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Tempo Smart Button
- What is the Tempo Smart Button?
The Tempo Smart Button™ is a data transmitter for your Tempo Insulin Pen that uses Bluetooth® wireless technology to send your dose-related data to your TempoSmart™ App. It comes ready to use. Simply attach the Tempo Smart Button to the Tempo Insulin Pen by following the instructions here. Please read the Instructions for Use included with the Tempo Smart Button.
To pair the Tempo Smart Button with the TempoSmart™ App:
- Make sure the dose indicator on your Tempo Pen™ is at “0.”
- Open the TempoSmart App on your mobile device in a location at least 9 feet (3 meters) away from other mobile devices actively in use. Warning: to help prevent others from accessing your data or settings, do not leave your Tempo Smart Button in an area that can be accessed by others.
- On the TempoSmart App, select the following:
- More
- Connections & Devices
- Tempo Smart Button
- Connect Tempo Smart Button
- Press and hold the Tempo Smart Button down for about 10 seconds until you see 1 green flash. Release the Tempo Smart Button after you see 1 green flash. This means that your Tempo Smart Button is ready to pair with your app.
- Follow your TempoSmart App’s onscreen prompts to finish pairing your Tempo Smart Button. You will receive confirmation in your app if pairing is successful.
- The light ring on the Tempo Smart Button will flash green 3 times when the Tempo Smart Button is connected (paired) with your app.
Please read the Instructions for Use included with the Tempo Smart Button in your Tempo™ Welcome Kit. You can also visit Setting Up Tempo.
- How do I safely store and travel with my Tempo Smart Button?
Place the Tempo Smart Button in a location where it cannot get pressed accidentally or repeatedly. This is to preserve the battery life of your Tempo Smart Button. You may keep the Tempo Smart Button attached to your Tempo Insulin Pen in between doses.
Further tips for storage and handling of the Tempo Smart Button:
- When attached to your Tempo Insulin Pen, store your Tempo Smart Button at room temperature below 86 °F (30 °C). Do not store your Tempo Smart Button in the refrigerator
- Keep your Tempo Smart Button away from excessive light, including sunlight
- Keep your Tempo Smart Button away from strong electromagnetic fields, such as magnetic resonance imaging (MRI). This may cause you harm or damage your Smart Button
- Avoid getting the Tempo Smart Button wet
- Please refer to the Instructions for Use
- What do I do if my insulin doses aren't appearing in TempoSmart?
You may need to manually sync your Smart Button with the TempoSmart App. Your Smart Button can store insulin dose-related data if your phone is not close or your TempoSmart app is not opened on your phone while you are giving your insulin dose. Follow these steps to transfer your insulin dose-related data:
- Place your mobile device within 9 feet of your Smart Button
- Open TempoSmart with Bluetooth® turned on
- Be sure your Tempo Insulin Pen dose indicator is dialed to “0”
- Press and hold the Smart Button down for 5 seconds. Release the Smart Button.
- View notification of data being synced
- View your insulin dose data in the Home Screen and Logbook
- If your insulin dose data does not appear, wait 30 seconds and try again
- If your insulin dose data still does not appear, contact Lilly Tempo Support at 1-855-LILLY-TEMPO (1-855-545-5983) or call your healthcare provider for help.
CAUTION: If you are not sure if you injected your insulin, DO NOT start over or repeat your injection. Monitor your blood glucose as instructed by your healthcare provider.
- What if I lose or break my Tempo Smart Button?
If you lose or break your Tempo Smart Button, give us a call at 1-855-LILLY-TEMPO (1-855-545-5983). We may be able to help!
TempoSmart App
- How do I pair the TempoSmart App with the Tempo Smart Button?
- Make sure the dose indicator on your Tempo Pen is at “0.”
- Open the TempoSmart App on your mobile device in a location at least 9 feet (3 meters) away from other mobile devices actively in use. Warning: to help prevent others from accessing your data or settings, do not leave your Tempo Smart Button in an area that can be accessed by others.
