BASAGLAR is a long-acting insulin used to control high blood sugar in adults and children with type 1 diabetes and adults with type 2 diabetes.
Limitation of Use
BASAGLAR is not for treating diabetic ketoacidosis.
Important Safety Information
Do not take BASAGLAR during episodes of low blood sugar or if you are allergic to insulin glargine or any of the ingredients in BASAGLAR.
Do NOT reuse needles or share insulin pens, even if the needle has been changed.
Before starting BASAGLAR, tell your doctor about all your medical conditions, including if you have liver or kidney problems, if you are pregnant or planning to become pregnant, or if you are breastfeeding or planning to breastfeed.
BASAGLAR should be taken once a day at the same time every day. Test your blood sugar levels while using insulin. 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.
The most common side effect of insulin, including BASAGLAR, is low blood sugar (hypoglycemia), which may be serious and life threatening. Signs and symptoms may include dizziness or light-headedness, sweating, confusion, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, mood change, or hunger.
Do NOT dilute or mix BASAGLAR with any other insulin or solution. It will not work as intended and you may lose blood sugar control, which could be serious. BASAGLAR 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.
BASAGLAR may cause serious side effects that can lead to death, such as severe allergic reactions. Get emergency help if you have:
- A rash over your whole body
- Trouble breathing
- A fast heartbeat
- Swelling of your face, tongue, or throat
- Shortness of breath
- Extreme drowsiness, dizziness, or confusion
Heart failure can occur if you are taking insulin together with medicines called TZDs (thiazolidinediones), even if you have never had heart failure or other heart problems. If you already have heart failure, it may get worse while you take TZDs with BASAGLAR. Your treatment with TZDs and BASAGLAR may need to be changed or stopped by your doctor if you have new or worsening heart failure. 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
Tell your doctor about all the medications you take, including over-the-counter medicines, vitamins, and herbal supplements.
While using BASAGLAR, do not drive or operate heavy machinery until you know how BASAGLAR affects you. Do not drink alcohol or use other medicines that contain alcohol.
Other possible side effects may include swelling, weight gain, low potassium, injection site reactions, including changes in fat tissue at the injection site, and allergic reactions. These are not all the possible side effects. Call your doctor for medical advice about side effects.
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.
The BASAGLAR KwikPen® is a disposable, prefilled insulin pen. Please talk to your healthcare provider about proper injection technique and follow instructions in the Instructions for Use that accompanies the pen. BASAGLAR is available by prescription only.
BV DTC ISI 24JUN2016
For more information, please see Full Prescribing Information, Patient Information, and Instructions for Use.