WHY IT MAY BE TIME FOR A CHANGE

Important Safety Information for Lantus (insulin glargine injection) SoloStar

Lantus SoloSTAR is a disposable single-patient-use prefilled insulin pen. Please talk to your healthcare provider about proper injection technique and follow instructions in the Instruction Leaflet that accompanies the pen.

Click here for Full Prescribing Information for Lantus.

What is Toujeo U-300 (insulin glargine) injection 300 Units/mL?

Prescription Toujeo is a long-acting man-made insulin used to control high blood sugar in adults and children who are 6 years of age and older with diabetes mellitus.

• Toujeo is not for the treatment of diabetic ketoacidosis
• It is not known if Toujeo is safe and effective in children under 6 years of age

Important Safety Information for Toujeo U-300 (insulin glargine) injection

Do not use Toujeo if you have low blood sugar or if you are allergic to insulin or any of the ingredients in Toujeo.

Do not share your pen(s) 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.

Before starting Toujeo, tell your doctor about all your medical conditions, including if you have liver or kidney problems, if you are pregnant or planning to become pregnant, or if you are breastfeeding or planning to breastfeed.

Change (rotate) your injection sites within the area you chose with each dose to reduce your risk of getting pitted or thickened skin (lipodystrophy) and skin with lumps (localized cutaneous amyloidosis ) at the injection sites. Do not use the same spot for each injection or inject where the skin is pitted, thickened, lumpy, tender, bruised, scaly, hard, scarred, or damaged.

Heart failure can occur if you are taking insulin together with pills called TZDs (thiazolidinediones), even if you have never had heart failure or other heart problems. If you have heart failure, it may get worse while you take TZDs with Toujeo. Your treatment with TZDs and Toujeo may need to be changed or stopped by your doctor if you have new or worsening heart failure. Tell your doctor if you have any new or worsening symptoms including:

• Shortness of breath
• Sudden weight gain
• Swelling of your ankles or feet

Tell your doctor about all the medications you take, including OTC medicines, vitamins, and supplements, and herbal supplements.

Toujeo should be taken at the same time once a day. Test your blood sugar levels daily while using any insulin. Do not change your dose or type of insulin without talking to your doctor. Verify you have the correct insulin before each injection. Do NOT use a syringe to remove Toujeo from your pen. Your dose for Toujeo may be different from other insulins you have taken. Any change of insulin should be made cautiously and only under medical supervision.

Do NOT dilute or mix Toujeo with any other insulin or solution. It will not work as intended and you may lose blood sugar control, which could be serious. Use Toujeo only if the solution is clear and colorless with no particles visible.

While using Toujeo, do not drive or operate heavy machinery until you know how Toujeo affects you. Don’t drink alcohol or use other medicines that contain alcohol.

The most common side effect of Toujeo is low blood sugar (hypoglycemia), which may be serious and life-threatening. Severe hypoglycemia may cause harm to your heart or brain. Symptoms of serious low blood sugar may include shaking, sweating, fast heartbeat, and blurred vision. The long-acting effect of Toujeo may delay recovery from low blood sugar compared to shorter-acting insulins.

Toujeo may cause severe allergic reactions that can lead to death. Get medical help right away if you have:

• A rash over your whole body
• Shortness of breath
• Swelling of your face, tongue, or throat
• Extreme drowsiness, dizziness, or confusion
• Trouble breathing
• Fast heartbeat
• Sweating

Toujeo may have additional side effects including swelling, weight gain, low potassium, and injection site reactions which may include change in fat tissue, skin thickening, redness, swelling, and itching.

Toujeo SoloStar and Toujeo Max SoloStar are single-patient-use prefilled insulin pens. It is important to perform a safety test when using a new pen for the first time. Talk to your doctor about proper injection technique and follow instructions in the Instruction Leaflet that comes with your Toujeo SoloStar or Toujeo Max SoloStar pen.

Click here for Full Prescribing Information for Toujeo.

SOLIQUA 100/33 is an injectable prescription medicine that contains 2 diabetes medicines, insulin glargine and lixisenatide, which may improve blood sugar (glucose) control in adults with type 2 diabetes when used with diet and exercise.

