Admelog

What is Admelog?

• Admelog is a man-made insulin used to control high blood sugar in adults and children with diabetes mellitus.
• It is not known if Admelog is safe and effective in children younger than 3 years of age or when used to treat children with type 2 diabetes mellitus.

What is the most important information I should know about Admelog?

Do not share your Admelog SoloStar Pen or syringe 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.

Who should not take Admelog?

Do not use Admelog if you:

• are having an episode of low blood sugar (hypoglycemia).
• have an allergy to Admelog or any of the ingredients in Admelog. See the end of this Patient Information leaflet for a complete list of ingredients in Admelog.

What should I tell my healthcare provider before taking Admelog?

Before using Admelog, tell your healthcare provider about all of your medical conditions, including if you:

• have liver or kidney problems.
• take other medicines, especially ones commonly called TZDs (thiazolidinediones).
• have heart failure or other heart problems. If you have heart failure, it may get worse while you take TZDs with Admelog.
• are pregnant, planning to become pregnant, or are breastfeeding. It is not known if Admelog may harm your unborn or breastfeeding baby.

Tell your healthcare provider about all the medicines you take, including prescription or over-the-counter medicines, vitamins, or herbal supplements.

Before you start using Admelog, talk to your healthcare provider about low blood sugar and how to manage it.

How should I take Admelog?

• Read the detailed Instructions for Use that come with your Admelog.
• Use Admelog exactly as your healthcare provider tells you to. Your healthcare provider should tell you how much Admelog to use and when to use it.
• Know the amount of Admelog you use. Do not change the amount of Admelog you use unless your healthcare provider tells you to. The amount of insulin and the best time for you to take your insulin may need to change if you take a different type of insulin.
• Check your insulin label each time you give your injection to make sure you are using the correct insulin.
• Admelog comes in a vial or in a SoloStar single-patient-use prefilled pen.
  Do not reuse needles. Always use a new needle for each injection. Reuse of needles increases your risk of having blocked needles, which may cause you to get the wrong dose of Admelog. Using a new needle for each injection also lowers your risk of getting an infection. If your needle is blocked, follow the instructions in Step 3 of the Instructions for Use of your pen.
• Admelog is a rapid-acting insulin. Take Admelog within 15 minutes before eating or right after eating a meal.
• Admelog is injected under the skin (subcutaneously) of your upper arms, thighs, buttocks, or stomach area (abdomen), or by continuous infusion under the skin (subcutaneously) through an insulin pump into an area of your body recommended in the instructions that come with your insulin pump.
• Change (rotate) your injection site 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.
• Check your blood sugar levels. Ask your healthcare provider what your blood sugar should be and when you should check your blood sugar levels.

Keep Admelog and all medicines out of the reach of children.

Your dose of Admelog may need to change because of:

• a change in physical activity or exercise, weight gain or loss, increased stress, illness, change in diet, or because of other medicines you take.

What should I avoid while taking Admelog?

While using Admelog do not:

• drive or operate heavy machinery, until you know how Admelog affects you.
• drink alcohol or use prescription or over-the-counter medicines that contain alcohol.

What are the possible side effects of Admelog?

Admelog 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, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability or mood changes, hunger.
• serious allergic reactions (whole body reaction). 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, feel faint, or sweating.
• low potassium in your blood (hypokalemia).
• heart failure. Taking certain diabetes pills called TZDs (thiazolidinediones) with Admelog may cause heart failure in some people. This can happen even if you have never had heart failure or heart problems before. If you already have heart failure it may get worse while you take TZDs with Admelog. Your healthcare provider should monitor you closely while you are taking TZDs with Admelog. Tell your healthcare provider if you have any new or worse symptoms of heart failure including:
  • shortness of breath, swelling of your ankles or feet, sudden weight gain.

Treatment with TZDs and Admelog may need to be adjusted or stopped by your healthcare provider if you have new or worse heart failure.
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, confusion.

The most common side effects of Admelog include:

• low blood sugar (hypoglycemia), allergic reactions, including reactions at the injection site, skin thickening or pits at the injection site (lipodystrophy), itching, and rash.

These are not all the possible side effects of Admelog. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of Admelog

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Admelog for a condition for which it was not prescribed. Do not give Admelog to other people, even if they have the same symptoms that you have. It may harm them.

You can ask your pharmacist or healthcare provider for information about Admelog that is written for health professionals. For more information, go to www.sanofi.com or call 1-800-633-1610.

How should I store Admelog?

*Do not put in the freezer. Do not use Admelog if it has been frozen.

Use in an External Insulin Pump

Insulin in the reservoir should be discarded after 7 days. However, as with other external insulin pumps, the infusion set should be replaced and a new infusion set insertion site should be selected at least every 3 days.

Diluted Admelog for Subcutaneous Injection

Diluted Admelog may remain in patient use for up to 24 hours when stored in a refrigerator (36°F-46°F [2°C-8°C]) or for up to 4 hours when stored at room temperature (86°F [30°C]). Do not dilute Admelog used in an external insulin pump.

What are the ingredients in Admelog?

Active ingredient: insulin lispro

Inactive ingredients: glycerin, dibasic sodium phosphate, metacresol, zinc oxide (zinc ion), and Water for Injection. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH.