What is insulin glargine recombinant?

Insulin glargine is a long-acting human insulin analog produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli (K12). Insulin glargine differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines are added to the C-terminus of the B-chain. Insulin glargine has a molecular weight of 6063 Da. LANTUS (insulin glargine) injection is a sterile, clear and colorless solution for subcutaneous use in a 10 mL multiple-dose vial or a 3 mL single-patient use prefilled pen (LANTUS Solostar). Prefilled Pen (LANTUS Solostar) and Vial: Each mL contains 100 units of insulin glargine and the inactive ingredients: glycerol 85% (20 mg), m-cresol (2.7 mg), zinc (30 mcg), and Water for Injection, USP. The vial also contains polysorbate 20 (20 mcg). The pH is adjusted by addition of aqueous solutions of hydrochloric acid and sodium hydroxide. LANTUS has a pH of approximately 4.

Can you take insulin glargine recombinant with other medicines?

It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run insulin glargine recombinant against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.

What brand names is insulin glargine recombinant sold under?

We track 4 insulin glargine recombinant-containing products in the U.S.: Lantus, Lantus Solostar, Toujeo Max Solostar and Toujeo Solostar. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.

What forms does insulin glargine recombinant come in?

Across the brands we track, insulin glargine recombinant is currently marketed as injectable, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.

Is there a generic insulin glargine recombinant?

We do not currently list a generic-labelled insulin glargine recombinant product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.

Insulin Glargine Recombinant: uses, dosing, side effects & brands

Insulin Glargine Recombinant is a medicine sold in the U.S. under 4 brand and generic names. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.

By the pharmaranks editorial teamReviewed against the FDA (openFDA label, NDC Directory & Enforcement) sourcesHow we research

Key facts

Available as: Injectable
Sold as: 4 products — Lantus, Lantus Solostar and Toujeo Max Solostar, and others
Prescription?: Prescription only
Generic available?: Not in our catalog

How insulin glargine recombinant is dosed

From the FDA label for Lantus (application BLA021081). Other insulin glargine recombinant products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.

Individualize dosage based on metabolic needs, blood glucose monitoring, glycemic control, type of diabetes, and prior insulin use. ( 2.2 ) Administer subcutaneously into the abdominal area, thigh, or deltoid once daily at any time of day, but at the same time every day. ( 2.1 ) Do not dilute or mix with any other insulin or solution. ( 2.1 ) Rotate injection sites to reduce risk of lipodystrophy and localized cutaneous amyloidosis. ( 2.1 ) See Full Prescribing Information for the recommended starting dosage in patients with type 2 diabetes ( 2.3 ) and how to change to LANTUS from other insulins ( 2.4 ) Closely monitor glucose when switching to LANTUS 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 LANTUS vials and SoloStar prefilled pens for particulate matter and discoloration prior to administration. Only use if the solution is clear and colorless with no visible particles. Administer LANTUS subcutaneously into the abdominal area, thigh, or deltoid, and 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 (5.2) and Adverse…

Insulin Glargine Recombinant side effects

The following adverse reactions are discussed elsewhere: Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen [see Warnings and Precautions (5.2) ] 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 LANTUS include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, edema, and weight gain. ( 6.1 ) 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 clinical trials of a drug cannot be directly compared to rates in the clinical trial of another drug and may not reflect the rates observed in practice. The data in Table 1 reflect the exposure of 2,327 patients with type 1 diabetes to LANTUS or NPH in Studies A, B, C, and D [see Clinical Studies (14.2) ] . The type 1 diabetes population had the following characteristics: the mean age was 39 years, 54% were male, and mean body mass index (BMI) was 25.1 kg/m 2 . Ninety-seven percent were White, 2% were Black or African American and less than 1%…

Every insulin glargine recombinant product we track (4)

Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.

Insulin Glargine Recombinant products
#	Drug	Rating	Type	Form	Generic?	Typical price
1	Lantus	Not yet rated	Prescription	Injectable	—	—	View →
2	Lantus Solostar	Not yet rated	Prescription	Injectable	—	—	View →

Frequently asked questions

What is insulin glargine recombinant?: Insulin glargine is a long-acting human insulin analog produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli (K12). Insulin glargine differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines are added to the C-terminus of the B-chain. Insulin glargine has a molecular weight of 6063 Da. LANTUS (insulin glargine) injection is a sterile, clear and colorless solution for subcutaneous use in a 10 mL multiple-dose vial or a 3 mL single-patient use prefilled pen (LANTUS Solostar). Prefilled Pen (LANTUS Solostar) and Vial: Each mL contains 100 units of insulin glargine and the inactive ingredients: glycerol 85% (20 mg), m-cresol (2.7 mg), zinc (30 mcg), and Water for Injection, USP. The vial also contains polysorbate 20 (20 mcg). The pH is adjusted by addition of aqueous solutions of hydrochloric acid and sodium hydroxide. LANTUS has a pH of approximately 4.
Can you take insulin glargine recombinant with other medicines?: It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run insulin glargine recombinant against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is insulin glargine recombinant sold under?: We track 4 insulin glargine recombinant-containing products in the U.S.: Lantus, Lantus Solostar, Toujeo Max Solostar and Toujeo Solostar. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does insulin glargine recombinant come in?: Across the brands we track, insulin glargine recombinant is currently marketed as injectable, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.

Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.

Insulin Glargine Recombinant drug interactions

Table 8 includes clinically significant drug interactions with LANTUS. Table 8: Clinically Significant Drug Interactions with LANTUS 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), 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 LANTUS is coadministered with these drugs. Drugs that May Decrease the Blood Glucose Lowering Effect of LANTUS 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 LANTUS is coadministered with these drugs. Drugs that May Increase or Decrease the Blood Glucose Lowering Effect of LANTUS Drugs : Alcohol, beta-blockers, clonidine, and lithium salts. Pentamidine may cause hypoglycemia, which may…