Lantus Solostar

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Lantus Solostar

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Treatment option: Diabetes Mellitus

Medically reviewed

Marina Burgos

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Lantus Solostar

Lantus Solostar is a specific delivery device containing a long-acting insulin, Insulin Glargine, used to provide continuous, background blood sugar control. It is a prescription-only medicine, manufactured by Sanofi.

Property Description
Active ingredient Insulin Glargine (100 units/mL)
Form Sterile Solution for Subcutaneous Injection
Pharmacological class Basal Insulin / Long-Acting Human Insulin Analogue
Common purpose To provide a steady, peakless supply of background insulin
Manufacturer Sanofi
Prescription Status Prescription-only medicine (Rx)

Lantus Solostar: Definition and Pharmacological Classification

Lantus Solostar is the brand name for a pre-filled pen containing the active ingredient Insulin Glargine. This medicine is classified as a long-acting human insulin analogue and is designated a basal insulin. Its primary role is to serve as a foundational therapy by replacing the body’s essential, non-meal-related insulin needs.

Insulin Glargine is a biosynthetic compound, created through recombinant DNA technology. This advanced engineering provides a molecule with a structure modified specifically to ensure a stable, delayed, and sustained release mechanism in the body.

Composition, Form, and Unique Features

The medicine is supplied as a clear, sterile solution for injection contained within the disposable, single-patient-use Solostar pre-filled pen device, administered via subcutaneous injection. The solution is formulated at an acidic pH of 4.0, a key property that helps the drug work: once injected into the body's neutral environment, the solution precipitates, creating a small depot of microprecipitates in the tissue.

This unique depot formation allows the Insulin Glargine to be released slowly and consistently. This mechanism is recognized for creating a relatively constant, peakless concentration profile over 24 hours, which is the defining characteristic of a long-acting insulin.

General Purpose of Long-Acting Basal Insulin

The fundamental purpose of using a long-acting basal insulin is to establish a predictable, continuous background insulin supply throughout the day and night. This sustained therapeutic level is vital for regulating the body's overall metabolism and stabilizing blood glucose levels in the critical periods between meals and during sleep. By maintaining this constant supply, the medicine supports overall stability and helps limit significant glucose fluctuations.

Regulatory References

  1. DailyMed Label for Insulin Glargine Solostar

What side effects are possible with Lantus Solostar?

Possible side effects and safety information

The official safety profile for Lantus Solostar (Insulin Glargine) is strictly based on documented adverse reactions and safety statements from government regulatory authorities.

Frequency-Classified Adverse Reactions

The most frequently reported adverse reaction is hypoglycemia (low blood sugar), which is classified in regulatory documents as a Very Common event. This is the principal serious adverse reaction and may lead to clinical consequences such as loss of consciousness or central nervous system impairment.

Common reactions primarily involve General Disorders and Administration Site Conditions, including various forms of localized Injection Site Reactions (such as pain, swelling, and redness), as well as Weight gain. Reactions categorized as Uncommon include skin effects such as pruritus (itching) and generalized rash.

System-Organ Safety and Constraints

Adverse effects are also categorized by the physiological system they affect, including Metabolism and Nutrition Disorders and Skin and Subcutaneous Tissue Disorders. Lipodystrophy (lipoatrophy or lipohypertrophy) is associated with long-term use of the medicine at injection sites.

Serious adverse reactions documented in the official safety profile include Severe Systemic Allergic Reactions (anaphylaxis) and Hypokalemia (low blood potassium). Safety notes for specific populations exist: patients with renal or hepatic impairment have a documented increased risk of hypoglycemia. Furthermore, rapid improvement in blood glucose management at treatment initiation may be temporarily associated with effects on Eye Disorders (transitory refraction disorder) and Nervous System Disorders (acute painful peripheral neuropathy).

The medicine is formally restricted and contraindicated during episodes of active hypoglycemia or in cases of known hypersensitivity to the active substance or its excipients.

