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Important Safety Information for Lantus® (insulin glargine [rDNA origin] injection)

Contraindications: Lantus® is contraindicated in patients hypersensitive to insulin glargine or one of its excipients.

Click here for additional Important Safety Information.

SoloSTAR® "How To" Video for Your Patients

Narrator VO: Remember what it was like learning how to play your favorite sport?

Narrator VO Or learning steps to a new dance?
Wasn't it great to have someone
there to teach you?

Super 6 easy-to-follow steps

Narrator VO Now that you want to learn how to use the SoloSTAR pen prefilled with Lantus®, we're here to teach you how to do it in 6 easy-to-follow steps.

Super Indications and Usage for Lantus® (insulin glargine [rDNA origin] injection)

Prescription Lantus® is a long-acting insulin used to treat adults with type 2 diabetes and adults and pediatric patients (6 years and older) with type 1 diabetes for the control of high blood sugar. It should be taken once a day at the same time each day to lower blood glucose.

Do not use Lantus® to treat diabetic ketoacidosis.

Please see Important Safety Information for Lantus® at the end of this video and full prescribing information at the link above.

Narrator VO Prescription Lantus® is a long-acting insulin used to treat adults with type 2 diabetes and adults and children (6 years and older) with type 1 diabetes for the control of high blood sugar. It should be taken once a day at the same time each day to lower blood glucose.

Do not use Lantus to treat diabetic ketoacidosis.

Please see Important Safety Information for Lantus® at the end of this video and full prescribing information at the link above.

Narrator VO Before we start the steps, let's take a look at the different parts of the pen and the needle.

The Lantus® SoloSTAR® pen is grey, has a flat, smooth injection button, and is filled with 300 Units of Lantus®, a long-acting insulin.

This is the pen cap. The pen cap protects the pen when you're not using it. When you remove the cap, you can see the rubber seal, which protects the insulin in the pen reservoir.

The dose window has large, easy-to-read numbers, so that you can clearly see the dose you're dialing.

Narrator VO The pen needle has an outer cap, an inner needle cap that covers the actual needle, and a protective seal.

Pen needles are not included with the pen. Lantus® SoloSTAR® is compatible with Becton Dickinson Ultra-Fine pen needles.

Super Important reminders

Narrator VO Before we start with step 1, here are some important reminders about using the pen:

Narrator VO

  • Store unopened Lantus® SoloSTAR® pens in the refrigerator until expiration date
  • You can also store unopened pens at room temperature, but only for 28 days
  • Before injecting, wait until the pen has been out of the refrigerator and warms up to room temperature, so the insulin in the pen will feel more comfortable when you inject it
  • After opening the pen, you should not refrigerate it, and you can use it for up to 28 days
  • Always attach the needle first before dialing the dose selector, and always use a new needle
  • Always wash your hands with soap and water before an injection, and remember to clean the injection site with alcohol

Super 1: Getting ready for an injection

Narrator VO Now let's go to Step 1: Getting ready for an injection.

Narrator VO Remove the pen cap.

Super Use

Narrator VO Before beginning, check to see that the insulin in the pen is clear and colorless. The insulin in this pen is clear, so it's OK to use it.

Super Don't use if not clear. Use another pen, or call 1-800-633-1610

Narrator VO If it is not clear, or if it has particles, do not use that Lantus® SoloSTAR® pen. Use another pen, or call the 24-hour helpline at 1-800-633-1610.

Super 2: Attaching a needle

Narrator VO OK! Now you've completed the first step. So let's go on to Step 2: Attaching a needle.

Super Right

Narrator VO First, remove the protective seal. Then, holding the needle straight, screw it on snugly, but don't make it too tight. If you have a push-on needle, keep it straight as you push it on.

Super Wrong

Narrator VO Never hold the needle at an angle when screwing it onto the pen.

Narrator VO After you've attached the needle, take off the outer needle cap. Save the outer needle cap, because you will need it later to safely remove the needle after your injection.

Narrator VO Now, take off the inner needle cap and throw it away.

Super 3: Doing a safety test

Narrator VO Now let's move on to Step 3: Doing a safety test.

Narrator VO First, dial a test dose of 2 Units.

