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Соликва СолоСтар

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Соликва СолоСтар

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Treatment option: Diabetes Mellitus

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.

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Overview of Соликва СолоСтар

What is Soliqua 100/33?

Soliqua 100/33 is a daily, injectable prescription medication approved for adults with type 2 diabetes mellitus to help improve blood sugar (glucose) control, when used alongside diet and exercise. The medicine is a fixed-ratio combination product, which means it contains two distinct active components in a single pen.

Property Description
Active Ingredients Insulin Glargine and Lixisenatide
Pharmacological Class Fixed-ratio combination of a Basal Insulin and a GLP-1 Receptor Agonist
Form Solution for injection in a pre-filled pen (SoloStar)
Common Use Adjunct to diet and exercise to improve glycemic control in Type 2 Diabetes
Manufacturer Sanofi

The formulation consists of Insulin Glargine, a long-acting basal insulin, and Lixisenatide, a glucagon-like peptide-1 (GLP-1) receptor agonist. These agents work together to address two major facets of type 2 diabetes management: basal glucose regulation and post-meal glucose response.

Soliqua 100/33 was first approved in 2016 for adults who were not adequately controlled on basal insulin or lixisenatide alone. The medication was also recognized for the benefit of co-formulating these two therapies into a single daily injection, noting its intended use as an escalation step in therapy. The drug is delivered via the SoloStar pen system, a defining feature of this formulation.

It is essential to note that this medication is indicated only for type 2 diabetes and must not be used by patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.

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What side effects are possible with Соликва СолоСтар?

Possible side effects and safety information

The safety profile for this medicine is based on the known risks associated with its two components, Insulin Glargine and Lixisenatide, and is formally classified according to regulatory standards.

Frequency-Classified Adverse Reactions

The most commonly documented adverse event, consistent with the inclusion of an insulin, is hypoglycemia (low blood sugar), which is classified as Very Common (occurring in 10% or more of patients). Other frequently documented effects are categorized as Common (occurring in 1/100 to <1/10 patients) and generally involve the gastrointestinal system or administration site.

Classification Example Adverse Reactions System-Organ Class Involved
Very Common Hypoglycemia Metabolism and nutrition disorders
Common Nausea, Diarrhoea, Vomiting, Headache, Injection site reactions Gastrointestinal, Nervous system
Uncommon Urticaria (hives), Immunogenicity reactions Skin, Immune system

Serious Adverse Reactions and Safety Restrictions

Official regulatory documentation identifies specific, less frequent but clinically important risks. These include the potential for severe hypoglycemia and serious hypersensitivity reactions, such as anaphylaxis. The lixisenatide component is also associated with reports of acute pancreatitis.

Safety limitations regarding use are explicitly documented in regulatory materials. The medicine is not indicated for individuals with Type 1 Diabetes Mellitus or diabetic ketoacidosis. Furthermore, the label advises against use in patients with a personal or family history of Medullary Thyroid Carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Use is also generally not recommended in cases of severe renal impairment due to lack of established data.

It is officially noted that common gastrointestinal effects like nausea and vomiting are often more frequent at the start of treatment or during dose increases, typically lessening with continuous exposure.

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Overdose and Emergency Response

Overdose and when to seek help

The official regulatory profile for Soliqua 100/33 overdose highlights two primary, severe manifestations. Overdose may result in severe and prolonged hypoglycemia (low blood sugar), which is potentially life-threatening and carries an associated risk of hypokalemia (low blood potassium). Due to the lixisenatide component, severe nausea and vomiting may also occur, which can lead to dehydration and subsequent acute kidney injury/failure, as noted in official documentation.


Immediate Emergency Action

Immediate medical attention must be sought for any suspected overdose. The official regulatory instruction is to contact Poison Control or go directly to a hospital emergency room.

Management of overdose is symptomatic and supportive. Due to the potential for delayed effects, prolonged hospital observation is required, particularly to monitor for the risk of recurrent hypoglycemia. Treatment involves the administration of intravenous glucose (dextrose) for hypoglycemia. No specific antidote is known for this combination product. Frequent monitoring of blood glucose concentration, electrolytes, and renal function is mandated throughout the observation period.

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Therapeutic Uses of Соликва СолоСтар

What Соликва СолоСтар treats: Main Uses and Benefits

Соликва СолоСтар is commonly used to help with managing glycemic control in adults with Type 2 Diabetes Mellitus. It is considered relevant in situations where blood sugar levels require additional management after other therapies, and is applied alongside diet and exercise for patients whose blood sugar levels require further intervention.

