Insulin Degludec Injection, Long-Acting

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KEY POINTS

• This medicine is given by injection just under the skin to treat diabetes. Use it exactly as directed.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Taking pioglitazone (Actos) or rosiglitazone (Avandia) with this medicine may cause or worsen heart failure, or increase your risk for a heart attack, stroke, or other heart problems. Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antidiabetic; long-acting human insulin analog

Generic and brand names: insulin degludec, injection; Tresiba

What is this medicine used for?

This medicine is given by injection (shots) just under the skin to treat diabetes. It helps maintain the proper amount of sugar in the blood.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to insulin
• Diabetic ketoacidosis (increased ketones in the blood or urine)
• Heart failure or other heart problems
• Hypoglycemic episodes (low blood sugar)
• Low levels of potassium in your blood
• Kidney or liver disease

Tell your healthcare provider if you get sick or injured, or if you are scheduled to have surgery. These things may change how much insulin you need to use.

Also tell your healthcare provider if you are taking pioglitazone (Actos) or rosiglitazone (Avandia).

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

This medicine comes in a prefilled pen. This type of insulin should look clear. Do not use it if it is cloudy or has particles in it.

Check with your healthcare provider before using this medicine in children under age 18.

This type of insulin is injected once a day. Do not mix this insulin with other insulins. You may give the separate injections in the same area of the body, such as the stomach, but do not give the injections right next to each other.

Most people with diabetes give themselves these shots or have someone at home give them. Check the label on the medicine for directions about your specific dose. Be sure you know when to use the medicine and how much medicine you should use. Carefully follow the instructions for using this medicine. If you are not sure how to use this medicine and your pen, ask your healthcare provider or pharmacist for help.

Follow your healthcare provider's instructions carefully regarding dosage. Your healthcare provider will adjust your dosage based on your blood sugar levels. Measure your dosage very carefully to avoid an overdose (insulin shock), which can lead to a coma. Do not stop taking this medicine without your healthcare provider's approval.

There are several types, strengths, and brands of insulin. Make sure you know the type, strength, and brand of insulin prescribed for you. Never change the type, strength, or brand of insulin without your healthcare provider's approval. Always be sure you have received the right insulin from the pharmacy. Check to make sure you inject the correct insulin and dose, especially if you use more than one type of insulin.

Ask your healthcare provider or pharmacist how to dispose of any used pens. Never share pens with anyone else.

What if I miss a dose?

If you miss a dose, use it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and use the next one as directed. Do not use 2 doses in less than 8 hours. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: confusion, trouble concentrating, irritability, shaking, weakness, strong hunger, sweating, headache, nausea, vision problems, fast heartbeat, tingling (in hands, feet, lips, or tongue), slurred speech, feeling faint.

What should I watch out for?

Taking pioglitazone (Actos) or rosiglitazone (Avandia) with this medicine may cause or worsen heart failure in some people. Contact your healthcare provider right away if you have new or worse symptoms of heart failure such as shortness of breath, swelling of your ankles or feet, or sudden weight gain.

Follow the diet and exercise program prescribed by your healthcare provider. Eat regular meals and avoid skipping meals, even when you travel or are sick. Your dosage of insulin is based on your food intake. If you do not follow the meal or exercise plan, you may have too much or too little insulin in your blood. Your insulin needs may also change because of illness, stress, or other medicines.

If you travel across 2 or more time zones, talk with your healthcare provider about how to time your injections. Make sure you have an adequate amount of insulin and supplies with you.

Test your blood sugar on the schedule your provider recommends and keep track of it. See your provider regularly for an A1c test to check the average of your blood sugar over 2 to 3 months. This average is different from your day to day blood sugar. Keep all appointments for these tests.

Alcohol may affect your response to medicine and food. Do not drink alcohol unless your healthcare provider approves.