Narrator VO Now, holding the pen with the needle pointing up, gently tap the reservoir so the air bubbles rise up to the needle.

Narrator VO Then, press the injection button all the way in...

Narrator VO ...and check to see that insulin comes out of the needle. The dial will automatically go back to zero after you perform the test.

Super If no insulin comes out after the fourth test, do not use the pen. Use another pen.

Narrator VO If no insulin comes out, repeat the test 2 more times. If that doesn't work, then use a new needle. If no insulin comes out after you've changed the needle, do not use the pen. Use another pen.

Narrator VO All right! We're already halfway through.

Super 4: Selecting the dose

Narrator VO So let's go on to Step 4: Selecting the dose.

Narrator VO Dial the dose your doctor has prescribed for you. For this demonstration, we're dialing a dose of 10 Units.

A great feature of the Lantus® SoloSTAR® pen is that if you dial too little or too much, you can dial back up or down until you reach your dose. But the dose can't be dialed past the number of insulin units that are still in the pen.

The pen has an automatic safety stop at 80 Units. If you need a dose of more than 80 Units, then you must give yourself another injection.

Use a new pen needle if you need to give yourself another injection.

You must always attach a new needle and discard the one you just used.

Super 5: Injecting your dose

Narrator VO Now let's go on to Step 5: Injecting your dose.

Super upper arms abdomen thighs

Narrator VO Injecting with the Lantus® SoloSTAR® pen is easy and takes seconds to do. The Lantus® SoloSTAR® pen uses a very thin needle that you can inject in the upper arms, the abdomen, or the thighs.

Narrator VO Keeping the pen straight, insert the needle into your skin.

Narrator VO Using your thumb, press the injection button all the way down.

Super 10 sec

Narrator VO Then, slowly count to 10 to make sure that you get your full insulin dose. After counting a full 10 seconds, release the button and remove the needle from your skin.

Super 6:Removing the needle

Narrator VO Congratulations! You've learned how to inject yourself with the Lantus SoloSTAR pen. Now let's go to the last step, Step 6: Removing the needle

Narrator VO Put the outer needle cap back on the needle...

Super www.safeneedledisposal.org

Narrator VO ...and use it to unscrew the needle from the pen. If you have a push-on needle, then pull the outer needle cap from the pen.

Discard the needle and the needle cap the way your healthcare provider told you to do it. You can use a sharps container or visit www.safeneedledisposal.org for other safe ways to dispose of used needles. Put the pen cap back on the pen and store it in a safe place.

Narrator VO With practice, you can do this. But if you forget a step or two, just play the video again. You can also read these injection instructions in the full Prescribing Information at the link above.

Please click below for additional Important Safety Information

Please click below for Full Prescribing Information

Proven HbA1c control

See how Lantus® provides effective, improved glycemic control in diabetes patients.

Lantus® Prescribing Information. February 2015.

Once-daily dosing

Lantus® is a once-daily, long-acting insulin.**

**Lantus® Prescribing Information. February 2015.

Demonstrated long-term CV safety

Lantus® is a basal insulin with demonstrated long-term CV safety data††

††Including CV death, nonfatal MI, nonfatal stroke, revascularization, or hospitalization for heart failure. No difference was observed between Lantus and standard of care in overall incidence of CV death, non-fatal MI, or non-fatal stroke. No difference was observed between treatment groups for death of any cause.

Indications and Usage for Lantus® (insulin glargine [rDNA origin] injection)

Lantus® is a long-acting insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. Lantus® should be administered once a day at the same time every day.

Important Limitations of Use: Lantus® is not recommended for the treatment of diabetic ketoacidosis. Use intravenous short-acting insulin instead.

Important Safety Information for Lantus® (insulin glargine [rDNA origin] injection)

Contraindications

Lantus® is contraindicated in patients hypersensitive to insulin glargine or one of its excipients.

Warnings and Precautions

Insulin pens, needles, or syringes must never be shared between patients. Do NOT reuse needles.

Monitor blood glucose in all patients treated with insulin. Modify insulin regimen cautiously and only under medical supervision. Changes in insulin strength, manufacturer, type, or method of administration may result in the need for a change in insulin dose or an adjustment in concomitant oral antidiabetic treatment.

