insulin inhaled (Rx)

Brand and Other Names:Afrezza
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

orally inhaled powder

  • Available as single-use cartridges
  • 4 units/cartridge
  • 8 units/cartridge
  • 12 units/cartridge
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Diabetes Mellitus (Types 1 and 2)

Orally inhaled rapid-acting insulin indicated to improve glycemic control in adults with diabetes mellitus

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

Dose adjustment

  • Adjust the inhaled insulin dosage based on the individual's metabolic needs, blood glucose monitoring results, and glycemic control goal
  • Dosage adjustments may be needed with changes in physical activity, changes in meal patterns (ie, macronutrient content or timing of food intake), and changes in renal or hepatic function or during acute illness
  • Carefully monitor blood glucose control in patients requiring high doses; if blood glucose control is not achieved with increased inhaled insulin doses, consider use of SC mealtime insulin

Dosing Considerations

Before initiating, perform a detailed medical history, physical examination, and spirometry (FEV1) in all patients to identify potential lung disease

Limitations of use

  • Not a substitute for long-acting insulin; must be used in combination with long-acting insulin in patients with type 1 diabetes mellitus
  • Not recommended for treatment of diabetic ketoacidosis
  • Safety and efficacy not established in patients who smoke and is not recommended in patients who smoke or who have recently stopped smoking

<18 years: Safety and efficacy not established

See adult dosing

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Interactions

Interaction Checker

and insulin inhaled

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    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Nonsevere hypoglycemia (67%)

            Cough (25.6-29.4%)

            1-10%

            Throat pain or irritation (4.4-5.5%)

            Severe hypoglycemia (5.1%)

            Headache (3.1-4.7%)

            Pulmonary function test decreased (2.8%)

            Diarrhea (2.7%)

            Bronchitis (2.5%)

            Urinary tract infection (2.3%)

            Productive cough (2.2%)

            Fatigue (2%)

            Nausea (2%)

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            Warnings

            Black Box Warnings

            Acute bronchospasm reported in patients with asthma and COPD using inhaled insulin

            Contraindicated in patients with chronic lung disease

            Before initiating, perform a detailed medical history, physical examination, and spirometry (FEV1) to identify potential lung disease in all patients

            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

            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 frequency of blood glucose monitoring

            Hypoglycemia reported and may be life-threatening; increase 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

            Do not use in patients with history of, at risk for, or active lung cancer

            More patients using inhaled insulin (0.43%) experienced diabetic ketoacidosis in clinical trials compared with comparators (0.14%); monitor and change to 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

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            Pregnancy & Lactation

            Pregnancy

            Limited available data with in 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 with 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 maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, stillbirth, and delivery complications; poorly controlled diabetes increases fetal risk for major birth defects, still birth, and macrosomia- related morbidity

            Lactation

            There are no data on the presence in human milk, effects on breastfed infant, or on 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 breastfed infant or from underlying maternal condition

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Recombinant regular human insulin administered as a powder for oral inhalation

            Lowers blood glucose levels by stimulating peripheral glucose uptake by skeletal muscle and fat and by inhibiting hepatic glucose production

            Inhibits lipolysis in adipocytes, inhibits proteolysis, and enhances protein synthesis

            Pharmacokinetics

            Peak plasma time: 12-15 minutes

            Median time to maximum effect: ~53 minutes (SD: 74 minutes)

            Return to baseline levels: 160 minutes

            39% of dose distributed to the lungs

            7% of dose swallowed

            Half-life: 28-39 minutes

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            Administration

            Administration

            Administer via oral inhalation only at the beginning of a meal

            Administer using a single inhalation per cartridge

            Keep inhaler level and white mouthpiece on top and purple base on the bottom after a cartridge has been inserted into the inhaler

            Loss of drug effect can occur if the inhaler is turned upside down, held with the mouthpiece pointing down, or shaken (or dropped) after the cartridge has been inserted but before the dose has been administered

            If any of the above occurs, the cartridge should be replaced before use

            The inhaler can be used for up to 15 days from the date of first use; after 15 days of use, the inhaler must be discarded and replaced with a new inhaler

            See complete illustrated administration instructions provided in packaging

            Inhaled insulin doses >12 units

            • Doses >12 units require inhalations from multiple cartridges
            • To achieve the required total mealtime dose, patients should use a combination of 4-unit, 8-unit, and 12-unit cartridges
            • For doses >24 units, combinations of different multiple cartridges can be used

            Storage

            Before use, cartridges and inhaler should be at room temperature for 10 minutes

            Cartridges not in use

            • Sealed [unopened] cartridges in foil package
            • Refrigerate at 2-8ºC (36-46ºF)
            • If foil package is not refrigerated, must use within 10 days

            Cartridges in use

            • Store at room temperature (25ºC [77ºF]), excursions permitted 15-30ºC (59-86ºF)
            • Sealed [unopened] blister cards and strips: Must be used within 10 days
            • Opened strips: Must be used within 3 days

            Inhaler

            • May be refrigerated, but should be at room temperature before use
            • Store between 2-25ºC (36-77ºF); excursions permitted
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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
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            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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