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MEDICARE PATIENTS: CHECK TO MAKE SURE YOU’RE COVERED NEXT YEAR. LEARN MORE SAUS.SQA.19.10.5213 | 10/19

Get to know SOLIQUA 100/33.

If you’re switching from an oral medication to SOLIQUA 100/33, it’s natural to have questions about using an injectable medicine for the first time. This brochure can help you learn more about how making the change may help you get to goal.

Even if you’re familiar with SoloStar® or other insulin injection pens, it’s important to learn how to use your SOLIQUA 100/33 SoloStar®pen. SOLIQUA 100/33 is injected once a day within one hour before your first meal using the prefilled disposable SoloStar® injection pen.

READY TO GET STARTED?

Watch our step-by-step video

Follow along with our instructor to learn the 6 steps for using SOLIQUA 100/33.

Tip! Please be sure to view each of the chapters in the video below.
Click on this list icon seen in the lower right-hand corner of the video player.

Full Important Safety Information

Full Prescribing Information

How to Use the SOLIQUA 100/33 Pen

Please see full Important Safety Information and link to full Prescribing Information on this website.


NARRATOR:

Welcome.

You’ve taken an important step in managing your diabetes.

To get you started, I’ll explain what SOLIQUA 100/33 is. And then I’ll show you the steps on how to use SOLIQUA 100/33. I’ll also point out some important safety tips throughout this presentation.

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.

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.

NARRATOR VO:

Before you use your pen, talk with your healthcare provider about how to inject, read all of the instructions that came with your pen, and watch this video to help you learn how to use it. If you do not follow the instructions correctly, you may get too much or too little medicine.

Your SOLIQUA 100/33 pen has a once-daily dose range of 15 to 60 units. You should inject your dose within one hour before your first meal of the day. Each unit dialed contains 1 unit of insulin glargine and .33 micrograms of lixisenatide. Your doctor will prescribe the dose that is right for you. Now, let’s get to know your pen.

At one end is the pen cap. Take it off to see the medicine scale, rubber seal, and where the needle will be attached. You may not see the plunger until you have injected a few doses.

On the other end are the dose window, dose pointer, dose selector, and injection button. As you can see, the label on your pen has the medicine name, SOLIQUA 100/33, the dose range, which is between 15 and 60 units, and the expiration date. Remember: If your SOLIQUA 100/33 pen is past the expiration date, do not use it.

NARRATOR:

Now, let’s learn how to use your pen in 6 steps.

The 6 steps for using SOLIQUA 100/33 are: 1. Prep and check your pen; 2. Attach a new needle; 3. Do a safety test; 4. Select the prescribed dose; 5. Inject the dose; and 6. Remove the needle and store the pen.

Make sure to go over these 6 steps carefully before using your pen. If you are unable to follow all of the instructions completely on your own, use the pen only if you have help from a person who is able to follow the instructions. Also, be sure to ask for help if you have problems like poor eyesight or unsteady hands that may prevent you from handling the pen correctly.

NARRATOR VO:

STEP 1:

Prep and check your pen

Before using your pen, be sure to gather alcohol swabs, a new sterile needle, and a sharps disposal container.

NARRATOR:

You may get the container from a pharmacy, an online pharmacy, or a medical supplies website, or through your healthcare provider.

As an alternative, you could also use a heavy-duty plastic household container that’s leak-resistant with a tight-fitting, puncture-resistant lid, such as a plastic laundry detergent container.

Keep your SOLIQUA 100/33 pen in the refrigerator before using it for the first time. Take a new pen out of the refrigerator at least 1 hour before you inject to allow it to adjust to room temperature, because medicine that is cold can be painful to inject.

NARRATOR VO:

Make sure you have the correct pen prescribed by your doctor. The SOLIQUA 100/33 pen is light green with an orange injection button. Also, be sure to check the name and expiration date on the label of your pen. If you have other medicines that use injector pens, making sure that you have the correct pen is especially important.

