Insulin Human Inhaled/Afrezza (Inhalation)

Overview

Insulin Human Inhaled is artificial insulin that's taken through inhalation by the mouth and used to manage high blood sugar levels in people with diabetes.

Insulin is a hormone that assists the body to convert food into energy. It does this by using blood glucose as fast energy. In addition, insulin helps to store energy so it can be used later.

When you've got sugar diabetes (diabetes mellitus), your body can't use insulin properly or make enough insulin. For this reason, you must take extra insulin to manage the sugar in your blood and stay healthy. This is vital as excess sugar in your blood can be hazardous.

Insulin Human Inhaled works more quickly than other forms of insulin and produces effects that don't last that long. It works more like the insulin normally produced by the body. As the effects of Insulin Human Inhaled are short-lived, your healthcare professional can also prescribe longer-acting insulin for your use.

The dose and how often you take Insulin Human Inhaled will depend on various factors, such as lifestyle, diet, and other medical conditions you suffer from. Insulin Human Inhaled is administered just before meals.

Common Insulin Human Inhaled side effects include low blood sugar (hypoglycemia), throat irritation or pain, and cough.

Hypoglycemia associated with Insulin Human Inhaled may also cause blurred vision, dizziness, and drowsiness. Do not operate heavy machines or drive until you're aware of how Insulin Human Inhaled affects you.

Insulin Human Inhaled is only available through a doctor's prescription and is marketed under the Afrezza brand name.

This medicine comes in the form of an Aerosol powder.

Conditions Treated

Type Of Medicine

  • Antidiabetic

Side Effects

Aside from its useful effects, Insulin Human Inhaled may cause some adverse effects. Not all of the effects below may occur, but if they happen they may require medical treatment.

If any of the side effects below occur, see your healthcare specialist right away:

More common:

  • Chills
  • Anxiety
  • Cold sweats
  • Blurred vision
  • Depression
  • Cough
  • Cool, pale skin
  • Confusion
  • Coma
  • Unusual tiredness/weakness
  • Slurred speech
  • Shakiness
  • Seizures
  • Nightmares
  • Nausea
  • Increased hunger
  • Headache
  • Fast heartbeat
  • Dizziness

    Incidence unknown:

  • Tightness in chest
  • Difficulty with swallowing
  • Noisy breathing
  • Difficulty with breathing
  • Swelling/puffiness of eyelids or around your face, lips, eyes, or tongue
  • Hives, skin rash, or itching

Some Insulin Human Inhaled side effects may happen that normally don't require medical intervention. These effects may disappear during your treatment as you adapt to Insulin Human Inhaled. Additionally, your healthcare specialist may recommend ways to relieve or prevent some of the following effects. Please see your healthcare specialist promptly if you've got any questions about these side effects, if they're troublesome, or if they persist.

Less common:

Incidence unknown:

  • Weight gain
  • Other Insulin Human Inhaled side effects not mentioned above may happen in some people. If you develop any other effects, please see your healthcare professional promptly.

Dosage

Only take Insulin Human Inhaled as ordered by your healthcare professional. Don't take less or more of it. Don't take it for a shorter or longer duration than prescribed by your healthcare professional.

Insulin Human Inhaled comes with a brochure containing patient information. It's vitally important that you check this information out. If you've got any questions or concerns, ask your doctor.

Insulin Human Inhaled is available in three different strengths: 12 unit (yellow), 8 unit (green), and 4 unit (blue) single use cartridges.

Insulin Human Inhaled is mealtime insulin. It's normally taken just before a meal.

Follow the special diet plan given by your doctor carefully. This is the most critical part of managing your high blood sugar and is vital for the medicine to work effectively. Have regular exercise and have sugar tests in your urine or blood as instructed.

For Insulin Human Inhaled to help treat your diabetes, you will need to use it daily at the same time and at evenly spaced intervals, as ordered by your doctor.

