Soliqua

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Soliqua

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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 Soliqua

What Type of Medicine is Soliqua?

Soliqua is a prescription-only Antidiabetic Agent that belongs to the Fixed-Ratio Combination class, containing the two distinct active ingredients: Insulin Glargine and Lixisenatide. This product is indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 Diabetes Mellitus. This dual-agent approach utilizes a clinically recognized ability to stabilize blood sugar in patients inadequately controlled on basal insulin alone.

The drug's composition consists of a combination of a long-acting basal insulin (Insulin Glargine) and a glucagon-like peptide-1 (GLP-1) receptor agonist (Lixisenatide). This medicine is delivered in a single prefilled pen for ease of use, merging two distinct glucose-lowering strategies into a streamlined regimen.

Composition and Origin: The Dual-Action Components

The formulation is an aqueous solution for injection delivered via the subcutaneous route. Insulin Glargine is an engineered insulin analog, created through recombinant DNA technology, designed for its predictable, long-lasting profile. Lixisenatide is a synthetic peptide hormone analog that mimics the body's natural incretin function.

This preparation's differentiating factor is the fixed ratio of the two agents, which ensures they are always administered together in a precise, predetermined proportion. This structural requirement ensures that the two complementary mechanisms are coordinated, unlike regimes where insulin and GLP-1 agents are managed and injected separately.

How Does This Combination Benefit Glycemic Control?

The fundamental therapeutic purpose of Soliqua is to achieve glycemic control by simultaneously managing the fasting and post-meal aspects of chronic hyperglycemia. The Insulin Glargine component provides the continuous glucose-lowering effect necessary for stabilizing baseline blood sugar throughout the day.

This effect is enhanced by the Lixisenatide component, which supports the body's natural insulin release after meals and delays gastric emptying. This dual strategy is intended to help adults with Type 2 Diabetes Mellitus reach and maintain more comprehensive and stable blood sugar levels.

Regulatory References

  1. NIH DailyMed Drug Label

What side effects are possible with Soliqua?

Soliqua: Possible Side Effects and Safety Information

Soliqua, a combination of insulin glargine and lixisenatide, carries a safety profile determined by both components. All clinical safety information is based on governmental regulatory documents from authorities such as the FDA and EMA.


Common and Clinically Significant Adverse Reactions

The most frequently reported adverse reaction is Hypoglycemia (low blood sugar), which is common with insulin-containing therapies and can be life-threatening. Other common adverse reactions (reported in ge 5% of patients) include Gastrointestinal events such as nausea and diarrhea, as well as nasopharyngitis, upper respiratory tract infection, and headache. Nausea and diarrhea typically occur more frequently upon treatment initiation and often decrease over time.

Serious Safety Warnings

Regulatory warnings highlight the potential for serious adverse events. These include:

  • Acute Pancreatitis: Symptoms may include persistent, severe abdominal pain, and the drug should be discontinued if pancreatitis is suspected.
  • Serious Hypersensitivity Reactions: Severe, life-threatening allergic reactions, including anaphylaxis and angioedema, have been reported and require immediate medical attention.
  • Hypokalemia: All insulin products can cause low potassium levels, which may be life-threatening.
  • Acute Kidney Injury: This may occur due to volume depletion in patients experiencing severe gastrointestinal adverse reactions (vomiting/diarrhea).
  • Heart Failure: Concurrent use with thiazolidinediones (TZDs) may cause or exacerbate heart failure.

Restrictions and Special Populations

Soliqua is contraindicated in patients with a known serious hypersensitivity to the drug or its components. It is not recommended for use in patients with Type 1 diabetes mellitus, diabetic ketoacidosis, or those with severe gastrointestinal disease, including severe gastroparesis. Use is also not recommended in patients with severe renal impairment (creatinine clearance < 30 mL/min) or end-stage renal disease due to insufficient therapeutic experience. The pen should never be shared between patients to prevent transmission of blood-borne pathogens.

Overdose and Emergency Response

Overdose and when to seek help

This section describes officially documented overdose manifestations and regulator-mandated emergency actions for Soliqua (Insulin Glargine and Lixisenatide).

Documented Overdose Manifestations

Overdose is primarily characterized by hypoglycemia (low blood sugar), which is a potential consequence of an excess of the Insulin Glargine component. The severe form is described in regulatory documents as potentially prolonged and life-threatening.

Signs of hypoglycemia documented in official prescribing information may include confusion, drowsiness, slurred speech, shakiness, and palpitation. In severe cases, convulsions or unconsciousness may occur. The Lixisenatide component may also lead to an increased severity of gastrointestinal adverse reactions, such as nausea and vomiting, following overdose.

