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General Tempo Platform Information
- What is the Tempo Personalized Diabetes Management Platform?
Tempo™ is a personalized diabetes management platform that combines the Tempo prefilled insulin pen, diabetes management devices, and app-driven support to deliver personalized guidance for people with diabetes.
The Tempo Platform consists of:
- Tempo Smart Button™: When attached to a Tempo Pen™, the Tempo Smart Button detects, stores, and transfers insulin dose-related data, which the TempoSmart™ App uses to display brand of insulin, dose amount, date, and time via Bluetooth® wireless technology. To transfer insulin dose-related data automatically, the Tempo Smart Button must be connected to the app and within 9 feet (3 meters) of the Bluetooth® enabled mobile device. Insulin dosing information can also be entered manually
- Tempo Pen: Compatible with the Tempo Smart Button and prefilled with select Lilly insulins
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TempoSmart™ is indicated for use by healthcare providers (HCPs) and their patients—aged 18 years and older—who have type 1 or type 2 diabetes. TempoSmart is intended to provide secure capture, storage, and transmission of glucose data as well as information to aid in diabetes self-management. TempoSmart analyzes and reports glucose test results and supports medication adherence. In addition, TempoSmart provides coaching messages (motivational, behavioral, and educational) based on real-time glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information
TempoSmart is not intended to replace the care provided by a licensed healthcare provider, including prescriptions, diagnosis, or treatment.
Tempo Insights™ is the healthcare provider-facing component of TempoSmart. Neither Tempo Insights nor TempoSmart is intended to replace the research, expertise, judgment, or treatment provided to patients by healthcare providers.
TempoSmart is not indicated for people with gestational diabetes or who use an insulin pump.
- What is the Tempo Smart Button?
The Tempo Smart Button is a reusable device that attaches to the top of a Tempo Pen and is used to detect insulin dose-related data, which the TempoSmart App uses to display brand of insulin, dose amount, date, and time of dose. Using Bluetooth® wireless technology, the Tempo Smart Button transfers captured data to the TempoSmart App. To transfer insulin dose-related data automatically, the Tempo Smart Button must be connected to the app and within 9 feet (3 meters) of the Bluetooth® enabled mobile device. Insulin dosing information can also be entered manually.
The Smart Button is intended to detect, store, and transfer insulin dose-related data from a Tempo Pen to a compatible application (App). The Smart Button is indicated for single-patient use by patients 18 years or older who are diagnosed with type 1 or type 2 diabetes mellitus, using prefilled insulin Tempo Pens, and using a compatible App.
The Tempo Smart Button may be used for up to 8 months if you:
- Do not frequently press the Tempo Smart Button without dosing your insulin
- Do not store the Tempo Smart Button with the button pressed
- Do not use the Tempo Smart Button outside of room temperature range, which is 59 °F (15 °C) to 86 °F (30 °C)
- Do not store the Tempo Smart Button outside the temperature range of 41 °F (5 °C) to 104 °F (40 °C)
The Tempo Smart Button uses a light system to indicate different actions or issues:
- 1 green flash: The Tempo Smart Button is entering the app-pairing mode
- 3 green flashes: The Tempo Smart Button is now paired with the app. Three green flashes also indicate that dosing data has been tracked and stored
- 3 amber flashes: The Tempo Smart Button could not pair with the app
- Amber and green flashes: The Tempo Smart Button will need to be replaced in 2 weeks or less because the battery is beginning to run low
- No light flash: If there is no light ring flash after use while attached to your Tempo Pen, your Tempo Smart Button is not working. Your Tempo Smart Button will only flash if it has enough battery life and is attached to a Tempo Pen. Make sure your Tempo Smart Button is fully attached to a Tempo Pen
- What is the Tempo Pen?
The Tempo Pen is an insulin pen that functions similarly to the Lilly KwikPen® and is modified to work with the Tempo Smart Button. It is available prefilled with these 3 Lilly insulins: Lyumjev® (insulin lispro-aabc) injection 100 units/mL, BASAGLAR® (insulin glargine) injection 100 units/mL, and Humalog® (insulin lispro injection) 100 units/mL.
When attached to the Tempo Smart Button, insulin dose-related data—which the TempoSmart App uses to display brand of insulin, dose amount, date, and time—is detected, stored, and transferred from the Tempo Smart Button to the TempoSmart App via Bluetooth® wireless technology. To transfer insulin dose-related data automatically, the Tempo Smart Button must be connected to the app and within 9 feet (3 meters) of the Bluetooth® enabled mobile device. Insulin dosing information can also be entered manually.
