Afrezza

Afrezza is a prescription medication used to control hyperglycemia (high blood sugar) in patients with type 1 and type 2 diabetes mellitus.

This medication comes in powder form to be inhaled. Afrezza is a man-made insulin that is breathed-in through your lungs (inhaled) and is used to control high blood sugar in adults with diabetes mellitus.

Afrezza helps move sugar from the blood into other tissues that use it for energy.

The dose and frequency of administration will depend on many factors, including diet, lifestyle, and other conditions you have. Afrezza is administered immediately before meals.

Common side effects of Afrezza include hypoglycemia (low blood sugar), cough, and throat pain or irritation.                          

Hypoglycemia related to Afrezza can also cause dizziness, drowsiness, and blurred vision. Do not drive or operate heavy machinery until you know how Afrezza affects you.

Afrezza is a prescription medication used to control hyperglycemia (high blood sugar) in patients with type 1 and type 2 diabetes mellitus.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Sanofi-Aventis U.S. LLC

Serious side effects have been reported with Afrezza. See the “Afrezza Precautions” section.

The most common side effect of Afrezza is hypoglycemia, which can include the following symptoms:

• Sweating
• Dizziness
• Palpitation
• Tremor
• Hunger
• Restlessness
• Tingling in the hands, feet, lips, or tongue
• Lightheadedness
• Decreased concentration
• Headache
• Drowsiness
• Sleep disturbances
• Anxiety
• Blurred vision
• Slurred speech
• Depressed mood
• Irritability
• Abnormal behavior
• Unsteady movement
• Personality changes

Afrezza can also cause cough and throat pain or irritation.  

This is not a complete list of Afrezza side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Many medicines alter glucose metabolism and may require insulin dose adjustment or close monitoring. Especially tell your doctor if you take:

• Angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec), fosinopril (Monopril), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), and trandolapril (Mavik)
• Beta blockers such as atenolol (Tenormin), labetalol (Normodyne), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), and propranolol (Inderal)
• Certain cholesterol-lowering medications such as fenofibrate (Antara, Lofibra, TriCor, Triglide), gemfibrozil (Lopid), and niacin (Niacor, Niaspan, in Advicor)
• Clonidine (Catapres, Catapres-TTS, in Clorpres)
• Danazol
• Digoxin (Digitek, Lanoxin)
• Disopyramide (Norpace, Norpace CR)
• Diuretics
• Fuoxetine (Prozac, Sarafem, in Symbyax)
• Hormone replacement therapy
• Isoniazid (INH, Nydrazid)
• Lithium (Eskalith, Lithobid)
• Medications for asthma and colds
• Medications for mental illness
• Medications for nausea
• Monoamine oxidase (MAO) inhibitors, including isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl) and Tranylcypromine (Parnate)
• Octreotide (Sandostatin)
• Oral contraceptives (birth control pills)
• Oral medications for diabetes such as pioglitazone (Actos, in Actoplus Met and others) and rosiglitazone (Avandia, in Avandamet and others)
• Oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), and prednisone (Deltasone); Pentamidine (NebuPent, Pentam)
• Reserpine
• Salicylate pain relievers such as aspirin, choline magnesium trisalicylate (Tricosal, Trilisate), choline salicylate (Arthropan), diflunisal (Dolobid), magnesium salicylate (Doan's, others), and salsalate (Argesic, Disalcid, Salgesic)
• Somatropin (Nutropin, Serostim, others)
• Sulfa antibiotics
• Thyroid medications

This is not a complete list of Afrezza drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Afrezza including the following:

• Hypoglycemia. Tell your healthcare provider right away if you have some or all of the following symptoms of hypoglycemia.
  • Sweating
  • Dizziness
  • Palpitation
  • Tremor
  • Hunger
  • Restlessness
  • Tingling in the hands, feet, lips, or tongue
  • Lightheadedness
  • Decreased concentration
  • Headache
  • Drowsiness
  • Sleep disturbances
  • Anxiety
  • Blurred vision
  • Slurred speech
  • Depressed mood
  • Irritability
  • Abnormal behavior
  • Unsteady movement
  • Personality changes

Hypoglycemia related to Afrezza can also cause dizziness, drowsiness, and blurred vision. Do not drive or operate heavy machinery until you know how Afrezza affects you.

• decreased lung function. Your healthcare provider should check how your lungs are working before you start using Afrezza, 6 months after you start using it and yearly after that.
• lung cancer. In studies of Afrezza in people with diabetes, lung cancer occurred in a few more people who were taking Afrezza than in people who were taking other diabetes medications. There were too few cases to know if lung cancer was related to Afrezza. If you have lung cancer, you and your healthcare provider should decide if you should use Afrezza.
• diabetic ketoacidosis. Talk to your healthcare provider if you have an illness. Your Afrezza dose or how often you check your blood sugar may need to be changed.
• severe allergic reaction (whole body reaction). Get medical help right away if you have any of these signs or symptoms of a severe allergic reaction such as a rash over your whole body, trouble breathing, a fast heartbeat, or sweating.
• low potassium in your blood (hypokalemia).
• heart failure. Taking certain diabetes pills called thiazolidinediones or "TZDs" with Afrezza may cause heart failure in some people. This can happen even if you have never had heart failure or heart problems before. If you already have heart failure it may get worse while you take TZDs with Afrezza. Your healthcare provider should monitor you closely while you are taking TZDs with Afrezza. Tell your healthcare provider if you have any new or worse symptoms of heart failure including shortness of breath, swelling of your ankles or feet, sudden weight gain. Treatment with TZDs and Afrezza may need to be changed or stopped by your healthcare provider if you have new or worse heart failure.