- On the TempoSmart App, select the following:
- More
- Connections & Devices
- Tempo Smart Button
- Add Smart Button
- Press and hold the Tempo Smart Button down for about 10 seconds until you see 1 green flash. Release the Tempo Smart Button after you see 1 green flash. This means that your Tempo Smart Button is ready to pair with your app.
- Follow your TempoSmart App’s onscreen prompts to finish pairing your Tempo Smart Button. You will receive confirmation in your app if pairing is successful.
- The light ring on the Tempo Smart Button will flash green 3 times when the Tempo Smart Button is connected (paired) with your app.
For further instructions, please read the Instructions for Use included with the Tempo Smart Button in your Tempo Welcome Kit. You can also visit Setting Up Tempo.
WARNING: DO NOT use the Tempo Smart Button while charging your mobile device. Even while not charging, keep the Tempo Smart Button at least 6 inches (15 cm) away from Apple’s MagSafe® charging accessories.
- How do I pair the TempoSmart App with my blood glucose meter (BGM) and/or Dexcom Continuous Glucose Monitoring (CGM) System?
Tap the More menu on the Home screen of your TempoSmart App and then tap Connections & Devices. From here you can select the options to pair your BGM and/or CGM.
Please visit your device manufacturer’s user guide for troubleshooting help.
Considerations for devices using Bluetooth® wireless technology:
- Make sure you know which Bluetooth® wireless device you are pairing with your TempoSmart App
- To ensure that data from your devices (eg, BGM, Tempo Smart Button) are sent wirelessly to the TempoSmart App, you must first pair your device with the TempoSmart App
- Does the Tempo Platform include an insulin dose calculator?
If you are a fast-acting insulin user, your healthcare professional may prescribe the Insulin Dose Calculator feature for you. This is used within your TempoSmart App to help you calculate your insulin doses based on your prescribed regimen, carb intake, and glucose value.
Once your healthcare professional has prescribed the Insulin Dose Calculator to be activated, you will be required to complete an in-app training on your TempoSmart App.
The Insulin Dose Calculator is only available for use with the following products*:
- Humalog® Tempo Pen (insulin lispro) injection 100 units/mL and Tempo Smart Button™
- Lyumjev® Tempo Pen (insulin lispro-aabc) injection 100 units/mL and Tempo Smart Button
*Each product requires an individual prescription from your healthcare professional.
The Insulin Dose Calculator works for the following insulin regimens:
- Insulin-to-carb ratio plus correction factor
- Fixed dose plus correction factor
WARNING: Using the fast-acting Insulin Dose Calculator with an incorrect dosing regimen or without all of your recent insulin logged may result in unsafe recommendations, which would lead to severe high blood sugar, low blood sugar, or injury.
- How do I calculate an insulin dose with the TempoSmart App?
Note: The following answer is for BGM users only. Please see the following questions for Dexcom CGM users.
To calculate a dose of bolus insulin, tap Calculate Now at the top of the home screen.
1. View your insulin and last recorded dose.* Then, tap Calculate a current dose and select what the bolus insulin dose is for: Breakfast, Lunch, Dinner, or As Needed
2. View your total Insulin on Board, if this feature is turned on with your prescription
3. Enter or verify your blood glucose and/or the amount of carbs, if needed
- Tap Calculate Dose to see your recommended dose
4. Review the calculation for your recommended dose and tap Continue
- Tap the i info icon to learn more about the calculation
5. Sync your dose with the Tempo Smart Button
Note: You can also Record a current dose or Record a previous dose without using the Insulin Calculator.
*The dose calculator cannot account for other factors like illness, alcohol use, etc. For those who do not have a CGM connected, the dose calculator cannot account for activity.
- Is the TempoSmart App fast-acting Insulin Dose Calculator compatible with Dexcom Continuous Glucose Monitoring (CGM) Systems?
Yes, if you have connected a Dexcom G6 or G7 CGM with TempoSmart, the Insulin Calculator will be customized to use your CGM data. This CGM Insulin Calculator is available for the insulin regimen: insulin-to-carb ratio plus correction factor.
TempoSmart recommends an insulin dose based on the following factors.