- What is the TempoSmart App?
TempoSmart is indicated for use by healthcare providers (HCPs) and their patients—aged 18 years and older—who have type 1 or type 2 diabetes. TempoSmart is intended to provide secure capture, storage, and transmission of glucose data as well as information to aid in diabetes self-management. TempoSmart analyzes and reports glucose test results and supports medication adherence. In addition, TempoSmart provides coaching messages (motivational, behavioral, and educational) based on real-time glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information.
TempoSmart is not intended to replace the care provided by a licensed healthcare provider, including prescriptions, diagnosis, or treatment.
Tempo Insights is the healthcare provider-facing component of TempoSmart. Neither Tempo Insights nor TempoSmart is intended to replace the research, expertise, judgment, or treatment provided to patients by healthcare providers.
TempoSmart is not indicated for people with gestational diabetes or who use an insulin pump.
Patients can customize reminders and receive data from compatible blood glucose meters. If patients are using Dexcom Continuous Glucose Monitoring (CGM) Systems, they can sync the TempoSmart App to receive data from their device via cloud-based integration. For automatic data transfer to occur, directions from your patient’s blood glucose meter User Guide or continuous glucose monitor User Guide must be followed. There is a 3-hour delay with visualization of CGM glucose data in the TempoSmart App. Patients should not make dosing decisions based on TempoSmart App CGM glucose data. They should follow the instructions on the CGM.
- What blood glucose meters are compatible with the Tempo Platform?
Compatible blood glucose meters include:
- Tempo™ Blood Glucose Meter
- Accu-Chek® Aviva Connect
- Accu-Chek® Guide
- Accu-Chek® Instant
- CONTOUR®NEXT ONE
- OneTouch Verio Flex®
- OneTouch Verio Reflect®
- TRUE METRIX® AIR
- What is Tempo Insights?
Tempo Insights is the HCP-facing component of the TempoSmart App. Neither Tempo Insights nor TempoSmart is intended to replace the research, expertise, judgment, or treatment provided to patients by healthcare providers. Decisions regarding diagnosis or treatment will be made solely by the healthcare providers.
- What resources are available if I’d like to learn more about the Tempo Platform?
In addition to the user guides that accompany each component, the following materials are available for reference:
- Tempo Platform—HCPs can refer to the “How to Use” video on the Getting Started portion of the Tempo patient website at www.LillyTempo.com for further guidance on how the platform works
- Tempo Insights—The Tempo Insights brochure provides information regarding the use of the Tempo Insights web portal. To register for a Tempo Insights account, please connect with your sales professional or call 1-855-LILLY-TEMPO (1-855-545-5983) to find a sales professional in your area
- Tempo Smart Button—An Instructions for Use (IFU) document is provided in the box that contains the Tempo Smart Button. For further details, IFUs are available on the website (www.LillyTempo.com)
- What is the intended use for the Tempo Smart Button, and what are the indications for use for the TempoSmart App and Tempo Pen?
TempoSmart is indicated for use by healthcare providers (HCPs) and their patients—aged 18 years and older—who have type 1 or type 2 diabetes. TempoSmart is intended to provide secure capture, storage, and transmission of glucose data as well as information to aid in diabetes self-management. TempoSmart analyzes and reports glucose test results and supports medication adherence. In addition, TempoSmart provides coaching messages (motivational, behavioral, and educational) based on real-time glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information.
TempoSmart is not intended to replace the care provided by a licensed healthcare provider, including prescriptions, diagnosis, or treatment.
Tempo Insights is the healthcare provider-facing component of TempoSmart. Neither Tempo Insights nor TempoSmart is intended to replace the research, expertise, judgment, or treatment provided to patients by healthcare providers.
TempoSmart is not indicated for people with gestational diabetes or who use an insulin pump.
The Tempo Smart Button is intended to detect, store, and transfer insulin dose-related data from a Tempo Pen to a compatible application (App). The Smart Button is indicated for single-patient use by patients 18 years or older who are diagnosed with type 1 or type 2 diabetes mellitus, using prefilled insulin Tempo Pens, and using a compatible App.
Tempo Pens are available prefilled with these 3 Lilly insulins: Lyumjev® (insulin lispro-aabc) injection 100 units/mL, BASAGLAR® (insulin glargine) injection 100 units/mL, and Humalog® (insulin lispro injection) 100 units/mL.
