Insulin glargine U-300

TOUJEO

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Pronunciation: IN-su-lin GLAR-jeen

Insulin glargine U-300 ballicule: receptor binding, kinetics and half-life diagram — Mechanism of action: Insulin glargine U-300 ballicule

What it isConcentrated long-acting insulin-receptor agonist; basal treatment of diabetes mellitus.

Why this oneIts smaller subcutaneous depot releases more smoothly and lasts longer than standard-concentration glargine.

What limits itHypoglycemia remains dose-limiting; never withdraw it from the pen or substitute by volume, and titrate cautiously.

Insulin glargine U-300 molecular structure (skeletal formula) — Molecular structure: Insulin glargine U-300

FDA label

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FDA dosing	Population	Start	Target	Max
Diabetes mellitus, type 1 (glycemic control)	Adults and pediatric ≥6 yr	~1/3 to 1/2 of total daily insulin dose (total daily ~0.2-0.4 units/kg)	Individualized	Individualized
Diabetes mellitus, type 2 (glycemic control)	Adults and pediatric ≥6 yr	0.2 units/kg QD	Individualized	Individualized

Titration No more frequently than every 3 to 4 days

Renal Not formally studied; frequent glucose monitoring and dose adjustment may be needed

Hepatic Not formally studied; frequent glucose monitoring and dose adjustment may be needed

U-300 concentration; on unit-for-unit basis has lower glucose-lowering effect than Lantus (U-100)

Instructions

Inject subcutaneously once daily at the same time each day (abdomen, thigh, or deltoid); rotate injection sites
Do not administer intravenously or in an insulin pump
Do not dilute or mix with any other insulin or solution
Do not transfer from the prefilled pen into a syringe

Available strengths

inj 300 units/mL

Contraindications

During episodes of hypoglycemia

Cautions

Never share pen between patients
Hyper- or hypoglycemia with changes in insulin regimen
Hypoglycemia (may be life-threatening)
Hypoglycemia due to medication errors
Hypersensitivity reactions including anaphylaxis
Hypokalemia
Fluid retention/heart failure with concomitant thiazolidinediones

Adverse reactions

Hypoglycemia
Allergic reactions
Injection site reactions
Lipodystrophy
Pruritus
Rash
Edema
Weight gain

Pregnancy Published studies have not reported a clear association with adverse developmental outcomes

Lactation Limited/no data on presence in human milk; endogenous insulin is present in human milk

Cost

Insulin glargine U-300 (TOUJEO)

Strength		#/mo	generic $/unit	CostPlus
300 units/mL	inj	per unit		not offered

NADAC is a voluntary CMS survey of what retail community pharmacies pay for the drugs they stock. Insulin glargine U-300 is administered under clinical supervision and dispensed outside retail pharmacies, so it rarely appears on surveyed invoices.

Other forms: Insulin glargine (LANTUS)

Available combined with: Lixisenatide (ADLYXIN)

NO BOXED WARNINGS

Principal riskHypoglycemia, including from dosing errors

Classes and tags

Clinical profile

Therapeutic safety burden3 / 4

Overdose danger4 / 4

Weight-gain liability3 / 4

Sedation liability0 / 4

QT / Torsades0 / 4

Direct muscarinic antagonism0 / 4

Embryofetal risk0 / 4

Legacy pregnancy categoryMultiple / indication-, trimester- or formulation-dependent

Defining liabilityHypoglycemia can rapidly cause seizures, coma or death; dosing and meal mismatches are the principal hazard.

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