To make use of the inhaler:

  • Read the dosage chart and determine the minimum cartridges you can take in your dose.
  • Check the foil package and remove a card. Remove one strip by tearing along the perforation.
  • Push the cartridge off the strip. Get the right amount of cartridges to prepare your dose.
  • Before using a cartridge, make sure it has been kept for 10 minutes at room temperature.
  • Only use a single inhaler per session. You should use the same inhaler for the 12, 8, or 4 unit cartridges.
  • Hold the inhaler with one hand and make sure the white mouthpiece is on top with the purple bottom below.
  • Open the inhaler so you can put the cartridge inside the inhaler. Ensure the cartridge is lying flat inside the inhaler.
  • After placing the cartridge inside the inhaler, make sure the inhaler is level with the white mouthpiece above and purple base below. Don't keep the inhaler facing downwards, with the mouthpiece facing down, dropped or shaken after you've placed the cartridge inside. If this happens, discard the cartridge and place a new one inside.
  • Remove the cover of the mouthpiece and fully breathe out, expelling as much air from the lungs as you can.
  • Put the entire mouthpiece in your mouth then tilt the inhaler downwards with your head in a level position.
  • Deeply inhale via the inhaler. Hold your breath as much as you can, then take the inhaler out of your mouth.
  • Replace the cover of the mouthpiece and discard the used cartridge.
  • If you're using more than eight units, you'll need more than a single cartridge. Repeat the above steps.
  • Use a dry, clean cloth to wipe the inhaler. Keep the inhaler dry. Don't wash it.
  • Don't place cartridges inside your mouth and don't swallow them.
  • After 15 days, discard the inhaler and find a new one.

Different patients will receive different doses of Insulin Human Inhaled based on its strength. How many doses you have each day, the interval between doses, as well as the duration in which you take Insulin Human Inhaled depends on your reason for taking the medication.

Interactions

Tell your healthcare professional about all kinds of drugs you take, such as prescription, nonprescription, herbal, dietary, nutritional, recreational, or illegal drugs you're using, especially:

  • Thyroid medications
  • Terbutaline
  • Sulfa medications
  • Diuretics (water pills)
  • Danazol
  • Niacin
  • Birth control pills (oral contraceptives)
  • AccuNeb, Proventil, ProAir, others (Albuterol)
  • Catapres-TTS, Catapres, Clorpres, Kapvay, others (Clonidine)
  • Norpace (Disopyramide)
  • Prozac, Symbyax (Fluoxetine), Selfemra, Sarafem
  • Lipofen, Triglide (Fenofibrate), TriCor
  • Clozaril, Versacloz (Clozapine), Fazaclo ODT
  • Lopid (Gemfibrozil)
  • Laniazid, Rifater (Isoniazid), Rifamate
  • Lithobid (Lithium)
  • Hormone replacement therapy
  • Pentoxil (Pentoxyfylline)
  • Sandostatin (Octreotide)
  • Reserpine
  • Symlin (Pramlintide)
  • Pentam (Pentamidine), NebuPent
  • Medications for colds and asthma
  • Medications for nausea and mental illness
  • Zydis, Zyprexa, Symbyax (Olanzapine)
  • Propoxyphene
  • Other inhaled medications

Genotropin, Nutropin, Serostim, Humatrope, others (Somatropin)

Beta-blockers like Corgard, Corzide (Nadolol); Inderal LA, Hemangeol, InnoPran XL (Propranolol);Trandate; Corzide (Labetalol); Lopressor, Toprol XL (Metoprolol); and Tenormin, Tenoretic (Atenolol)

HIV protease inhibitors like Crixivan (Indinavir); Kaletra (Lopinavir); Reyataz (Atazanavir); Viekira Pak (Ritonavir), Norvir, Kaletra; Invirase (Saquinavir); and Viracept (Nelfinavir)

ACE (angiotensin-converting enzyme) inhibitors like Altace (Ramipril); Capoten (Captopril); Univasc, Uniretic (Moexipril); Lotensin, Lotrel (Benazepril); Fosinopril; Vaseretic (Enalapril), Enalaprilat, Vasotec; Prinzide, Zestoretic (Lisinopril), Aceon, Prestalia (Perindopril); and Accuretic, Accupril, Quinaretic (Quinapril)

ARB (angiotensin receptor blockers) like Avalide (irbesartan); Atacand HCT (Candesartan), Atacand; Twynsta (Telmisartan), Micardis, Micardis HCT; Edarbi, Edarbyclor (Azilsartan); Cozaar, Hyzaar (Losartan); Diovan, Diovan HCT; Avapro; and Teveten HCT (Eprosartan), Teveten