Lyumjev is a rapid-acting human insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus.
BASAGLAR is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.
Limitation of Use: BASAGLAR is not recommended for the treatment of diabetic ketoacidosis.
Humalog is a rapid-acting human insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus.
To learn more about Lyumjev, BASAGLAR, and Humalog, and their indication details, please visit their respective websites.
- Can the TempoSmart App connect to other smart devices (eg, Apple Watch®) or software?
The TempoSmart App is compatible with several smart devices, including activity trackers and Dexcom Continuous Glucose Monitoring (CGM) Systems. There is a 3-hour delay with visualization of CGM glucose data in the TempoSmart App. Patients should not make dosing decisions based on TempoSmart App CGM glucose data. They should follow the instructions on the CGM.
If you have an activity tracker such as Fitbit® or Garmin®, the Apple Health app (iOS devices), or the Google Fit™ app (Android™ devices), you can connect it to sync your data.
- Is Tempo available only by prescription? How do I get my patients started?
The components of the Tempo Platform except the app and the Refill Kit are available only by prescription. You may still prescribe the Refill Kit in order for insurance to be billed.
To get patients started, write a prescription for the Tempo™ Welcome Kit and the appropriate Tempo Pen. For more information regarding prescribing Tempo kits, please visit www.LillyTempo.com/hcp. You can enter “Tempo” into your e-prescribing software to determine if Tempo is available. Patients do not need a prescription to access the Logbook.
The Tempo Welcome Kit includes an introductory letter, a Tempo Smart Button, 100 pen needles, a Tempo Blood Glucose Monitoring System with a quantity of 100 each of lancets and blood glucose test strips, and access to the TempoSmart App.
You’ll also need to prescribe the Tempo Pen, which is prefilled with one of select Lilly insulins—Lyumjev® (insulin lispro-aabc) injection 100 units/mL, BASAGLAR® (insulin glargine) injection 100 units/mL, or Humalog® (insulin lispro injection) 100 units/mL—and the Tempo™ Refill Kit, which comes with a quantity of 100 each of lancets, blood glucose test strips, and pen needles.
Each Tempo Smart Button has a limited battery life. It can be reused multiple times for up to 8 months and attached to different Tempo Pens. Patients will require a prescription for a replacement Tempo Smart Button once the battery life ends. Your Tempo Insights portal will notify you when your patient’s Tempo Smart Button battery is getting low so you can proactively write a replacement Tempo Smart Button prescription. Please advise your patients that the Tempo Smart Button is reusable even after their Tempo Pen is empty. It can be reused when switching between a used and a new insulin pen or when switching between a mealtime insulin pen and a basal insulin pen.
If your patient already has a compatible blood glucose meter, you can prescribe the Tempo Smart Button and a Tempo Pen. To use the Tempo Platform, patients must download the TempoSmart App and pair it with their devices.
- Can the TempoSmart App connect to my electronic health records (EHRs)?
No, but this functionality may be available in the future. To learn more about EHR integration, please contact your sales professional or call 1-855-LILLY-TEMPO (1-855-545-5983) to find a sales professional in your area.
- Will my patients get a new Tempo™ Welcome Kit every year?
The Tempo Welcome Kit is part of the onboarding process to set new patients up with the materials necessary to start, and it only needs to be prescribed once. When necessary, you may prescribe the Tempo Refill Kit, which contains a quantity of 100 each of test strips, lancets, and pen needles.
To search for Tempo products within your e-prescribing software, type “Tempo” into the search bar. If the 6 different Tempo products do not populate through this search, please proceed with writing a paper prescription for the patient to take to their pharmacy. Further, please contact 1-855-LILLY-TEMPO (1-855-545-5983) to ensure that all Tempo products are added to your respective e-prescribing software moving forward.
- How can I request more information or a demo of components within the Tempo Platform?
The Tempo website offers more in-depth information about the Tempo Platform, including details about:
- Tempo Smart Button
- Tempo Pen, prefilled with one of the following Lilly insulins: Lyumjev® (insulin lispro-aabc) injection 100 units/mL, BASAGLAR® (insulin glargine) injection 100 units/mL, or Humalog® (insulin lispro injection) 100 units/mL. To learn more about each insulin, visit the respective websites for those insulins
- TempoSmart App
- Tempo Insights web portal
- Tempo Welcome Kit and Tempo Refill Kit
To schedule a demo of the Tempo Platform, please connect with your sales professional or call 1-855-LILLY-TEMPO (1-855-545-5983).