Do not use your pen after the expiration date or if the pen has been used for more than 28 days.

With clean hands, pull off the pen cap and...

...check that the medicine is clear and colorless to almost colorless. Do not use the pen if the medicine contains particles — return it to your pharmacy for a replacement. Wipe the rubber seal with an alcohol swab to clean.

Now you’re ready for Step 2.

STEP 2:

Attach a new needle

NARRATOR:

Now, take a new needle and peel off the protective seal. You should never reuse a needle. Always use a new, sterile needle for each daily injection to help prevent blocked needles, contamination, and infection.

Also, do not share your pen with other people, even if the needle has been changed.

Always use needles that are compatible with SOLIQUA 100/33. If you do not know which needles to use, ask your healthcare provider or pharmacist.

NARRATOR VO:

To attach the needle, keep the needle straight while you screw it onto the pen.

DO NOT bend or angle the needle as you screw it onto the pen. Be careful not to over-tighten.

Pull off the pen cap...

...and keep it for later when you finish injecting and need to store your pen.

Next, remove the inner needle cap and throw it away.

And of course, always use care when handling needles to prevent injury and cross-infection.

STEP 3:

Do a safety test

NARRATOR:

Always do a safety test before each injection to make sure the pen and needle are working correctly and you get the correct dose.

NARRATOR VO

Let’s do a safety test. Select 2 units by turning the dose selector until the dose pointer is at the 2 mark. Then press the injection button all the way in.

You’ll know your pen is working correctly when you see medicine come out of the tip. If you do not see liquid, repeat the safety test up to 3 times.

If you still see no medicine, the needle may be blocked. If you have a blocked needle, remove the needle and attach a new one. Then, repeat the safety test.

If no medicine comes out after changing the needle, your SOLIQUA 100/33 pen may be damaged. Do not use it. Use a new pen and follow the instructions for preparing to inject again. Also, do not use a syringe to remove medicine from your pen. If you do, you may not get the correct dosage of medicine.

You may see air bubbles in the medicine. This is normal and won’t harm you.

STEP 4:

Select the prescribed dose

The SOLIQUA 100/33 pen should only be used for a single 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 or less than 15 units.

When you dial your dose, you will notice that the dose window is black between 2 units and 15 units.

To select your dose, make sure a needle is attached and the dose is set to “0.” Do not select a dose or press the injection button without a needle attached.

Next, turn the dose selector until the pointer lines up with your dose. The number that appears in the window indicates your dose and is the number you need to pay attention to.

In this example, we are selecting a dose of 30 units. Do not dial your dose by counting the clicks. You may dial the wrong dose. Always check the number in the dose window to make sure you dialed the correct dose.

It’s OK if you go past your dose — just dial back.

Each line in the dose win¬dow equals 1 unit of SOLIQUA 100/33. This pen contains 300 units of medicine.

You can see how many approximate units of medicine are left by looking at where the plunger is on the medicine scale on your SOLIQUA 100/33 pen. If you have vision problems or trouble seeing, please have someone help you!

After continued daily use, you may find that there is not enough medicine left in your SOLIQUA 100/33 pen for your full dose. If your pen doesn’t have enough medicine for you to select the full dose that you were prescribed, you should use a new pen.

STEP 5:

Inject the dose

NARRATOR:

Now that your pen is ready, let’s get started on the injection. This kind of injection is called a “subcutaneous” injection — a short needle is used that goes just under the skin.

Remember, SOLIQUA 100/33 is a once-daily injection. You should inject your dose within one hour before your first meal of the day, preferably at the same time each day. If you miss your dose, take your next scheduled dose at your regular time. Do not take an extra dose or increase your dose to make up for the missed dose.

NARRATOR VO:

You can inject SOLIQUA 100/33 in one of three areas of your body:

Anywhere in your stomach area, except for a 2-inch radius around your navel;

In the fatty tissue on the outer back area of your upper arm; OR

In your outer thigh, away from your knee.