You may have low blood sugar if you miss or delay meals, drink too much alcohol, take too much insulin, or exercise more than usual. Symptoms of low blood sugar include shaking, anxiety, cold sweats, irritability, fast heartbeat, feeling faint, strong hunger, vision problems, headache, nausea, slurred speech, confusion, unusual mood changes, tingling in the lips or tongue, and weakness. Treat the condition quickly by eating or drinking something with sugar in it such as candy, juice, or nondiet soda. Taking glucose tablets or gels (available in drug stores) is another quick way to treat hypoglycemia. Talk with your healthcare provider if you have low blood sugar often.

Low blood sugar may affect your ability to drive or operate machinery. Do not drive or operate machinery unless you are fully alert and can see clearly.

Contact your healthcare provider if you develop the signs of high blood sugar. Some of the signs of high blood sugar are increased thirst, drowsiness, fruity-smelling breath, flushing, increased urination, fast breathing, stomach pain, fast heartbeat, and loss of appetite. This can happen if you do not take enough insulin, skip a dose, or do not follow your diet.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine. Wear some form of ID stating that you are a diabetic (such as a Medic Alert bracelet). If you become unconscious, the ID tells emergency healthcare providers that you are a diabetic and need special care.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Symptoms of hypoglycemia (shaking, anxiety, cold sweats, irritability, fast heartbeat, feeling faint, strong hunger, vision problems, headache, nausea, slurred speech, confusion, unusual mood changes, tingling in the lips or tongue, weakness); symptoms of high blood sugar (increased thirst, drowsiness, fruity breath, flushing, increased urination, fast breathing, stomach pain, loss of appetite); seizures; fast or irregular heartbeat; shortness of breath; swelling of hands or feet; sudden weight gain; severe muscle pain or weakness.

