IMPORTANT SAFETY INFORMATION
SEMGLEE (insulin glargine injection) 100 Units/mL is a prescription long-acting man-made-insulin used to treat adults with type 2 diabetes and adult and pediatric patients (children 6 years and older) with type 1 diabetes for the control of high blood sugar.
- Do not use SEMGLEE to treat diabetic ketoacidosis.
It is not known if SEMGLEE is safe and effective in children less than 6 years of age with type 1 diabetes. It is not known if SEMGLEE is safe and effective in children with type 2 diabetes.
Do not use SEMGLEE during episodes of low blood sugar or if you are allergic to insulin or any of the inactive ingredients of SEMGLEE. See the end of this Patient Information leaflet for a complete list of ingredients in SEMGLEE.
Do not share needles, insulin pens, or syringes with others. Do NOT reuse needles.
Do not share your pen 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.
Before using SEMGLEE, tell your healthcare provider about all your medical conditions including if you:
- 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 SEMGLEE.
- are pregnant, planning to become pregnant, or are breastfeeding. It is not known if SEMGLEE may harm your unborn baby or breastfeeding baby.
Tell your healthcare provider about all the medicines you take including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Before you start using SEMGLEE, talk to your healthcare provider about low blood sugar and how to manage it.
Change (rotate) your injection sites within the area you chose with each dose to reduce your risk of getting lipodystrophy (pitted or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites. Do not use the same spot for each injection or inject where the skin is pitted, thickened, lumpy, tender, bruised, scaly, hard, scarred or damaged. Tell your doctor if you have any new or worsening symptoms of heart failure, including shortness of breath, swelling of your ankles or feet, sudden weight gain.
SEMGLEE should be taken once a day at the same time every day. Test your blood sugar levels while using insulin, such as SEMGLEE. Do not make any changes to your dose or type of insulin without talking to your healthcare provider. Any change of insulin should be made cautiously and only under medical supervision.
Do NOT dilute or mix SEMGLEE with any other insulin or solution. It will not work as intended and you may lose blood sugar control, which could be serious. SEMGLEE must only be used if the solution is clear and colorless with no particles visible. Always make sure you have the correct insulin before each injection.
While using SEMGLEE, do not drive or operate heavy machinery until you know how SEMGLEE affects you. You should not drink alcohol or use other medicines that contain alcohol.
The most common side effect of insulin, including SEMGLEE, is low blood sugar (hypoglycemia), which may be serious and life threatening. It may cause harm to your heart or brain. Symptoms of serious low blood sugar may include shaking, sweating, fast heartbeat, and blurred vision.
SEMGLEE may cause serious side effects that can lead to death, such as severe allergic reactions. Get medical help right away if you have: A rash over your whole body, trouble breathing, a fast heartbeat, sweating, swelling of your face, tongue, or throat, shortness of breath, extreme drowsiness, dizziness, or confusion.
Other possible side effects may include swelling, weight gain, low potassium levels, injection site reactions, including changes in fat tissue at the injection site, and allergic reactions.
Important Safety Information for SEMGLEE (insulin glargine injection) pen.
SEMGLEE pen is a disposable single-patient-use prefilled insulin pen. Please talk to your healthcare provider about proper injection technique and follow instructions in the Instruction Leaflet that accompanies the pen.
These are not all the possible side effects of SEMGLEE. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
This summary does not include all the information about SEMGLEE and is not meant to take the place of a discussion with your healthcare provider about your treatment.