Pronunciation:

IN-su-lin HUE-man in-HAYLD

Brand Names:

• Afrezza

Dosage Forms:

• Aerosol Powder

Warnings:

Acute bronchospasm has been observed in patients with asthma and COPD using insulin, human inhaled. Insulin, human inhaled, is contraindicated in patients with chronic lung disease such as asthma or COPD. Before initiating insulin, human inhaled, perform a detailed medical history, physical examination, and spirometry (FEV1) to identify potential lung disease in all patients .

Classifications:

Therapeutic—

Antidiabetic

Pharmacologic—

Insulin, Rapid Acting

Uses of This Medicine:

Insulin human inhaled is a man-made insulin that is breathed in through your lungs and is used to control high blood sugar in patients with diabetes. 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 (sugar diabetes), your body cannot make enough insulin or does not use insulin properly. So, you must take additional insulin to regulate your blood sugar and keep your body healthy. This is very important as too much sugar in the blood can be harmful to your health.

Insulin human starts to work faster than some other types of insulin, and its effects do not last as long. It should act more like the insulin your body would normally produce. Because the effects of insulin human are short-acting, your doctor may also prescribe a longer-acting insulin for you to use.

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 have not been performed on the relationship of age to the effects of insulin human inhaled in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of insulin human inhaled in the elderly.

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
• Acarbose
• Alogliptin
• Bexagliflozin
• Bromocriptine
• Canagliflozin
• Chloroquine
• Chlorothiazide
• Chlorpropamide
• Chlorthalidone
• Ciprofloxacin
• Dapagliflozin
• Delafloxacin
• Empagliflozin
• Enoxacin
• Ertugliflozin
• Furosemide
• Gatifloxacin
• Gemifloxacin
• Glimepiride
• Glipizide
• Glyburide
• Grepafloxacin
• Hydrochlorothiazide
• Hydroflumethiazide
• Hydroxychloroquine
• Indapamide
• Lanreotide Acetate
• Levofloxacin
• Linagliptin
• Liraglutide
• Lomefloxacin
• Macimorelin
• Metformin
• Metoclopramide
• Metolazone
• Metreleptin
• Miglitol
• Moxifloxacin
• Nateglinide
• Norfloxacin
• Octreotide Acetate
• Ofloxacin
• Pasireotide Diaspartate
• Pioglitazone
• Polythiazide
• Pramlintide
• Repaglinide
• Rosiglitazone
• Semaglutide
• Sitagliptin
• Somatrogon-ghla
• Sotagliflozin
• Sparfloxacin
• Testosterone
• Thioctic Acid
• Tolazamide
• Tolbutamide
• Triamterene
• Trovafloxacin
• Vildagliptin

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
• Bitter Melon
• Carteolol
• Carvedilol
• Celiprolol
• Dulaglutide
• Esmolol
• Exenatide
• Fenugreek
• Glucomannan
• Guar Gum
• Isocarboxazid
• Labetalol
• Levobunolol
• Linezolid
• Lixisenatide
• Methylene Blue
• Metipranolol
• Metoprolol
• Nadolol
• Nebivolol
• Oxprenolol
• Ozanimod
• Penbutolol
• Phenelzine
• Pibrentasvir
• Pindolol
• Practolol
• Procarbazine
• Propranolol
• Psyllium
• Rasagiline
• Safinamide
• Saxagliptin
• Selegiline
• Sotalol
• Timolol
• Tirzepatide
• 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:

• Asthma, severe or
• Chronic obstructive pulmonary disease (COPD)—Should not be used in patients with these conditions.

• Emotional disturbances or
• Fever or
• Illness or
• Infection or
• Stress—These conditions increase blood sugar and may increase the amount of insulin you need.

• 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.

• Hypokalemia (low potassium in the blood)—May make this condition worse and increase your chance of having serious side effects.

• Kidney disease or
• Liver disease—The effects of insulin human inhaled may be increased because of the slower removal of the medicine from the body.

• Lung cancer, active or history of or at risk or
• Lung disease—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

Inhaled insulin human is used with Afrezza® inhaler that comes with a Medication Guide and patient instructions. Read the directions carefully before using this medicine. If you do not understand the directions or you are not sure how to use the inhaler, ask your doctor to show you what to do. Also, ask your doctor to check regularly how you use the inhaler to make sure you are using it properly.

Use this medicine only as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. Also, do not stop using this medicine without telling your doctor. To do so may increase the chance of side effects.

This medicine is available in 3 strengths: 4 unit (blue cartridge), 8 unit (green cartridge), and 12-unit (yellow cartridge) single use cartridges.

Afrezza® is a mealtime insulin. It should be taken at the beginning of a meal.

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.

