Education and support resources for you and your patients taking Toujeo^®

ANNOUNCER: These instructions do not replace the guidance of your doctor or the instructions for use that accompanies the Toujeo (insulin glargine injection) 300 Units/mL SoloStar or Toujeo Max SoloStar pens. People who have vision problems should not use the Toujeo SoloStar or Toujeo Max SoloStar pen without help from a person trained to use the respective pens.
MAX AMY: In this diabetes journey we’re on, have you ever wished you could go back in time and tell yourself the things that you know now, but you didn’t know then?
MAX AMY: Thanks to the wonders of modern technology, we can.
MAX AMY: Hey look at that, our first SoloStar pen! I remember that.
MAX AMY: It was a really big deal when I came home with my first pen – it feels like it was only yesterday.
PAST AMY: Oh hey, is that one the same as this one?
MAX AMY: Well your pen is the SoloStar. This one is the Max SoloStar. They’re very similar but there’re some really important differences – but I’ll get to those in a second.
MAX AMY: Did your doctor show you how to use it?
PAST AMY: Yeah, she showed me, but now that I’m home I still have some questions.
MAX AMY: Let me help you get the hang of this.
MAX AMY: There are six steps you need to know: Check the pen, attach the needle, test for safety, select the dosage, inject the insulin, and then remove the needle.
PAST AMY [repeating as if memorizing]: OK. Check the pen, attach the needle, test for safety, select the dosage, inject the insulin, and remove the needle.
MAX AMY: That’s it! You’re ahead of the game already! I knew there was a reason why I liked you. 
MAX AMY: So, before we do anything, we’re going to make sure the pen is at room temperature, that we have the correct pen, and that it’s working properly.
MAX AMY: Did you take the pen out of the refrigerator about an hour ago? 'Cause cold insulin can be painful…
PAST AMY: Really? Who knew?
MAX AMY: You.
PAST AMY: Good point. This one’s been out of the fridge about an hour.  
MAX AMY: Now look at your pen. I mean, really look at it.
MAX AMY: Is that your pen?
PAST AMY: Yeah.
MAX AMY: Great. Take off the pen cap and check the insulin. It’s clear, not cloudy?
PAST AMY: Clear.
MAX AMY: Perfect! If the insulin’s cloudy, don’t use it, just take it back to your pharmacy.
MAX AMY: Is it past the use-by date?
PAST AMY: Nope.
MAX AMY: Great! Now it’s time to attach the needle.
MAX AMY: Remember, you’re going to need a fresh needle every time you use the pen.
MAX AMY: Don’t reuse and never share needles.
PAST AMY: Even with you?
MAX AMY: Yes, even with me.
PAST AMY: What kind of needles can I use?
MAX AMY: These Kind.
MAX AMY: Before you attach the needle, sterilize the tip of the pen with an alcohol wipe.
MAX AMY: Then with the needle you’re going to peel off the protective seal and screw the needle onto the pen until it feels fixed.
MAX AMY: Then you’re going to remove the outer cap and put that somewhere safe. Then remove the inner needle cap and throw it in the trash.
PAST AMY: Keep the outer cap, toss the inner, got it.
MAX AMY: That’s step two done! With me so far?
PAST AMY: I’m with you.
MAX AMY: Yes, you are. So, before we do anything else, we need to make sure the pen’s working properly.
PAST AMY: What could go wrong?
MAX AMY: Well, sometimes the insulin won’t come out, so we usually check for that.
PAST AMY: OK.
MAX AMY: Testing the pen also resets the dosage knob which is also important.
PAST AMY: Great, so how do I do that?
MAX AMY: Turn the dosage dial to 3, then you’re going to hold it straight up and you’re going to press the injection button all the way in.
MAX AMY: If you see insulin coming out of the needle, then the pen is working and you’re good to go.
MAX AMY: However, if you don’t see insulin coming out, repeat that last step again.
MAX AMY: If you have a new pen, you may need to do this up to six times. Just to get that working. If it still doesn’t work, you need to replace the needle.
PAST AMY: Like in step two?
MAX AMY: Precisely. Oh, and by the way, if you see bubbles in your insulin, don’t sweat it.
PAST AMY: Aren’t bubbles in injections bad?
MAX AMY: Nope, not here. You’ve been watching too much TV.
MAX AMY: Ready to inject some insulin?
PAST AMY: OK.
MAX AMY: First, we need to select the correct dosage. So, we’re going to turn the dosage selector to your dose.
MAX AMY: Whatever you and your doctor discussed is what you turn the dial to.
PAST AMY: OK, I need 38 units, so I turn the dial to 38, correct?
MAX AMY: Correct.
MAX AMY: Now this is important: If you have the SoloStar pen, the increments on the dial are one click for one unit, but on the Max SoloStar pen, it’s one click for two units.
MAX AMY: So, don’t dial your dose by counting the clicks, or you may dial the wrong dose.
MAX AMY: Either way, just turn the dial so your prescribed dose appears in this window. If there’s not enough insulin in the pen for your prescribed dose, you’ll only be able to dial to the amount that’s left in the pen, and then you’ll need to supplement with a new pen.
PAST AMY: How do I know whether I need the SoloStar or the Max SoloStar?
MAX AMY: As your diabetes changes, your dose may change too, so your doctor may recommend you use a Max SoloStar. Like me.
PAST AMY: That makes total sense.
MAX AMY: OK, we’re in the home stretch.
MAX AMY: Are you ready for your injection?
PAST AMY: Where can I inject?
MAX AMY: You can inject your dose here, here or here.
MAX AMY: Push the needle into your skin, but don’t touch the injection button yet.
MAX AMY: Put your thumb on the button, press all the way in and hold.
MAX AMY: Hold the button in. When you see “0” in the window, then count to five to make sure you get your full dose.
MAX AMY: After counting to five, release the button and remove the needle from your skin.
PAST AMY: OK, that was pretty easy.
PAST AMY: Well, I barely noticed it at all. How do they do that?
MAX AMY: Thin needles.
MAX AMY: We’re almost done. Now we just need to remove the needle and throw it away safely.
PAST AMY: This really is pretty straightforward.
MAX AMY: I know, right?
MAX AMY: To remove the needle, get the outer needle cap we set aside earlier and carefully place it back on the pen. You put that somewhere safe, right?

