Afrezza

1 What is Afrezza?

Brand: Afrezza

Generic: Insulin human

Afrezza is a man-made insulin that is inhaled through the lungs and used to control high blood sugar in patients with Diabetes.

Insulin is a type of hormone that helps the body turn food into energy. This is done by using the glucose in the blood as quick energy. Insulin also helps us store energy so that we can use it later.

When you have Diabetes Mellitus (sugar diabetes), your body cannot make enough insulin or use the insulin properly. Because of this, you must take additional insulin to regulate your blood sugar and keep your body healthy. This is important, as too much sugar in the blood can be harmful.

Insulin human works faster than other types of insulin and its effects do not last very long. It acts more like the insulin your body normally produces. Because the effects of insulin human are short-acting, your doctor may also prescribe a longer-acting insulin for you to use.

This medication is available only through your doctor’s prescription.

This medication is available in the following forms:

  • Aerosol powder

2 What To Know Before Using

As with all medicines, the risks of using Afrezza must be compared to how much it will help you. This is a decision that you and your doctor will make together.

For this medication, there are many things that need to be considered:

  • Allergies: Inform your doctor if you have ever had an allergic reaction to Doxorubicin or to any other medications. It is also important to inform your doctor of any non-medicine allergies such as foods, dyes, preservatives or animals.
  • Pediatric: No appropriate studies have been performed on the relationship of age to the effects of this medication in children. Safety and efficacy have not been established.
  • Geriatric Usage: Up-to-date studies have not shown any problems specific to the elderly that would limit the use of this medication in the elderly population.
  • Pregnancy: This medication is listed as Pregnancy Category C. This means that animal studies have shown an adverse effect and no studies have been performed on pregnant women OR there are no adequate studies on pregnant animals and pregnant women.There are no up-to-date studies in women for determining infant risk when using this medication while breastfeeding. Weigh the potential risks with the benefits before taking this medication while breastfeeding.
  • Drug Interactions: Certain medications should not be used together. However, in certain cases, two medications may be used together, even if an interaction might occur. In these cases, your doctor may want to change your dose or take other precautions. When taking this medication, it is important that you inform your doctor if you are taking any of the medications listed below. The following interactions were selected on the basis of potential significance and are not all-inclusive.
    • Balofloxacin
    • Besifloxacin
    • Ciprofloxacin
    • Enoxacin
    • Fleroxacin
    • Flumequine
    • Gatifloxacin
    • Gemifloxacin
    • Lanreotide
    • Levofloxacin
    • Liraglutide
    • Lomefloxacin
    • Metreleptin
    • Moxifloxacin
    • Nadifloxacin
    • Norfloxacin
    • Octreotide
    • Ofloxacin
    • Pasireotide
    • Pazufloxacin
    • Pefloxacin
    • Pioglitazone
    • Pramlintide
    • Prulifloxacin
    • Rosiglitazone
    • Rufloxacin
    • Sparfloxacin
    • TosufloxacinUsing this medication with any of the following medications may increase your risk of side effects. However, using both medications may be the best treatment for you. If both medications are prescribed together, your doctor may change the dose or how often you take one or both medications:
    • Acebutolol
    • Albiglutide
    • Atenolol
    • Betaxolol
    • Bisoprolol
    • Bitter Melon
    • Carteolol
    • Carvedilol
    • Celiprolol
    • Dulaglutide
    • Esmolol
    • Exenatide
    • Fenugreek
    • Furazolidone
    • Glucomannan
    • Guar Gum
    • Iproniazid
    • Isocarboxazid
    • Labetalol
    • Levobunolol
    • Linezolid
    • Lixisenatide
    • Methylene Blue
    • Metipranolol
    • Metoprolol
    • Moclobemide
    • Nadolol
    • Nebivolol
    • Nialamide
    • Oxprenolol
    • Penbutolol
    • Phenelzine
    • Pindolol
    • Practolol
    • Procarbazine
    • Propranolol
    • Psyllium
    • Rasagiline
    • Safinamide
    • Selegiline
    • Sotalol
    • Timolol
    • TranylcypromineCertain medications should not be used while eating, or while eating certain foods in case of negative interactions. Using alcohol or tobacco with certain medications may also cause negative interactions. Talk with your doctor about the use of your medication with food, alcohol or tobacco.Using this medication with any of the following is not normally recommended, but may be unavoidable. If used together, your doctor may change the dose or how often you take your medication, or give you special instructions about the use of food, alcohol or tobacco:
    • Ethanol
  • Other Medical Problems: Pre-existing medical problems may affect the use of this medication. Be sure to tell your doctor if you have any other medical problems, especially:
    • Chronic obstructive pulmonary disorder (COPD)
    • Severe asthma - Should not be used in patients with these conditions.
    • Emotion disturbances
    • Fever
    • Illness
    • Infection
    • 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) - May make this condition worse and increase your chances of serious side effects.
    • Kidney disease
    • Liver disease - The effects of insulin human inhaled may be increased because of the slower removal of the medication from the body.
    • Lung cancer (active, history of, or at risk)
    • Lung disease - Use with caution. May make these conditions worse.