• It has not been studied in people with a history of pancreatitis.
• It is not recommended for people who also take lixisenatide or other medicines called GLP-1 receptor agonists.
• It is not for use in people with type 1 diabetes, or people with diabetic ketoacidosis.
• It has not been studied in people who have a stomach problem that causes slow emptying (gastroparesis) and is not for people with slow emptying of the stomach.
• It has not been studied in people who also take a short-acting (prandial) insulin.
• It is not known if SOLIQUA 100/33 is safe and effective in children under 18 years of age.

Important Safety Information for SOLIQUA 100/33 (insulin glargine and lixisenatide) injection 100 Units/mL and 33 mcg/mL

What is the most important information I should know about SOLIQUA 100/33?
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 can cause serious side effects, including inflammation of the pancreas, which may be severe and lead to death.

Before using SOLIQUA 100/33, tell your doctor if you have had pancreatitis, stones in your gallbladder (cholelithiasis), or a history of alcoholism. These medical problems may make you more likely to get pancreatitis.

Stop taking SOLIQUA 100/33 and call your healthcare provider right away if you have pain in your stomach area (abdomen) that is severe, and will not go away. The pain may be felt in the back area. The pain may happen with or without vomiting.

Who should not use SOLIQUA 100/33?

Do not use SOLIQUA 100/33 if you:

• are having an episode of low blood sugar (hypoglycemia)
• are allergic to insulin glargine, lixisenatide, or any of the ingredients in SOLIQUA 100/33. Symptoms of a severe allergic reaction with SOLIQUA 100/33 may include swelling of the face, lips, tongue, or throat, fainting or feeling dizzy, problems breathing or swallowing, very rapid heartbeat, severe rash or itching, or low blood pressure.

Before using SOLIQUA 100/33, tell your healthcare provider about all your medical conditions, including if you:

• have or have had problems with your pancreas, your kidneys, or your liver, stones in your gallbladder, or a history of alcoholism.
• have heart failure or other heart problems. If you have heart failure, it may get worse while you take thiazolidinediones (TZDs).
• have severe problems with your stomach, such as slowed emptying of your stomach or problems digesting food.
• are taking certain medicines called glucagon-like peptide 1 receptor agonists (GLP-1 receptor agonists).
• have had an allergic reaction to a GLP-1 receptor agonist.
• are pregnant or breastfeeding or plan to become pregnant or to breastfeed. It is not known if SOLIQUA 100/33 will harm your unborn baby or pass into your breast milk.

Tell your healthcare provider about all the medicines you take, including all prescription and over-the-counter medicines, vitamins, and herbal supplements. SOLIQUA 100/33 may affect the way some medicines work. Before using SOLIQUA 100/33, talk to your healthcare provider about low blood sugar and how to manage it.

How should I use SOLIQUA 100/33?

• Do not change your dose without first talking to your healthcare provider.

• Check the pen label each time you inject to make sure you are using the correct medicine.
• Do not take more than 60 units of SOLIQUA 100/33 each day. Do not take SOLIQUA 100/33 with other GLP-1 receptor agonists.
• Only use SOLIQUA 100/33 that is clear and colorless to almost colorless. If you see small particles, return it to your pharmacy for replacement.
• Change (rotate) your injection sites within the area you chose with each dose to reduce your risk of getting pitted or thickened skin (lipodystrophy) and skin with lumps (localized cutaneous amyloidosis) at the injection sites. Do not use the same spot for each injection or inject where the skin is pitted, thickened, lumpy, tender, bruised, scaly, hard, scarred or damaged.
• Do not remove SOLIQUA 100/33 from the pen with a syringe.
• Do not re-use or share needles with other people. You may give other people a serious infection, or get a serious infection from them.
• Check your blood sugar levels. Ask your healthcare provider what your blood sugar should be and when you should check.

What are the possible side effects of SOLIQUA 100/33?