PAST AMY: Yep.

MAX AMY: OK.

MAX AMY: These things are sharp. Avoid puncturing the cap, 'cause it will go through.

MAX AMY: Grip and squeeze the widest part of the outer needle cap, then turn your pen several times with your other hand to remove the needle.
PAST AMY: But what if it doesn’t come off right away?
MAX AMY: Just keep trying, it’ll come off eventually.
MAX AMY: Once the needle’s been removed, then we dispose of it in a puncture resistant container.
PAST AMY: Can I just leave the needle on and use it again later?
MAX AMY: No, that’s not a great idea for several reasons: It can leak or get clogged if you leave it on, air could get into the insulin, and there’s the possibility of a bacterial infection.
PAST AMY: So, do I need to put the pen back in the refrigerator when I’m done?
MAX AMY: Nope, that’s the great thing about these pens – you’re good for up to eight weeks after your first use without refrigeration.
PAST AMY: Well that’s handy.
MAX AMY: It sure is.
MAX AMY: So, there you go. That’s all six steps of how to use the Toujeo SoloStar and Max SoloStar insulin pens.
MAX AMY: Just to recap, we learned how to check the pen, attach the needle, test for safety, select your dosage, inject the insulin, and then remove the needle.
PAST AMY: Hey, that was really straightforward. I know the doctor explained it to me, but it really helped to have you explain it again.
MAX AMY: No sweat.
PAST AMY: You know, now that I know, it’s pretty simple. If I wasn’t so nervous, I guess I could have taught myself to do it.
MAX AMY: Well, you know, you kinda did.
ANNOUNCER: An unopened Toujeo SoloStar or Toujeo Max SoloStar pen should be stored in the refrigerator with the pen cap on, at a temperature between 36 degrees Fahrenheit and 46 degrees Fahrenheit (2 degrees Celsius and 8 degrees Celsius) in the box it came in.
Do not freeze new pens.
Refrigerate pens until expiration date.
Discard pens after the expiration date.
An opened Toujeo SoloStar or Toujeo Max SoloStar pen should be stored at room temperature below 86 degrees Fahrenheit (30 degrees Celsius).
Do not refrigerate an opened pen.
Keep out of direct heat and light.
Do not store your pen with the needle attached.
Store your pen with the pen cap on.
Keep pens and needles out of the reach of children.
Discard 56 days after first use, even if the pen still contains insulin.