• trouble breathing, shortness of breath, fast heartbeat, swelling of your face, tongue, or throat, sweating, extreme drowsiness, dizziness, confusion.

Do not take Afrezza if you:

• are allergic to Afrezza or to any of its ingredients
• are experiencing hypoglycemia
• chronic lung disease, such as asthma, or chronic obstructive pulmonary disease

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Afrezza, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Afrezza, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Afrezza or to any of its ingredients
• have or had chronic lung disease, such as asthma, or chronic obstructive pulmonary disease
• have or had lung cancer
• are using any inhaled medications
• smoke or recently stopped smoking
• have liver disease
• have kidney disease
• are pregnant or planning to become pregnant
• are breastfeeding or planning to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Afrezza falls into category C. There are no well-done studies that have been done in humans with Afrezza. Afrezza should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus.

Extensive literature demonstrates that blood glucose control is important during pregnancy.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is likely Afrezza is excreted in human breast milk. A decision should be made whether to discontinue nursing orsuspend use of the drug since Afrezza has not been studied in lactating women.

Use Afrezza exactly as prescribed. This medication comes in powder form to be inhaled.

• Afrezza is administered immediately before meals.
• Do not drink alcohol or use over-the-counter medicines that contain alcohol while using Afrezza.
• Afrezza is not for use in place of long-acting insulin. Afrezza must be used with long-acting insulin in people who have type 1 diabetes mellitus.
• Afrezza is not for use to treat diabetic ketoacidosis.
• Do not smoke while using Afrezza. It is not known if Afrezza is safe and effective for use in people who smoke. Afrezza is not for use in people who smoke or have recently stopped smoking (less than 6 months).
• It is not known if Afrezza is safe and effective in children under 18 years of age

• 4 units (blue cartridge)
• 8 units (green cartridge)

• Do not try to open the Afrezza cartridges.
• The Afrezza Inhaler opens the cartridge automatically during use.
• Afrezza cartridges should only be used with the Afrezza Inhaler. Do not try to breathe in the Afrezza powder in any other way.
• Do not put cartridges in your mouth and do not swallow cartridges.
• Use only 1 Afrezza Inhaler at a time. The same inhaler should be used for the 4 unit or 8 unit cartridges.
• Throw away your Afrezza Inhaler after 15 days and get a new one.
• After using Afrezza, powder residue in the mouthpiece is normal, this does not affect your dose.

• If your prescribed dose is 4 units, use 1 blue cartridge
• If your prescribed dose is 8 units, use 1 green cartridge
• If your prescribed Afrezza dose is higher than 8 units, you will need to use more than 1 cartridge.
• If your prescribed dose is 12 units, use 1 blue cartridge and use 1 green cartridge
• If your prescribed dose is 16 units, use 2 green cartridges
• If your prescribed dose is 20 units, use 1 blue cartridge and use 2 green cartridges
• If your prescribed dose is 24 units, use 3 green cartridges

If you are having problems with your Afrezza inhaler or if it breaks and you need a new one, call 1-800-633-1610.

Use this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight (weight loss or weight gain)
• your level of physical activity
• your meal times and eating habits
• increased stress
• if you are feeling ill

If you use too much Afrezza, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

Not in Use: Refrigerated Storage

• Unopened sealed foil packages of Afrezza for inhalation should be stored in the refrigerator: 36-46°F (2-8°C).
• Sealed unopened foil packages kept in the refrigerator, may be used until the expiration date. (If a foil package is not refrigerated, the contents must be used within 10 days)

In Use: Room Temperature Storage

• Sealed (unopened) blister cards and/or strips can be kept at room temperature but must be used within 10 days.
• Opened strips of Afrezza can be kept at room temperature but must be used within 3 days.

Storage Instructions:

• Once you have taken your full dose, make sure the purple mouthpiece cover has been replaced and the inhaler is closed.
• Keep the inhaler in a clean, dry place until the mouthpiece cover on until your next dose.
• May be stored refrigerated, but must be at room temperature before use.
• Never leave or store cartridges in the inhaler.
• Keep out of reach of children.

Care Instructions:

• Use one inhaler at a time. The same inhaler should be used to take 4 unit or 8 unit cartridges.
• Replace the inhaler every 15 days to maintain drug delivery.
• The outside of the inhaler can be wiped with a clean, dry cloth if needed. Never wash the inhaler. Keep it dry.

Inhalational:

WARNING: RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASE

Acute bronchospasm has been observed in patients with asthma and COPD using AFREZZA.

Afrezza is contraindicated in patients with chronic lung disease such as asthma or COPD.

Before initiating Afrezza, perform a detailed medical history, physical examination, and spirometry (FEV1) to identify potential lung disease in all patients