- Insulin for Correction: adjusts your insulin dose when your glucose value is above range
- Insulin for Carbs: accounts for how much insulin to take based on how many carbs you are eating
- Trend Adjustment: raises or lowers your dose when a large upward or downward trend is found in your recent glucose data while using CGM
- The trend adjustment defaults to the standard setting and will change to conservative setting automatically if the system detects that you have been experiencing frequent low glucose. Your trend adjustment will be reduced but you may still continue with your insulin dose calculation.
- Ask your healthcare team if you should change the Trend Adjustment back to the standard setting. To change the setting, go to More. Select Settings and then My Preferences.
- Insulin on Board: helps to prevent hypoglycemia due to insulin stacking
- Exercise Adjustment: lowers your recommended insulin dose for trend adjustment when you have exercised in the past hour or will exercise in the next hour
- If you will be involved in moderate or vigorous exercise, you should indicate “Yes” when answering this question. Since exercise can affect individuals with diabetes differently, you may want to discuss these options with your health care team.
Examples of moderate exercise:
brisk walking (at least 2.5 miles per hour)
water aerobics
dancing (ballroom or social)
gardening
tennis (doubles)
biking slower than 10 miles per hour
Examples of vigorous exercise:
hiking uphill or with a heavy backpack
running
swimming laps
aerobic dancing
heavy yardwork like continuous digging or hoeing
tennis (singles)
cycling 10 miles per hour or faster
jumping rope
Note: There are situations when the Insulin Calculator will not use the CGM data. These situations include times that the CGM data or trend arrow are changing rapidly or not available. You can wait till your CGM data stabilizes or you can enter a fingerstick blood glucose for the calculator.
CAUTION: DO NOT connect TempoSmart™ to your Dexcom CGM if you are taking hydroxyurea or taking more than the maximum dose of acetaminophen (eg, >1 gram every 6 hours in adults). Your CGM data may be falsely elevated and result in inaccurate dosing recommendations.
WARNING: If your CGM data do not match your symptoms or expectations, enter a fingerstick blood glucose from a glucose meter to make diabetes treatment decisions.
At any time, you can review the Insulin Calculator tutorial through the Help section.
- As a Dexcom CGM user, how do I calculate an insulin dose with the TempoSmart App?
Calculate a Dose (with CGM connected)
To calculate a dose of bolus insulin, tap Calculate Now at the top of the home screen.
1. View your insulin and last recorded dose.* Then, tap Calculate a current dose and select what the bolus insulin dose is for: Breakfast, Lunch, Dinner, or As Needed
2. View your total Insulin on Board, if this feature is turned on with your prescription
3.Verify your Glucose from CGM or enter a fingerstick† BG, enter the amount of carbs, and answer the Activity question
- Tap Calculate Dose to see your recommended dose
4. Review the calculation for your recommended dose and tap Continue
- Tap How was this dose calculated? to see how the recommended dose was calculated.
- Tap the i info icon to learn more about the factors that go into the calculation
5. Sync your dose with the Tempo Smart Button
Note: You can also Record a current dose or Record a previous dose without using the Insulin Calculator.
*The dose calculator cannot account for other factors like illness, alcohol use, etc. For those who do not have a CGM connected, the dose calculator cannot account for activity.
†The BG reading's timestamp must be within 10 minutes before or up to 5 minutes after the current time in order to be used in the dose calculation.
WARNING: If your CGM data do not match your symptoms or expectations, enter a fingerstick blood glucose from a glucose meter to make diabetes treatment decisions.
- How do I change my TempoSmart App medication reminders?
On the Discover tab, you can set or change medication reminders based on your healthcare professional’s guidance for each medication added to your profile. Select:
- More
- Medications
- Medication Reminders
Then follow the onscreen instructions.
- How do I share a SMART Visit Report?
The SMART Visit Report helps you and your healthcare team keep track of and discuss your progress at office visits or between visits. All the information you enter, including your medication list, blood glucose values for the last 30 days, responses to health assessment surveys, notes, and other health information helps you and your healthcare team manage your diabetes.
You can share a SMART Visit Report with your healthcare professional or another person in your support system. To send a SMART Visit Report, select:
- More
- Health Information
- SMART Visit Report (which will create a summary of your data)
You can send it to yourself (it goes to your inbox on the Home screen) or click on Add Another Person. This will send your summary by email or fax to your healthcare professional or another person in your support system.