3 Proper Usage

Only take Afrezza as directed by your doctor. Do not take more, less or for a longer or shorter period of time than your doctor tells you.

This medication comes with a patient information brochure. It is very important that your read this information. Ask your doctor if you have any questions.

This medication is available in 3 different 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.

Carefully follow the special meal plan your doctor gives you. This is the most important part of controlling your Diabetes and is necessary for the medication to work properly. Exercise regularly and test for sugar in your blood or urine as directed.

In order for this medication to help treat diabetes, it needs to be used every day at regularly spaced intervals and used at the same time each day, as specified 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 card from the foil package. Tear along the perforation to remove one strip.
  • Push the cartridge out of the strip. Remove the right number of cartridges for your dose.
  • Make sure the cartridge has been at room temperature for 10 minutes before using.
  • Use only 1 inhaler at a time. The same inhaler should be used for the 4, 8 or 12 unit cartridges.
  • Hold the inhaler in one hand with the white mouthpiece on the top and purple base at the bottom.
  • Open the inhaler and place the cartridge into the inhaler. Make sure the cartridge lies flat in the inhaler.
  • Keep the inhaler level and the white mouthpiece on top and purple base on the bottom after the cartridge has been placed into the inhaler. Do not turn the inhaler upside-down, held with the mouthpiece pointing down, shaken or dropped after the cartridge has been placed inside. If these circumstances occur, throw away the cartridge and load a new one.
  • Remove the mouthpiece cover and breathe out fully, getting as much air out of the lungs as possible.
  • Put the mouthpiece fully in your mouth. Tilt the inhaler down while keeping your head level.
  • Inhale deeply through the inhaler and hold your breath for as long as is comfortable, then remove the inhaler from your mouth.
  • Replace the mouthpiece cover and throw away the used cartridge.
  • If your dose is more than 8 units, you will need more than one cartridge. Repeat the steps above.
  • Wipe the inhaler with a clean, dry cloth. Do not wash the inhaler. Keep it dry.
  • Do not put cartridges in your mouth. Do not swallow the cartridges.
  • Throw the inhaler away after 15 days and get a new one.

Dosing

Different patients will be given a different dose of this medication based on the strength of the medication. The number of doses you take each day, the time between doses and the length of time you take this medication depends on the reason you are taking this medication.

The following information only includes the average dose of this medication. If your dose is different, do not change it without first speaking to your doctor.

  • Adults
    • Patients who are not receiving insulin: Start with 4 units at each meal. Your doctor may adjust the dose as needed.
    • Patients receiving mealtime 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 the 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 the dose as needed.
  • Children - Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medication, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and resume your normal dosing schedule. Do not double dose.