Overdose and Emergency Response

Overdose and When to Seek Help

Overdose of Lantus Solostar, like all insulin products, primarily results in hypoglycemia (very low blood glucose levels). Due to the prolonged action of insulin glargine, this low blood sugar event can be severe and persistent, potentially lasting for many hours. The risk of severe hypoglycemia increases with factors such as inappropriate dosing or accidental product mix-ups.

Clinical Manifestations of Overdose

Symptoms of hypoglycemia can range from mild to severe, affecting the nervous system and overall body function. Early symptoms may include sweating, clammy skin, fast heartbeat, anxiety, or confusion. If hypoglycemia is severe, it can lead to:

  • Seizures (convulsions)
  • Loss of consciousness (coma)
  • Permanent or temporary impairment of brain function

Specific populations, such as those with certain heart or brain vessel conditions, or patients with hypoglycemia unawareness, may be at higher risk for complications from severe hypoglycemia.

Emergency Response

Immediate medical help is required in the event of an overdose or if severe hypoglycemia occurs. The patient should be taken to an emergency department or a poison control center should be contacted right away.

Treatment for mild hypoglycemia typically involves the immediate intake of oral carbohydrates. Treatment for severe hypoglycemia requires the assistance of another person and may necessitate an injection of glucagon or the intravenous administration of glucose solution by healthcare professionals. Close monitoring in a clinical setting is crucial due to the extended duration of the insulin's effect.

Therapeutic Uses of Lantus Solostar

What Lantus Solostar Treats: Main Uses and Benefits

Lantus Solostar is commonly used to support stability in conditions associated with systemic imbalance. It is used to address the systemic imbalance associated with Type 1 Diabetes Mellitus and Type 2 Diabetes Mellitus in adults and children.

The medicine is generally relevant for addressing the symptom cluster of chronic hyperglycemia and conditions involving fluctuating manifestations of glucose levels. This therapeutic support contributes to easing the overall symptom load and helps manage symptoms that create noticeable physiological strain, such as excessive thirst and fatigue. It is used across domains where additional symptomatic support is needed, such as in contexts involving conditions marked by increased physiological stress. Its application contributes to easing the overall symptom load and helps patients cope more steadily with symptom fluctuations.

“Its application assists with maintaining functional stability when symptoms interfere with routine activities, particularly during prolonged periods without food.”


Quick Fact: Relief for Metabolic Instability
Common Use Context: Applied in clinical settings that involve acute or unstable symptom patterns, such as persistently high blood sugar levels upon waking.
Primary Benefit: Provides supportive relief when symptoms related to chronic hyperglycemia interfere with routine activities.

Regulatory References

  1. NIH MedlinePlus overview

Eligibility and Restrictions for Use

Who Can and Cannot Use Lantus Solostar?

This section defines population eligibility based strictly on official government regulatory documents.


Contraindications and Prohibited Populations

Lantus Solostar is contraindicated for patients with a known hypersensitivity (allergy) to insulin glargine or any of its excipients. It must not be used during acute episodes of hypoglycemia (low blood sugar). Furthermore, the medicine is not recommended for the treatment of Diabetic Ketoacidosis (DKA).


Approved Age Groups and Conditional Use

Official labeling establishes eligibility for adults with both Type 1 and Type 2 Diabetes Mellitus. For pediatric patients, use is approved only for those 6 years of age and older who have Type 1 Diabetes Mellitus; use is not established in children younger than 6 years of age.

Patients with renal (kidney) or hepatic (liver) impairment, as well as older adults (ge 65 years), are eligible but require caution and close monitoring. Use during pregnancy and lactation is permitted, but the official label mandates that the potential benefit must justify the potential risk.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official interaction profile for Insulin Glargine (Lantus Solostar) is primarily based on pharmacodynamic interference, meaning co-administered substances are documented in regulatory sources to affect blood glucose levels.