You can also schedule a report to be sent on a regular basis by clicking on Schedule a Report. Then you can choose when you would like to have the report sent to your healthcare professional or another person in your support system.
IMPORTANT: The SMART Visit Report is intended to supplement, not replace, medical expertise, research, judgment, or diabetes treatment provided by the healthcare providers. The report provides information that can be used to identify trends to help inform healthcare provider’s treatment decisions. Decisions regarding diagnosis or treatment of patients will be made solely by the healthcare providers.
- How do I change my password?
To change your password, click on Forgot Password and follow the onscreen instructions. For additional assistance, you can also call Lilly Tempo Support at 1-855-LILLY-TEMPO (1-855-545-5983) Monday to Friday, 9 ᴀᴍ to 5 ᴘᴍ ET.
- How will my data be handled?
Data handling is done in accordance with Lilly policy. For more information, please read Lilly’s Privacy Statement
and Consumer Health Privacy Notice.
Tempo Pen
- Which insulins are compatible with Tempo?
The insulins that work with the Tempo Smart Button are Lyumjev® (insulin lispro-aabc) injection 100 units/mL, BASAGLAR® (insulin glargine) injection 100 units/mL, and Humalog® (insulin lispro) injection 100 units/mL. To use these insulins, you must have a Lyumjev® Tempo Pen, BASAGLAR® Tempo Pen, or Humalog® Tempo Pen.
- Can I use the Tempo Pen without the Tempo Smart Button?
The Tempo Pen functions in a similar way to the prefilled insulin KwikPen® and is modified to work with the Tempo Smart Button.
You can use the Tempo Pen to give your insulin injection without the Tempo Smart Button. However, if used independently, the dose-related data from the Tempo Pen will not be captured by the Tempo Smart Button. This will make the data within the TempoSmart App incomplete until each dose taken without a Tempo Smart Button connection is accurately logged manually.
- Can I use the insulin I already have?
Not using a Tempo Insulin Pen is possible but is not recommended. Each dose of non-Tempo Pen insulin must be manually and accurately logged into the TempoSmart App. Access to the TempoSmart App is only available for 6 months if the Tempo Smart Button is not used.
Other
- Do I need a prescription for Tempo?
Tempo Welcome Kit: prescription required
Tempo Pen prefilled with Lilly insulin: prescription required
Tempo™ Refill Kit: available over the counter. Prescription required for use with savings card for eligible patients.
A prescription is not required to download the TempoSmart App.
- Can I individually order replacement devices or components?
Once you have received the Tempo Welcome Kit, your healthcare professional can prescribe you a Tempo Refill Kit. The Tempo Smart Button can also be prescribed again individually as a replacement when the battery runs out.
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)
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. Welcome Kit and Refill Kit are prescribed separately. Refill Kit is also available over the counter.
- How much does Tempo cost?
The TempoSmart App is available at no charge and can be used without a prescribed compatible device, with limited features, for up to 180 days. To learn the cost of your Tempo Welcome Kit, Tempo Refill Kit, and Tempo Pen, please call your insurance plan’s customer service line.
If you have commercial drug insurance, you may also be eligible for the Tempo Savings Card.
If you don’t have insurance and need help paying for your care, you may have another option available to you.
- Can I use any BGM and/or CGM with the Tempo Platform?
Not all BGMs and CGMs are compatible with the Tempo Platform. Tempo is compatible with the Dexcom G6 and G7 Systems and the following BGMs:
Tempo™ Blood Glucose Meter
AgaMatrix Jazz™ Wireless 2
Contour® next ONE
CVS Health Advanced Bluetooth Glucose Meter
CVS Health True Metrix® Air
OneTouch® Verio Flex Meter
OneTouch® Verio Reflect Meter
ReliOn™ Premier BLU
RITE AID True Metrix Air
Roche Accu-Check® Guide
Roche Accu-Check® Guide Me
Walgreens True Metrix Air
- How do I get started with my Tempo Personalized Diabetes Management Platform?