Emergency Actions and Required Monitoring

Action/Requirement Official Regulatory Statement
Emergency Response Seek immediate medical attention for suspected overdose [FDA Label].
Help-Seeking Promptly seek medical attention or go to the nearest hospital emergency room when severe symptoms are suspected [NIH MedlinePlus].
Supportive Management Required treatment includes glucose replacement therapy (oral or intravenous) and symptomatic and supportive treatment [EMA SmPC].
Monitoring Increased frequency of glucose monitoring and observation of potassium levels is required due to the risk of Hypokalemia [FDA Label].

Patients with renal or hepatic impairment are noted in official labeling to have an increased risk of hypoglycemia following an overdose.

Therapeutic Uses of Soliqua

The therapeutic use of Soliqua is considered relevant for the management of Type 2 Diabetes Mellitus in adults who require intensified treatment. It is generally indicated as an adjunct to diet and exercise to improve glycemic control. It is applied in clinical settings that involve acute or unstable symptom patterns where prior single-agent regimens have been insufficient to manage symptoms.

Comprehensive Management of Daily Blood Sugar Patterns

Soliqua is used for managing symptoms related to systemic imbalance, including both elevated baseline readings and pronounced increases following meals. It contributes to easing the overall symptom load by supporting the control of these dual components of high blood sugar. This combined approach is relevant when symptoms become temporarily overwhelming and patients experience symptoms that interfere with daily functioning in conditions marked by increased physiological stress.

Quick Fact: Relief for Systemic Imbalance
Soliqua is primarily used when symptoms of chronic hyperglycemia persist, providing necessary support for managing uncontrolled blood sugar in adult patients.

Regulatory References

  1. NIH DailyMed Drug Label

Eligibility and Restrictions for Use

Who Can and Cannot Use Soliqua?

Regulatory documentation strictly defines the patient population eligible for Soliqua (insulin glargine and lixisenatide) based on disease type, age, and existing medical conditions.

Contraindications and Non-Eligibility

Contraindications prohibit the use of this medicine for patients with known serious hypersensitivity to any component or during episodes of acute hypoglycemia (low blood sugar). Soliqua is not for use in patients with Type 1 Diabetes Mellitus or for the treatment of diabetic ketoacidosis.

Population Group Eligibility Status Specific Restriction/Limitation
Adults (≥18 years) Indicated Approved for Type 2 Diabetes Mellitus only.
Pediatric Population Use Not Established Safety and effectiveness have not been established in children under 18.
Severe Renal Impairment Not Recommended Use is not recommended in patients with severe renal impairment (CrCl < 30 mL/min) or end-stage renal disease.
Severe GI Disease Not Recommended Use is not recommended for patients with severe gastrointestinal disease, including severe gastroparesis.
Pregnancy Conditional Use Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Lactation Not Recommended Should not be used during breast-feeding (EMA SmPC).

Use is also not recommended in combination with any other product containing a GLP-1 receptor agonist.

What should I know about interactions with other medicines?

Soliqua Interactions with other medicines and products

This section outlines the officially documented interaction patterns for Soliqua (Insulin Glargine / Lixisenatide), as reported in government regulatory labeling.

Interaction Type Interacting Agents / Classes Restriction or Official Outcome
Contraindicated or Restricted Other GLP-1 Receptor Agonists Concomitant use is not recommended by regulatory authorities.
Hypoglycemia Administration is formally contraindicated during an episode of low blood sugar.
Pharmacodynamic Other glucose-lowering agents (including other insulin products) Increased risk of hypoglycemia (low blood sugar) due to additive effects.
Alcohol Ingestion Documented to increase the risk of hypoglycemia.
Thiazolidinediones (TZDs) Co-administration has an official documented link to fluid retention, which may lead to or exacerbate heart failure.
Antiadrenergic Drugs (e.g., beta-blockers) May reduce the signs and symptoms of hypoglycemia, masking the body's counter-regulatory response.
Physiologic/Absorption Oral Contraceptives Delayed absorption (Cmax is decreased) due to delayed gastric emptying.
Oral Antibiotics, Acetaminophen Delayed absorption of medications dependent on reaching a threshold concentration.

Administration Timing Requirements

The Lixisenatide component delays gastric emptying, a documented effect that reduces the rate of absorption for certain oral medications. To mitigate this effect, specific timing rules are required by official documents:

  • Oral Contraceptives must be administered at least 1 hour prior to or 11 hours after Soliqua administration.
  • Oral medications, such as acetaminophen and antibiotics, must be taken at least 1 hour prior to Soliqua administration.

