Soliqua

(Insulin Glargine/Lixisenatide)

Soliqua contains two active ingredients with different mechanisms of action:

Insulin glargine is a long-acting basal insulin that helps lower blood glucose by facilitating glucose uptake into tissues and suppressing hepatic glucose production.

Lixisenatide is a glucagon-like peptide-1 receptor agonist that stimulates glucose-dependent insulin secretion, suppresses glucagon release, and slows gastric emptying, which helps reduce post-meal blood sugar spikes.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Soliqua. However, the following is a synopsis of the general guidelines for the use of Soliqua:

Soliqua is injected subcutaneously once daily within one hour before the first meal of the day.

Wash your hands and gather your Soliqua 100/33 pre-filled pen and a new disposable needle.

Check the medication label to make sure you have the correct drug and strength.

Inspect the solution through the viewing window. It should be clear and colorless. Do not use if it appears cloudy or contains particles.

Attach a new needle to the pen by twisting it on securely.

Remove both needle caps and discard the outer cap safely.

Prime the pen (if required) by dialing a small dose and pressing the injection button until a drop of solution appears at the needle tip.

Choose an injection site on your abdomen, thigh, or upper arm. Do not inject into areas with scars, stretch marks, moles, or irritation.

Clean the skin with an alcohol swab and let it dry.

Dial your prescribed dose on the pen by turning the dose selector until the correct number of units and micrograms are aligned with the dose indicator.

Insert the needle into the skin at the injection site with a steady motion. Press the injection button fully and hold it down until the dose counter returns to “0.” Keep the needle in place for several seconds to ensure the full dose is delivered.

Withdraw the needle from your skin and apply gentle pressure with a cotton swab if needed. Do not rub the area.

Carefully remove the needle from the pen and dispose of it in a proper sharps container.

Rotate injection sites with each dose to reduce the risk of lipodystrophy or irritation.

If a dose is missed, skip the missed dose and resume the next scheduled dose the following day. Do not take extra doses.

Blood glucose should be monitored regularly, particularly during dose titration. If your reading shows less than 4 mmol/L on the blood sugar monitor, immediately consume 15g of sugar in the form of a cup of juice, a spoonful of honey, or 4 Dex4 glucose tablets. Recheck your sugar level in 15 minutes, and if it is still less than 4 mmol/L, take another 15g of sugar. Eat your next meal at the regular time, unless it is more than 1 hour away, then eat a snack.

Some mild or common side effects of Soliqua seen in clinical trials as compared to placebo include:

Low blood sugar (hypoglycemia).

Nausea or vomiting.

Diarrhea.

Injection site reactions such as redness or swelling.

Sore throat.

Some individuals may experience serious side effects while using Soliqua. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

Severe hypoglycemia with confusion, seizures, or loss of consciousness.

Pancreatitis (inflammation of the pancreas), which may present as persistent, severe abdominal pain.

Life-threatening severe allergic reactions, including swelling of the face, lips, or throat, hives, or difficulty breathing.

Low potassium (hypokalemia) may present as severe muscle weakness, fatigue, heart palpitations, and increased thirst/ urination.

Gallbladder problems, including gallstones or cholelithiasis.

Kidney injury or worsening kidney problems, which may present as changes in thirst or urination, dark urine, or severe dehydration.

Signs and symptoms of heart failure include shortness of breath, chest pain, sudden weight gain, or swelling in the legs.

These are not all of the possible side effects of Soliqua. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Soliqua, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including:

A history of pancreatitis or gallbladder disease.

Kidney problems or kidney injury.

Taking other GLP-1 receptor agonists.

A scheduled surgery or procedure that requires general anesthesia.

Gastroparesis or other severe gastrointestinal disease.

Low potassium levels or conditions affecting potassium balance.

A history of severe hypoglycemia.

Soliqua should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.

Soliqua is contraindicated in patients with a known hypersensitivity to insulin glargine, lixisenatide, or any component of the formulation. It should not be used during episodes of hypoglycemia or in those with diabetic ketoacidosis.

Soliqua begins lowering blood glucose after the first dose. Full stabilization of blood sugar levels may take several days to weeks as the dose is titrated to the individual patient’s needs.

When Soliqua is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

Beta-blockers, clonidine, reserpine, and lithium may mask the symptoms of hypoglycemia.

Thiazolidinediones (TZDs) may increase the risk of fluid retention and symptoms of heart failure when used with insulin.

Drugs such as olanzapine (atypical antipsychotic), corticosteroids, estrogens, and diuretics may decrease the blood glucose-lowering effect of Soliqua.

Oral contraceptives (birth control pills), antibiotics, and acetaminophen may have delayed absorption and efficacy due to slowed gastric emptying caused by lixisenatide. They should be taken at least one hour before your injection.

Other antidiabetic agents, including sulfonylureas or long-acting insulin, as well as antihypertensives, fibrates, and antidepressants such as fluoxetine, may increase the risk of hypoglycemia when used together.

Thyroid hormone replacements, such as levothyroxine (Synthroid).

Soliqua 100/33 is a pre-filled pen containing 100 mg/mL of insulin glargine and 33 mcg/mL of lixisenatide.

Prior to first use, the pens should be kept refrigerated and protected from light. Thereafter, it should be stored at room temperature, away from the reach of children or pets. Discard the pen 28 days after first use, and always remove the needle before storing the pen.

Soliqua is manufactured by Sanofi.

No, there is currently no generic version available.

Do not stop using Soliqua without consulting your healthcare provider. Stopping treatment abruptly may lead to worsening blood sugar control.

Soliqua should be used during pregnancy only if the potential benefit justifies the potential risk. Discuss pregnancy plans with your healthcare provider.

It is not known whether lixisenatide passes into breast milk. Insulin glargine may be present in breast milk in small amounts. Your healthcare provider can help weigh the benefits and risks of using Soliqua while breastfeeding.