- How can I get access to Tempo Insights?
To create a Tempo Insights account, please connect with your sales professional or call 1-855-LILLY-TEMPO (1-855-545-5983) to find a sales professional in your area.
- How can I request a demo of the Tempo Platform?
A sales professional can visit your office with a demo of the Tempo Platform to explain what patients receive when they get started with the platform.
To request a demo of the Tempo Platform or to connect with a sales professional, please call 1-855-LILLY-TEMPO (1-855-545-5983). You may also be able to schedule a demo of the Tempo Pen, as well as the Tempo Smart Button.
Devices
- What is a Tempo Welcome Kit?
The Tempo™ Welcome Kit includes:
- Tempo Smart Button™
- Tempo™ Blood Glucose Monitoring System
- Tempo™ Lancets (Quantity: 100)
- Tempo™ Blood Glucose Test Strips (Quantity: 100)
- Pen needles (Quantity: 100)
Tempo kits do not include insulin. Tempo Welcome and Refill Kits are prescribed separately. Refill Kits are also available over the counter.
- What is a Tempo Refill Kit?
The Tempo™ Refill Kit includes:
- Tempo Lancets (Quantity: 100)
- Tempo Blood Glucose Test Strips (Quantity: 100)
- Pen needles (Quantity: 100)
- Gauze Pads (Quantity: 2)
Tempo kits do not include insulin. Tempo Welcome and Refill Kits are prescribed separately. Refill Kits are also available over the counter.
- Which blood glucose meters (BGMs) are compatible with the TempoSmart App?
Several BGMs are compatible with the TempoSmart App and can be paired through a Bluetooth® wireless connection. These include:
- Tempo™ Blood Glucose Meter
- Accu-Chek® Aviva Connect
- Accu-Chek® Guide
- Accu-Chek® Instant
- CONTOUR®NEXT ONE
- OneTouch Verio Flex®
- OneTouch Verio Reflect®
- TRUE METRIX® AIR
- Is the TempoSmart App compatible with continuous glucose monitors?
The TempoSmart App is compatible with Dexcom Continuous Glucose Monitoring (CGM) Systems. Patients will need to log in to their Dexcom accounts to connect their Dexcom CGM Systems with the TempoSmart App. When a patient connects a Dexcom CGM, the current day’s glucose data will be available after a 3-hour delay due to the cloud-to-cloud integration between Dexcom and the TempoSmart App. For automatic data transfer to occur, directions from your patient’s continuous glucose monitor User Guide must be followed.
Warning: Do not make dosing decisions based on CGM data from the TempoSmart App. Follow instructions on your CGM system.
- Is there customer support for Dexcom Continuous Glucose Monitoring (CGM) Systems?
The Dexcom CARE team of trainers and Certified Diabetes Care and Education Specialists (CDCESs) are available to help patients. They provide live, interactive support.
To reach the Dexcom CARE team, please call their toll-free number at 1-888-738-3646, available Monday to Friday, 6 AM to 5 PM PST (9 AM to 8 PM EST).
- How do Dexcom Continuous Glucose Monitoring (CGM) Systems integrate with the TempoSmart App?
Patients will need to log in to their Dexcom accounts to connect their Dexcom CGM Systems with the TempoSmart App. Data in the TempoSmart App should be used as a retrospective review of glucose data. Neither Tempo Insights nor TempoSmart is intended to replace the research, expertise, judgment, or treatment provided to patients by healthcare providers. Decisions regarding diagnosis or treatment will be made solely by the healthcare providers. Patients should not make dosing decisions based on TempoSmart App CGM glucose data. They should follow the instructions on the CGM.
- How do I/patients pair my/their Dexcom Continuous Glucose Monitoring (CGM) Systems with the TempoSmart App?
You/Your patients can pair their devices within the TempoSmart App by following these steps:
- At the bottom of the TempoSmart App screen, select More from the menu.
- Click on Connections and Devices.
- Click on Continuous Glucose Monitor.
- Click on CGM Data by Dexcom, and follow the directions provided.
- Will the Tempo Smart Button work with Lilly KwikPens?
The Tempo Smart Button does not work with current Lilly KwikPens. It is designed to work with the Lyumjev® Tempo Pen™, BASAGLAR® Tempo Pen™, and Humalog® Tempo Pen™, which are Lilly KwikPens that have been modified for compatibility.
To learn about updates to Tempo Platform components, see What Is Tempo/Platform Overview.