Population-Specific Notes

Official labeling states that when used with other glucose-lowering agents, an increased frequency of glucose monitoring is required for patients with documented renal or hepatic impairment.

Mechanism of Action

How Soliqua Works

Soliqua, a fixed-ratio combination of insulin glargine and lixisenatide, exerts effects on glucose homeostasis pathways through two distinct, complementary mechanisms.


Insulin Receptor Agonism

Insulin glargine functions as a long-acting insulin analog, primarily engaging the insulin receptors on peripheral target tissues, including skeletal muscle and adipocytes. Receptor binding initiates a signaling cascade that stimulates the uptake and utilization of circulating glucose by these cells. Concurrently, this mechanism suppresses endogenous glucose production within the liver. The resulting physiological consequence is the modulation of basal glucose flux, affecting circulating glucose levels in the fasting state.


Glucagon-Like Peptide-1 (GLP-1) Receptor Modulation

Lixisenatide acts as a GLP-1 receptor agonist. Its binding to the GLP-1 receptor initiates a glucose-dependent sequence: it stimulates the release of insulin from pancreatic beta-cells and inhibits the secretion of glucagon from alpha-cells. Lixisenatide also modifies gastrointestinal function by slowing the rate of gastric emptying. The combined mechanistic actions result in the modification of the postprandial glucose excursion.

Dosage and Administration Information

How to use Soliqua — Official Administration Guidelines

Soliqua (insulin glargine and lixisenatide) is administered as a subcutaneous injection once daily. The dose is provided via a pre-filled, single-patient-use pen. The maximum daily dose is 60 units (60 units of insulin glargine and 20 mcg of lixisenatide).

Dosing and Timing

Timing Frequency Maximum Daily Dose
Within 1 hour prior to the first meal of the day Once daily 60 units

It is preferable that the injection is performed before the same meal every day. The dose must be individualized and is titrated based on the patient's metabolic needs and blood glucose monitoring results.

Procedural Requirements

  • Route and Site: Inject subcutaneously into the abdomen, deltoid (upper arm), or thigh. Injection sites must be rotated within the same region from one injection to the next to reduce the risk of injection site reactions.
  • Preparation: Visually inspect the solution before use; it should be clear and colorless to almost colorless. Do not use if small particles are visible or if the solution is discolored. Always attach a new sterile needle for each injection. The pen must never be shared with other people.
  • Missed Dose: If a dose is missed, patients should skip the missed dose and resume the once-daily regimen with the next scheduled dose. Do not administer two doses on the same day or increase the dose to compensate for a missed dose.
  • Administration Notes: Do not administer intravenously, intramuscularly, or via an insulin pump. Soliqua should not be diluted or mixed with any other insulin products or solutions.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Soliqua


Evidence for Use in Adults with Inadequate Glycemic Control

The primary research for Soliqua was conducted using large Randomized Controlled Trials (RCTs). These studies were designed to evaluate the fixed-ratio combination in adults with Type 2 Diabetes whose blood sugar was not adequately managed by their current treatment plan. Specifically, researchers examined two major groups: those taking common oral diabetes medicines (like Metformin) and those who were already using a basal, or long-acting, insulin. The main outcomes that research examined included the long-term glucose biomarker, Glycated Hemoglobin (A1C), and the proportion of participants whose A1C measurements fell within specific ranges.

The studies report how blood sugar levels were measured and how A1C measurements changed during the study period. Findings describe patterns observed in the studies, which regulators review when considering the role of each component in the combination. Studies also monitored changes in Fasting Plasma Glucose (FPG) and tracked participants' body weight. The research provides insight into short-term changes over the study duration, particularly in participants who were moving from a single type of therapy to the combined fixed-ratio regimen.


Studies Comparing Soliqua to Standard Therapies

Studies explored how the Soliqua combination compared to regimens that used only one of the active components. For instance, some trials compared the fixed-ratio combination to taking only Insulin Glargine (a basal insulin) and others compared it to taking only Lixisenatide (a GLP-1 receptor agonist). The research examined the measured variables, such as A1C and changes in body weight.

The studies describe the A1C and body weight measurements that were tracked across the different comparison groups. Findings related to body weight were also tracked in these comparative trials, with studies reporting measurements showing different average weight changes depending on the specific comparator used. Overall, the evidence contributes to understanding symptom patterns and provides context on the group response, but research does not determine whether an individual will respond similarly.


Long-Term Evidence and Follow-up Duration

Most of the core evidence used for the initial regulatory evaluation of Soliqua comes from pivotal RCTs that had a relatively short follow-up duration of about 30 weeks (around seven months). This research is characterized by data collected during the defined follow-up period and explores changes in biomarkers over specific time intervals.