Documented Interaction Patterns

Interaction Type Examples of Interacting Medicinal Products (Official Labeling)
Increased Hypoglycemia Risk Other insulins, sulfonylureas, salicylates, Angiotensin-Converting Enzyme (ACE) inhibitors, Monoamine Oxidase Inhibitors (MAOIs), beta-blockers, and alcohol.
Increased Hyperglycemia Risk Corticosteroids, sympathomimetics, diuretics (e.g., thiazides), atypical antipsychotics, and estrogens.
Other Significant Interactions Thiazolidinediones (TZDs): Co-administration is officially linked to an increased risk of fluid retention and potential worsening of heart failure.

Official Regulatory Constraints

Insulin Glargine is not documented to have clinically relevant pharmacokinetic interactions via the Cytochrome P450 (CYP) enzyme system or drug transporters, as it is cleared by general proteolysis. Therefore, regulatory information is defined by the direct effects on glucose balance. A key restriction is that the solution must not be diluted or mixed with any other insulin or solution, as this officially alters its prolonged action profile. No specific time separation rules between Insulin Glargine and other medicines are mandated in the regulatory documents.

Mechanism of Action

Lantus Solostar contains Insulin Glargine, a long-acting insulin analogue whose mechanism is defined by two fundamental, interconnected actions: a physical control system for release and a molecular target system for effect.


️ Physical Control: Depot Formation and Peakless Release

The drug is formulated at an acidic pH (4.0). Upon injection into the body's neutral subcutaneous tissue, this solution forms microprecipitates, creating a stable, physical depot. This mechanism ensures Glargine molecules are released extremely slowly, producing a continuous, peakless concentration in the bloodstream over approximately 24 hours. This constant rate of entry provides the sustained, basal hormonal signal that modulates glucose concentration over the day-night cycle.


Molecular Action: Receptor Agonism and Metabolic Cascades

Once in the circulation, Insulin Glargine acts as a full agonist at the Insulin Receptor ( IR) on cells in the liver, muscle, and fat tissue. Activation of the IR initiates the PI3K/Akt pathway, which has two major physiological consequences: it promotes the rapid movement of GLUT4 transporters to peripheral cell surfaces to enhance glucose uptake, and it signals the liver to suppress endogenous glucose production (gluconeogenesis and glycogenolysis). These combined systemic effects modulate plasma glucose concentration throughout the fasting period.


️ Mechanistic Limitation: Basal Focus

The specialized slow-release mechanism is structurally suited for continuous background (basal) action. It is unable to generate the rapid, high insulin concentration required to respond to the sudden, large glucose load that follows a meal.

Dosage and Administration Information

Lantus SoloStar is a pre-filled pen intended for once-daily subcutaneous (SC) injection of insulin glargine. The dose must be individualized based on the patient's metabolic needs and blood glucose monitoring.

Administration Scope

Feature Guidance
Route & Timing Administer SC once daily at the same time every day.
Injection Sites Abdominal area, thigh, or deltoid. Injection sites must be rotated within the same region to reduce the risk of lipodystrophy.
Preparation Visually inspect: the solution must be clear and colorless with no particles. Do not dilute or mix with any other insulin or solution.
Dosing Limit The pen dials in 1-unit increments, with a maximum single dose of 80 units. Doses exceeding 80 units require multiple injections.
Sharing Rule The SoloStar pre-filled pen is for single-patient use only and must never be shared, even if the needle is changed.

Procedural Requirements (Key Steps)

Before each use, a new sterile needle must be attached, and a safety test (priming) must be performed by selecting 2 units and pressing the injection button to ensure insulin flow and remove air bubbles. Once the dose is injected, the injection button must be kept pressed all the way in for a slow count to 10 before withdrawing the needle to ensure the full dose is delivered. The needle must be removed and discarded immediately after use.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Lantus Solostar

Evidence Overview and Study Landscape

The research base for Insulin Glargine 100 U/mL (Lantus Solostar) primarily consists of Randomized Controlled Trials (RCTs) and various comparative studies. These study designs were used in research exploring how symptoms change over time and are designed to track changes observed in blood sugar markers. Researchers monitored specific outcomes related to systemic or functional imbalance, most commonly measuring the average long-term blood sugar marker, HbA1c (Glycated Hemoglobin), and daily blood sugar levels, such as Fasting Plasma Glucose (FPG). The findings describe patterns observed in the studies regarding these key measurements over set periods.