- Who can my patients and I contact if we have questions about any of the Tempo Platform components?
Lilly Tempo Support can be reached at 1-855-LILLY-TEMPO (1-855-545-5983) to assist with questions related to components. The toll-free number is a service provided by Lilly USA, LLC and is not intended to replace medical advice.
Troubleshooting Tempo Platform Components
- If my patient’s Tempo Welcome Kit is missing an item, an item they received doesn’t work, or one of the components stops working after initial setup, can they get a replacement?
Patients can contact the Lilly Tempo Support team and file a product complaint. Representatives will determine replacement eligibility once they have assessed the issue. Please have patients contact Lilly Tempo Support by dialing 1-855-LILLY-TEMPO (1-855-545-5983). The toll-free number is a service provided by Lilly USA, LLC and is not intended to replace medical advice.
- Can my patients get refills for items in the Tempo Welcome Kit?
The Tempo Welcome Kit is part of the onboarding process to set new patients up with the materials necessary for a smooth start, and it will only need to be prescribed once.
If a Tempo Smart Button indicates that its battery is running low (amber and green lights will flash), indicating the unit needs to be replaced within 2 weeks or less, you can prescribe a replacement unit. Patients will have to pair their new Tempo Smart Button attached to a Tempo Pen with the TempoSmart App for insulin dose-related data to be transferred. To transfer insulin dose-related data automatically, the Tempo Smart Button must be connected to the app and within 9 feet (3 meters) of the Bluetooth® enabled mobile device. Insulin dosing information can also be entered manually.
You can also prescribe refills for a patient’s Lyumjev® Tempo Pen™, BASAGLAR® Tempo Pen™, or Humalog® Tempo Pen™.
You can prescribe a Tempo Refill Kit for patients who need replacement test strips, lancets, and pen needles.
Cost and Coverage
- Is there a savings card for Tempo Platform products?
To qualify for a Tempo Savings Card, your patients must be eligible, commercially insured residents of the United States or Puerto Rico and be aged 18 years or older. They CANNOT be enrolled in federal or state government–sponsored prescription programs (eg, Medicaid or Medicare Part D).
Lilly is continuously partnering with the Centers for Medicare and Medicaid Services (CMS) to gain availability and will provide updates to the Lilly Tempo Implementation Team as they become available.
Eligible patients can visit www.LillyTempo.com to download a copy of the Tempo Savings Card.
- How can my patients receive Tempo Platform products at a reduced cost?
Patients can visit the Tempo website to see if they’re eligible for the Tempo Savings Card. Advise your patients to visit www.LillyTempo.com to see if they qualify and to enroll.
- Are Tempo Platform products covered by Medicare?
Tempo Platform products are currently available for patients enrolled in federal or state government–funded prescription programs (eg, Medicaid or Medicare Part D), but this group of patients is not eligible for the Tempo Savings Card. Lilly is continuously partnering with the Centers for Medicare and Medicaid Services (CMS) to gain availability and will provide updates to the Lilly Tempo Implementation Team as they become available.
- Are Tempo Platform products covered by insurance?
Yes, the Tempo Platform products are covered by insurance. Please refer to the plan-specific formulary to determine if your patients are eligible for insurance coverage. Patients can also reach out to their insurance provider to confirm that they qualify for coverage.
- If some of my patients are not insured, can they still obtain Tempo Platform products?
Your patients do not need insurance coverage to obtain Tempo Platform products. You can write a prescription for the individual Tempo Platform devices, as there are several components within the Tempo Platform (eg, Tempo Smart Button, Tempo Pen, Tempo Welcome Kit, and Tempo Refill Kit), but patients will have to pay the full list price of the individual products.
- If my patients change insurance providers, will this affect their access to Tempo Platform products?
If any of your patients change insurance providers, they will need to verify whether Tempo Platform products are covered under the new plan. Please have your patients contact their new provider to ensure that differences in the new plan won’t affect coverage.
- Can patients use different co-pay and savings cards to cover Tempo Platform products?
All Tempo components are covered by the Tempo Savings Card, which is available for commercially insured patients. Currently, only the Tempo Savings Card can be used to cover Tempo Platform products.
- Do Tempo Platform products come with a warranty?
There is no warranty program; however, the Tempo Smart Button has a replacement allowance if the product stops working or is damaged or broken within an 8-month time frame. This replacement also applies to other Tempo Platform products if the product is damaged or broken. Have patients contact Lilly Tempo Support at 1-855-LILLY-TEMPO (1-855-545-5983) to report a product complaint and for guidance on how to obtain replacements.
