Afrezza inhalation

Name: Afrezza inhalation

What is the most important information I should know about insulin inhalation?

Insulin inhalation can cause sudden or serious lung problems. You should not use this medicine if you smoke or have recently quit, or if you have chronic lung disease such as COPD or asthma.

What should I discuss with my healthcare provider before taking insulin inhalation?

You should not use this medicine if you are allergic to insulin, or if you are having an episode of hypoglycemia (low blood sugar).

Insulin inhalation can cause sudden or serious lung problems. Do not use this medicine if you have:

  • chronic lung disease, such as asthma or chronic obstructive pulmonary disease (COPD); or

  • diabetic ketoacidosis (call your doctor for treatment).

Do not use insulin inhalation if you smoke or have recently quit smoking (within the past 6 months).

In studies with insulin inhalation, lung cancer occurred in a small number of people. It is not clear whether this medicine was the actual cause of lung cancer. Your doctor will perform lung function tests before and during your treatment with insulin inhalation.

Insulin inhalation is not approved for use by anyone younger than 18 years old.

To make sure insulin inhalation is safe for you, tell your doctor if you have ever had:

  • asthma, COPD, or other breathing problems;

  • lung cancer;

  • liver or kidney disease; or

  • if you use other inhaled medicines.

Tell your doctor if you also take pioglitazone or rosiglitazone (sometimes contained in combinations with glimepiride or metformin). Taking certain oral diabetes medicines while you are using insulin may increase your risk of serious heart problems.

It is not known whether insulin inhalation will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether insulin inhalation passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

What happens if I miss a dose?

If you forget to use your dose at the beginning of a meal, use the medicine as soon as you remember. Do not use extra medicine to make up the missed dose.

Insulin inhalation, rapid acting Pregnancy Warnings

In pregnant rats receiving carrier particle (vehicle without insulin) subcutaneously at doses 14 to 21 times the expected human exposure, no major malformations were observed; however maternal adverse effects were observed. In pups received 30 mg/kg/day (6 times expected human exposure) impaired learning was observed. There are no controlled data in human pregnancy. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus. US FDA pregnancy category: C

Insulin inhalation, rapid acting Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Data not available Excreted into animal milk: Yes Inhaled insulin has not been studied in lactating women. In rats, approximately 10% of the inhaled insulin carrier is excreted in milk; therefore it is highly likely that inhaled insulin is excreted in human milk.

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