Introduction
Basaglar Tempo Pen is a long-acting insulin analog indicated for the management of diabetes mellitus. It contains insulin glargine, which is biosimilar to Lantus insulin. The Tempo Pen is a prefilled, disposable insulin delivery device designed for subcutaneous administration, offering patients a convenient and accurate dosing option for basal insulin requirements.
Mechanism of Action
Insulin glargine is a recombinant human insulin analog that exerts its action by binding to insulin receptors on target cells (primarily muscle, fat, and liver cells). This binding activates the receptor's tyrosine kinase activity, initiating a cascade of intracellular signaling that promotes glucose uptake into cells, inhibits hepatic glucose production, and regulates metabolism of carbohydrates, lipids, and proteins. Unlike human insulin, insulin glargine has been modified to form microprecipitates in subcutaneous tissue, resulting in a slow, prolonged absorption and a relatively constant concentration-time profile over 24 hours.
Indications
- Treatment of type 1 diabetes mellitus in adults and pediatric patients ≥6 years
- Treatment of type 2 diabetes mellitus in adults
- Used as basal insulin to control hyperglycemia throughout the day
Dosage and Administration
Route: Subcutaneous injection only Standard dosing: Individualized based on metabolic needs, blood glucose monitoring, and glycemic control goals Typical starting dose:- Type 1 diabetes: Approximately one-third to one-half of total daily insulin requirements
- Type 2 diabetes: 0.2 units/kg or 10 units once daily
- Administer once daily at the same time each day
- Rotate injection sites within the same region (abdomen, thigh, or upper arm)
- Do not dilute or mix with other insulins
- The Tempo Pen delivers doses from 1 to 80 units in 1-unit increments
- Renal impairment: Requires careful glucose monitoring and dose adjustment
- Hepatic impairment: Increased risk of hypoglycemia; requires dose reduction and frequent monitoring
- Geriatric patients: Higher susceptibility to hypoglycemia; initiate with lower doses
Pharmacokinetics
Absorption: Slowly absorbed from subcutaneous tissue due to precipitation at neutral pH; onset of action occurs within 2-4 hours Distribution: Distributed throughout extracellular fluid; protein binding approximately 98% Metabolism: Metabolized in liver and kidney to active and inactive metabolites Elimination: Half-life approximately 12 hours; duration of action up to 24 hours Time to peak effect: No pronounced peak; relatively flat pharmacokinetic profileContraindications
- Hypersensitivity to insulin glargine or any component of the formulation
- During episodes of hypoglycemia
- Do not use in insulin infusion pumps
Warnings and Precautions
Hypoglycemia: Most common adverse reaction; risk increased with changes in meal patterns, physical activity, and concomitant glucose-lowering medications Hypokalemia: Insulin preparations may cause potassium shifts into intracellular space Lipodystrophy: May occur at injection sites; rotate injection sites to reduce risk Weight gain: Can occur with insulin therapy Fluid retention: May cause edema, particularly with improved glycemic control Allergic reactions: Both local and systemic reactions possible Medication errors: Do not substitute without medical supervision; different insulin products have different pharmacokinetic profilesDrug Interactions
Drugs that may increase hypoglycemia risk:- Oral antidiabetic agents
- GLP-1 receptor agonists
- ACE inhibitors
- Disopyramide
- Fluoxetine
- Fibrates
- Propoxyphene
- Salicylates
- Somatostatin analogs
- Sulfonamide antibiotics
- Corticosteroids
- Diuretics
- Sympathomimetic agents
- Phenothiazines
- Thyroid hormones
- Estrogens
- Progestogens
- Atypical antipsychotics
- Protease inhibitors
Adverse Effects
Very common (>10%):- Hypoglycemia
- Injection site reactions (redness, swelling, itching)
- Allergic reactions
- Lipodystrophy
- Weight gain
- Peripheral edema
- Pruritus
- Rash
- Severe hypoglycemia
- Anaphylaxis
- Sodium retention
- Hypokalemia
Monitoring Parameters
- Blood glucose levels (fasting and periodic postprandial)
- HbA1c every 3 months until stable, then every 6 months
- Hypoglycemia symptoms and awareness
- Injection sites for lipodystrophy or reactions
- Renal and hepatic function in patients with impairment
- Electrolytes (particularly potassium) in at-risk patients
- Weight changes
- Signs of fluid retention
Patient Education
- Never share pens or needles with others
- Rotate injection sites within the same body region
- Use a new needle for each injection
- Always have a source of fast-acting glucose available
- Recognize and treat hypoglycemia early
- Do not skip doses; administer at the same time daily
- Proper storage: refrigerate unused pens; in-use pens may be kept at room temperature for up to 28 days
- Do not freeze or expose to excessive heat
- Regular self-monitoring of blood glucose
- Carry diabetes identification
- Inform all healthcare providers about insulin therapy
- Report any signs of allergic reactions or persistent injection site reactions
References
1. FDA Prescribing Information: Basaglar (insulin glargine) injection. 2022 2. American Diabetes Association. Standards of Medical Care in Diabetes—2023. Diabetes Care. 2023;46(Suppl 1) 3. Home PD. The pharmacokinetics and pharmacodynamics of rapid-acting insulin analogues and their clinical consequences. Diabetes Obes Metab. 2012;14(9):780-788 4. Rosenstock J, et al. Similar efficacy and safety of Basaglar and Lantus in patients with type 2 diabetes in age subgroups. Diabetes Technol Ther. 2018;20(7):465-472 5. Blonde L, et al. Patient-directed titration for achieving glycaemic goals using a once-daily basal insulin analogue: an assessment of two different fasting plasma glucose targets—the TITRATE study. Diabetes Obes Metab. 2009;11(6):623-631 6. Heinemann L, et al. Insulin glargine: a systematic review of a long-acting insulin analogue. Clin Ther. 2013;35(8):S1-S31