Other: Redness or skin thickening at the spot where an injection has been given, minor rash or itching, weight gain, runny nose, diarrhea.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• ACE inhibitors such as benazepril (Lotensin), captopril, enalapril (Vasotec), fosinopril, lisinopril (Prinivil, Zestril), moexipril (Univasc), quinapril (Accupril), and ramipril (Altace)
• Acetazolamide (Diamox)
• Alcohol
• Allergy, cold, or cough medicines that contain phenylephrine (Neo-Synephrine, Sudafed PE) or pseudoephedrine (Sudafed)
• Androgen hormones such as methyltestosterone (Android, Testred) and testosterone (Androderm, AndroGel, Axiron, Testim)
• Angiotensin receptor blockers (ARBs) such as azilsartan (Edarbi), candesartan (Atacand), eprosartan (Teveten), irbesartan (Avapro), losartan (Cozaar), olmesartan (Benicar), telmisartan (Micardis), and valsartan (Diovan)
• Antibiotics such as ciprofloxacin (Cipro), isoniazid, levofloxacin (Levaquin), linezolid (Zyvox), moxifloxacin (Avelox), ofloxacin, pentamidine (NebuPent, Pentam), and tetracycline
• Antipsychotic medicines such as chlorpromazine, clozapine (Clozaril, FazaClo), fluphenazine, olanzapine (Zyprexa), perphenazine, quetiapine (Seroquel), thioridazine, trifluoperazine, and ziprasidone (Geodon)
• Antiseizure medicines such as fosphenytoin (Cerebyx) and phenytoin (Dilantin, Phenytek)
• Beta blockers such as atenolol (Tenormin), betaxolol, bisoprolol (Zebeta), carteolol, metoprolol (Lopressor, Toprol), nadolol (Corgard), pindolol, sotalol (Betapace, Sorine), and timolol
• Cholesterol-lowering medicines such as cholestyramine (Prevalite), colesevelam (Welchol), colestipol (Colestid), fenofibrate (Antara, Fenoglide, Lipofen, TriCor, Triglide), and gemfibrozil (Lopid)
• Clonidine (Catapres, Kapvay)
• Corticosteroids such as betamethasone, cortisone, dexamethasone, fludrocortisone, hydrocortisone (A-Hydrocort, Cortef), methylprednisolone (Medrol, Solu-Medrol), prednisolone (Omnipred, Orapred, Prelone), prednisone (Prednisone Intensol), and triamcinolone (Aristospan, Kenalog)
• Danazol
• Disopyramide (Norpace)
• Diuretics (water pills) such as bumetanide, chlorothiazide (Diuril), chlorthalidone, furosemide (Lasix), hydrochlorothiazide (Microzide), and torsemide (Demadex)
• HIV medicines such as indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), ritonavir (Norvir), and saquinavir (Invirase)
• Hormonal birth control implants, IUDs, patches, pills, shots, and vaginal rings, and hormones such as Estinyl, Estratab, Estrovis, and Premarin
• Lithium (Lithobid)
• MAO inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate) (Do not take this medicine and an MAO inhibitor within 14 days of each other.)
• Medicines to treat breathing or lung problems such as albuterol (ProAir, Proventil, Ventolin), epinephrine (Adrenalin, Asthmanefrin, Auvi-Q, EpiPen), and terbutaline
• Metreleptin (Myalept)
• Natural remedies such as alfalfa, aloe, bilberry, bitter melon, celery, chromium, fenugreek, garcinia, garlic, ginger, ginseng, green tea, gymnema, St. John's wort, stinging nettle, and willow
• Nausea medicines such as prochlorperazine (Compro) and promethazine
• Niacin
• Octreotide (Sandostatin)
• Other diabetes medicines such as acarbose (Precose), canagliflozin (Invokana), dapagliflozin (Farxiga), dulaglutide (Trulicity), empagliflozin (Jardiance), exenatide (Bydureon, Byetta), glipizide (Glucotrol), glyburide (Glynase), metformin (Fortamet, Glucophage, Riomet), miglitol (Glyset), nateglinide (Starlix), pioglitazone (Actos), pramlintide (Symlin), repaglinide (Prandin), rosiglitazone (Avandia), saxagliptin (Onglyza), and sitagliptin (Januvia)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Procarbazine (Matulane)
• Products that contain methylene blue (Hyophen, Prosed DS, Urophen, Uta)
• Propranolol (Hemangeol, Inderal, InnoPran)
• Reserpine
• Somatropin (Genotropin, Humatrope, Nutropin, Serostim)
• SSRI antidepressants such as fluoxetine (Prozac), fluvoxamine (Luvox), and sertraline (Zoloft)
• Sulfa antibiotics such as sulfadiazine, sulfamethoxazole/trimethoprim (Bactrim, Septra), and sulfasalazine (Azulfidine)
• Thyroid medicines such as levothyroxine (Levo-T, Levothroid, Levoxyl, Synthroid, Unithroid), liothyronine (Cytomel, Triostat), liotrix (Thyrolar), and thyroid USP (Armour Thyroid, Nature-Throid)

Ask your healthcare provider or pharmacist if medicines you are taking are in any of these groups.

Do not drink alcohol while you are taking this medicine unless your healthcare provider approves.

Many medicines may change how well this medicine controls your blood sugar. Tell any healthcare providers who treat you that you are taking this medicine for diabetes.

Many nonprescription products contain sugar, alcohol, or other ingredients that may interfere with this medicine or increase your blood sugar. Check product labels for warnings for diabetics or ask your healthcare provider or pharmacist for advice.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Check the package instructions for the proper storage information. Always check the expiration date for insulin.

Store the pens in the refrigerator until you use them. Do not let the insulin freeze. Do not expose insulin to very hot temperatures, such as direct sunlight or leave it in a closed, hot car. Protect it from heat, high humidity, and bright light.

Before using the pen for the first time, take it out of the refrigerator and allow it to warm to room temperature. After you use the pen for the first time, keep it at room temperature for 56 days and then discard it. Do not refrigerate the pen once it has been used.

Talk with your healthcare provider or pharmacist if you have any questions about how to store your insulin.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicines in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.