Insulin Degludec Solution for injection
What is this medicine?
INSULIN DEGLUDEC (IN su lin de GLOO dek) is a human-made form of insulin. This drug lowers the amount of sugar in your blood. It is a long-acting insulin that is usually given once a day.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
episodes of hypoglycemia
an unusual or allergic reaction to insulin, other medicines, foods, dyes, or preservatives
pregnant or trying to get pregnant
How should I use this medicine?
This medicine is for injection under the skin. Use exactly as directed. This insulin should never be mixed in the same syringe with other insulins before injection. Do not vigorously shake before use. You will be taught how to use this medicine and how to adjust doses for activities and illness. Do not use more insulin than prescribed.
Always check the appearance of your insulin before using it. This medicine should be clear and colorless like water. Do not use it if it is cloudy, thickened, colored, or has solid particles in it.
It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or healthcare provider to get one.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
It is important not to miss a dose. Your health care professional or doctor should discuss a plan for missed doses with you. If you do miss a dose, follow their plan. Do not take double doses.
What may interact with this medicine?
other medicines for diabetes
Many medications may cause an increase or decrease in blood sugar, these include:
alcohol containing beverages
aspirin and aspirin-like drugs
certain medicines for HIV like indinavir, lopinavir; ritonavir, nelfinavir, ritonavir, saquinavir
female hormones, like estrogens or progestins and birth control pills
medicines for allergies, asthma, cold, or cough
medicines for mental problems
medicines called MAO Inhibitors like Nardil, Parnate, Marplan, Eldepryl
quinolone antibiotics like ciprofloxacin, levofloxacin, ofloxacin
some herbal dietary supplements
steroid medicines like prednisone or cortisone
Some medications can hide the warning symptoms of low blood sugar. You may need to monitor your blood sugar more closely if you are taking one of these medications. These include:
beta-blockers such as atenolol, metoprolol, propranolol
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
Visit your health care professional or doctor for regular checks on your progress.
A test called the HbA1C (A1C) will be monitored. This is a simple blood test. It measures your blood sugar control over the last 2 to 3 months. You will receive this test every 3 to 6 months.
Learn how to check your blood sugar. Learn the symptoms of low and high blood sugar and how to manage them.
Always carry a quick-source of sugar with you in case you have symptoms of low blood sugar. Examples include hard sugar candy or glucose tablets. Make sure others know that you can choke if you eat or drink when you develop serious symptoms of low blood sugar, such as seizures or unconsciousness. They must get medical help at once.
Tell your doctor or health care professional if you have high blood sugar. You might need to change the dose of your medicine. If you are sick or exercising more than usual, you might need to change the dose of your medicine.
Do not skip meals. Ask your doctor or health care professional if you should avoid alcohol. Many nonprescription cough and cold products contain sugar or alcohol. These can affect blood sugar.
Make sure that you have the right kind of syringe for the type of insulin you use. Try not to change the brand and type of insulin or syringe unless your health care professional or doctor tells you to. Switching insulin brand or type can cause dangerously high or low blood sugar. Always keep an extra supply of insulin, syringes, and needles on hand. Use a syringe one time only. Throw away syringe and needle in a closed container to prevent accidental needle sticks.
Insulin pens and cartridges should never be shared. Even if the needle is changed, sharing may result in passing of viruses like hepatitis or HIV.
Wear a medical ID bracelet or chain, and carry a card that describes your disease and details of your medicine and dosage times.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
signs and symptoms of high blood sugar such as dizziness, dry mouth, dry skin, fruity breath, nausea, stomach pain, increased hunger or thirst, increased urination
signs and symptoms of low blood sugar such as feeling anxious, confusion, dizziness, increased hunger, unusually weak or tired, sweating, shakiness, cold, irritable, headache, blurred vision, fast heartbeat, loss of consciousness
Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):
increase or decrease in fatty tissue under the skin due to overuse of a particular injection site
itching, burning, swelling, or rash at site where injected
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
Keep out of the reach of children.
Store Flextouch Pens in a refrigerator between 2 and 8 degrees C (36 and 46 degrees F.) Do not freeze or use if the insulin has been frozen. Once opened, the pens should be kept at room temperature, below 30 degrees C (86 degrees F). Do not store in the refrigerator once opened. Once opened, the insulin can be used for 56 days. After 56 days, the Flextouch Pen should be thrown away.
Protect from light and excessive heat. Throw away any unused medicine after the expiration date or after the specified time for room temperature storage has passed.
NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
March 21, 2017
U.S. FDA-approved Package Insert