This medication is commonly used in situations involving certain distressing symptoms, and helps address symptom clusters related to systemic imbalance, such as persistently high blood sugar levels and an elevated HbA1c (long-term blood sugar average). It is relevant for managing symptoms that interfere with daily comfort due to poor long-term control. It is commonly used across conditions presenting with acute episodes in patients who are not adequately controlled on basal insulin or a GLP-1 receptor agonist alone.

The formulation is applied in addressing symptoms related to episodic or fluctuating manifestations of blood sugar, which includes both the sustained levels and the spikes after eating. It supports patients during episodes of heightened discomfort and may assist with maintaining functional stability.


Quick Fact: Relief for Glucose Dysregulation

This medicine is commonly used to help with the simultaneous management of two key types of symptoms related to systemic imbalance.

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Eligibility and Restrictions for Use

Соликва СолоСтар is indicated as an adjunct to diet and exercise to improve blood sugar control in adults with Type 2 Diabetes Mellitus. Eligibility is strictly defined by regulatory authorities and includes several limitations and contraindications.

Classification Population/Condition Status (Official Labeling)
Contraindicated Type 1 Diabetes Mellitus or Diabetic Ketoacidosis Not Indicated/Contraindicated
Contraindicated Current episode of hypoglycemia (low blood sugar) Contraindicated
Contraindicated Known serious hypersensitivity to any component Contraindicated
Restriction Severe renal impairment (CrCl < 30 mL/min) or End-Stage Renal Disease (ESRD) Not Recommended
Restriction Patients under 18 years of age Use Not Established
Restriction Severe gastroparesis or other severe gastrointestinal disease Not Recommended
Restriction Concomitant use with any other GLP-1 receptor agonist Not Recommended

Use is not recommended during pregnancy or lactation unless the potential benefit justifies the potential risk. Caution is advised in patients with a history of pancreatitis. The medicine is not to be used with other GLP-1 receptor agonists or short-acting insulin.

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What should I know about interactions with other medicines?

Interactions with other medicines and products

The officially documented interaction profile for Soliqua 100/33 involves two primary mechanisms: pharmacodynamic effects on blood glucose and a pharmacokinetic effect on oral drug absorption.

Pharmacodynamic Effects

Many co-administered substances are documented to either intensify or diminish the glucose-lowering activity. Agents that may increase the glucose-lowering effect include salicylates, ACE inhibitors, ARBs, and MAO inhibitors. Substances that may diminish the glucose-lowering effect include corticosteroids, thyroid hormones, diuretics, and atypical antipsychotics. The consumption of alcohol is officially noted to both intensify or diminish the glucose-lowering effect. Furthermore, beta-blockers may reduce or mask the typical signs of hypoglycemia. Co-administration with Thiazolidinediones (TZDs) is documented to cause fluid retention that may lead to or exacerbate heart failure.

Pharmacokinetic Effects and Administration Timing

The lixisenatide component causes a delayed gastric emptying, reducing the rate of absorption of certain co-administered oral medicines. For most oral medicines, particularly those with a narrow therapeutic ratio, administration must be separated by at least one hour prior to or four hours after Soliqua 100/33. Oral contraceptives require a longer separation period: at least one hour prior to or eleven hours after administration. Use of the drug is not recommended in patients with severe renal impairment due to insufficient regulatory experience with one component.

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Mechanism of Action

How Соликва СолоСтар Works

Соликва СолоСтар utilizes a dual mechanism, combining the actions of insulin glargine and lixisenatide to influence glucose regulation. The insulin glargine component acts as a basal insulin analog, binding to insulin receptors on liver, muscle, and fat cells. This binding initiates a signaling cascade that inhibits hepatic glucose production and promotes glucose uptake by peripheral tissues over an extended, steady-state period.

The lixisenatide component functions as a glucagon-like peptide-1 (GLP-1) receptor agonist. It selectively activates GLP-1 receptors in a glucose-dependent manner, primarily resulting in the stimulation of insulin secretion from pancreatic beta-cells and the inhibition of glucagon release from alpha-cells. Furthermore, lixisenatide slows gastric emptying, which modulates the rate of postprandial glucose absorption. This synergistic, parallel pathway modulation affects both sustained basal metabolism and acute postprandial glucose dynamics.

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Dosage and Administration Information

How to Use Соликва СолоСтар

Соликва СолоСтар (Soliqua 100/33) is intended for long-term subcutaneous injection and is administered once daily at the same time each day. Specific guidelines are established to ensure proper application as an adjunct to diet and exercise for managing Type 2 Diabetes Mellitus.