MAOIs (monoamine oxidase inhibitors) like Nardil (Phenelzine); Marplan (Isocarboxazid); Emsam, Eldepryl, Zelapar (Selegiline); and Parnate (Tranylcypromine)

Oral medicines for diabetes called thiazolidinediones , like Avandia (Rosiglitazone) and Actos (Pioglitazone)

Oral steroids like Rayos (Prednisone), Medrol (Methylprednisolone), and Dexamethasone

Salicylate pain relievers like Aspirin, Choline Salicylate, Choline Magnesium Trisalicylate, Salsalate, Diflunisal , and Magnesium Salicylate (Doan's)

Alcohol may affect your level of blood sugar. Ask your healthcare professional if it's okay to take alcoholic drinks while you're using Insulin Human Inhaled.

Warnings

Before using Insulin Human Inhaled, tell your pharmacist and physician if you have allergies to insulin (Humulin, Apidra, Levemir, Lantus, Novolog, etc), any other medicines, or any of Insulin Human Inhaled's active ingredients.

Tell your physician and pharmacist what sort of medications you take, including prescription and nonprescription medicines, nutritional supplements, herbal products, and vitamins you're using or plan to use. Make sure to name any of these:

ACE (angiotension-converting enzyme) inhibitors like Benazepril (in Lotrel, Lotensin), Fosinopril, Lisinopril (in Zestoretic, in Prinzide, Zestril, Prinivil), Enalapril (in Vaseretic, Vasotec), Ramipril (Altace), and Quinapril (in Quinaretic), Accupril)

Angiotensin receptor blockers like Eprosartan (in Teveten HCT), Azilsartan (Edarbi), Candesartan (in Atacand HCT, Atacand), Ibesartan (in Avalide, Avapro), Olmesartan (in Azor, in Tribenzor, in Benicar HCT, Benicar), Losartan (in Hyzaar, Cozaar), Valsartan (in Diovan HCT, Diovan, in Exforge HCT, etc), Telmisartan (in Micardis HCT, Micardis, in Twynsta)

Beta blockers like Propranolol (Innopran XL, Inderal, Hemangeol), Nadolol (in Corzide, Corgard), Atenolol (in Tenoretic, Tenormin), Metoprolol (in Dutoprol, Toprol XL, Lopressor, etc), Labetalol (Trandate)

HIV protease inhibitors like Indinavir (Crixivan), Atazanavir (Reyataz), Saquinavir (Invirase), Ritonavir (Norvir, in Viekira Pak, in Kaletra), Lopinavir (in Kaletra), Nelfinavir (Viracept)

MAOIs (monoamine oxidase inhibitors) like Selegiline (Zelapar, Emsam, Eldepryl), Isocarboxazid (Marplan), Tranylcypromine (Parnate), Phenelzine (Nardil)

Oral medicines for diabetes like Pioglitazone (in Actoplus Met, Actos, in Oseni, in Duetact), or Rosiglitazone (in Avandaryl, Avandia, in Avandamet)

Salicylate pain relievers like Aspirine, Somatropin (Nutropin, Humatrope, Genotropin, etc.)

Oral steroids like Prednisone (Rayos), Methylprednisolone (Medrol), and Dexamethasone

  • Medications for mental illness, nausea, colds, and asthma
  • Hormone replacement therapy
  • Isoniazid (in Rifamate, Laniazid, in Rifater)
  • Niacin
  • Lithium (Lithobid)
  • Birth control pills (oral contraceptives)
  • Other inhaled medications
  • Sulfa antibiotics
  • Thyroid medications
  • Terbutaline
  • Octreotide (Sandostatin)
  • Pentamidine (Pentam, NebuPent)
  • Pramlintide (Symlin)
  • Pentoxifylline (Pentoxil)
  • Olanzapine (in Symbyax, Zydis, Zyprexa)
  • Reserpine
  • Propoxyphene
  • Albuterol (Ventolin, Proventil, Proair HFA)
  • Clonidine (Catapres-TTS, Catapres, Kapvay, etc)
  • Clozapine (Versacloz, Clozaril, Fazaclo ODT)
  • Disopyramide (Norpace CR, Norpace)
  • Danazol
  • Diuretics
  • Fenofibrate (Triglide, TriCor, Lipofen)
  • Gemfibrozil (Lopid)
  • Fluoxetine (Selfemra, Sarafem, Prozac, in Symbyax)

Your physician may need to alter your doses of drugs or carefully monitor you for side effects.

