"Miriam E. Tucker
Medscape Medical News
The U.S. Food and Drug Administration (FDA) will now require a "for single patient use only" warning on all multidose pen devices used for injectable diabetes medications.
Limitations of Use
- AFREZZA is not a substitute for long-acting insulin. AFREZZA must be used in combination with long-acting insulin in patients with type 1 diabetes mellitus.
- AFREZZA is not recommended for the treatment of diabetic ketoacidosis [see WARNING AND PRECAUTIONS].
- The safety and efficacy of AFREZZA in patients who smoke has not been established. The use of AFREZZA is not recommended in patients who smoke or who have recently stopped smoking.
DOSAGE AND ADMINISTRATION
Route Of Administration
AFREZZA should only be administered via oral inhalation using the AFREZZA Inhaler. AFREZZA is administered using a single inhalation per cartridge.
Administer AFREZZA at the beginning of the meal.
Dosage adjustment may be needed when switching from another insulin to AFREZZA [see WARNINGS AND PRECAUTIONS].
Starting Mealtime Dose
- Insulin Na´ve 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, and Use In Specific Populations].
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.
AFREZZA Administration For Doses Exceeding 12 Units
For AFREZZA doses exceeding 12 units, inhalations from multiple cartridges are necessary. To achieve the required total mealtime dose, patients should use a combination of 4 unit, 8 unit and 12 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.
Dosage Adjustment Due To Drug Interactions
Dosage adjustment may be needed when AFREZZA is coadministered with certain drugs [see DRUG INTERACTIONS].
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 and WARNINGS AND PRECAUTIONS].
Important Administration Instructions
See Patient Instructions for Use for complete administration instructions with illustrations.
Keep the inhaler level with the 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.
Dosage Forms And Strengths
AFREZZA (insulin human) Inhalation Powder is available as 4 unit, 8 unit and 12 unit single use cartridges to be administered via oral inhalation with the AFREZZA Inhaler only. [see Storage and Handling].
Storage And Handling
AFREZZA (insulin human) Inhalation Powder is available as 4 unit, 8 unit and 12 unit single-use cartridges. Three cartridges are contained in a single cavity of a blister strip. Each card contains 5 blister strips separated by perforations for a total of 15 cartridges. For convenience, the perforation allows users to remove a single strip containing 3 cartridges. Two cards of the same cartridge strength are packaged in a foil laminate overwrap (30 cartridges per foil package).
The cartridges are color-coded, blue for 4 units, green for 8 units and yellow for 12 units. Each cartridge is marked with “afrezza” and “4 units”, “8 units” or “12 units”.
The AFREZZA Inhaler is individually packaged in a translucent overwrap. The inhaler is fully assembled with a removable mouthpiece cover. The AFREZZA 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.
AFREZZA is available in the following configurations:
NDC 0024-5874-90, AFREZZA (insulin human [rDNA origin])
Inhalation Powder: 90 - 4 unit cartridges and 2 inhalers
NDC 0024-5878-90, AFREZZA (insulin human [rDNA origin]) Inhalation Powder: 90 - 8 unit cartridges and 2 inhalers
NDC 0024-5884-63, AFREZZA (insulin human [rDNA origin]) Inhalation Powder: 90 cartridges; 60 – 4 unit cartridges and 30 - 8 unit cartridges and 2 inhalers
NDC 0024-5882-36, AFREZZA (insulin human [rDNA origin]) Inhalation Powder: 90 cartridges; 30 – 4 unit cartridges and 60 - 8 unit cartridges and 2 inhalers
NDC 0024-5880-18, AFREZZA (insulin human [rDNA origin]) Inhalation Powder: 180 cartridges; 90 -4 unit cartridges and 90 – 8 unit cartridges and 2 inhalers
NDC 0024-5890-90, AFREZZA (insulin human [rDNA origin]) Inhalation Powder: 90 12 unit and 2 Inhalers
NDC 0024-5893-36, AFREZZA (insulin human [rDNA origin]) Inhalation Powder: 90 cartridges; 30 – 8 unit cartridges and 60 -12 unit cartridges and 2 inhalers
NDC 0024-5894-63, AFREZZA (insulin human [rDNA origin]) Inhalation Powder: 90 cartridges; 60 – 8 unit cartridges and 30 -12 unit cartridges and 2 inhalers
NDC 0024-5895-33, AFREZZA (insulin human [rDNA origin]) Inhalation Powder: 90 cartridges; 30 – 4 unit cartridges, 30 – 8 unit cartridges and 30 -12 unit cartridges and 2 inhalers
Not in Use: Refrigerated Storage 2-8°C (36-46°F)
|Sealed (Unopened) Foil Package||May be stored until the Expiration Date*|
* If a foil package is not refrigerated, the contents must be used within 10 days.
In Use: Room Temperature Storage 25°C (77°F), excursions permitted 15-30°C (59-86°F)
|Sealed (Unopened) Blister Cards + Strips||Must be used within 10 days|
|Opened Strips||Must be used within 3 days|
Store at 2-25°C (36-77°F); excursions permitted. Inhaler may be stored refrigerated, but should be at room temperature before use.
Before use, cartridges should be at room temperature for 10 minutes.
Manufactured by: MannKind Corporation Danbury, CT 06810 Distributed by: sanofi-aventis U.S. LLC Bridgewater, NJ 08807 A SANOFI COMPANY. Approved: 4/2015This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 5/5/2015
Additional Afrezza Information
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