Because the follow-up periods were limited, the research is less informative about how long any observed changes might last. Information regarding outcomes over extended periods (e.g., beyond two years) and long-term physiological outcomes are not well characterized by these trials. Evidence contributes to the broader evidence landscape but certainty remains low regarding the effects of the combination beyond the initial study period.


Research in Specific Patient Groups

Research examined specific subgroups within the main trials. For example, data show patterns related to outcomes in older adults (age 65 and up) with Type 2 Diabetes, as well as in patients who presented with very uncontrolled blood sugar levels at the beginning of the study.

However, the data are still emerging, and evidence is limited for certain patient groups. Specifically, there are insufficient data from trials evaluating the fixed-ratio combination in patients with specific severe organ impairments. Additionally, this fixed-ratio combination has not been studied alongside other injectable meal-time insulins, nor has it been evaluated in children or pregnant populations. The results apply only to the populations studied, and data for certain groups remain insufficient.


What is Still Uncertain About the Research Base

The current research highlights what is known—and what is still uncertain—about Soliqua. The follow-up durations were limited in the pivotal trials, meaning long-term effects are not fully established, particularly regarding blood sugar control and the eventual impact on cardiovascular health.

This fixed ratio means the dose flexibility is restricted, and therefore, research related to highly varying doses of the individual components is not covered. Comparative evidence is lacking for many alternative fixed-ratio combinations. The findings describe group patterns, but research provides context but not individual predictions regarding the ultimate impact of Soliqua on long-term health outcomes.

Frequently Asked Questions (FAQ)

Common questions about Soliqua (FAQ)

Q: How is Soliqua different from taking separate Lantus and Adlyxin?

Soliqua is officially defined as a fixed-ratio combination that provides both active ingredients, insulin glargine (Lantus) and lixisenatide (Adlyxin), in a single prefilled pen. This design ensures that the two distinct agents are administered together in one injection at a specific, predetermined proportion, streamlining the daily treatment regimen.

Q: What happens if I miss a day of using Soliqua?

According to the official product information, if a dose is missed, patients are instructed to skip that dose completely. Patients should then resume the normal once-daily schedule with the next planned injection. Regulatory documents advise against administering two doses on the same day to make up for the missed one.

Q: What are some common signs that Soliqua might not be working as expected?

Soliqua is indicated to improve blood sugar control. Symptoms of high blood sugar (hyperglycemia) may indicate that the treatment is not achieving its intended effect. These symptoms can include increased thirst, needing to urinate frequently, or feeling confused. Worsening control may be accompanied by a requirement for increased blood glucose monitoring.

Q: Can Soliqua cause low blood sugar, and if so, how is it typically described?

Yes, low blood sugar (hypoglycemia) is the most frequently reported adverse reaction associated with this medication. Official documents describe signs and symptoms that may include physical effects like sweating, dizziness, and shakiness. Cognitive and mood changes, such as confusion, anxiety, irritability, and slurred speech, are also noted.

Q: What is the typical time frame for the full effect to be noticeable?

Soliqua is a combination product designed to manage both baseline and post-meal blood sugar. The insulin glargine component is long-acting, starting to affect blood sugar about two hours after injection and providing coverage for a full day. The lixisenatide component begins its action to slow digestion and support insulin release shortly after administration.

Q: How is Soliqua typically made available in the US?

Soliqua is supplied as a sterile solution for subcutaneous injection in a prefilled pen. Official information notes that the pen is available in two distinct dosage strengths. These strengths allow the doctor to select the most appropriate dosing range for the individual patient.

Q: Who is Soliqua approved for?

Soliqua is approved by regulatory agencies for use in adults diagnosed with Type 2 Diabetes Mellitus. It is intended to be used alongside diet and exercise to help improve overall blood sugar (glycemic) control.

Q: Do people typically experience weight changes when using Soliqua?

Clinical studies examined changes in body weight over the course of the trials. Results indicated that the combination was generally associated with a lower risk of weight gain when compared to receiving basal insulin alone. In some studies, participants experienced an average loss of body weight compared to certain other treatment groups.

Q: Is it normal to feel a bit nauseous when starting this medication?

Nausea is listed as a commonly reported adverse reaction in the official product labeling. Gastrointestinal side effects, which include nausea and diarrhea, tend to occur more frequently when a patient first begins treatment. Official documents indicate that these side effects are often temporary and may decrease over time.

Q: Why would a doctor switch a patient from an oral medication to Soliqua?

