HOW IT WORKS
How once-weekly Awiqli® works
Awiqli® works the same as insulin naturally made in the body but is designed to work over the course of 1 week.
When you inject Awiqli®, it has a slow and steady blood sugar lowering effect on your body over the once-weekly dosing period. This means you only need to inject Awiqli® once a week on the same day each week.
A1C RESULTS
Blood sugar improved when adults with type 2 diabetes took Awiqli®
In clinical studies, adults with type 2 diabetes—some new to insulin, some already taking a daily basal insulin—improved their glycemic control with once-weekly Awiqli®, compared to a daily basal insulin. In these studies, Awiqli® was used along with other diabetes medications. Certain diabetes medications were discontinued or reduced at the start of the study.
Adults with type 2 diabetes who switched to once-weekly Awiqli® improved their blood sugar control—with 1 basal insulin injection a week.
In a study of adults with type 2 diabetes already taking a daily basal insulin, switching to once-weekly Awiqli® improved their blood sugar control—while going from a daily basal insulin shot to just 1 a week.
Study snapshot:
- Who was in the study: A total of 526 adults with type 2 diabetes already taking a once- or twice-daily basal insulin, with or without other non-insulin oral or injectable diabetes medications
- What they took: Once-weekly Awiqli® (263 people) or a daily basal insulin—insulin degludec U-100 (263 people)—each along with their other diabetes medicines. Certain diabetes medications were discontinued at the start of the study
- How long was the study: 26 weeks
- What was measured: A1C—average blood sugar over about 3 months—to compare how well each basal insulin controlled blood sugar
- Where they started: An average A1C of 8.17% in the Awiqli® group and 8.10% in the insulin degludec U-100 group
- How much A1C came down: At the end of the 26-week study, 0.90% with once-weekly Awiqli® and 0.71% with insulin degludec U-100—0.19% more with Awiqli®, a statistically significant difference
- How many reached an A1C under 7%: At the end of the 26-week study, 37.5% with once-weekly Awiqli® vs 25.4% with insulin degludec U-100
Adults new to insulin improved their blood sugar control with once-weekly Awiqli®—with 1 basal insulin injection a week.
In 2 studies of adults with type 2 diabetes starting insulin for the first time, once-weekly Awiqli® improved their blood sugar control—with 1 basal insulin shot a week from the start.
Study snapshot:
- Who was in the studies: A combined total of 1,572 adults with type 2 diabetes new to insulin, not yet controlled on one or more of their oral anti-diabetic or GLP-1 medications. Certain diabetes medications were stopped or reduced at the start of the study
- What they took: Once-weekly Awiqli® or a daily basal insulin, each along with their other diabetes medicines. The 26-week study compared Awiqli® (294 people) to insulin degludec U-100 (294 people); the 52-week study compared Awiqli® (492 people) to insulin glargine U-100 (492 people). Certain diabetes medications were stopped or reduced at the start of the study.
- How long were the studies: One study was 26 weeks; the other was 52 weeks
- What was measured: A1C—average blood sugar over about 3 months—to compare how well each basal insulin controlled blood sugar
- Where they started: 26-week study—an average A1C of 8.55% (Awiqli®) and 8.48% (insulin degludec U-100). 52-week study—8.50% (Awiqli®) and 8.44% (insulin glargine U-100)
- How much A1C came down: At the end of the 26-week study—1.56% with Awiqli® and 1.34% with insulin degludec U-100, a difference of 0.22%. At the end of the 52-week study—1.51% with Awiqli® and 1.33% with insulin glargine U-100, a difference of 0.18%. Both differences were statistically significant
- How many reached an A1C under 7%: At the end of the 26-week study—56.5% with Awiqli® vs 41.0% with insulin degludec U-100. At the end of the 52-week study—56.5% with Awiqli® vs 44.6% with insulin glargine U-100
SIDE EFFECTS
What are the possible side effects of Awiqli®?
The most common side effect with Awiqli®, which can be serious and lead to death, is low blood sugar (hypoglycemia). Your doctor can help you understand what symptoms to watch for and how to manage low blood sugar if it happens.
