Insulin Inhaled

Insulin Inhaled is a prescription medicine used for the treatment of diabetes mellitus (types 1 and 2)

• Insulin Inhaled is available under the following different brand names: Afrezza

Common side effects of Insulin Inhaled include:

• headache,
• weight gain,
• diarrhea,
• stuffy nose,
• sinus pain,
• sneezing, and
• sore throat

Serious side effects of Insulin Inhaled include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• unusual muscle pain,
• feeling cold,
• dizziness,
• lightheadedness,
• tiredness,
• weakness,
• stomach pain,
• vomiting,
• slow or irregular heart rate,
• pink or red urine,
• painful or difficult urination,
• new or worsening urge to urinate,
• changes in the vision,
• swelling,
• rapid weight gain,
• shortness of breath,
• loss of appetite,
• nausea,
• vomiting,
• stomach pain,
• tiredness,
• dark urine,
• yellowing of the skin or eyes (jaundice),
• pale skin,
• unusual tiredness,
• shortness of breath, and
• cold hands and feet

Rare side effects of Insulin Inhaled include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out. 

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Orally inhaled powder

• Available as single-use cartridges
  • 4 units/cartridge
  • 8 units/cartridge
  • 12 units/cartridge

Diabetes Mellitus (Types 1 and 2)

Adult dosage

• Dosing must be individualized
• Starting mealtime dose
  • Insulin naïve: 4 units at each meal initially
  • Converting from SC mealtime (prandial) insulin: Determine the appropriate inhaled insulin dose for each meal by converting from the injected dose (see Mealtime dose conversion)
  • Using SC premixed insulin: Estimate the mealtime injected dose by dividing half of the total daily injected premixed insulin dose equally among the 3 meals of the day; convert each estimated injected mealtime dose to an appropriate inhaled insulin dose (see Mealtime dose conversion); administer half of the total daily injected premixed dose as an injected basal insulin dose
• Mealtime dose conversion
• Dosage adjustment may be needed when switching from insulin to inhaled insulin
  • Up to 4 units SC = 4 units inhaled
  • 5-8 units SC = 8 units inhaled
  • 9-12 units SC = 12 units inhaled
  • 13-16 units SC = 16 units inhaled
  • 17-20 units SC = 20 units inhaled
  • 21-24 units SC = 24 units inhaled

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Insulin Inhaled has severe interactions with no other drugs.
• Insulin Inhaled has serious interactions with the following drug:
  • ethanol
  • macimorelin
• Insulin Inhaled has moderate interactions with at least 175 other drugs.
• Insulin Inhaled has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• During episodes of hypoglycemia
• Chronic lung disease (eg, asthma, COPD), because of the risk of acute bronchospasm
• Hypersensitivity to regular human insulin or any inhaled insulin excipients

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Insulin Inhaled?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Insulin Inhaled?”

Cautions

• Acute bronchospasm observed in patients with asthma and COPD; before initiating, perform spirometry (FEV1) in all patients; do not use in patients with chronic lung disease
• Change insulin regimen under close medical supervision and increase the frequency of blood glucose monitoring
• Hypoglycemia reported and may be life-threatening; increased frequency of glucose monitoring with changes to insulin dosage, coadministered glucose-lowering medications, meal pattern, and physical activity; and in patients with renal or hepatic impairment and hypoglycemia unawareness
• Assess pulmonary function (eg, spirometry) before initiating, after 6 months of therapy, and annually, even in the absence of pulmonary symptoms
• Two cases (2 in 2750 patient-years exposure) of lung cancer were reported during clinical trials, both were in patients with a history of heavy smoking; 2 additional cases of lung cancer (squamous cell and lung blastoma) occurred in nonsmokers were reported by investigators after clinical trial completion; in patients with active lung cancer, a prior history of lung cancer, or those at risk for lung cancer, consider whether the benefits of use outweigh this potential risk
• More patients using inhaled insulin (0.43%) experienced diabetic ketoacidosis in clinical trials compared with comparators (0.14%); monitor and change to an alternate route of insulin delivery, if indicated
• Hypersensitivity reactions, including severe, life-threatening, generalized allergy, and anaphylaxis can occur with insulin products
• Hypokalemia may occur, including life-threatening low serum levels; monitor potassium levels in patients at risk
• Monitor for fluid retention and heart failure with concomitant use of thiazolidinediones; consider dosage reduction or discontinuation if heart failure occurs

Pregnancy and Lactation

• Limited available data on pregnant women are insufficient to determine drug-associated risks for adverse developmental outcomes; available information from published studies with human insulin use during pregnancy has not reported a clear association between human insulin and adverse developmental outcomes; there are risks to mother and fetus associated with poorly controlled diabetes in pregnancy; in animal reproduction studies, there were no adverse developmental outcomes with subcutaneous administration of carrier particles (vehicle without insulin) to pregnant rats during organogenesis at doses 14-21 times the maximum recommended daily dose
• Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, stillbirth, and delivery complications; poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia-related morbidity
• Lactation
  • There are no data on the presence in human milk, its effects on the breastfed infant, or milk production; one small published study reported that exogenous insulin was present in human milk; no adverse effects in infants were noted; carrier particles are present in rat milk; potential adverse effects that are related to inhalational administration are unlikely to be associated with potential exposure through breast milk; the developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on the breastfed infant or from an underlying maternal condition