Storage

Keep this medication away form heat, moisture and direct light. Do not freeze.

Keep out of the reach of children.

Do not keep expired medication or medication you no longer need. Ask your doctor how to dispose of any medication you do not use.

Store sealed and unopened foil packages in the refrigerator. If it is stored at room temperature, the cartridges must be used within 10 days.

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

4 Precautions To Take

It is very important that your doctor checks in with you often while you are receiving Afrezza to make sure that it is working properly. Blood and lung function tests may be needed to check for unwanted side effects.

It is very important to follow any instructions from your doctor carefully:

  • Alcohol - May cause severe low blood sugar.
  • Other medications - Do not take other medications while taking insulin human inhaled unless you have talked with your doctor about it first.
  • Counseling - It is important for other family members to learn how to prevent or help with side effects if they occur. Patients with diabetes may need special counselling about diabetes medications and dosing changes that may occur because of lifestyle changes, such as diet and exercise. Counselling on contraception and pregnancy may be needed because of problems that may occur during pregnancy in patients with diabetes.
  • Travel - Keep a recent prescription and your medical history with you. Be prepared for any emergency that may arise. Make allowances for changing time zones and keep your meal times as close as possible to your normal meal times.

In case of emergency - There may be a time when you need emergency medical help. In these cases, it is a good idea to:

  • Wear a medical identification (ID) bracelet or neck chain at all times. Carry an ID card in your wallet or purse that includes extra information such as your diagnoses and a list of your medications.
  • Keep an extra supply of insulin on your person in case of an instance of high blood sugar.
  • Keep a type of quick-acting sugar on your person in case of low blood sugar.
  • Have a glucagon kit and a syringe and needle on your person in case of severe low blood sugar.

Inform your doctor if you are smoking or have recently stopped smoking while using this medication.

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

If symptoms of hypoglycemia occur, eat glucose tablets or gel to relieve the symptoms. Check your blood for hypoglycemia. Go to your doctor or hospital immediately if symptoms do not approve.

Someone should call for emergency medical help immediately if severe symptoms such as convulsions or unconsciousness occur. Have a glucagon kit available, along with a syringe and needle, and know how to use it. Members of your household should also know how to use it.

Hyperglycemia (high blood sugar) may occur if you do not take enough or you skip a dose of your antidiabetic medication, overeat or do not follow your meal plan, have a fever or infection or do not exercise as much as usual.

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

If symptoms of hyperglycemia occur, check your blood sugar levels and call your doctor for instructions.

This medication may make you dizzy or drowsy. Do not drive or do anything else that may be dangerous until you know how this medication affects you.

Inform your doctor immediately if you have a recurring cough, shortness of breath or difficulty breathing.

This medication may cause a serious allergic reaction called anaphylaxis. This is a life-threatening condition and requires immediate medical attention. Inform your doctor immediately if you have a rash, itching, swelling of the face, tongue and throat, difficulty breathing or chest pain after you receive this medication.

Using this medication together with other diabetes medications (i.e. pioglitazone, rosiglitazone, Actos, Actoplus Met, Avandia) may cause serious heart problems or edema (fluid retention). Inform your doctor immediately if you are rapidly and unintentionally gaining weight, experience shortness of breath, chest pain, extreme fatigue or weakness, difficulty breathing, uneven heartbeat or excessive swelling of the hands, wrists, ankles or feet.

5 Potential Side Effects

Afrezza may produce unwanted affects along with the intended 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 you experience any of the following side-effects:

More Common

Some side effects that may occur do not normally need medical attention. These may leave as your body becomes accustomed to treatment. Ask your doctor about ways to prevent or reduce some of these side effects.

Talk to your doctor if any of the following side effects continue or are bothersome, or if you have questions:

Less Common

Some patients may experience other side effects that are not listed. Check with your doctor if you notice any other side effects.

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

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