Let your physician know if you have hypoglycemia symptoms (low blood sugar). He or she will probably ask you to not take Insulin Human Inhaled if you've got this condition.

High blood sugar, also called hyperglycemia) can occur if you don't take adequate diabetes medication, skip a dose, overeat or don't follow your diet plan, don't exercise regularly, or have an infection or fever.

Hyperglycemia symptoms include drowsiness, blurred vision, dry and flushed skin, dry mouth, increased urination (polyuria), fruit-like breath odor, loss of appetite, ketones in urine, nausea or vomiting, stomach ache, difficulty with breathing, fatigue, unconsciousness, or unusual thirst (polydipsia).

If these hyperglycemia symptoms occur, test your levels of blood sugar and call your healthcare professional for directions.

Insulin Human Inhaled can make you drowsy or dizzy. Don't drive, operate machines, or do any task or activity that can be hazardous until you understand how Insulin Human Inhaled affects you.

Let your physician know if you've got an infection, if you smoke cigarettes, or if you've quit smoking within the last 6 months. In addition, let your physician know if you've ever had or have nerve damage due to diabetes, lung cancer, liver or kidney disease, or heart failure.

Let your physician know if you're expecting, plan to get pregnant, or are nursing an infant. Call up your physician if you fall pregnant while taking Insulin Human Inhaled.

No relevant studies have been carried out on the link between age and the effects of Insulin Human Inhaled in children. Efficacy and safety haven't been determined.

Recent studies haven't shown any issues specific to older adults that would restrict the use of Insulin Human Inhaled in the elderly.

If you're having an operation, for example dental surgery, inform your dentist or doctor that you're taking Insulin Human Inhaled.

Ask your physician how frequently you should test your blood sugar. You should know that low levels of blood sugar can affect your capacity to do tasks like driving or operating machinery. Ask your physician if you should test your blood sugar prior to operating machinery or driving.

Alcohol can change your blood sugar levels. Ask your physician about the safe intake of alcoholic drinks while you're taking Insulin Human Inhaled.

Ask your physician what to do in case you get sick, lose or gain weight, suffer unusual stress, change your activity schedule or exercise, or intend to travel in different time zones. These changes may affect your dosing program and the quantity of insulin you'll need.

Get emergency assistance if you have the following symptoms while using Insulin Human Inhaled: shortness of breath, trouble breathing, fast heartbeat, sweating, dizziness, extreme drowsiness, confusion, or swelling of your face/throat/tongue.

Taking Insulin Human Inhaled can cause reduced lung function. Your doctor should assess your lung function before you begin taking Insulin Human Inhaled, six months after you begin using it and every year after that.

Taking Insulin Human Inhaled may cause lung cancer. In research carried out on people using the medication for their diabetes, lung cancer developed in more subjects who were using Insulin Human Inhaled than in those who were using other diabetes medicines. The cases were too few to know if Insulin Human Inhaled caused lung cancer. If you've got lung cancer, consult your healthcare professional to know if you should take Insulin Human Inhaled.

Get medical help at once if you've got any of the signs/symptoms of a very serious allergic reaction, including a rash over your entire body, difficulty with breathing, sweating, or a fast heartbeat.

Using certain diabetes pills known as thiazolidinediones with Insulin Human Inhaled may lead to heart failure in certain people. This may happen even if you've never had heart problems or heart failure problems previously. If you already suffer from heart failure, it can worsen while you take thiazolidinediones with Insulin Human Inhaled. Please inform your doctor if you experience any worse or new heart failure symptoms, including shortness of breath, sudden weight gain, or swelling of feet or ankles. Treatment with thiazolidinediones and Insulin Human Inhaled may have to be stopped or changed by your doctor if you have worse or new heart failure.

Please follow all dietary and exercise recommendations given by your dietitian or doctor. It is vital to eat healthy and eat around the same quantities of the same foods at around the same times daily. Delaying or skipping meals or making changes to the type and amount of food you consume may cause issues with management of your blood sugar.

It is vitally important for your physician to check on you regularly while you're being treated with Insulin Human Inhaled to ensure it's working well. Lung and blood function tests may be required to test for undesirable effects.

