Pronunciation:

IN-su-lin de-GLOO-dek

Brand Names:

• Tresiba

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Antidiabetic

Pharmacologic—

Insulin, Long Acting

Uses of This Medicine:

Insulin degludec is a long-acting type of insulin that works slowly, over about 24 hours. Insulin is one of many hormones that help the body turn the food we eat into energy. This is done by using the glucose (sugar) in the blood as quick energy. Also, insulin helps us store energy that we can use later. When you have diabetes mellitus, your body cannot make enough insulin or does not use insulin properly. This causes you to have too much sugar in your blood. Like other types of insulin, insulin degludec is used to keep your blood sugar level close to normal.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of insulin degludec injection in children 1 year of age and older. However, safety and efficacy have not been established in children younger than 1 year of age.

Older adults—

Appropriate studies on the relationship of age to the effects of insulin degludec injection have not been performed in the geriatric population, no geriatric-specific problems have been documented to date. However, elderly patients are more likely to have age-related hypoglycemia, which may require caution and an adjustment in the dose for patients receiving insulin degludec.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abiraterone Acetate
• Bexagliflozin
• Chloroquine
• Chlorothiazide
• Chlorthalidone
• Ciprofloxacin
• Delafloxacin
• Enoxacin
• Furosemide
• Gatifloxacin
• Gemifloxacin
• Grepafloxacin
• Hydrochlorothiazide
• Hydroflumethiazide
• Hydroxychloroquine
• Indapamide
• Lanreotide
• Levofloxacin
• Liraglutide
• Lomefloxacin
• Macimorelin
• Metoclopramide
• Metolazone
• Metreleptin
• Moxifloxacin
• Norfloxacin
• Octreotide
• Ofloxacin
• Pasireotide
• Pioglitazone
• Polythiazide
• Pramlintide
• Rosiglitazone
• Semaglutide
• Somatrogon-ghla
• Sotagliflozin
• Sparfloxacin
• Thioctic Acid
• Triamterene
• Trovafloxacin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acebutolol
• Albiglutide
• Atenolol
• Betaxolol
• Bisoprolol
• Carteolol
• Carvedilol
• Celiprolol
• Dulaglutide
• Esmolol
• Exenatide
• Isocarboxazid
• Labetalol
• Levobunolol
• Linezolid
• Lixisenatide
• Methylene Blue
• Metipranolol
• Metoprolol
• Nadolol
• Nebivolol
• Oxprenolol
• Ozanimod
• Penbutolol
• Phenelzine
• Pindolol
• Practolol
• Procarbazine
• Propranolol
• Rasagiline
• Safinamide
• Saxagliptin
• Selegiline
• Sotalol
• Timolol
• Tranylcypromine

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Congestive heart failure or
• Hypokalemia (low potassium in the blood)—May make these conditions worse and increase your chance of having serious side effects.

• Diabetic ketoacidosis—Use is not recommended in patients with this condition.

• Hypoglycemia (low blood sugar)—Should not be used in patients with this condition. If you have low blood sugar and take insulin, your blood sugar may reach dangerously low levels.

• Kidney disease or
• Liver disease—Use with caution. The effects may be increased because of the slower removal of the medicine from the body.

Proper Use of This Medicine:

When you start using this medicine, it is very important that you check your blood sugar often, especially before and after meals and at bedtime. This will help lower the chance of having very low blood sugar.

A nurse or other trained health professional may give you this medicine. You may also be taught how to give your medicine at home. This medicine is given as a shot under your skin.

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.

This medicine comes with a patient information leaflet and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Each package of insulin degludec contains a patient information sheet. Read this sheet carefully and make sure you understand:

• How to prepare the medicine.
• How to inject the medicine.
• How to dispose of syringes, needles, and injection devices.

This medicine is given as a shot under the skin of your stomach, upper arm, or thighs. 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. This will help prevent skin problems from the injections.

Since insulin degludec lowers the blood glucose over 24 hours, it is best to use it at about the same time every day.

Check the liquid in the FlexTouch® pen or vial. It should be clear and colorless. Do not use it if it looks cloudy, thick, or discolored, or if it has particles in it.

Use a new needle for the prefilled pen each time you give yourself an injection. Always remove and throw the needle after each injection from the pen. Store it without a needle attached.

Follow carefully the special meal plan your doctor gave you. This is the most important part of controlling your condition, and is necessary if the medicine is to work properly. Also, exercise regularly and test for sugar in your blood or urine as directed.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form (solution):
  • For Type 1 diabetes:
    • Adults and children 1 year of age and older—Dose is based on your blood sugar and must be determined by your doctor.
    • Children up to 1 year of age—Use and dose must be determined by your doctor.
  • For Type 2 diabetes:
    • Adults and children 1 year of age and older—Dose is based on your blood sugar and must be determined by your doctor.
    • Children up to 1 year of age—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you missed a dose, make sure that there are at least 8 hours between doses.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Unopened prefilled pen or vial: Store in the refrigerator. You may also store the medicine at room temperature for 56 days. Protect from light. Do not freeze. Do not use the medicine if it has been frozen.