SOLIQUA 100/33 can cause serious side effects including:

• See "What is the most important information I should know about SOLIQUA 100/33?"
• Severe allergic reactions. Severe allergic reactions can happen with SOLIQUA 100/33. Stop taking SOLIQUA 100/33 and get medical help right away if you have any symptoms of a severe allergic reaction. See "Who should not use SOLIQUA 100/33?"
• Low blood sugar (hypoglycemia). Your risk for getting low blood sugar is higher if you take another medicine that can cause low blood sugar. Signs and symptoms of low blood sugar include: 

  headache	dizzines	drowsiness	sweating
  weakness	irritability	hunger	blurred vision
  fast heartbeat	feeling jittery	confusion	anxiety

  headache	drowsiness
  weakness	hunger
  fast heartbeat	confusion
  dizziness	sweating
  irritability	blurred vision
  feeling jittery	anxiety

• Kidney problems (kidney failure). In people who have kidney problems, the occurrence of diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems to get worse.
• Low potassium in your blood (hypokalemia).
• Heart failure. Taking certain diabetes pills called TZDs with SOLIQUA 100/33 may cause heart failure in some people. This can happen even if you have never had heart failure or heart problems before. If you already have heart failure it may get worse while you take TZDs with SOLIQUA 100/33. Your healthcare provider should monitor you closely while you are taking TZDs with SOLIQUA 100/33. Tell your healthcare provider if you have any new or worse symptoms of heart failure including shortness of breath, swelling of your ankles or feet, or sudden weight gain. Treatment with TZDs and SOLIQUA 100/33 may need to be adjusted or stopped by your healthcare provider if you have new or worse heart failure.
• Gallbladder problems. Gallbladder problems have happened in some people who take SOLIQUA 100/33. Tell your healthcare provider right away if you get symptoms of gallbladder problems which may include:

  pain in your upper stomach (abdomen)	yellowing of skin or eyes (jaundice)
  fever	clay-colored stools

  pain in your upper stomach (abdomen)

  fever

  yellowing of skin or eyes (jaundice)

  clay-colored stools

The most common side effects of SOLIQUA 100/33 include:

Nausea and diarrhea usually happen more often when you first start using SOLIQUA 100/33.

These are not all the possible side effects of SOLIQUA 100/33. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 1-800-FDA-1088.

Click here for Full Prescribing Information for SOLIQUA 100/33.

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*Eligibility Restrictions & Offer Terms:

Insulins Valyou Savings Program: This savings program is not insurance.

For a complete list of participating brands, products, and National Drug Codes (NDCs) Click Here. This offer is not valid for prescriptions covered by or submitted for reimbursement, in whole or in part, under Medicare, Medicaid, VA, DOD, TRICARE, similar federal or state programs, including any state pharmaceutical programs, or commercial/private insurance. Only patients without prescription medication insurance can apply for this offer. Void where prohibited by law. For the duration of the program, eligible cash paying patients will pay $35 per 30 Day Supply. To pay $35 per 30 Day Supply, you must fill all your Sanofi Insulin prescriptions at the same time, together each month. The Insulins Valyou Savings Program applies to the cost of medication. There are other relevant costs associated with overall treatment. Sanofi reserves the right to rescind, revoke, terminate, or amend this offer, eligibility, and terms of use at any time without notice. Upon registration, patients will receive all program details. For questions regarding your eligibility or benefits, or if you wish to discontinue your participation, call the Insulins Valyou Savings Program at (833) 813-0190 (833) 813-0190 (8:00 am-8:00 pm EST, Monday-Friday).
 

Sanofi Insulins Co-pay Savings Program: This savings program is not insurance.

For a complete list of participating brands, products, and National Drug Codes (NDCs) Click Here. This offer is not valid for prescriptions covered by or submitted for reimbursement, in whole or in part, under Medicare, Medicaid, VA, DOD, TRICARE, similar federal or state programs, including any state pharmaceutical programs. If you have an Affordable Care (Health Care Exchange) plan, you may still be qualified to receive and use this savings card. Please note: the Federal Employees Health Benefits (FEHB) Program is not a federal or state government health care program for purposes of the savings program. Void where prohibited by law. For the duration of the program, eligible commercially insured patients pay no more than $35 per 30-day supply, up to 10 packs per fill; Offer valid for one fill every 30 days. Savings may vary depending on patients’ out-of-pocket costs. The Sanofi Insulins Co-pay Savings Program applies to the cost of medication. There are other relevant costs associated with overall treatment. Sanofi reserves the right to rescind, revoke, terminate, or amend this offer, eligibility, and terms of use at any time without notice. Upon registration, patients will receive all program details. For questions regarding your eligibility or benefits, or if you wish to discontinue your participation, call the Sanofi Insulins Co-pay Savings Program at (866) 255-8661 (866) 255-8661 (8:00 am-8:00 pm EST, Monday-Friday).