Brand Name
Soliqua
Generic Name
Lixisenatide
View Brand Information FDA approval date: November 21, 2016
Classification: GLP-1 Receptor Agonist
Form: Injection
What is Soliqua (Lixisenatide)?
SOLIQUA 100/33 is a combination of insulin glargine and lixisenatide and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. SOLIQUA 100/33 is a combination of a long-acting human insulin analog with a glucagon-like peptide-1 receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use : Has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis. Not recommended for use in combination with any other product containing a GLP-1 receptor agonist. Not for treatment of type 1 diabetes mellitus or diabetic ketoacidosis. Not recommended for use in patients with gastroparesis. Has not been studied in combination with prandial insulin. Limitations of Use : SOLIQUA 100/33 has not been studied in patients with a history of pancreatitis [see Warnings and Precautions.
Approved To Treat
Top Global Experts
Save this treatment for later
Not sure about your diagnosis?
Related Clinical Trials
Multicentre Phase IV Single Arm Clinical Trial to Evaluate the Safety and Efficacy of a Fixed Ratio Combination of Insulin Glargine and Lixisenatide in Adult Patients With Type 2 Diabetes Who Are Sub Optimally Controlled on Oral Anti-hyperglycemic Drugs and/or Basal Insulin/GLP-1 RA
Summary: This is an intervention, phase IV, single-arm study to assess the safety and efficacy of iGlarLixi in adult patients with Type 2 diabetes.
A 20-week, Multicenter, Prospective, Parallel-group Treatment, Open-label, 2-Arm, Phase 4, Randomized Study to Evaluate the Efficacy of iGlarLixi Versus Gla-100 on Glycemic Time in Range (TIR) From Continuous Glucose Monitoring (CGM) in Chinese Insulin Naïve Patients With Type 2 Diabetes (T2D) Inadequately Controlled With Oral Antidiabetics
Summary: This study is an open-label, 1:1 randomized, active-controlled, 2-arm, 20-week treatment duration, parallel-group, multicenter, phase IV study to evaluate the effect of iGlarLixi versus Gla-100 on glycemic control measured as TIR from CGM device in Chinese insulin naïve patients with T2D inadequately controlled with OADs. At the end of the screening period, eligible participants will be randomized...
Related Latest Advances
Brand Information
Soliqua 100/33 (insulin glargine and lixisenatide)
1INDICATIONS AND USAGE
SOLIQUA 100/33 is a combination of insulin glargine and lixisenatide and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
2DOSAGE FORMS AND STRENGTHS
SOLIQUA 100/33 is a clear, colorless to almost colorless solution available as:
Injection: 100 units of insulin glargine and 33 mcg of lixisenatide per mL in a 3 mL prefilled, disposable, single-patient-use SoloStar
3CONTRAINDICATIONS
SOLIQUA 100/33 is contraindicated:
- During episodes of hypoglycemia
- In patients with serious hypersensitivity to insulin glargine, lixisenatide, or any of the excipients in SOLIQUA 100/33. Hypersensitivity reactions including anaphylaxis have occurred with both lixisenatide and insulin glargine
4ADVERSE REACTIONS
The following adverse reactions are discussed elsewhere:
- Anaphylaxis and Serious Hypersensitivity Reactions
- Acute Pancreatitis
- Hypoglycemia
- Acute Kidney Injury Due to Volume Depletion
- Severe Gastrointestinal Adverse Reactions
- Hypokalemia
- Acute Gallbladder Disease
- Pulmonary Aspiration During General Anesthesia or Deep Sedation
4.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trial of another drug and may not reflect the rates observed in practice.
The safety of SOLIQUA 100/33 (n=834, with a mean treatment duration of 203 days) has been evaluated in two clinical studies (30 weeks duration) in type 2 diabetes patients. The studies, Study A and B
4.2Postmarketing Experience
The following additional adverse reactions have been identified during post approval use. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
5DESCRIPTION
SOLIQUA 100/33 is a combination of insulin glargine, an insulin analog, and lixisenatide, a GLP-1 receptor agonist.
Insulin glargine is a human insulin analog produced by recombinant DNA technology utilizing a nonpathogenic laboratory strain of
Lixisenatide is a synthetic analogue of human GLP-1, which acts as a GLP-1 receptor agonist. Lixisenatide is a protein containing 44 amino acids, which is amidated at the C-terminal amino acid (position 44) and has a molecular weight of 4.8585 kDa.