Evidence for Use in Type 2 Diabetes Mellitus (T2DM)

The substance was studied for use in adults with Type 2 Diabetes. Research examined populations including individuals who were starting insulin therapy for the first time (insulin-naïve) and those who were already using oral medications.

Researchers utilized controlled trials that compared the substance to other treatments or placebo. Key outcomes tracked included changes in the biomarkers HbA1c and FPG, shifts in body weight, and patient-reported outcomes describing perceived discomfort related to the delivery device. Some trials were specifically designed to see if the outcomes were similar between the groups studied.

Evidence for Use in Type 1 Diabetes Mellitus (T1DM)

The research was evaluated in patient groups with Type 1 Diabetes who were studied with a treatment regimen that included mealtime insulin. Studies explored the use of the substance in both adults and pediatric patients (aged 6 years and older). Pharmacokinetic studies monitored the substance's concentration profile, which research describes as exhibiting a peakless pattern over 24 hours in the subjects observed. The results apply only to the populations studied, and research provides context but research does not determine whether an individual will respond similarly.

Frequently Asked Questions (FAQ)

Common questions about Lantus Solostar (FAQ)


Q: How quickly does Lantus Solostar start to work after an injection?

A: According to official pharmacokinetic studies of insulin glargine, the start of action—when the medicine begins to be absorbed—is described as approximately mathbf1 mathbfhour after the injection. Because it is a long-acting insulin, its action is continuous and sustained over a full 24-hour period after this initial onset.


Q: Does Lantus Solostar cause weight gain?

A: Official regulatory documents list weight gain as a Common adverse reaction associated with the use of insulin glargine. This effect is generally attributed to insulin's role in the body's metabolism, which can promote the storage of fat and reduce the loss of fluid.


Q: Can Lantus Solostar be used with certain cholesterol medications?

A: The official interaction profile documents that Thiazolidinediones (TZDs), a type of drug sometimes used in people with type 2 diabetes, can increase the risk of fluid retention when used with insulin glargine. Information regarding interactions is general; the comprehensive review of all medications is typically performed by a healthcare professional.


Q: Can Lantus Solostar be used in patients with kidney problems?

A: Official regulatory documents state that people with kidney (renal) impairment are eligible to use insulin glargine. However, patients with kidney problems have a documented mathbfincreased mathbfrisk mathbfof mathbfhypoglycemia (low blood sugar), and regulatory documents note that mathbfclose monitoring may be needed due to the increased risk.


Q: Can Lantus Solostar cause vision changes?

A: Official safety documents indicate that rapid improvement in blood sugar control when starting therapy may be temporarily associated with some eye effects. These include temporary conditions like transitory refraction disorder, which involves changes in vision. Official information describes this as a transitory condition.


Q: Are there any restrictions on driving or operating machinery while using Lantus Solostar?

A: Regulatory guidance suggests that a person's mathbfability mathbfto mathbfconcentrate mathbfand mathbfreact may become impaired due to hypoglycemia (low blood sugar). This caution is mentioned because low blood sugar can affect attention and reaction time, which applies to situations like driving or operating machinery.


Q: What is the difference between Lantus Solostar and another drug called Levemir?

A: The primary difference lies in the active ingredient: Lantus Solostar contains insulin glargine (typically once daily), while Levemir contains insulin detemir (which may be dosed once or twice daily). Both are classified as long-acting basal insulins.


Q: Does Lantus Solostar have a black box warning?

A: The U.S. FDA Prescribing Information for insulin glargine does not contain a 'Black Box Warning' (Boxed Warning). This type of warning is reserved for drug products that carry the most serious risks. The document does highlight important warnings concerning hypoglycemia, allergic reactions, and potassium levels.


Q: What is the risk of high blood sugar (hyperglycemia) when using Lantus Solostar?