Don't take other medicines while using Insulin Human Inhaled without first talking about it with your doctor.

It's vital for your family members to know how to treat the side effects that occur or prevent them. Diabetes patients may require special counseling on diabetes medicines and dosage changes that can occur due to lifestyle changes, including exercise and diet. Counseling on pregnancy and contraception may be required because of issues that may happen during pregnancy in diabetes patients.

Any change of Insulin Human Inhaled should be done carefully and only under the supervision of a medical professional. Changes in strength, purity, type (lente, regular, NPH), brand (manufacturer), species (human, beef, beef-pork, pork) and/or manufacture method may necessitate a change in dosage.

Regular exercise, proper diet, and regular blood sugar tests are vital for optimal results when taking Insulin Human Inhaled.

Storage

Refrigerated storage/Not in use:

Unopened sealed Insulin Human Inhaled foil packages should be kept in the refrigerator at 2 to 8 degrees Celsius.

Unopened sealed foil packages stored in the fridge may be taken until they expire. If the foil package isn't refrigerated, you must use the content within 10 days.

Room temperature storage/In use:

Unopened sealed blister cards or strips may be stored at room temperature. However, you must use them within 10 days.

Opened strips of Insulin Human Inhaled can be stored at room temperature. You must use them within 3 days, though.

Storage Instructions

Keep Insulin Human Inhaled out of your children's reach.

Never store or leave cartridges in your inhaler.

Insulin Human Inhaled may be kept in the refrigerator, but will need to be kept at room temperature prior to use.

Keep your inhaler in a dry, clean place with the cover of the mouthpiece on until the next dose.

Once you've had your full dose of the medicine, make sure to close the inhaler and replace the purple cover of the mouthpiece.

Care instructions:

Use a single inhaler at one time. Use the same inhaler to take 12, 8, or 4 unit cartridges.

To maintain the delivery of the drug, replace your inhaler after every 15 days.

Wipe the exterior of the inhaler with a dry, clean cloth if necessary. Keep the inhaler dry. Never wash it.

Summary

Let all your healthcare professionals know that you use Insulin Human Inhaled. This includes your nurse, doctor, dentist, and pharmacist.

This medicine may cause allergic reactions. In rare cases, some reactions may be very serious or potentially fatal. Talk to your physician about this.

Using Insulin Human Inhaled may cause low blood sugar. Extremely low blood sugar may result in passing out, long-lasting brain damage, seizures, and even death. Discuss this with your physician.

This medicine may cause low blood potassium. If left untreated, this can cause an abnormal heartbeat, very serious breathing difficulties, and even death. Talk to your physician about this.

Avoid driving, operating machines, or doing other activities or tasks that require you to stay alert until you understand how Insulin Human Inhaled affects you.

Some diabetes medicines like rosiglitazone or pioglitazone may result in heart failure or worsen heart failure in persons who already have the condition. Using Insulin Human Inhaled with these medicines may up this risk. Please talk to your physician if you also use one of these medicines.

Don't switch between various forms of Insulin Human Inhaled without first consulting your doctor.

It may be more difficult to manage your blood sugar in times of stress such as when you've got an infection, an injury, fever, or surgery. Changes in your diet and level of exercise or physical activity may also have an effect on your blood sugar. Discuss this with your physician.

If your blood sugar is low, don't drive or you are highly likely to have an accident.

Test your blood sugar levels as you've been instructed by your doctor.

Have your blood work examined as instructed by your doctor. You can discuss this with your doctor.

Avoid taking alcohol or products that contain alcohol while you're using Insulin Human Inhaled.

Don't smoke while taking Insulin Human Inhaled.

If you're 65 or over, use Insulin Human Inhaled carefully. You could develop more side effects.

Inform your healthcare professional if you plan to get pregnant or are pregnant. You'll need to discuss the good and bad side of using Insulin Human Inhaled while you're pregnant.

Your glycosylated haemoglobin and blood sugar should be regularly checked to find out your response to Insulin Human Inhaled. Your physician will also show you how to test your response to Insulin Human Inhaled by measuring your urine and blood sugar levels by yourself at home. Please carefully follow these instructions.

Don't let anybody else take your Insulin Human Inhaled medication. If you've got any questions about having your prescription refilled, ask your pharmacist.