Insulin Glargine-yfgn, Recombinant (IN-su-lin GLAR-jeen - yfgn, ree-KOM-bi-nant)

Treats diabetes.

Brand Name(s):

Semglee, Semglee Pen

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin. It is usually given in the stomach, thigh, or upper arm.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• If you use insulin once a day, it is best to use it at about the same time every day.
• Always double-check both the concentration (strength) of your insulin and your dose. Concentration and dose are not the same. The dose is how many units of insulin you will use. The concentration tells how many units of insulin are in each milliliter (mL), such as 100 units/mL (U-100), but this does not mean you will use 100 units at a time.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• This medicine should be clear and colorless before you use it. Do not use it if it looks cloudy colored, or has particles in it. Do not shake the vial. Do not mix this medicine with any other insulin or with water.
• You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. Do not use the exact same spot for each injection.
• Use a new needle and syringe each time you inject your medicine. If you use a syringe, use only the kind that is made for insulin injections. Some insulins must be given with a specific type of syringe or needle. Ask your pharmacist if you are not sure which one to use.
• Always check the label before use, to make sure you have the correct type of insulin. Do not change the brand, type, or concentration unless your doctor tells you to. If you use a pump or other device, make sure the insulin is made for that device.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Unopened medicine: Store the vials and pens in the refrigerator. You may store the medicine at room temperature for 28 days. Protect from light. Do not freeze.
• Opened medicine:
  • Vials: Store in the refrigerator or at room temperature in a cool place, away from sunlight and heat. Use within 28 days.
  • Prefilled pens: Store at room temperature, away from direct heat and light. Do not refrigerate. Throw away any opened pen after 28 days.
• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can change the amount of insulin you need to use and make it harder for you to control your diabetes. Tell your doctor about all other medicines that you are using.
• Do not drink alcohol while you are using this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, heart disease (including heart failure), or ketoacidosis (high ketones and acid in the blood).
• This medicine may cause the following problems:
  • Low blood sugar
  • Fluid retention or heart failure (when used with thiazolidinedione [TZD] medicine)
• Never share insulin pens, needles, or cartridges with anyone. Sharing these can pass hepatitis viruses, HIV, or other illnesses from one person to another.
• This medicine may make you dizzy or drowsy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blurred vision or changes in vision, severe headache, slow heartbeat, dizziness
• Dry mouth, increased thirst, muscle cramps, nausea, vomiting, uneven heartbeat
• Fever, chills, cough, stuffy or runny nose, sore throat, body aches
• Rapid weight gain, swelling in your hands, ankles, or feet, trouble breathing, tiredness
• Shaking, trembling, sweating, fast or pounding heartbeat, lightheadedness, hunger, confusion

If you notice these less serious side effects, talk with your doctor:

• Arm, leg, back, or joint pain
• Redness, pain, itching, swelling, or any skin changes where the shot was given
• Skin rash or itching

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088