As someone starting on Tempo, you are provided a step-by-step guide to help you fill your prescription and get started on Tempo.
Tempo users are also provided a complimentary onboarding session in the form of a free, one-on-one, live video session with a specialist who will guide you through the set-up process. To get started, Text TEMPO to 85099.
If you have already received the prescription from your healthcare professional and picked up your Tempo Welcome Kit or Tempo Smart Button and Tempo Pen(s) from the pharmacy, you can start using the Tempo Platform.
To get started, download the TempoSmart App onto your smartphone. You can use the link provided by your healthcare professional to create your user ID and password and complete your registration. Then you can pair the TempoSmart App with your Tempo Smart Button and compatible BGM or CGM.
Follow these steps to connect your TempoSmart App with your Tempo Smart Button:
- Make sure the dose indicator on your Tempo Pen is at “0.”
- Open the TempoSmart App on your mobile device in a location at least 9 feet (3 meters) away from other mobile devices actively in use. Warning: to help prevent others from accessing your data or settings, do not leave your Tempo Smart Button in an area that can be accessed by others.
- On the TempoSmart App, select the following:
- More
- Connections & Devices
- Tempo Smart Button
- Connect Tempo Smart Button
- Press and hold the Tempo Smart Button down for about 10 seconds until you see 1 green flash. Release the Tempo Smart Button after you see 1 green flash. This means that your Tempo Smart Button is ready to pair with your app.
- Follow your TempoSmart App’s onscreen prompts to finish pairing your Tempo Smart Button.
- The light ring on the Tempo Smart Button will flash green 3 times when the Tempo Smart Button is connected (paired) with your app.
For further instructions, please read the Instructions for Use included with the Tempo Smart Button in your Tempo Welcome Kit. You can also visit Setting Up Tempo.
Still Have Questions?
Contact Lilly Tempo Support at
1-855-LILLY-TEMPO
(1-855-545-5983)
Monday to Friday, 9 ᴀᴍ to 5 ᴘᴍ ET.
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 professionals (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 automatically receives insulin dose-related data when connected to a compatible Tempo Smart Button™ device via wireless Bluetooth® technology and has the ability to detect and mark which doses are prime and which are injected insulin. 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 patient use on mobile phones and software intended for healthcare professional use through computer web browsers. The software also allows for entry of other diabetes-related healthcare information and provides educational information.
The following TempoSmart features require a prescription:
For fast-acting insulin users with type 1 and type 2 diabetes, TempoSmart includes an Insulin Dose Calculator (IDC) to allow patients to use their prescribed regimen to calculate a dose of fast-acting insulin for a given amount of carbohydrates and/or glucose value from a blood glucose meter (BGM).
When connected to a compatible FDA-cleared integrated continuous glucose monitor (iCGM) and if an insulin-to-carb ratio plus correction factor insulin regimen is prescribed, TempoSmart includes a iCGM IDC. The TempoSmart iCGM IDC is software intended for the management of type 1 or type 2 diabetes in persons aged 18 years and older requiring fast-acting insulin. The TempoSmart iCGM IDC allows patients to calculate a dose of fast-acting insulin for a given amount of carbohydrates, the most recent iCGM glucose reading and rate of change, activity, and insulin on board (IOB).
For basal insulin users with type 2 diabetes, TempoSmart includes a basal titration feature which calculates appropriate long-acting basal insulin doses for titrating insulin levels based on configuration by a healthcare professional. The healthcare professional must activate the basal titration feature and configure it for patient-specific parameters.
TempoSmart is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.
TempoSmart is not indicated for people with gestational diabetes or who use an insulin pump.
Important Safety Information for Tempo Personalized Diabetes Management Platform
DO NOT start over, skip, or repeat your injection when using the Tempo Personalized Diabetes Management Platform if you are not sure you took your insulin or if you are not sure your insulin dosing information is correct. Instead, monitor your blood glucose and consult your Healthcare Professional. Call 911 if you are experiencing a medical emergency. Ensure you work with your Healthcare Professional on a backup diabetes management plan if your Tempo Smart Button or TempoSmart App stops working. Having a backup plan and supplies can help avoid severe low and high glucose. Using the fast-acting Insulin Dose Calculator with incorrect dosing regimen or without all your recent insulin logged, may result in unsafe recommendations, which could lead to severe low or high blood glucose, or injury. Keep the Tempo Smart Button away from children. For product and safety information, including Warnings and Cautions, read the Tempo Smart Button Instructions for Use, TempoSmart App User Guides and Tempo Welcome Kit and Tempo Refill Kit Instructions.