Soliqua is indicated for adults with Type 2 Diabetes whose blood sugar is not adequately managed by their current treatment, which may include oral medications or basal insulin alone. Clinical studies demonstrated that switching these patients to the fixed-ratio combination resulted in improvements in blood sugar control.

Q: Are there any common over-the-counter medicines that interact with Soliqua?

The lixisenatide component can slow down the emptying of the stomach, which affects how some oral medications are absorbed. Official documents specify that common over-the-counter medicines, such as acetaminophen, should be taken at least one hour before the Soliqua injection to mitigate this effect.

Q: What kind of studies have looked at the long-term effects of Soliqua?

The core evidence for regulatory approval is based primarily on pivotal randomized controlled trials that were relatively short, with a follow-up duration of about 30 weeks. Because the follow-up periods were limited, official information notes that the long-term effects beyond this period, such as the full impact on cardiovascular health, are not yet fully established by the core research.

Q: Is Soliqua considered a long-acting treatment?

Yes, Soliqua is officially defined as a fixed-ratio combination containing Insulin Glargine. Insulin glargine is classified as a long-acting basal insulin analog, and the combination is used to provide long-lasting blood sugar control throughout the day.

Q: Can Soliqua affect a person's mood or energy levels?

Changes in mood and energy are documented as potential signs of low blood sugar (hypoglycemia), which is a common adverse reaction. Official documents specifically list anxiety, irritability, confusion, drowsiness, and weakness as symptoms that can occur during an episode of low blood sugar.

Q: Does Soliqua have any known impact on the gallbladder?

Yes, official warnings highlight that gallbladder problems have been reported in some individuals using the drug. These problems may involve symptoms like pain in the upper stomach (abdomen), jaundice (yellowing of the skin or eyes), fever, or stools that appear clay-colored.

Q: Does taking certain vitamins or supplements affect Soliqua?

Regulatory guidance advises patients to inform their healthcare providers about all medications, vitamins, and herbal supplements they are taking. The lixisenatide component may impact the absorption rate of any concurrently taken oral product due to its effect on gastric emptying.

Q: How does Soliqua help with high blood sugar?

The product is designed to affect blood sugar using two complementary actions. The insulin glargine component provides the essential, continuous glucose-lowering effect necessary for managing baseline sugar throughout the day. This action is supported by the lixisenatide component, which aids the body’s natural insulin release after meals and slows down the rate at which food enters the bloodstream.

Q: Are there any specific organs the drug is known to affect?

Official warnings and precautions highlight potential effects related to several organs. These include the pancreas (risk of acute pancreatitis), the kidneys (risk of acute kidney injury, particularly with severe dehydration), and the gallbladder (risk of acute gallbladder disease).

Q: Is Soliqua safe to use for people with kidney problems?

Official documents advise that use is not recommended for patients who have severe renal impairment (a creatinine clearance of less than 30 mL/min) or end-stage renal disease. The label also contains a warning that acute kidney injury can occur in some patients who experience severe gastrointestinal adverse reactions like vomiting and diarrhea.

Q: Is there evidence for Soliqua improving long-term health outcomes beyond blood sugar?

The primary research used for initial regulatory review is characterized by follow-up durations of approximately seven months. Because of this limited time frame, the long-term physiological outcomes, such as the ultimate impact on cardiovascular health, are not yet fully established by the available core evidence base.

Q: Why is this combination drug preferred over using the ingredients separately?

Clinical trials demonstrated that the fixed-ratio combination resulted in improvements in blood sugar control compared to when its individual components were administered separately in certain patient populations. The product's design also offers the advantage of a single, streamlined injection regimen for the two complementary agents.

How should Soliqua be stored and disposed of?

Storage and Disposal of Soliqua 100/33

The storage and disposal instructions for Soliqua 100/33 are divided into pre-use, in-use, and final discard requirements to ensure stability and safety.


Storage Requirements

Condition Unopened Pen (Before First Use) In-Use Pen (After First Use)
Temperature Refrigerate: 36 F to 46 F (2 C to 8 C) Store at room temperature: Maximum 77 F (25 C)
Prohibition Do not freeze. Discard if frozen. Do not refrigerate. Do not store with the needle attached.
Stability Limit Use by expiration date. Discard 28 days after first use.
Protection Store in original carton to protect from light. Replace pen cap after each use to protect from light.

Disposal Instructions

Both used needles and the entire used Soliqua pen must be placed immediately in an FDA-cleared sharps disposal container; they are prohibited from being thrown into household trash. All pens and supplies must always be kept out of the sight and reach of children.

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

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