Administration and Timing

Administration is exclusively via subcutaneous injection into approved areas, such as the thigh, upper arm, or abdomen. The injection is given within one hour before the first meal of the day. To minimize the risk of administration-site complications, the injection site must be rotated within the chosen region with each daily dose. The fixed-ratio solution must be undiluted upon injection.


Dosing and Adjustment Patterns

The dosage is measured in dose steps (units), with a maximum permitted daily dose of 60 dose steps (60 units Insulin Glargine/20 mcg Lixisenatide). Starting doses are determined by a patient’s prior medication regimen. For instance, patients new to basal insulin or GLP-1 agonists typically initiate therapy at 15 dose steps. The dose is subsequently adjusted based on metabolic needs, with adjustments made in increments of 2 dose steps and no more frequently than once weekly.

If a dose is missed, the protocol is to resume the once-daily schedule at the next planned main meal and to not take an extra dose to compensate for the missed one.


Population-Specific Rules

Use is not recommended for patients under 18 years of age due to a lack of established safety and efficacy data. Furthermore, use is not recommended in adults with severe renal impairment (creatinine clearance < 30 mL/min), which is an important constraint on its usage scope.

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Recent Clinical Evidence

Recent Clinical Evidence Overview

Clinical research on Соликва СолоСтар (insulin glargine and lixisenatide injection) has primarily focused on adults with Type 2 diabetes mellitus whose condition was not adequately managed by basal insulin or oral antidiabetic medications alone. The pivotal trials, LixiLan-L and LixiLan-G, compared the fixed-ratio combination with its individual components or continued single-component therapy.


Efficacy Findings

  • LixiLan-L Trial: This 30-week, open-label, randomized controlled study evaluated participants inadequately controlled on basal insulin (with or without metformin). The study measured glycosylated hemoglobin (HbA1c), finding that the combination group demonstrated a greater reduction in HbA1c from baseline compared to those continuing basal insulin alone.
  • LixiLan-G Trial: This 26-week study examined participants inadequately controlled on a GLP-1 receptor agonist (GLP-1 RA) and metformin. It observed a statistically superior decrease in mean HbA1c for participants who switched to the combination therapy compared to those who continued GLP-1 RA therapy.

Safety and Tolerability Profile

Adverse events reported in clinical trials were generally consistent with the known safety profiles of its two components, insulin glargine and lixisenatide. The most frequently reported adverse events included nausea, diarrhea, and hypoglycemia (low blood sugar). Gastrointestinal events, such as nausea, were observed more often in the combination group than in the insulin glargine group alone. The incidence of severe hypoglycemia was reported to be low in both treatment groups.

Key Studies & References

  1. Efficacy and Safety of LixiLan, a Titratable Fixed-Ratio Combination of Insulin Glargine Plus Lixisenatide in Type 2 Diabetes Inadequately Controlled on Basal Insulin and Metformin: The LixiLan-L Randomized Trial
  2. Switching to iGlarLixi Versus Continuing Daily or Weekly GLP-1 RA in Type 2 Diabetes Inadequately Controlled by GLP-1 RA and Oral Antihyperglycemic Therapy: The LixiLan-G Randomized Clinical Trial
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Frequently Asked Questions (FAQ)

Common questions about Соликва СолоСтар (FAQ)


Q: Why is this medication a fixed combination of two different drugs (insulin glargine and lixisenatide)?

A: This medicine is a fixed combination because it includes a long-acting insulin and a GLP-1 receptor agonist in a single injection. Official studies indicated that the combined treatment was more effective at achieving blood sugar control (HbA1c reduction) than using either component alone. Clinical studies indicated that the combination was associated with a lower risk of weight gain compared to intensive insulin therapy alone, consistent with regulatory findings.


Q: How long can a person expect symptoms like nausea or diarrhea to last after beginning treatment?

A: Official product information states that common gastrointestinal side effects like nausea and vomiting are most frequent when starting treatment or when the dose is increased. These symptoms are often observed to lessen with continuous exposure, according to official information.


Q: What are the signs of low blood sugar that patients should be aware of?

A: Symptoms of hypoglycemia (low blood sugar) can vary among individuals. Commonly reported signs in official documents may include sweating, fast heartbeat, shaking, anxiety, confusion, or tremor. Since this medicine can cause low blood sugar (hypoglycemia), regulatory information notes the potential importance of being familiar with symptoms that may be experienced.


Q: What symptoms should prompt someone to immediately stop the medicine and seek medical attention?

A: Official guidance describes that a patient should stop the medicine and seek immediate medical help if signs of a severe allergic reaction are experienced (such as a widespread rash or trouble breathing). Immediate attention is also needed for symptoms of acute pancreatitis, which include severe, persistent abdominal pain that may spread to the back.