SOLIQUA 100/33 (insulin glargine and lixisenatide) injection is a sterile, colorless to almost colorless solution for subcutaneous use. SOLIQUA 100/33 is supplied as a prefilled single-patient-use disposable pen contain 300 units of insulin glargine and 100 mcg of lixisenatide in 3 mL of a clear, colorless to almost colorless, sterile, and aqueous solution. Each mL contains 100 units of insulin glargine and 33 mcg of lixisenatide and the inactive ingredients: glycerol (20 mg), metacresol (2.7 mg), methionine (3 mg), zinc (30 mcg), and Water for Injection, USP. Hydrochloric acid and/or sodium hydroxide may be added to adjust the pH. The approximate pH is 4.5.
6PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).
7INSTRUCTIONS FOR USE SOLIQUA®/33 (So - lee - kwa (insulin glargine and lixisenatide) Injection, for subcutaneous use
Read these instructions carefully before using your SOLIQUA 100/33 pen.
Do not share your SOLIQUA 100/33 pen with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.
SOLIQUA 100/33 is an injectable prescription medicine that contains 2 diabetes medicines, insulin glargine and lixisenatide in a SoloStar pen. The drug combination in this pen is only for the daily injection of 15 to 60 units of SOLIQUA 100/33. Each unit dialed contains 1 unit insulin glargine and 0.33 mcg lixisenatide.
People who are blind or have other vision problems should not use the SOLIQUA 100/33 pen without help from a person trained to use the pen.
Important information
- Check the label on the SOLIQUA 100/33 pen each time you give your injection to make sure you are using the correct medicine.
- Do not use your pen if it is damaged or if you are not sure that it is working correctly.
- Perform a safety test before each injection (see
- Always carry a spare pen and spare needles in case they are lost or stop working.
- Do not reuse needles. Always use a new sterile needle for each injection. This helps stop blocked needles, contamination, and infection. If you reuse needles, you might not get your dose (underdosing) or get too much (overdosing).
- Do not use SOLIQUA 100/33 in an insulin pump or inject SOLIQUA 100/33 into your vein (intravenously).
- Do not mix SOLIQUA 100/33 in any other type of insulin or liquid medicine prior to injection.
- Change (rotate) your injection sites within the area you chose with each dose (see
Learn to inject
- Talk with your healthcare provider about how to use the SOLIQUA 100/33 pen and how to inject correctly before using your pen.
- Ask for help if you have problems handling the pen.
- Read all of these instructions before using your pen. You may get too much or too little medicine if you do not follow the instructions correctly.
Need help?
If you have any questions about your pen or about diabetes, ask your healthcare provider, go to
Supplies you will need:
- 1 SOLIQUA 100/33 pen
- 1 new sterile needle (see
- 1 alcohol swab
- a puncture-resistant container for used needles and pens (see
Places to inject
- Inject your SOLIQUA 100/33 dose exactly as your healthcare provider has shown you.
- Inject your SOLIQUA 100/33 dose under the skin (subcutaneously) of your upper legs (thighs), upper arms, or stomach area (abdomen).
- Change (rotate) your injection sites within the area you choose for each dose to reduce your risk of getting pits in skin or thickened skin (lipodystrophy) and skin with lumps (localized cutaneous amyloidosis) at the injection sites.
- Do not inject where the skin has pits, is thickened, or has lumps.
- Do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin.
Get to know your pen
Step 1: Check your pen
Take a new pen out of the refrigerator at least 1 hour before you inject. Cold medicine is more painful to inject.
- Check the name and expiration date on the label of your pen.
- Make sure you have the correct medicine. This pen is colored light green with an orange injection button (see the
- Do not use your pen after the expiration date on the pen label.
- Pull off the pen cap.
- Check that the medicine is clear and colorless to almost colorless.
- If you see small particles, return it to your pharmacy for a replacement.
- Wipe the rubber seal with an alcohol swab.
If you have other injector pens
- Making sure you have the correct medicine is especially important if you have other injector pens.
Step 2: Attach a new needle
- Do not reuse needles. Always use a new sterile needle for each injection. This helps stop blocked needles, contamination and infection.
- Only use needles that are meant to be used with SOLIQUA 100/33. Needles are supplied separately. If you do not know what needles to use, ask your healthcare provider or pharmacist.
- Take a new needle and peel off the protective seal.
- Keep the needle straight and screw it onto the pen until fixed. Do not over-tighten.
- Pull off the outer needle cap. Keep this for later.
- Pull off the inner needle cap and throw it away.
Handling needles
- Take care when handling needles to prevent needle-stick injury and cross-infection.