Pharmacy
- What if my patient receives a prescription for a KwikPen along with components of the Tempo Platform?
Contact the prescriber to verify whether they intended to initiate the patient on Tempo therapy. If so, request a new prescription for a Tempo Pen of the brand of insulin they are taking.
- What if my patient receives a prescription for Tempo but no corresponding components of the Tempo Platform?
Contact the prescriber to verify whether they intended to initiate the patient on Tempo therapy. If so, request a prescription for the Tempo Welcome Kit, Tempo Pen (with the correct type(s) of insulin), and a sufficient number of Tempo Refill Kit renewals to ensure that the patient has all the products required to start and stay on therapy.
- What if my patient hasn’t received a Tempo Refill Kit along with the initiation-month prescriptions?
Contact the prescriber to verify whether they intended to initiate the patient on the Tempo Platform. If so, inform the prescriber that the patient will need Tempo Refill Kit prescriptions in subsequent months to continue treatment if using a Tempo Savings Card.
- What if my patient loses or damages their test strips, lancets, pen needles, or Tempo Smart Button?
Direct your patient to Lilly Tempo Support at 1-855-LILLY-TEMPO (1-855-545-5983).
- What if my patient has been prescribed the Tempo Smart Button but does not have ongoing prescriptions for compatible devices and supplies for the components of the Tempo Platform?
Contact the prescriber to verify that the patient does not need their diabetic supplies through the Tempo Welcome Kit and Tempo Refill Kit offerings. If not, inform the prescriber that the patient will need continued prescriptions for supplies compatible with the Tempo Platform. If the prescriber intended the patient to also get their diabetic supplies through the Tempo Platform, ask them to prescribe the needed quantity of Tempo Welcome Kits and Tempo Refill Kits if using a Tempo Savings Card.
- What if my patient has issues with coverage, connectivity of the Tempo Platform, or technical issues related to the Tempo Platform?
Direct your patient to Lilly Tempo Support at 1-855-LILLY-TEMPO (1-855-545-5983) to report a product complaint.
- Will my patients need to reactivate their Tempo Savings Card if they change to a new pharmacy?
No, but patients should be advised to bring their Tempo Savings Card to their new pharmacy. Direct patients to Lilly Tempo Support at 1-855-LILLY-TEMPO (1-855-545-5983).
- For retail pharmacist/pharmacy staff: What resources can I refer to when consulting with patients who have a Tempo prescription?
We have developed the Pharmacy Guide to support you and walk you through how to process, dispense, and consult with patients with Tempo prescriptions.
Call Us
For support and information about Tempo™, please call 1-855-LILLY-TEMPO (1-855-545-5983) Monday to Friday, 8 ᴀᴍ to 8 ᴘᴍ ET, and Saturday, 9 ᴀᴍ to 5 ᴘᴍ ET.
If you need information about a Lilly product or want to report an adverse event or a product complaint, you may call 1-800-LillyRx (1-800-545-5979) .
Tempo Smart Button™ Intended Use
The Smart Button is intended to detect, store, and transfer insulin dose-related data from a Tempo Pen to a compatible application (App). The Smart Button is indicated for single-patient use by patients 18 years or older who are diagnosed with type 1 or type 2 diabetes mellitus, using prefilled insulin Tempo Pens, and using a compatible App.
TempoSmart™ and Tempo Insights™ Indications for Use and Contraindications
TempoSmart is indicated for use by healthcare providers (HCPs) and their patients—aged 18 years and older—who have type 1 or type 2 diabetes. TempoSmart is intended to provide secure capture, storage, and transmission of glucose data as well as information to aid in diabetes self-management. TempoSmart analyzes and reports glucose test results and supports medication adherence. In addition, TempoSmart provides coaching messages (motivational, behavioral, and educational) based on real-time glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information.
TempoSmart is not intended to replace the care provided by a licensed healthcare provider, including prescriptions, diagnosis, or treatment.
Tempo Insights is the healthcare provider-facing component of TempoSmart. Neither Tempo Insights nor TempoSmart is intended to replace the research, expertise, judgment, or treatment provided to patients by healthcare providers.
TempoSmart is not indicated for people with gestational diabetes or who use an insulin pump.
