Soliqua

Soliqua is a prescription medication used to treat type 2 diabetes in adults. 

Soliqua is a single product containing 2 medications: insulin glargine and lixisenatide.

Insulin glargine is a long-acting, man-made version of human insulin. Insulin glargine works by replacing the insulin that is normally produced by the body and by helping move sugar from the blood into other body tissues where it is used for energy. It also stops the liver from producing more sugar.

Lixisenatide belongs to a group of medications called incretin mimetics. Lixisenatide works by helping the pancreas to secrete insulin when blood sugar levels are high, decreases the amount of sugar the liver produces, and slows the emptying of the stomach.

Soliqua comes in a prefilled disposable SoloStar injection pen. Soliqua is injected just under the skin, once daily, within an hour before meals.

Common side effects of Soliqua include low blood sugar (hypoglycemia), allergic reactions, nausea, and diarrhea.

Soliqua can cause low blood sugar, which may lead to blurry bision or dizziness. Do not drive or operate heavy machinery until you know how Soliqua affects you. 

Soliqua is a prescription medication used along with diet and exercise to treat type 2 diabetes in adults. Soliqua may be started in those with type 2 diabetes who are not well-controlled on 60 units or less of long-acting insulin. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information. 

• Sanofi-Aventis U.S. LLC

Serious side effects have been reported with Soliqua. See the “Soliqua Precautions” section. 

Common side effects of Soliqua include the following:

• Low blood sugar
• Allergic reactions
• Nausea
• Cold-like symptoms
• Diarrhea
• Upper respiratory infection
• Headache

This is not a complete list of Soliqua side effects. Ask your doctor or pharmacist for more information. Tell your doctor if you have any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. 

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Soliqua and other medicines may affect each other. Always check with your doctor before starting or stopping any medicines. Especially tell your doctor if you take: 

• oral medicines for diabetes
• pramlintide (Symlin)
• angiotensin converting enzyme (ACE) inhibitors such as benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec), fosinopril (Monopril), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), and trandolapril (Mavik)
• beta-blockers such as atenolol (Tenormin), labetalol (Normodyne), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), and propranolol (Inderal)
• certain cholesterol-lowering medications such as fenofibrate (Antara, Lofibra, TriCor, Triglide), gemfibrozil (Lopid), and niacin (Niacor, Niaspan, in Advicor)
• clonidine (Catapres, Catapres-TTS, in Clorpres)
• danazol; disopyramide (Norpace)
• diuretics ('water pills')
• fluoxetine (Prozac, Sarafem, in Symbyax)
• glucagon
• hormone replacement therapy
• isoniazid (INH, Nydrazid)
• lithium (Eskalith, Lithobid)
• medications for asthma and colds
• medications for mental illness and nausea
• monoamine oxidase (MAO) inhibitors, including isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl) and tranylcypromine (Parnate)
• octreotide (Sandostatin)
• oral contraceptives (birth control pills)
• oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), and prednisone (Deltasone)
• pentamidine (NebuPent, Pentam)
• pentoxifylline (Trental)
• reserpine 
• salicylate pain relievers such as aspirin, choline magnesium trisalicylate (Tricosal, Trilisate), choline salicylate (Arthropan), diflunisal (Dolobid), magnesium salicylate (Doan's, others), and salsalate (Argesic, Disalcid, Salgesic)
• somatropin (Nutropin, Serostim, others)
• sulfa antibiotics
• sulfinpyrazone (Anturane)
• thyroid medications

This is not a complete list of Soliqua drug interactions. Ask your doctor or pharmacist for more information. 

Serious side effects have been reported with Soliqua including the following: 

Anaphylaxis or serious allergic reaction. Tell your healthcare provider about any signs or symptoms of hypersensitivity such as:

• chest pain
• swelling of the face, eyes, lips, tongue, arms, or legs
• difficulty breathing or swallowing
• rash

Pancreatitis. Pancreatitis is an inflammation of the pancreas, which may be severe and lead to death. Tell your healthcare provider if you have had a history of pacreatitis, alcoholism, or gallstones as this may increase your risk of pancreatitis. Report any signs or symptoms of pancreatitis such as:

• pain in the stomach area that is severe, does not go away, and may spread to the back
• vomiting

Low blood sugar (hypoglycemia). Tell your healthcare provider right away if you have some or all of the following symptoms of hypoglycemia:

• headache
• weakness
• fast heartbeat
• dizziness
• irratibility
• drowsiness
• hunger
• confusion
• sweating
• feeling jittery

Acute kidney injury. Tell your healthcare provider right away if you have some or all of the following symptoms of acute kidney injury:

• decreased urination
• swelling of the face, arms, hands, feet, ankles, or lower legs
• unusual tiredness or weakness.

Low potassium. Tell your healthcare provider right away if you have some or all of the following symptoms of low potassium:

• abnormal heartbeat or feeling of skipped beats
• fatigue
• constipation
• muscle weakness or spasms
• tingling or numbness

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Soliqua, there are no specific foods that you must exclude from your diet when receiving this medication. 

Before taking Soliqua, tell your doctor about all of your medical conditions. Especially tell your doctor if you: 

• are allergic to Soliqua or any of its ingredients
• have a history of pancreatitis
• have a history of alcoholism
• have gallstones
• have kidney or liver problems
• have heart failure or heart problems
• have severe stomach problems
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. 

Tell your doctor if you are pregnant or plan to become pregnant. 

There are no well-controlled studies that have been done in pregnant women. Soliqua should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Soliqua crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Soliqua.

Take Soliqua exactly as prescribed. 

Soliqua comes in a prefilled SoloStar injection pen. The medication is injected once daily within one hour before a meal. Take a new pen out of the refrigerator at least one hour before you inject. Cold medicine is more painful to inject.

Inject Soliqua as follows:

• Take the cap off of the pen.
• Check that the medicine is clear.
• Wipe the rubber seal with an alcohol swab.
• Attach a new pen needle; do not reuse needles.
• Turn the dose selector to 2 units and press the injection button all the way. You should see a drop of medicine. If you do not see a drop of medicine, repeat this step until a drop of medicine is visible at the end of the needle. 
• Select the dose and inject the needle into your skin and press the injection button all the way down. Hold the needle in the skin for 10 seconds so that all of the medicine is injected.
• Release the button and remove the needle from your skin.
• Remove the needle from the pen and replace the cap.
• Always dipose needles in a sharps container.
• Do not put the pen back in the refrigerator.

Do not draw up medicine out of pen using an insulin syringe. 

Never share Soliqua pens with other people, even if the needle is changed.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Soliqua at the same time. 

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following: 

• other medical conditions you have
• other medications you are taking
• how you respond to this medication

The recommended dose range of Soliqua for the treatment of type 2 diabetes is 15 units (insulin glargine 15 units/lixisenatide 5 mcg) to 60 units (insulin glargine 60 units/lixisenatide 20 mcg) daily. 

If you take too much Soliqua, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away. 

Prior to first use, Soliqua should be stored in a refrigerator at 36°F-46°F (2°C-8°C). Do not freeze. Protect from light. Discard after expiration date printed on label. 

After first use, Soliqua can be stored at room temperature below 86°F (30°C). Replace the pen cap after each use to protect medicine from light. Discard pen 14 days after first use.