Step 3: Do a safety test
Perform a safety test before each injection to:
- Check your pen and the needle to make sure they are working properly.
- Make sure that you get the correct dose.
- Select 2 units by turning the dose selector until the dose pointer is at the 2 mark.
- Press the injection button all the way in.
- When the medicine comes out of the needle tip, your pen is working correctly.
If no liquid appears:
- You may need to repeat this step up to
- If no medicine comes out after the third time, the needle may be blocked. If this happens:
- Do not use your pen if still no medicine comes out of the needle tip. Use a new pen.
- Do not use a syringe to remove medicine from your pen.
If you see air bubbles
- You may see air bubbles in the medicine. This is normal, they will not harm you.
Step 4: Select the dose
- Do not select a dose or press the injection button without a needle attached. This may damage your pen.
- Only use this pen to inject your daily dose from 15 to 60 units. Do not change your dose unless your healthcare provider has told you to change your dose.
- Do not use this pen if you need a single daily dose that is more than 60 units.
- Do not use the pen if your single daily dose is less than 15 units, the black area in dose window as shown in the picture.
- Make sure a needle is attached and the dose is set to "0".
- Turn the dose selector until the dose pointer lines up with your dose.
- Do not dial your dose by counting the clicks, because you might dial the wrong dose. Always check the number in the dose window to make sure you dialed the correct dose.
- If you turn past your dose, you can turn back down.
- If there are not enough units left in your pen for your dose, the dose selector will stop at the number of units left.
- If you cannot select your full prescribed dose, use a new pen.
How to read the dose window
- Each line in the dose window equals 1 unit of SOLIQUA 100/33.
- Even numbers are shown in line with the dose pointer, as shown in picture.
30 units selected- Odd numbers are shown as a line between even numbers, as shown in picture.
29 units selectedUnits of medicine in your pen
- This pen contains 300 units of SOLIQUA 100/33 and it is intended to be used for more than one dose.
Step 5: Inject your dose
If you find it hard to press the injection button in,
- Choose a place to inject as shown in the picture labeled "Places to inject."
- Push the needle into your skin as shown by your healthcare provider.
- Do not touch the injection button yet.
- Place your thumb on the injection button. Then press all the way in and hold.
- Do not press injection button at an angle. Your thumb could block the dose selector from turning.
- Keep the injection button held in and when you see "0" in the dose window, slowly count to 10.
- This will make sure you get your full dose.
- After holding and slowly counting to 10, release the injection button. Then remove the needle from your skin.
If you find it hard to press the injection button in:
- Change the needle (
- If you still find it hard to press in, get a new pen.
- Do not use a syringe to remove medicine from your pen.
Step 6: Remove the needle
- Take care when handling needles to prevent needle-stick injury and cross-infection.
- Do not put the inner needle cap back on.
- Grip the widest part of the outer needle cap. Keep the needle straight and guide it into the outer needle cap back. Then push firmly on.
- The needle can puncture the cap if it is recapped at an angle.
- Grip and squeeze the widest part of the outer needle cap. Turn your pen several times with your other hand to remove the needle.
- Try again if the needle does not come off the first time.
- Throw away the used needle in a puncture-resistant container (see " at the end of this Instructions for Use).
- Put your pen cap back on.
- Do not put the pen back in the refrigerator.
Use by
- Only use your pen for up to
How to store your pen
Before first use
- Keep new pens in the refrigerator between
- Do not freeze. If you accidentally freeze your pen, throw it away.
After first use
- Keep your pen at room temperature, up to
- Do not put your pen back in the refrigerator.
- Do not store your pen with the needle attached.
- Store the pen with your pen cap on.
Keep this pen out of the sight and reach of children.
How to care for your pen
Handle your pen with care
- Do not drop your pen or knock it against hard surfaces.
- If you think that your pen may be damaged,
Protect your pen from dust and dirt
- You can clean the outside of your pen by wiping it with a damp cloth (water only).
Throwing your pen away
- Put the used SOLIQUA 100/33 pen in a FDA-cleared sharps disposal container right away after use.
- If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
- When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal.
Manufactured by:
©2025 sanofi-aventis U.S. LLC
SOLIQUA and SoloStar are registered trademarks of sanofi-aventis U.S. LLC.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Revised: July 2025
8PRINCIPAL DISPLAY PANEL - 3 mL Pen Carton
NDC 0024-5761-05
SOLIQUA
For Single Patient Use Only
Solution for injection in a SoloStar
Five 3 mL prefilled pens (15 mL total) – Dispense in this sealed carton
SANOFI