Q: Can the medication cause severe allergic reactions, and what are the signs?

A: Yes, regulatory documentation confirms that severe, life-threatening allergic reactions (anaphylaxis) can occur. Signs may include a rash over the entire body, trouble breathing, a fast heartbeat, swelling of the face or throat, or sweating.


Q: Is there a known association between Соликва СолоСтар and gallbladder issues?

A: Official labeling notes a potential risk of developing acute gallbladder disease, including gallstones (cholelithiasis) or inflammation of the gallbladder (cholecystitis). The official label notes this as a potential risk that may require further medical evaluation.


Q: Is Соликва СолоСтар associated with changes in body weight?

A: Clinical studies on the combination therapy observed a reduced risk of weight gain compared to more intensive basal insulin treatment alone. This finding is consistent with the known weight effects of the lixisenatide component within the combination.


Q: Does Соликва СолоСтар affect potassium levels in the body?

A: Official labeling notes that the product can cause hypokalemia (low potassium in the blood), which is described as a potentially serious condition. This is a recognized risk associated with the medicine.


Q: Why is it important to inject the medicine around the same meal time each day?

A: Regulatory instructions require the medication to be administered once daily at the same time each day, specifically within one hour prior to the first meal. This consistent timing is necessary to ensure the predictable combined action of the long-acting insulin and the GLP-1 receptor agonist components.


Q: Can a patient with impaired vision use the SoloStar pen safely?

A: Official information indicates that the SoloStar pen is not recommended for use by patients who are blind or have significant vision problems unless they receive assistance from a person trained to use the pen. Assistance is necessary to confirm the proper dose is administered.


Q: Is the Соликва СолоСтар pen compatible with a standard insulin pump?

A: No. The official labeling states to not administer the product via an infusion pump or intravenously. The medication is specified for subcutaneous injection using the pre-filled pen.


Q: Why is it dangerous to share the injection pen with another person?

A: The pre-filled pen must never be shared between patients, even if the needle is changed. This prohibition is in place because sharing an injection pen carries a serious risk for the transmission of blood-borne pathogens.


Q: Are there any special considerations for using this drug in elderly patients?

A: Official guidance notes that no specific overall dose adjustment is universally required for patients 65 years or older. However, the official labeling notes that the dose range may need to start at the low end for older patients, reflecting the greater frequency of decreased kidney or liver function in this population.


Q: Can Соликва СолоСтар be taken along with other oral diabetes medications like Metformin?

A: Yes. Regulatory indications state that this medicine is approved for use alongside appropriate diet and exercise, and it can be used together with Metformin and/or SGLT-2 inhibitors.


Q: Are there certain common non-prescription medicines or supplements that can interact with this drug?

A: The glucose-lowering effect may be intensified by some common non-prescription products, such as certain salicylates (which include aspirin-containing medicines). Additionally, alcohol consumption is noted in regulatory documents to potentially affect the drug's blood sugar-lowering effect.


Q: Is it possible to use this drug at the same time as other types of insulin?

A: No. Official product information states that the medicine must not be diluted or mixed with any other insulin products or solutions. The medication is described in official documents as the sole insulin component, and it has not been studied in combination with prandial (mealtime) insulin.


Q: Why would a doctor switch a patient from a different basal insulin (like Lantus) to Соликва СолоСтар?

A: The medicine is indicated for adults with type 2 diabetes whose blood sugar control is not adequately maintained on basal insulin alone (with or without other oral medications). Switching to this combination is considered a therapeutic escalation step designed to improve glycemic control by adding the GLP-1 component.


Q: What does the long-term research say about maintaining blood sugar control with this drug?

A: The pivotal efficacy studies that established the regulatory approval of this fixed-ratio combination were of a 30-week duration (LixiLan-L) and a 26-week duration (LixiLan-G). The efficacy of the combination was demonstrated within the time frame of these trials.

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How should Соликва СолоСтар be stored and disposed of?

How to Store and Dispose of Соликва СолоСтар?

Strict storage and handling rules are defined to maintain the quality and efficacy of the medication.

Condition Temperature and Duration Handling and Protection
Unused Pen Store refrigerated between 2 C and 8 C (36 F and 46 F) until the expiration date. Keep in the original carton to protect from light. Do not freeze.
In-Use Pen Store at room temperature, below 25 C (77 F), for a maximum of 28 days after first use. Do not refrigerate the in-use pen. Do not store with the needle attached.

Disposal Requirements

Used needles must be immediately placed in an FDA-cleared, puncture-resistant sharps disposal container. The pen must be discarded 28 days after the first use, even if some medication remains. Keep the pen and needles 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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