INDICATION AND SAFETY SUMMARY
Lyumjev® (LOOM-jehv) (insulin lispro-aabc) injection 100 units/mL and Humalog® (HU-ma-log) (insulin lispro) injection 100 units/mL
- Lyumjev is a fast-acting insulin used to control high blood sugar in adults and children with diabetes. Humalog is a fast-acting insulin. Humalog is used to control high blood sugar in adults and children with diabetes.
- Lyumjev and Humalog come in two strengths: U-100 (100 units per milliliter) and U-200 (200 units per milliliter). Lyumjev U-200 and Humalog U-200 contain 2 times as much insulin in 1 milliliter as standard (U-100) insulin. Lyumjev U-100 and Humalog U-100 contain 100 units of insulin per milliliter. The dose window of the pen shows the number of insulin units to be delivered.
- It is not known if Humalog is safe and effective for children with type 2 diabetes or for children younger than 3 years of age with type 1 diabetes as there were no studies done with Humalog in these groups of children. If your doctor decides to give your child any insulin products, he or she may give you special instructions.
All Lyumjev and Humalog products contain insulin lispro.
Warnings - Do not take Lyumjev or Humalog if you have:
- symptoms of low blood sugar (hypoglycemia)
- an allergy to insulin lispro-aabc, Humalog, or any of the ingredients in Lyumjev or Humalog.
Do not reuse needles or share your insulin injection supplies with other people. This includes your:
- prefilled pen for use by a single patient
- cartridges
- reusable pen that works with Lilly 3mL cartridges available for Humalog
- needles
- syringes
You or the other person can get a serious infection. This can happen even if you change the needle.
Do not change the type of insulin you take or your dose unless your doctor tells you to. This could cause low or high blood sugar, which could be serious.
Do not use a syringe to remove Lyumjev or Humalog from your prefilled pen. This can cause you to take too much insulin. Taking too much insulin can lead to severe low blood sugar. This may result in seizures or death.
Lyumjev and Humalog may cause serious side effects. Some of these can lead to death. The possible serious side effects are:
- Low blood sugar. This can cause:
- dizziness or lightheadedness
- headache
- shakiness
- irritability
- sweating
- blurred vision
- fast heartbeat
- mood change
- confusion
- slurred speech
- anxiety
- hunger
If you are at risk of having severely low blood sugar, your doctor may prescribe a glucagon rescue medication. These are used when your blood sugar becomes too low and you are unable to take sugar by mouth. Glucagon helps your body release sugar into your bloodstream. - Low potassium in your blood. This can lead to severe breathing problems, irregular heartbeat, and death.
- Severe allergic reaction.
Get emergency help right away if you have:- a rash over your whole body
- sweating
- extreme drowsiness
- swelling of your face, tongue, or throat
- trouble breathing
- a faint feeling
- dizziness
- a fast heartbeat
- shortness of breath
- confusion
- Heart failure. Taking diabetes pills called thiazolidinediones (thIE-uh-zOH-li-dEEn-dIE-OHns), or “TZDs,” with Lyumjev or Humalog may cause heart failure in some people. This includes people who do not have any heart problems. If you have heart failure, it may get worse if you take TZDs with Lyumjev or Humalog. Tell your doctor if you have any new symptoms of heart failure, or if they get worse. Some symptoms of heart failure include shortness of breath, swelling of ankles and feet, and sudden weight gain. Your doctor may need to change or stop treatment with TZDs and your insulin lispro product.
- Sudden onset of high blood sugar and high amounts of ketones in your blood or urine. You can have these serious side effects when your insulin pump or infusion set is not working the right way, if there are handling errors, or if your insulin is no longer effective. For these reasons, you may not get the right amount of insulin, so always keep extra insulin and injection supplies with you.
