• 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^®.

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.

• 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.

• 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

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 you 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.