Awiqli® may cause serious side effects that can lead to death, including:
- Low blood sugar (hypoglycemia). Signs and symptoms that may indicate low blood sugar include:
- dizziness or light-headedness
- sweating
- confusion
- fast heartbeat
- blurred vision
- slurred speech
- shakiness
- anxiety, irritability, or mood changes
- hunger
- headache
- Severe allergic reaction (whole body reaction). Stop using Awiqli® and get medical help right awayif you have any of these signs or symptoms of a severe allergic reaction: rash over your whole body, trouble breathing, a fast heartbeat, or sweating.
- Low potassium in your blood (hypokalemia).
- Heart failure. Taking certain diabetes pills called thiazolidinediones or "TZDs" with Awiqli® may cause heart failure in some people, even if you've never had heart failure or heart problems before. If you already have heart failure, it may get worse while you take TZDs with Awiqli®. Your healthcare provider should monitor you closely while you are taking TZDs with Awiqli®. Tell your healthcare provider about any new or worse symptoms of heart failure, such as shortness of breath, tiredness, swelling of your ankles or feet, or sudden weight gain. Treatment with TZDs and Awiqli® may need to be adjusted or stopped by your healthcare provider if you have new or worse heart failure.
- Your insulin dose may need to change because of:
- change in level of physical activity or exercise
- weight gain or loss
- increased stress
- illness
- change in diet
- Common side effects of Awiqli® may include: hypoglycemia, serious allergic reactions (whole body reactions), reactions at the injection site, skin thickening or pits at the injection site (lipodystrophy), itching, rash, swelling of your hands and feet, and weight gain.
- Get emergency medical help if you have: trouble breathing, shortness of breath, fast heartbeat, swelling of your face, tongue, or throat, sweating, extreme drowsiness, dizziness, or confusion.
These are not all the serious and possible side effects of Awiqli®. Read the Awiqli® Important Safety Information and Prescribing Information. Call your doctor for medical advice about side effects.
If low blood sugar happens, the Rule of 15 can help:
15 grams of fast-acting carbs
Wait 15 minutes
Then recheck
Repeat if blood sugar is still low
If low blood sugar happens, talk to your doctor.
FAQs
Questions people often ask about Awiqli®.
Awiqli® is a long-acting insulin (U-700) that helps lower blood sugar in adults with type 2 diabetes in combination with diet and exercise. It is taken only once a week on the same day each week.
It is not known if Awiqli® is safe and effective in children and adolescents.
It’s pronounced “Ah-WIK-lee.”
Awiqli® is a long-acting basal insulin—the same category as the daily basal insulins some adults with type 2 diabetes already use. What’s new is the dosing schedule: it’s the world’s first basal insulin that is taken once a week, on the same day each week, instead of once a day and that is FDA approved for adults with type 2 diabetes.
After you inject Awiqli®, it attaches to albumin, a protein already in your blood, which carries the insulin in the blood and is slowly released over 7 days.
Awiqli® is a once-weekly basal insulin with its own dosing. Your healthcare provider will decide if Awiqli® is right for you and how your dose should be started or changed. Do not convert or change your insulin dose on your own.
Common side effects of Awiqli® may include: hypoglycemia, serious allergic reactions (whole body reactions), reactions at the injection site, skin thickening or pits at the injection site (lipodystrophy), itching, rash, swelling of your hands and feet, and weight gain.
These are not all the serious and possible side effects of Awiqli®. For more safety information, read the Awiqli® Important Safety Information.
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Important Safety Information
Do not share your Awiqli® FlexTouch® pen or needles with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.
Make sure you use the right type and dose of insulin. Always check the label on your insulin pen before each injection to avoid mix-ups with Awiqli® and other insulin products or injectable medicines used to treat diabetes. If you use another injectable medicine to treat your diabetes, pay close attention to how you select your Awiqli® dosage. The dosage of Awiqli® is different from other injectable medicines used to treat diabetes.