Common side effects
The most common side effects of Lyumjev and Humalog are:
- low blood sugar
- reactions or pain at the injection or infusion site with insulin pump use
- itching
- weight gain
- allergic reactions
- skin thickening or pits at the injection or infusion site
- rash
Other most common side effects with Humalog include swelling of your hands or feet.
These are not all of the possible side effects. Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.
Before using
Talk with your doctor about low blood sugar and how to manage it. Also tell your doctor:
- about all of the medicines you take, including over-the-counter medicines, vitamins, and herbal supplements.
- about any other prescription medicines you take, especially ones called TZDs.
- about all of your medical conditions, including if you have heart failure or other heart, liver, or kidney problems.
- if you are pregnant, breastfeeding, or plan to become pregnant or breastfeed.
How to take
Read the Instructions for Use that come with your Lyumjev or Humalog. Be sure to take your Lyumjev or Humalog and check your blood sugar levels exactly as your doctor tells you to. Your doctor may tell you to change your dose because of illness, increased stress, or changes in your weight, diet, or physical activity level. He or she may also tell you to change the amount or time of your dose because of other medicines or different types of insulin you take.
Before injecting your Lyumjev or Humalog
You can inject your insulin dose yourself, or you can have a trained caregiver inject it for you. Make sure you or your caregiver:
- Check the insulin label before each injection. This will help you make sure that you are taking the correct insulin.
- Use a new needle for each injection. You can get a serious infection or the wrong dose of insulin if you reuse needles.
- Change (rotate) where you inject your insulin with each dose. This can reduce your chance of getting pits, lumps, or thickened skin where you inject your insulin. Do not inject your insulin into the exact same spot or where the skin has pits or lumps. Avoid injecting into thickened, tender, bruised, scaly, hard, scarred, or damaged skin.
- Monitor injection and infusion sites closely when initiating therapy with Lyumjev in children. Contact a healthcare provider if persistent injection or infusion site reactions occur.
When you are ready to inject
- Inject Lyumjev under your skin at the beginning of a meal or within 20 minutes after you start eating a meal.
- Inject Humalog under your skin within 15 minutes before a meal or right after you eat a meal.
Staying safe while taking your Lyumjev or Humalog
To stay safe while taking your insulin, be sure to never inject Lyumjev U-200 or Humalog U-200 in your vein, muscle, or with an insulin pump. Also be sure not to:
- mix Lyumjev or Humalog with other insulins or liquids.
- drive or use heavy machinery until you know how your Lyumjev or Humalog affects you.
- drink alcohol or use other medicines that contain alcohol when taking your Lyumjev or Humalog.
Learn more
Lyumjev and Humalog are prescription medicines. For more information, call 1-800-545-5979 or go to www.Lyumjev.com or www.humalog.com.
This summary provides basic information about Lyumjev and Humalog. It does not include all information known about these medicines. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other healthcare provider about your insulin lispro product and how to take it. Your doctor is the best person to help you decide if these medicines are right for you.
UR HI CON BS 11OCT2023
Lyumjev® and Humalog® are registered trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.
INDICATION AND SAFETY SUMMARY
BASAGLAR® (bāz-a-glar) (insulin glargine) injection 100 units/mL is a long-acting insulin used to control high blood sugar in:
- adults with type 1 or type 2 diabetes
- children with type 1 diabetes
It is not known if BASAGLAR is safe and effective in children with type 2 diabetes or in children younger than 6 years with type 1 diabetes. There were no studies done with BASAGLAR in these groups of children. If your doctor decides to give your child BASAGLAR, he or she may give you special instructions.
BASAGLAR is not used to treat diabetic ketoacidosis.
Warnings - Do not take BASAGLAR if you have:
- symptoms of low blood sugar (hypoglycemia)
- an allergy to BASAGLAR or any of its ingredients
Do not reuse needles or share your BASAGLAR prefilled pen with other people. You or the other person can get a serious infection. This can happen even if you change the needle.
Do not change the insulin you use or your dose, unless your doctor tells you to. This could cause low or high blood sugar, which could be serious.