Toujeo is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients 6 years and older with diabetes mellitus.
Limitations of Use: Toujeo is not recommended for the treatment of diabetic ketoacidosis.

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

Contraindications
Toujeo is contraindicated during episodes of hypoglycemia and in patients hypersensitive to insulin glargine or any of the excipients in Toujeo.

Warnings and Precautions
Toujeo contains the same active ingredient, insulin glargine, as Lantus. The concentration of insulin glargine in Toujeo is 300 units per mL.

Insulin pens and needles must never be shared between patients. Do NOT reuse needles.

Monitor blood glucose in all patients treated with insulin. Modify insulin regimens only under medical supervision. Changes in insulin regimen, strength, manufacturer, type, injection site or method of administration may result in the need for a change in insulin dose or an adjustment in concomitant oral antidiabetic treatment. Changes in insulin regimen may result in hyperglycemia or hypoglycemia. Dosage adjustments are recommended to lower the risk of hypoglycemia when switching patients to Toujeo from another insulin therapy.

Repeated insulin injections into areas of lipodystrophy or localized cutaneous amyloidosis may result in hyperglycemia; sudden change in the injection site (to unaffected area) has been reported to result in hypoglycemia. Advise patients to rotate injection site to unaffected areas and closely monitor for hypoglycemia.

Unit for unit, patients started on, or switched to, Toujeo required a higher dose than patients controlled with Lantus. When switching from another basal insulin to Toujeo, patients experienced higher average fasting plasma glucose levels in the first few weeks of therapy until titrated to their individualized fasting plasma glucose targets. Higher doses were required in titrate-to-target studies to achieve glucose control similar to Lantus.

Hypoglycemia is the most common adverse reaction in patients treated with Toujeo and may be life-threatening. The long-acting effect of Toujeo may delay recovery from hypoglycemia compared to shorter-acting insulins.

Medication errors that may lead to hypoglycemia, such as accidental mix-ups between insulin products, have been reported. Patients should be instructed to always verify the insulin label before each injection.

Do not dilute or mix Toujeo 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 Toujeo via an insulin pump or intravenously because severe hypoglycemia can occur.

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

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

All insulins, including Toujeo, can lead to life-threatening hypokalemia. Untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death. Closely monitor potassium levels in patients at risk of hypokalemia and treat if indicated.

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 dosage 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 Toujeo include hypoglycemia, hypersensitivity reactions, injection site reactions, lipodystrophy, pruritus, rash, edema, and weight gain.

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

Toujeo SoloStar and Toujeo Max SoloStar are single-patient-use prefilled insulin pens. To help ensure an accurate dose each time, patients should follow all steps in the Instruction Leaflet accompanying their pen; otherwise, they may not get the correct amount of insulin, which may affect their blood glucose levels. It is especially important to perform a safety test when a patient is using a new pen for the first time.

Do not withdraw Toujeo from the SoloStar and Max SoloStar single-patient-use prefilled pens with a syringe.

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SAUS.TJO.17.12.9487(2) | 01/20