Always make sure that you select the correct dosage of your Awiqli® FlexTouch® pen as prescribed by your healthcare provider, to avoid dosing errors and accidental overdose. People who are blind or have vision problems should not use this pen without help from a person trained to use the pen.
Do not dial the maximum single dosage (700 units) of your Awiqli® FlexTouch® pen, unless prescribed by your healthcare provider.
Do not use a syringe to withdraw Awiqli® from your pen.
Talk to your healthcare provider if you have any questions about how to correctly dose Awiqli® FlexTouch®.
Who should not take Awiqli®?
Do not take Awiqli® if you:
- are having an episode of low blood sugar (hypoglycemia)
- have an allergy to Awiqli® or any of the ingredients in Awiqli®. See the full Patient Information for a complete listing of ingredients in Awiqli®
Before taking Awiqli®, tell your healthcare provider about all your medical conditions, including if you are:
- have liver or kidney problems
- take other medicines, especially ones called TZDs (thiazolidinediones)
- have heart failure or other heart problems. If you have heart failure, it may get worse while you take TZDs with Awiqli®
- pregnant, planning to become pregnant, or are breastfeeding
- taking new prescription or over-the-counter medicines, vitamins, or herbal supplements
Talk to your health care provider about low blood sugar and how to manage it.
How should I take Awiqli® FlexTouch®?
- Read the Instructions for Use that come with your Awiqli® FlexTouch® pen
- Your healthcare provider should show you how to use Awiqli® FlexTouch® pen before you use it for the first time
- Take Awiqli® exactly as your healthcare provider tells you to. Do not do any conversion of your dose. The dose counter always shows the selected dose in units. Awiqli® FlexTouch® pens are made to deliver your insulin dose in units
- Know the type and strength of insulin you take. Do not change the type of insulin you take unless your health care provider tells you to. The amount of insulin and best time for you to take your insulin may need to change if you take different types of insulin
- Inject Awiqli® FlexTouch® 1 time each week on any day of the week on the same day each week
- If you need to change the day of the week, you may do so if your last dose has been at least 4 days
- If you have missed your dose, take your missed dose as soon as possible as long as it has been 4 days or less. Then continue the 1 time each week schedule 1 week from the day your missed dose was taken
- If more than 4 days has passed, skip the missed dose and take your next Awiqli® dose on your regularly scheduled day.
- Check your blood sugar levels. Ask your health care provider what your blood sugar levels should be and when you should check them
- Never inject Awiqli® FlexTouch® into a vein or muscle or use Awiqli® in an infusion pump
- Never use a syringe to remove Awiqli® from the FlexTouch® pen
- Do not dilute or mix Awiqli® with any other insulin or solution
- Awiqli® FlexTouch® can be injected under the skin (subcutaneously) of your upper legs (thighs), upper arms, or stomach area (abdomen)
- Change (rotate) your injection sites within the area you choose with each dose to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites.
- Do not use the exact same spot for each injection
- Do not inject where the skin has pits, is thickened, or has lumps
- Do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin
- Keep Awiqli® and all medicines out of the reach of children.
What should I avoid while taking Awiqli®?
- Do not drive or operate heavy machinery, until you know how Awiqli® affects you
- Do not drink alcohol or use prescription or over-the-counter medicines that contain alcohol
What are the possible side effects of Awiqli®?