In order for this medicine to help treat diabetes, it must be used every day in regularly spaced doses and be used at the same time each day, as ordered by your doctor.

To use the inhaler:

• Use the dosage chart to determine the least number of cartridges you can use for your dose.
• Remove a blister card from the foil package. Tear along the perforation to remove one strip.
• Push the cartridge out from the strip. Remove the right number of cartridges for your dose.
• Allow the cartridge to be at room temperature for 10 minutes before use.
• Use only 1 inhaler at a time. The same inhaler should be used for the 4 unit, 8 unit, or 12 unit cartridges.
• Hold the inhaler in one hand with the white mouthpiece on the top and the purple base on the bottom.
• Open the inhaler and place the cartridge into the inhaler. Make sure that the cartridge lies flat in the inhaler.
• Keep the inhaler level and white mouthpiece on top and purple base on the bottom after a cartridge has been inserted into the inhaler. Do not turn the inhaler upside down, held with the mouthpiece pointing down, shaken or dropped after the cartridge has been inserted. If these occur, throw away the cartridge and load a new one.
• Remove the mouthpiece cover and then breathe out fully, trying to get as much air out of the lungs as possible.
• Put the mouthpiece fully into your mouth and close your lips around it. Tilt the inhaler downward while keeping your head level.
• Inhale deeply through the inhaler and hold your breath for as long as comfortable and slowly remove the inhaler from your mouth.
• Replace the mouthpiece cover and remove and throw away the used cartridge.
• If your prescribed dose is more than 8 units, you will need to use more than 1 cartridge and repeat the same steps above.
• Wipe the inhaler with a clean, dry cloth. Do not wash the inhaler and keep it dry.
• Do not put cartridges in your mouth and do not swallow cartridges.
• Throw away the inhaler after 15 days and get a new one.

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 inhalation dosage form (aerosol powder):
  • For diabetes:
    • Adults—
      • Patients who are not receiving insulin: At first, 4 units (one puff) at each meal. Your doctor may adjust your dose as needed.
      • Patients receiving mealtime (prandial) insulin injection: Your mealtime dose is determined by converting your injected dose to the number of 4, 8, or 12 unit cartridges needed. Your doctor may adjust your dose as needed.
      • Patients receiving pre-mixed insulin injection: Your mealtime dose is determined by dividing half of the total daily injected pre-mixed insulin dose equally among the 3 meals of the day. Your doctor may adjust your dose as needed.
    • Children—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.

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.

Store sealed and unopened foil package in the refrigerator. Do not freeze. If it is stored at room temperature, the cartridges must be used within 10 days.

Store sealed or unopened blister cards or strips at room temperature and must be used with 10 days. The opened strips are stored at room temperature and must be used within 3 days. Do not put a blister card or strip back into the refrigerator after being stored at room temperature.

Precautions While Using This Medicine:

Your doctor will want to check your progress at regular visits, especially during the first few weeks you take this medicine. Blood and lung function 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 (including beer and wine) may cause severe low blood sugar. Discuss this with your health care team.
• Other medicines—Do not take other medicines during the time you are taking this medicine 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 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.

Tell your doctor if you are smoking or have recently stopped smoking while using this medicine.

Too much insulin human inhaled can cause hypoglycemia (low blood sugar). Symptoms of low blood sugar include anxiety, behavior change similar to being drunk, blurred vision, cold sweats, confusion, depression, difficulty in thinking, dizziness or lightheadedness, drowsiness, excessive hunger, fast heartbeat, headache, irritability or abnormal behavior, nervousness, nightmares, restless sleep, shakiness, slurred speech, and tingling in the hands, feet, lips, or tongue.

If symptoms of low blood sugar occur, eat glucose tablets or gel to relieve the symptoms. Also, check your blood for low blood sugar. Get to a doctor or a hospital right away if the symptoms do not improve. Someone should call for emergency help immediately if severe symptoms such as convulsions (seizures) or unconsciousness occur. Have a glucagon kit available, along with a syringe and needle, and know how to use it. Members of your household also should 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, 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, ketones in the urine, loss of appetite, stomachache, nausea, or vomiting, tiredness, troubled 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 may make you dizzy or drowsy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Check with your doctor right away if you have a cough that keeps coming back or does not go away, shortness of breath, or trouble breathing.

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

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

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:

More common

Anxiety

blurred vision

chills

cold sweats

coma

confusion

cool, pale skin

cough

depression

dizziness

fast heartbeat

headache

increased hunger

nausea

nightmares

seizures

shakiness

slurred speech

unusual tiredness or weakness

Incidence not known

Difficulty breathing

difficulty swallowing

hives, itching, or skin rash

noisy breathing

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

tightness in the chest

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:

Less common

Diarrhea

sore throat

Incidence not known

Weight gain

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.