Usual Adult Dose for Diabetes Type 2

Insulin glargine 100 units/lixisenatide 33 mcg per mL (100/33); dosage is expressed in insulin glargine units

DISCONTINUE basal insulin or glucagon-like peptide-1 (GLP-1) receptor agonist prior to initiating this drug:

• For Patients Naive to Basal Insulin or GLP-1 Receptor Agonist; Currently on a GLP-1 Receptor Agonist; or Currently Receiving Less Than 30 units per day of Basal Insulin:
• Initial dose: 15 units subcutaneously once a day

For Patients Receiving 30 to 60 units of Basal Insulin With or Without a GLP-1 Receptor Agonist:

• Initial dose: 30 units subcutaneously once a day

TITRATE dose up or down in increments of 2 to 4 units/week based on metabolic needs, blood glucose monitoring results, and glycemic goal until desired fasting plasma glucose is achieved

• Maintenance dose: 15 to 60 units per day
• Maximum dose: Insulin glargine 60 units/lixisenatide 20 mcg once a day

Comments:

• Administer once a day within the hour prior to the first meal of the day.
• This drug should be titrated until desired fasting plasma glucose is achieved.
• Additional titration may be needed to minimize the risk of hypoglycemia or hyperglycemia (e.g., with changes in physical activity, diet or timing of food intake, during acute illness; or when used with other medications.

Use: As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Renal Dose Adjustments

Mild to severe renal impairment: Use with caution; frequent glucose monitoring and dose adjustment may be necessary
ESRD (CrCl less than 15 mL/min): Not recommended

Liver Dose Adjustments

Use with caution; frequent glucose monitoring and dose adjustment may be necessary

Dose Adjustments

Elderly:

• Initial dosing, dose increments, and maintenance dose should be conservative to avoid hypoglycemic reactions.

Dosed as insulin glargine units; product labeling provides a dose chart with lixisenatide mcg dose corresponding to insulin glargine units.

Concomitant Use of an Insulin Secretagogue (e.g., Sulfonylurea) or Insulin:

• Risk of hypoglycemia may be lowered by reducing the dose of the insulin secretagogue or insulin

Additional titration of dose may be needed with changes in physical activity, meal patterns (macronutrient content or timing of meals), during acute illness, or when used with other medications.

Precautions

CONTRAINDICATIONS:

• During episodes of hypoglycemia
• Hypersensitivity to active substances or product excipients

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• For subcutaneous use only; do not administer IV, IM, or use in an insulin pump
• To avoid medication errors, always check label prior to injection
• Administer subcutaneously once a day within 1 hour prior to the first meal of the day; administer into thigh, upper arm, or abdomen; rotate injection sites within same region to reduce the risk of lipodystrophy
• Patients should be trained on proper use and injection technique
• Do not dilute or mix with any other insulin product or solution; do not split dose
• Pen dials in 1 unit increments; use caution in patients with visual impairment who may rely on audible clicks to dial their dose

Missed doses:

• If a dose is missed, resume once-daily regimen with next scheduled dose; do not administer an extra dose or increase a dose to make up for missed dose.

Storage requirements:

• Prior to first opening: Store in refrigerator 36F to 46F (2C to 8C); protect from light; do not use if it has been frozen
• After first opening, store at room temperature (below 77F [25C]); do not put pen back in the refrigerator; remove needle and replace pen cap after each use to protect from light; discard 28 days after first opening

Reconstitution/preparation techniques:

• Prefilled syringe is for single-patient-use only; use needles compatible with syringe
• Use a new needle for each injection; always remove needle after each injection and store pen without a needle attached; this prevents contamination or leakage
• Consult product labeling for detailed instructions, including illustrations, for use

Compatibility: Do not mix with any other products; do not add to infusion fluids

General:

• This drug has not been studied in patients with a history of pancreatitis; consider other antidiabetic therapies in patients with a history of pancreatitis.
• This drug should not be used in combination with any other product containing lixisenatide or another GLP-1 receptor agonist.
• This drug is not indicated for use in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
• This drug has not been studied in patients with gastroparesis and is not recommended in patients with severe gastroparesis.
• This drug has not been studied in combination with prandial insulin.

Monitoring:

• Monitor glycemic control; dose adjustments should be based on fasting plasma glucose; patients should self-monitor blood glucose (SMBG) frequently during therapy initiation and as clinically indicated.
• Monitor for hyper and hypoglycemia; the prolonged effect of this insulin may delay recovery from hypoglycemia.
• Monitor serum potassium in patients at risk of hypokalemia
• Monitor for edema or worsening heat failure in patients receiving concomitant PPAR-gamma agonists

Patient advice:

• Patients should be instructed to read the US FDA-approved patient labeling (Medication Guide and Instructions for Use).
• Patients should be advised to never share pen with another person, even if the needle is changed; patients should understand that sharing needles or syringes with another person carries a risk for transmission of blood-borne pathogens
• Patients should be instructed to always check labels before dosing to prevent mix-ups between this drug and other injectable diabetes products.
• Patients should be instructed on glucose monitoring, proper injection technique, and the management of hypoglycemia and hyperglycemia.
• Patients should be instructed to check blood sugar prior to driving a car or operating machinery.
• Patients should be instructed to seek medical advice during periods of stress, such as fever, trauma, infection, or surgery as medical management of diabetes may change.
• Patients should be aware of the potential for hypersensitivity reactions and steps to take if they occur.
• Patients should be aware of the potential for gastrointestinal reactions and take measures to ensure adequate fluid intake to avoid dehydration and to seek medical advice for persistent and severe events.
• Patients should understand there is a potential risk for pancreatitis; patients should report persistent severe abdominal pain, especially if pain radiates to the back.
• Advise patient to speak to physician or health care professional if pregnant, intend to become pregnant, or are breastfeeding.

Frequently asked questions

• What are the different types of insulin?
• What is the difference between Soliqua and Xultophy?