Awiqli® may cause serious side effects that can be life-threatening, including:
- Low blood sugar (hypoglycemia). Signs and symptoms that may indicate low blood sugar include: dizziness or light-headedness, sweating, confusion, fast heartbeat, blurred vision, slurred speech, shakiness, anxiety, irritability, mood changes, hunger and headache
- Severe allergic reactions (whole body reaction). Stop using Awiqli® and get medical help right away, if you have any of these signs or symptoms of a severe allergic reaction: a rash over your whole body, trouble breathing, a fast heartbeat or sweating
- Low potassium in your blood (hypokalemia)
- Heart failure in some people if taken with thiazolidinediones (TZDs). This can happen even if you have never had heart failure or heart problems. If you already have heart failure, it may get worse while you take TZDs with Awiqli®. Tell your health care provider if you have any new or worse symptoms of heart failure including shortness of breath, tiredness, swelling of your ankles or feet, and sudden weight gain
Your insulin dose may need to change because of change in level of physical activity or exercise, increased stress, change in diet, weight gain or loss, or illness
Common side effects may include: hypoglycemia, serious allergic reactions (whole body reactions), reactions at the injection site, skin thickening or pits at the injection site (lipodystrophy), itching, rash, swelling of your hands and feet, and weight gain
Get emergency medical help if you have trouble breathing, shortness of breath, fast heartbeat, swelling of your face, tongue, or throat, sweating, extreme drowsiness, dizziness, or confusion
These are not all the possible side effects of Awiqli®. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Please see Prescribing Information for Awiqli®.
Awiqli® is a prescription medication.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
What is Awiqli® (insulin icodec-abae) injection 700 units/mL?
- Prescription Awiqli® is a long-acting insulin (U-700) that is used to control high blood sugar in adults with type 2 diabetes mellitus
- It is not known if Awiqli® is safe and effective in children and adolescents
- Awiqli® is available in 1 concentration: U-700
- Prescription Awiqli® is a long-acting insulin (U-700) that is used to control high blood sugar in adults with type 2 diabetes mellitus
- It is not known if Awiqli® is safe and effective in children and adolescents
- Awiqli® is available in 1 concentration: U-700
Do not share your Awiqli® FlexTouch® pen or needles with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.
Make sure you use the right type and dose of insulin. Always check the label on your insulin pen before each injection to avoid mix-ups with Awiqli® and other insulin products or injectable medicines used to treat diabetes. If you use another injectable medicine to treat your diabetes, pay close attention to how you select your Awiqli® dosage. The dosage of Awiqli® is different from other injectable medicines used to treat diabetes.
Always make sure that you select the correct dosage of your Awiqli® FlexTouch® pen as prescribed by your healthcare provider, to avoid dosing errors and accidental overdose. People who are blind or have vision problems should not use this pen without help from a person trained to use the pen.
Do not dial the maximum single dosage (700 units) of your Awiqli® FlexTouch® pen, unless prescribed by your healthcare provider.
Do not use a syringe to withdraw Awiqli® from your pen.
Talk to your healthcare provider if you have any questions about how to correctly dose Awiqli® FlexTouch®.
Important Safety Information
Do not share your Awiqli® FlexTouch® pen or needles with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.
Make sure you use the right type and dose of insulin. Always check the label on your insulin pen before each injection to avoid mix-ups with Awiqli® and other insulin products or injectable medicines used to treat diabetes. If you use another injectable medicine to treat your diabetes, pay close attention to how you select your Awiqli® dosage. The dosage of Awiqli® is different from other injectable medicines used to treat diabetes.
Always make sure that you select the correct dosage of your Awiqli® FlexTouch® pen as prescribed by your healthcare provider, to avoid dosing errors and accidental overdose. People who are blind or have vision problems should not use this pen without help from a person trained to use the pen.
Do not dial the maximum single dosage (700 units) of your Awiqli® FlexTouch® pen, unless prescribed by your healthcare provider.
Do not use a syringe to withdraw Awiqli® from your pen.
Talk to your healthcare provider if you have any questions about how to correctly dose Awiqli® FlexTouch®.
Who should not take Awiqli®?
Do not take Awiqli® if you:
- are having an episode of low blood sugar (hypoglycemia)
- have an allergy to Awiqli® or any of the ingredients in Awiqli®. See the full Patient Information for a complete listing of ingredients in Awiqli®
Before taking Awiqli®, tell your healthcare provider about all your medical conditions, including if you are:
- have liver or kidney problems
- take other medicines, especially ones called TZDs (thiazolidinediones)
- have heart failure or other heart problems. If you have heart failure, it may get worse while you take TZDs with Awiqli®
- pregnant, planning to become pregnant, or are breastfeeding
- taking new prescription or over-the-counter medicines, vitamins, or herbal supplements
Talk to your health care provider about low blood sugar and how to manage it.