Avoid injecting too close to the bony area above your knee.

Select one of these 3 injection areas and always rotate injection sites within this area. DO NOT use the same exact spot for each injection. For example, if you have chosen to inject SOLIQUA 100/33 in your stomach area, you will want to inject at a different site within this area each time you administer your daily dose.

It’s important to make sure that your thumb can push the injection button straight on, not at an angle. Otherwise, your thumb may prevent the dose selector from turning.

Before you press the injection button and begin the injection, be sure to place the pen at a 90 degree angle against the site you have chosen to inject. Now push the needle into your skin as shown by your healthcare provider. Be sure to press all the way in and hold. Keep the injection button down, and when you see “0” in the dose window, slowly count to 10 to make sure you get your full dose.

Now, release the injection button. Then remove the needle from your skin. If you have any trouble pressing the injection button in, do not force it. Instead, change the needle and do a safety test, as we did in Steps 2 and 3. Do not use a syringe to remove medicine from your pen.

STEP 6:

Remove the needle and store the pen

It’s time to dispose of the used needle and store your pen for future use. Do not put the inner needle cap back on, and remember to take care when handling needles to prevent needle injury and cross-infection.

First, pick up the outer needle cap that you set aside earlier...

...by holding on to the widest part of the outer needle cap and guiding the needle into the cap. Keep the pen straight to avoid puncturing the cap. Then push the cap firmly on.

Grip and squeeze the widest part of the outer needle cap, then turn the pen several times with your other hand to remove the needle. If the needle does not come out at first, try again.

Always throw away used needles in a puncture-resistant sharps container. Do not throw away in your household trash. For more information on sharps containers, learn more at www.fda.gov/safesharpsdisposal.

Now put the outer pen cap back on, but do not put the pen back in the refrigerator. Find a clean, safe place to store it until tomorrow.

Keep an open pen at room temperature below 77°F (25°C) with the pen cap on. Do not refrigerate an opened pen and be sure to protect it from light.

Do not store your pen with the needle attached.

Always treat your pen with care and do not drop it or knock it against hard surfaces. Never try to “fix” a pen you think may be damaged — always replace it with a new pen. If you need to, you may wipe your pen with a damp cloth, using only water. Washing, soaking, or lubricating your pen can damage it.

Be sure to discard your pen 28 days after first use, even if the pen still contains medicine.

An unopened pen should be stored with its cap on in the box it came in, in the refrigerator at a temperature between 36 and 46°F or 2 and 8°C. Do not freeze. If you accidentally freeze your pen, throw it away. And always discard your pen after the expiration date.

Also, always remember to keep your pen out of the sight and reach of children — regardless of whether the pen is opened or unopened.

This completes the 6 steps you would take to use SOLIQUA 100/33:

1. Prep and check your pen; 2. Attach a new needle; 3. Do a safety test; 4. Select the prescribed dose; 5. Inject the dose; and 6. Remove the needle and store the pen.

NARRATOR:

Feel free to watch any step in this video over again until you feel comfortable with the injection process.

If you have any questions at any time about SOLIQUA 100/33, your pen, or managing your overall diabetes, speak to your doctor, nurse, or pharmacist; review the printed instructions that came with your pen, or call Sanofi US at 1-800-633-1610.

Now we will present the Full Important Safety Information and how to obtain the Full Prescribing Information for SOLIQUA 100/33.

NARRATOR VO:

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.
  • 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 may cause serious side effects, including:

  • Serious allergic reactions. Stop taking SOLIQUA 100/33 and get help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue, or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, and very rapid heartbeat.
  • 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 may include headache, dizziness, drowsiness, sweating, weakness, irritability, hunger, blurred vision, fast heartbeat, feeling jittery, confusion, and anxiety.
  • Kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may worsen kidney problems.
  • Low potassium in your blood (hypokalemia).
  • Heart failure. Taking certain diabetes pills called TZDs (thiazolidinediones) 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. 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 if you have new or worse heart failure.

