO (≥5%) are: Hypoglycemia, allergic reactions, injection site reaction, lipodystrophy, pruritus, rash, edema, and weight gain. ( 6.1 , 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact sanofi-aventis at 1-800-633-1610 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials 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 actually observed in clinical practice. The data in Table 1 reflect the exposure of 304 patients with type 1 diabetes to TOUJEO with mean exposure duration of 23 weeks. The type 1 diabetes population had the following characteristics: Mean age was 46 years and mean duration of diabetes wa…

Frequently Asked Questions

What is TOUJEO used for?

TOUJEO contains insulin glargine. It is a injection, solution taken subcutaneous. Consult your doctor for specific uses.

Is TOUJEO a controlled substance?

TOUJEO is not classified as a controlled substance by the DEA.

What is the generic name for TOUJEO?

The generic name for TOUJEO is insulin glargine. There are 11 other brand versions of insulin glargine.

What is the NDC code for TOUJEO 300 U/mL?

The NDC (National Drug Code) for TOUJEO 300 U/mL is 0024-5869, listed by Sanofi-Aventis U.S. LLC.

Product NDC

0024-5869

Package NDC

0024-5869-00

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)