Mannkind Corporation

Mannkind Corporation Drugs

• Afrezza
  

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  Afrezza

  

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  2.1 Route of Administration

  AFREZZA should only be administered via oral inhalation using the AFREZZA Inhaler. AFREZZA is administered using a single inhalation per cartridge.

  2.2 Dosage Information

  Administer AFREZZA at the beginning of the meal.

  Dosage adjustment may be needed when switching from another insulin to AFREZZA [see Warnings and Precautions (5.2)].

  Starting Mealtime Dose:

  Insulin Naïve Individuals: Start on 4 units of AFREZZA at each meal. Individuals Using Subcutaneous Mealtime (Prandial) Insulin: Determine the appropriate AFREZZA dose for each meal by converting from the injected dose using Figure 1. Individuals Using Subcutaneous Pre-mixed Insulin: Estimate the mealtime injected dose by dividing half of the total daily injected pre-mixed insulin dose equally among the three meals of the day. Convert each estimated injected mealtime dose to an appropriate AFREZZA dose using Figure 1. Administer half of the total daily injected pre-mixed dose as an injected basal insulin dose.

  Figure 1. Mealtime AFREZZA Dose Conversion Table

  Mealtime Dose Adjustment

  Adjust the dosage of AFREZZA 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 (i.e., macronutrient content or timing of food intake), changes in renal or hepatic function or during acute illness [see Warnings and Precautions (5.3), and Use in Specific Populations (8.5, 8.6)] .

  Carefully monitor blood glucose control in patients requiring high doses of AFREZZA. If, in these patients, blood glucose control is not achieved with increased AFREZZA doses, consider use of subcutaneous mealtime insulin.

  2.3 AFREZZA Administration for Doses Exceeding 8 units

  For AFREZZA doses exceeding 8 units, inhalations from multiple cartridges are necessary. To achieve the required total mealtime dose, patients should use a combination of 4 unit and 8 unit cartridges. Examples of cartridge combinations for doses of up to 24 units are shown in Figure 1. For doses above 24 units, combinations of different multiple cartridges can be used.

  2.4 Dosage Adjustment due to Drug Interactions

  Dosage adjustment may be needed when AFREZZA is coadministered with certain drugs [see Drug Interactions (7)].

  2.5 Lung Function Assessment Prior to Administration

  AFREZZA is contraindicated in patients with chronic lung disease because of the risk of acute bronchospasm in these patients. Before initiating AFREZZA, perform a medical history, physical examination and spirometry (FEV1) in all patients to identify potential lung disease [see Contraindications (4) and Warnings and Precautions (5.1)].

  2.6 Important Administration Instructions

  See Patient Instructions for Use for complete administration instructions with illustrations.

  Keep the 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, shaken (or dropped) after the cartridge has been inserted but before the dose has been administered. If any of the above occur, the cartridge should be replaced before use.

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