Insulin Inhalation, Rapid-Acting

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KEY POINTS

• This medicine is inhaled through the mouth to treat diabetes. Use it exactly as directed.
• This medicine should not be used by people with lung problems such as asthma or COPD. It is very important that you do not smoke while using this medicine. This medicine may cause coughing, shortness of breath, wheezing, and trouble breathing.
• 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.
• 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

Generic and brand names: rapid-acting insulin, inhalation; Afrezza

What is this medicine used for?

This medicine is inhaled through the mouth to treat diabetes. It helps maintain the proper amount of sugar in the blood. This type of insulin acts quickly for a short time, so it may be used with a longer-acting insulin.

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
• Breathing problems or lung disease such as asthma or COPD
• Diabetic ketoacidosis (DKA)
• Diabetic neuropathy (nerve problems)
• Heart failure or other heart problems
• Hypoglycemic episodes (low blood sugar)
• Kidney or liver disease
• Lung cancer
• Low levels of potassium in your blood

Tell your healthcare provider if you smoke. This medicine should not be used if you smoke or if you quit smoking in the past 6 months. Also, tell your healthcare provider if you use any other inhaled medicines.

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.

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?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Your healthcare provider will teach you how to use this medicine the right way before you use it for the first time. Check the label on the medicine for directions about your specific dose. Be sure you know how to use the medicine and how much medicine you should take. Do not shake, drop, or tilt the inhaler after you have loaded the cartridge. If you are not sure how to use this medicine, 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. Do not change your dosage or stop taking this medicine without your healthcare provider's approval. Contact your healthcare provide before switching injectable insulins.

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

You will inhale this medicine at the beginning of a meal.

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 doses of medicine. Make sure you have an adequate amount of insulin and supplies with you.

What if I miss a dose?

Ask your healthcare provider what to do if you miss a dose.

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?

This medicine may cause sudden lung or breathing problems. It should not be used by people with long-term (chronic) lung problems such as asthma or COPD. Contact your healthcare provider if you have trouble breathing, shortness of breath, coughing, or wheezing while using this medicine. Your healthcare provider may do lung tests before you start this medicine and regularly while you are using this medicine. Keep all appointments.

It is very important that you not smoke while you are using this medicine. Talk with your healthcare provider about this.

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

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.

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), trouble breathing or wheezing, shortness of breath, new or worsening cough, severe or continued coughing, seizures, fast or irregular heartbeat, swelling of hands or feet, sudden weight gain, severe muscle pain or weakness.

Other: Minor rash or itching, sore throat, runny nose, mild cough.

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 or products that contain alcohol, such as allergy, cold, or cough medicines, lopinavir/ritonavir (Kaletra), and tipranavir (Aptivus)
• 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), olanzapine (Zyprexa), quetiapine (Seroquel), thioridazine, trifluoperazine, and ziprasidone (Geodon)
• Antiseizure medicines such as fosphenytoin (Cerebyx) and phenytoin (Dilantin, Phenytek)
• Aspirin and other salicylates
• Beta blockers such as atenolol (Tenormin), betaxolol, bisoprolol (Zebeta), carteolol, metoprolol (Lopressor, Toprol), nadolol (Corgard), pindolol, sotalol (Betapace, Sorine), and timolol
• Cancer medicines such as ceritinib (Zykadia), dabrafenib (Tafinlar), and nilotinib (Tasigna)
• Cholesterol-lowering medicines such as 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), 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
• Immunosuppressants such as sirolimus (Rapamune) and tacrolimus (Astagraf, Prograf, Protopic)
• Liraglutide (Saxenda, Victoza)
• 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, chromium, fenugreek, garlic, ginger, ginseng, 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), albiglutide (Tanzeum), 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)
• Pasireotide (Signifor)
• Pentoxifylline
• 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?

This medicine comes in a foil package. Inside the foil package are blister cards with blister strips.

Store unopened foil packages in the refrigerator until the expiration date on the package. You may store unopened blister cards and strips in the refrigerator for up to 30 days.

If you keep the unopened foil package, blister cards, or strips at room temperature, use the medicine within 10 days. Do not put a blister card or strip back into the refrigerator after being stored at room temperature. Protect it from heat, high humidity, and bright light.

Once a strip is opened, use the cartridges in that strip within 3 days. If stored in the refrigerator, keep the cartridges at room temperature for 10 minutes before using this medicine.

Keep the inhaler in a clean, dry place with the mouthpiece cover on. Never wash the inhaler. Throw away your Afrezza Inhaler after 15 days and get a new one.

Follow the instructions in the medicine package for proper storage and care of this medicine and inhaler. Talk with your healthcare provider or pharmacist if you have any questions.

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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.