BASAGLAR may cause serious side effects. Some of these can lead to death. The possible serious side effects of BASAGLAR are:
- Low blood sugar. This can lead to:
- dizziness or light-headedness
- headache
- shakiness
- irritability
- sweating
- blurred vision
- fast heartbeat
- mood change
- confusion
- slurred speech
- anxiety
- hunger
- Severe allergic reaction.
Get emergency help right away if you have:- a rash over your whole body
- swelling of your face, tongue, or throat
- extreme drowsiness, dizziness, or confusion
- trouble breathing
- sweating
- a fast heartbeat
- shortness of breath
- Low potassium in your blood. This can lead to severe breathing problems, irregular heartbeat, and death.
- Heart failure. Taking diabetes pills called thiazolidinediones /thIE-uh-zOH-li-dEEn-dIE-OHns/ (TZDs) with BASAGLAR may cause heart failure in some people. This includes people who do not have any heart problems. If you have heart failure, it may get worse if you take TZDs with BASAGLAR. Tell your doctor if you have any new symptoms of heart failure, or if they get worse. These are: shortness of breath, swelling of the ankles or feet, and sudden weight gain. Your doctor may need to change or stop treatment with TZDs and BASAGLAR.
Common side effects
The most common side effects of BASAGLAR are:
- low blood sugar
- minor reactions where you have injected BASAGLAR
- itching
- swelling
- allergic reactions
- changes in fat tissue where you have injected BASAGLAR
- rash
- weight gain
These are not all of the possible side effects. Tell your doctor if you have any side effects.
You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.
Before using
Talk with your doctor about low blood sugar and how to manage it. Tell your doctor:
- about all of the medicines you take, including over-the-counter medicines, vitamins, and herbal supplements.
- about any other prescription medicines you take, especially ones called TZDs.
- about all of your medical conditions, including if you have heart failure or other heart, liver, or kidney problems. If you have heart failure, it may get worse while you take TZDs with BASAGLAR.
- if you are pregnant, breastfeeding, or plan to become pregnant. It is not known if BASAGLAR may harm your unborn or breastfeeding baby.
How to take
The BASAGLAR prefilled pen is a disposable insulin delivery device for use by a single patient to inject BASAGLAR. Read the Instructions for Use that come with your BASAGLAR prefilled pen. These instructions provide details on how to prepare and inject a dose of BASAGLAR, and how to throw away used BASAGLAR prefilled pens and needles.
Be sure to check your blood sugar levels and use BASAGLAR exactly as your doctor tells you to. Your doctor may tell you to change your dose because of illness, increased stress, or changes in your weight, diet, or level of physical activity or exercise. He or she may also tell you to change your dose because of other medicines you take.
Before injecting your BASAGLAR
You can inject BASAGLAR yourself, or you can have a trained caregiver inject it for you. Make sure you or your caregiver:
- Check your insulin label each time you give your injection. This will help you make sure that you are using the correct insulin.
- Use a new needle for each injection. You can get a serious infection or the wrong dose of insulin if you re-use needles.
When you are ready to inject
- Take BASAGLAR once a day, at the same time each day.
- Change (rotate) where you inject your insulin with each dose. This can help reduce your chance of getting pits, lumps, or thickened skin where you inject your insulin. Do not inject your insulin into the exact same spot or where the skin has pits or lumps. Avoid injecting into thickened, tender, bruised, scaly, hard, scarred, or damaged skin.
Staying safe while taking your BASAGLAR
To stay safe while taking BASAGLAR, be sure you only use BASAGLAR that is clear and colorless and does not have any particles.
Be sure you do not:
- mix BASAGLAR with any other type of insulin or solution.
- drive or use heavy machinery until you know how BASAGLAR affects you.
- drink alcohol or use other medicines that contain alcohol when taking BASAGLAR.
Learn more
BASAGLAR is a prescription medicine. For more information, call 1-800-545-5979 or go to BASAGLAR.com.
This summary provides basic information about BASAGLAR but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other health care provider about BASAGLAR and how to take it. Your doctor is the best person to help you decide if BASAGLAR is right for you.
BV CON BS 14SEP2022
BASAGLAR® is a registered trademark owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.