The most common side effects of SOLIQUA 100/33 include low blood sugar (hypoglycemia), nausea, diarrhea, upper respiratory infection, stuffy or runny nose, and headache. Nausea and diarrhea usually happen more often when you first start using SOLIQUA 100/33.

Please see link to full Prescribing information on this website.

SAUS.SQA.17.03.0850(5)


View detailed instructions for using SOLIQUA 100/33.

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Get to know your SOLIQUA 100/33 pen

SOLIQUA® 100/33 pen image

The SOLIQUA 100/33 Pen
For a daily dose range of 15-60 units.
Each pen contains 300 units of medicine.

One Pen. The SOLIQUA 100/33 pen uses the award-winning SoloStar® technology.

Once-daily DOSE. You inject your dose once a day within one hour before your first meal of the day.

Special features help you select and inject your prescribed dose

Small thin needle
that goes just under the skin.

Needle not included with pen. Always use needles compatible with your pen.

SOLIQUA® 100/33 selector dial and push-button injection image

Dose selector dial and push-button injection
work together so you can select and inject your prescribed dose.

SOLIQUA® 100/33 small thin needle image

Large dose window
lets you clearly see your selected dose. Each line in the dose window equals 1 unit of SOLIQUA 100/33.

SOLIQUA® 100/33 large dose window image

Helpful tips for using SOLIQUA 100/33

Before you use SOLIQUA 100/33

Your healthcare provider should teach you how to inject SOLIQUA 100/33. However, before you use your pen:

  • Read all the information that came with your pen, including the Instructions for Use.
  • Speak with your doctor or healthcare provider if you have questions about your pen or do not understand the instructions.
  • Know your dose and don't change your dose unless directed by your doctor.

Take special note

  • Do not re-use needles.
  • Do not use a syringe to remove medicine from your pen.
  • Do not share your pen with other people, even if the needle has been changed.
  • Check the label on the SOLIQUA 100/33 pen each time you inject to make sure you are using the correct medicine.
  • If you have problems handling the pen or can't see the numbers in the dose window clearly, have another person prepare and inject your dose.
  • Finding the right dose can take some time. Stay in close contact with your doctor about how you feel so he or she can adjust your dose to find the dose that works best for you.
SOLIQUA® 100/33 (insulin glargine & lixisenatide injection) 100 Units/mL & 33 mcg/mL pen image

When dialing your dose

  • Do not dial your dose by counting the clicks or you may dial the wrong dose.
  • Always check the number in the dose window to make sure you dial the correct dose.
  • As you dial your dose, you may notice that the dose window is black between 2 units and 15 units. This is because SOLIQUA 100/33 should not be used for a dose of less than 15 units.

When to inject

  • Inject your dose once a day within one hour before your first meal of the day.
  • If you miss a dose, skip the dose and continue as prescribed on the next day. You should never administer two doses on the same day or increase the dose to make up a missed dose.

Choosing a place to inject

You can inject SOLIQUA 100/33 in three areas of your body:

  • Anywhere in your stomach area, except for a two-inch radius around your navel
  • In the fatty tissue on the outer back area of your upper arm
  • In your thigh, away from your knee

Take special note

  • Always rotate the injection sites within the area you have selected. DO NOT use the same exact spot for each injection.

Storing your SOLIQUA 100/33 pen

Before you use your pen for the first time:

  • Store with cap on in original packaging.
  • Refrigerate between 36°F and 46°F (2°C and 8°C).
  • Do not freeze. If you accidentally freeze your pen, throw it away.
  • Discard if past the expiration date and use a new pen.

After you use your pen:

  • Do not put the pen back in the refrigerator.
  • Keep your pen at room temperature below 77°F (25°C).
  • Do not store your pen with the needle attached.
  • Store with cap on to protect from light.
  • Discard the pen 28 days after first use.

Always keep your pen and all medicines out of the sight and reach of children.

Storing your SOLIQUA® 100/33 pen image