How should I take Awiqli® FlexTouch®?
- Read the Instructions for Use that come with your Awiqli® FlexTouch® pen
- Your healthcare provider should show you how to use Awiqli® FlexTouch® pen before you use it for the first time
- Take Awiqli® exactly as your healthcare provider tells you to. Do not do any conversion of your dose. The dose counter always shows the selected dose in units. Awiqli® FlexTouch® pens are made to deliver your insulin dose in units
- Know the type and strength of insulin you take. Do not change the type of insulin you take unless your health care provider tells you to. The amount of insulin and best time for you to take your insulin may need to change if you take different types of insulin
- Inject Awiqli® FlexTouch® 1 time each week on any day of the week on the same day each week
- If you need to change the day of the week, you may do so if your last dose has been at least 4 days
- If you have missed your dose, take your missed dose as soon as possible as long as it has been 4 days or less. Then continue the 1 time each week schedule 1 week from the day your missed dose was taken
- If more than 4 days has passed, skip the missed dose and take your next Awiqli® dose on your regularly scheduled day.
- Check your blood sugar levels. Ask your health care provider what your blood sugar levels should be and when you should check them
- Never inject Awiqli® FlexTouch® into a vein or muscle or use Awiqli® in an infusion pump
- Never use a syringe to remove Awiqli® from the FlexTouch® pen
- Do not dilute or mix Awiqli® with any other insulin or solution
- Awiqli® FlexTouch® can be injected under the skin (subcutaneously) of your upper legs (thighs), upper arms, or stomach area (abdomen)
- Change (rotate) your injection sites within the area you choose with each dose to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites.
- Do not use the exact same spot for each injection
- Do not inject where the skin has pits, is thickened, or has lumps
- Do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin
- Keep Awiqli® and all medicines out of the reach of children.
What should I avoid while taking Awiqli®?
- Do not drive or operate heavy machinery, until you know how Awiqli® affects you
- Do not drink alcohol or use prescription or over-the-counter medicines that contain alcohol
What are the possible side effects of Awiqli®?
Awiqli® may cause serious side effects that can be life-threatening, including:
- Low blood sugar (hypoglycemia). Signs and symptoms that may indicate low blood sugar include: dizziness or light-headedness, sweating, confusion, fast heartbeat, blurred vision, slurred speech, shakiness, anxiety, irritability, mood changes, hunger and headache
- Severe allergic reactions (whole body reaction). Stop using Awiqli® and get medical help right away, if you have any of these signs or symptoms of a severe allergic reaction: a rash over your whole body, trouble breathing, a fast heartbeat or sweating
- Low potassium in your blood (hypokalemia)
- Heart failure in some people if taken with thiazolidinediones (TZDs). This can happen even if you have never had heart failure or heart problems. If you already have heart failure, it may get worse while you take TZDs with Awiqli®. Tell your health care provider if you have any new or worse symptoms of heart failure including shortness of breath, tiredness, swelling of your ankles or feet, and sudden weight gain
Your insulin dose may need to change because of change in level of physical activity or exercise, increased stress, change in diet, weight gain or loss, or illness
Common side effects may include: hypoglycemia, serious allergic reactions (whole body reactions), reactions at the injection site, skin thickening or pits at the injection site (lipodystrophy), itching, rash, swelling of your hands and feet, and weight gain
Get emergency medical help if you have trouble breathing, shortness of breath, fast heartbeat, swelling of your face, tongue, or throat, sweating, extreme drowsiness, dizziness, or confusion
These are not all the possible side effects of Awiqli®. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Please see Prescribing Information for Awiqli®.
Awiqli® is a prescription medication.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
What is Awiqli® (insulin icodec-abae) injection 700 units/mL?
- Prescription Awiqli® is a long-acting insulin (U-700) that is used to control high blood sugar in adults with type 2 diabetes mellitus
- It is not known if Awiqli® is safe and effective in children and adolescents
- Awiqli® is available in 1 concentration: U-700