Important Safety Information for the Tempo™ Personalized Diabetes Management Platform
When using the Tempo Personalized Diabetes Management Platform, if your patient is not sure if they injected their insulin or if their insulin dosing information is accurate, they should NOT start over or repeat the injection. Your patient should monitor their blood glucose per your instructions. Ensure your patient has a backup diabetes management plan if their Tempo Smart Button or TempoSmart App stops working. Having a backup plan and supplies can help avoid hyperglycemia and hypoglycemia. Keep the Tempo Smart Button away from children. For additional product and safety information, including Warnings and Cautions, consult the Tempo Smart Button Instructions for Use, TempoSmart App User Guides and Tempo Welcome Kit and Tempo Refill Kit Instructions.
Lyumjev® (insulin lispro-aabc) injection 100 units/mL
Indication
Lyumjev is a rapid-acting human insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus.
Humalog® (insulin lispro injection) 100 units/mL
Indication
Humalog is a rapid-acting human insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus.
Important Safety Information for Lyumjev and Humalog
- Contraindications - Lyumjev and Humalog are contraindicated during episodes of hypoglycemia and in patients who are hypersensitive to these insulins or any of their excipients.
- Warnings and Precautions
Never Share a Lyumjev or Humalog Prefilled Pen, Cartridge, Syringe, or Humalog Reusable Pen Compatible with Lilly 3 mL Cartridges Between Patients, even if the needle is changed. Patients using Lyumjev or Humalog vials must never share needles or syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens.
Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen: Changes in insulin strength, manufacturer, type, injection site, or method of administration may affect glycemic control and predispose to hypoglycemia or hyperglycemia. Use caution and close medical supervision when making any changes in insulin regimen and increase the frequency of blood glucose monitoring. Due to reports of hyperglycemia and hypoglycemia, advise patients who have repeatedly injected into areas of lipodystrophy or localized cutaneous amyloidosis to change the injection site to unaffected areas and closely monitor blood glucose. For patients with type 2 diabetes, dosage adjustments of concomitant antidiabetic products may be needed.
Hypoglycemia: Severe hypoglycemia may be life threatening, may lead to unconsciousness, and can cause seizures or death. Hypoglycemia is the most common adverse reaction of Lyumjev and Humalog. Monitor blood glucose and increase monitoring frequency with changes to insulin dosage, coadministered medications, meal pattern, or physical activity; in patients with renal or hepatic impairment; and in patients with hypoglycemia unawareness.
Hypoglycemia Due to Medication Errors: Instruct patients to always check the insulin label before each injection to avoid medication errors. Do not transfer Lyumjev U-200 from the Lyumjev KwikPen® to a syringe and do not transfer Humalog U-200 from the Humalog KwikPen® to a syringe as overdose and severe hypoglycemia can occur.
Hypokalemia: Hypokalemia may be life threatening. Insulins, including Lyumjev and Humalog, cause a shift in potassium from the extracellular to intracellular space possibly leading to hypokalemia, which, if untreated, may result in respiratory paralysis, ventricular arrhythmia, and death. Monitor potassium levels in patients at risk for hypokalemia (e.g., patients using potassium-lowering medications or medications sensitive to serum potassium concentrations).
Hypersensitivity Reactions: Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with Lyumjev and Humalog. If hypersensitivity reactions occur, discontinue the use of Lyumjev or Humalog and treat per standard of care until signs and symptoms resolve.
Fluid Retention and Heart Failure with Concomitant Use of PPAR-gamma Agonists: Thiazolidinediones (TZDs), which are PPAR-gamma agonists, can cause dose-related fluid retention, particularly when used in combination with insulin, including Lyumjev and Humalog. This may lead to or exacerbate heart failure. Observe patients for signs and symptoms of heart failure and consider discontinuation or dose reduction of the PPAR-gamma agonist.
Hyperglycemia and Ketoacidosis Due to Insulin Pump Device Malfunction: Pump or infusion set malfunctions and insulin degradation can lead to a rapid onset of hyperglycemia and ketoacidosis. Prompt identification is necessary. Patients using subcutaneous insulin infusion pumps must be trained to administer insulin by injection and have alternate insulin therapy available in case of pump failure. - Adverse Reactions
Adverse reactions associated with Lyumjev and Humalog include hypoglycemia, hypokalemia, allergic reactions, injection- or infusion-site reactions, lipodystrophy, localized cutaneous amyloidosis, pruritus, rash, weight gain, and peripheral edema. - Drug Interactions
Some medications may alter glucose metabolism, insulin requirements, and the risk for hypoglycemia or hyperglycemia. Signs of hypoglycemia may be reduced or absent in patients taking anti-adrenergic drugs. Particularly close monitoring may be required. - Pediatric Use
Lyumjev-treated pediatric patients reported a higher incidence of subcutaneous injection site-related reactions compared to Lyumjev-treated adults. It is expected that Lyumjev-treated pediatric patients who receive continuous subcutaneous insulin infusion (CSII) are more likely to have infusion site-related adverse reactions than those who receive subcutaneous injections. Monitor injection and infusion sites closely when initiating therapy with Lyumjev in pediatric patients. If persistent injection or infusion site reactions occur, discontinue Lyumjev and initiate therapy with an alternative insulin.