Opened prefilled pen or vial: Store in the refrigerator. You may store the medicine at room temperature, away from direct heat and light. Use within 56 days. Throw away any opened pen or vial away after 56 days, even if there is still insulin in it.

Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Precautions While Using This Medicine:

Never share insulin pens with others under any circumstances. It is not safe for one pen to be used for more than one person. Sharing needles or pens can result in transmission of hepatitis viruses, HIV, or other bloodborne illnesses.

It is very important that your doctor will want to check your progress at regular visits, to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

It is very important to follow carefully any instructions from your health care team about:

• Alcohol—Drinking alcohol may cause severe low blood sugar. Discuss this with your health care team.
• Other medicines—Do not take other medicines during the time you or your child is taking insulin degludec unless they have been discussed with your doctor. This especially includes nonprescription medicines such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.
• Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, patients with diabetes may need special counseling about diabetes medicine dosing changes that might occur because of lifestyle changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy may be needed because of the problems that can occur in patients with diabetes during pregnancy.
• Travel—Keep a recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.

In case of emergency—There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to:

• Wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says that you have diabetes and a list of all of your medicines.
• Keep an extra supply of insulin degludec and syringes with needles or injection devices on hand in case high blood sugar occurs.
• Keep some kind of quick-acting sugar handy to treat low blood sugar.
• Have a glucagon kit and a syringe and needle available in case severe low blood sugar occurs. Check and replace any expired kits regularly.

Too much insulin degludec can cause hypoglycemia (low blood sugar). Low blood sugar also can occur if you use insulin degludec with another antidiabetic medicine, changes in insulin regimen (eg, insulin strength, type of insulin, injection site), delay or miss a meal or snack, exercise more than usual, or drink alcohol. Symptoms of low blood sugar must be treated before they lead to unconsciousness (passing out). Different people may feel different symptoms of low blood sugar. It is important that you learn which symptoms of low blood sugar you usually have so that you can treat it quickly.

• Symptoms of low blood sugar include anxiety, behavior change similar to being drunk, blurred vision, cold sweats, confusion, cool, pale skin, difficulty with thinking, drowsiness, excessive hunger, fast heartbeat, headache (continuing), nausea, nervousness, nightmares, restless sleep, shakiness, slurred speech, or unusual tiredness or weakness.
• If symptoms of low blood sugar occur, eat glucose tablets or gel, corn syrup, honey, or sugar cubes, or drink fruit juice, non-diet soft drink, or sugar dissolved in water to relieve the symptoms. Also, check your blood for low blood sugar. Glucagon is used in emergency situations when severe symptoms including seizures or unconsciousness occur. Have a glucagon kit available, along with a syringe and needle, and know how to use it. Members of your family should also know how to use it.

Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your antidiabetic medicine or insulin, changes in insulin regimen, you overeat or do not follow your meal plan, have a fever or infection, or do not exercise as much as usual.

• Symptoms of high blood sugar include blurred vision, drowsiness, dry mouth, flushed, dry skin, fruit-like breath odor, increased urination (frequency and amount), ketones in the urine, loss of appetite, stomachache, nausea, or vomiting, tiredness, trouble breathing (rapid and deep), unconsciousness, or unusual thirst.
• If symptoms of high blood sugar occur, check your blood sugar level and then call your doctor for instructions.

This medicine can cause low blood sugar. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you or your child have a rash, itching, swelling of the face, tongue, and throat, trouble breathing, or chest pain after you use the medicine.

This medicine may cause hypokalemia (low levels of potassium in your blood). Do not use medicines, supplements, or salt substitutes that contain potassium unless you have discussed this with your doctor.

Using this medicine together with other diabetes medicine (eg, pioglitazone, rosiglitazone, Actos®, Actoplus Met®, Avandia®) may cause serious heart problems or edema (fluid retention). Check with your doctor immediately if you are rapidly gaining weight, having chest pain or discomfort, extreme tiredness or weakness, trouble breathing, uneven heartbeat, or excessive swelling of the hands, wrist, ankles, or feet.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Bloating or swelling of the face, arms, hands, lower legs, or feet

rapid weight gain

tingling of the hands or feet

unusual weight gain or loss

Incidence not known

Anxiety

blurred vision

chest tightness

chills

cold sweats

confusion

cool, pale skin

cough

decreased urine

depression

difficulty with swallowing

dizziness

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

dry mouth

fast heartbeat

headache

hives, itching, or skin rash

increased hunger

increased thirst

irregular heartbeat

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals

loss of appetite

muscle pain or cramps

nausea

nightmares

numbness or tingling in the hands, feet, or lips

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

seizures

shakiness

slurred speech

sweating

unusual tiredness or weakness

vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Body aches or pain

diarrhea

dry mouth

ear congestion

fever

headache

loss of voice

runny or stuffy nose

sneezing

sore throat

stomach pain

Incidence not known

Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

redistribution or accumulation of body fat

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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