A: Official labels note that hyperglycemia (high blood sugar) can occur if the medication is not working as intended. Potential causes include medication errors, improper dosing, failure to rotate injection sites, or when the dose is insufficient. In cases of persistent high blood sugar, seeking medical consultation is generally recommended by regulatory sources.


Q: Is the needle for the Solostar pen included in the box?

A: Official instructions for using the Solostar pen mandate that a mathbfnew mathbfsterile mathbfneedle mathbfmust mathbfbe mathbfattached before every single use. However, the needles themselves are not typically included in the Lantus Solostar pen carton and are typically supplied separately.


Q: What is the recommended timeframe for using a Solostar pen after opening it?

A: According to regulatory storage instructions, once a Lantus Solostar pen is first used (in-use), it must be used within a maximum of 28 days. After this time, any remaining product should be discarded to comply with storage instructions, even if it appears to contain unused insulin.


Q: If I miss a dose of Lantus Solostar, what does official guidance say about what to do?

A: Official guidance emphasizes that this medicine should be administered mathbfonce mathbfdaily mathbfat mathbfthe mathbfsame mathbftime mathbfevery mathbfday. If a dose is missed, a correction should not involve taking an extra dose or a larger amount to compensate. Patients are generally directed to return to their regular schedule and contact a healthcare professional for guidance on specific situations.


Q: What is the chemical name of the active ingredient in Lantus Solostar?

A: The active ingredient in the Solostar pen is insulin glargine. Its formal chemical description found in regulatory documents is a complex molecule with the formula mathbfC267H404N72O78S6. This structure is noted for having specific modifications that allow it to be long-acting.


Q: What is the difference between U-100 and other insulin concentrations?

A: The designation U-100 means the solution contains 100 units of insulin per milliliter (mL) of fluid. Regulatory documents classify this as a standard concentration, distinguishing it from higher concentrations available for other types of insulin, such as U-300 (300 units/mL).


Q: What if I experience pain at the injection site consistently?

A: Official safety information notes that injection site pain is a mathbfCommon side effect. If you experience consistent pain or other reactions, this may relate to administration technique. Regulatory instructions emphasize the importance of rotating the injection site within the approved areas, and if site reactions are persistent, consultation with a healthcare professional is generally appropriate.


Q: Is Lantus Solostar a commonly used treatment for diabetes?

A: Insulin glargine (Lantus) is classified in authoritative public health resources, such as those from the NIH, as a widely adopted mathbflong-acting human insulin analogue. It is frequently cited as a foundational mathbfbasal mathbfinsulin therapy used for managing blood sugar stability in patients with both Type 1 and Type 2 diabetes.


Q: What is the maximum single dose that can be set on the Solostar pen?

A: The Solostar pen is physically designed to dial in single-unit increments, with a mathbfmaximum mathbfsingle mathbfdose setting of mathbf80 mathbfunits. The instructions for use indicate that doses greater than 80 units may require multiple separate injections.


Q: Does Lantus Solostar interact with blood pressure medications?

A: Official documents describe that several types of blood pressure medications, including ACE inhibitors (like Lisinopril) and beta-blockers (like Metoprolol), are associated with an increased risk of hypoglycemia when co-administered with insulin glargine. This highlights the need for careful blood sugar monitoring when taking these combinations.

How should Lantus Solostar be stored and disposed of?

How to Store and Dispose of Lantus SoloStar?

Official regulatory labeling outlines distinct storage requirements based on the pen's status:

Pen Status Temperature Requirement Stability Period
Unopened/Spare Refrigerated (36 F to 46 F / 2 C to 8 C) Until Expiration Date
In-Use/Opened Room Temperature (Below 86 F / 30 C) 28 Days Maximum

Unopened pens must be kept in the original outer carton to protect them from light and must not be frozen. Once an in-use pen is opened, it must not be put back into the refrigerator. The pen must be protected from direct heat and light. After each use, the needle must be removed and placed in a designated sharps disposal container. The used pen body (needle-free) must be discarded according to local regulations, and any remaining product must be thrown away after 28 days.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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