Do not dilute or mix Lantus® with any other insulin or solution. If mixed or diluted, the solution may become cloudy, and the onset of action/time to peak effect may be altered in an unpredictable manner. Do not administer Lantus® via an insulin pump or intravenously because severe hypoglycemia can occur.

Hypoglycemia is the most common adverse reaction of insulin therapy, including Lantus®, and may be life-threatening.

Severe life-threatening, generalized allergy, including anaphylaxis, can occur. Discontinue Lantus®, monitor and treat if indicated.

A reduction in the Lantus® dose may be required in patients with renal or hepatic impairment.

Fluid retention, which may lead to or exacerbate heart failure, can occur with concomitant use of thiazolidinediones (TZDs) with insulin. These patients should be observed for signs and symptoms of heart failure. If heart failure occurs, dosage reduction or discontinuation of TZD must be considered.

Drug Interactions

Certain drugs may affect glucose metabolism, requiring insulin dose adjustment and close monitoring of blood glucose. The signs of hypoglycemia may be reduced in patients taking anti-adrenergic drugs (e.g., beta-blockers, clonidine, guanethidine, and reserpine).

Adverse Reactions

Adverse reactions commonly associated with Lantus® include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, edema and weight gain.

Important Safety Information for Lantus® SoloSTAR®

Lantus® SoloSTAR® is a disposable prefilled insulin pen. To help ensure an accurate dose each time, patients should follow all steps in the Instruction Leaflet accompanying the pen; otherwise they may not get the correct amount of insulin, which may affect their blood glucose.

Full Prescribing Information for Lantus®
Sanofi's Commitment to Fighting Counterfeit Drugs

Indications and Usage for Lantus® (insulin glargine [rDNA origin] injection)

Lantus® is a long-acting insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. Lantus® should be administered once a day at the same time every day.

Important Limitations of Use: Lantus® is not recommended for the treatment of diabetic ketoacidosis. Use intravenous short-acting insulin instead.

Important Safety Information for Lantus® (insulin glargine [rDNA origin] injection)

Contraindications

Lantus® is contraindicated in patients hypersensitive to insulin glargine or one of its excipients.

Warnings and Precautions

Insulin pens, needles, or syringes must never be shared between patients. Do NOT reuse needles.

Monitor blood glucose in all patients treated with insulin. Modify insulin regimen cautiously and only under medical supervision. Changes in insulin strength, manufacturer, type, or method of administration may result in the need for a change in insulin dose or an adjustment in concomitant oral antidiabetic treatment.

Do not dilute or mix Lantus® with any other insulin or solution. If mixed or diluted, the solution may become cloudy, and the onset of action/time to peak effect may be altered in an unpredictable manner. Do not administer Lantus® via an insulin pump or intravenously because severe hypoglycemia can occur.

Hypoglycemia is the most common adverse reaction of insulin therapy, including Lantus®, and may be life-threatening.

Severe life-threatening, generalized allergy, including anaphylaxis, can occur. Discontinue Lantus®, monitor and treat if indicated.

A reduction in the Lantus® dose may be required in patients with renal or hepatic impairment.

Fluid retention, which may lead to or exacerbate heart failure, can occur with concomitant use of thiazolidinediones (TZDs) with insulin. These patients should be observed for signs and symptoms of heart failure. If heart failure occurs, dosage reduction or discontinuation of TZD must be considered.

Drug Interactions

Certain drugs may affect glucose metabolism, requiring insulin dose adjustment and close monitoring of blood glucose. The signs of hypoglycemia may be reduced in patients taking anti-adrenergic drugs (e.g., beta-blockers, clonidine, guanethidine, and reserpine).

Adverse Reactions

Adverse reactions commonly associated with Lantus® include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, edema and weight gain.

Important Safety Information for Lantus® SoloSTAR®

Lantus® SoloSTAR® is a disposable prefilled insulin pen. To help ensure an accurate dose each time, patients should follow all steps in the Instruction Leaflet accompanying the pen; otherwise they may not get the correct amount of insulin, which may affect their blood glucose.

Full Prescribing Information for Lantus®
Sanofi's Commitment to Fighting Counterfeit Drugs

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