UR HI HCP ISI 14OCT2023
Please click to access Lyumjev Full Prescribing Information including Patient Prescribing Information and Instructions for Use for the Lyumjev® Tempo Pen™ (insulin lispro-aabc) injection 100 units/mL.
Please click to access Humalog U-100 Full Prescribing Information including Humalog U-100 Patient Prescribing Information and Instructions for Use for the Humalog® Tempo Pen™ (insulin lispro injection) 100 units/mL.
BASAGLAR® (insulin glargine) injection 100 units/mL
Indication
BASAGLAR is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.
Limitation of Use
BASAGLAR is not recommended for the treatment of diabetic ketoacidosis.
Important Safety Information for BASAGLAR
Contraindications - BASAGLAR is contraindicated during episodes of hypoglycemia, and in patients with hypersensitivity to insulin glargine or any of the excipients in BASAGLAR.
Warnings and Precautions
BASAGLAR prefilled pens must never be shared between patients, even if the needle is changed. Sharing poses a risk of transmission of blood borne pathogens.
Changes in insulin strength, manufacturer, type, injection site, or method of administration may affect glycemic control and predispose to hypoglycemia or hyperglycemia. Any changes in insulin regimen should be made cautiously and only under close medical supervision, and the frequency of blood glucose monitoring should be increased. Due to reports of hypoglycemia and hyperglycemia, advise patients who have repeatedly injected into areas of lipodystrophy or localized cutaneous amyloidosis to change the injection site to unaffected areas and closely monitor blood glucose. For patients with type 2 diabetes, dosage adjustments of concomitant anti-diabetic products may be needed.
Hypoglycemia is the most common adverse reaction associated with insulins, including BASAGLAR. Severe hypoglycemia can cause seizures, may be life-threatening, or cause death.
Accidental mix-ups between insulin products have been reported. To avoid hypoglycemia due to medication errors between BASAGLAR and other insulins, instruct patients to always check the insulin label before each injection.
Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulins, including BASAGLAR. If hypersensitivity reactions occur, discontinue BASAGLAR; treat per standard of care and monitor until symptoms and signs resolve. BASAGLAR is contraindicated in patients who have had hypersensitivity reactions to insulin glargine or one of the excipients.
All insulins, including BASAGLAR, cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia. Untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death. Monitor potassium levels in patients at risk for hypokalemia if indicated.
Thiazolidinediones (TZDs), which are peroxisome proliferator-activated receptor (PPAR)-gamma agonists, can cause dose-related fluid retention, particularly when used in combination with insulin. Fluid retention may lead to or exacerbate heart failure. 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.
Adverse Reactions
Adverse reactions commonly (>5%) associated with insulin glargine products are: hypoglycemia, allergic reactions, injection site reaction, lipodystrophy, pruritus, rash, edema, and weight gain.
Drug Interactions
Certain drugs may affect glucose metabolism, requiring insulin dose adjustment and close monitoring of blood glucose.
The risk of hypoglycemia may increase when antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analog (e.g., octreotide), and sulfonamide antibiotics are co-administered with BASAGLAR.
The blood glucose lowering effect of BASAGLAR may decrease when co-administered with atypical antipsychotics, corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline), and thyroid hormones. The blood glucose lowering effect of BASAGLAR may increase or decrease when co-administered with alcohol, beta-blockers, clonidine, lithium salts, and pentamidine.
The signs and symptoms of hypoglycemia may be blunted when beta-blockers, clonidine, guanethidine, and reserpine are co-administered with BASAGLAR.
BV HCP ISI 14SEP2023
For more information, please click to access Full Prescribing Information including Patient Information and Instructions for Use for the BASAGLAR® Tempo Pen™ (insulin glargine) injection 100 units/mL.