AFREZZA Inhalation Powder Ref.[49684] Active ingredients: Insulin (human)

Source: FDA, National Drug Code (US)  Revision Year: 2021 

Product description

11.1 AFREZZA Cartridges

AFREZZA consists of single-use plastic cartridges filled with a white powder containing insulin (human), which is administered via oral inhalation using the AFREZZA Inhaler only.

AFREZZA cartridges contain human insulin produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli (K12). Chemically, human insulin has the empirical formula C257H383N65O77S6 and a molecular weight of 5808. Human insulin has the following primary amino acid sequence:

Insulin is adsorbed onto carrier particles consisting of fumaryl diketopiperazine (FDKP) and polysorbate 80.

AFREZZA Inhalation Powder is a dry powder supplied as 4 unit, 8 unit or 12 unit cartridges. The 4 unit cartridge contains 0.35 mg of insulin. The 8 unit cartridge contains 0.7 mg of insulin. The 12 unit cartridge contains 1 mg of insulin.

11.2 AFREZZA Inhaler

The AFREZZA Inhaler is breath-powered by the patient. When the patient inhales through the device, the powder is aerosolized and delivered to the lung. The amount of AFREZZA delivered to the lung will depend on individual patient factors.

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 How Supplied/Storage and Handling (16)].
How Supplied

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 clear 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 47918-874-90, AFREZZA (insulin human) Inhalation Powder: 90-4 unit cartridges and 2 inhalers
  • NDC 47918-878-90, AFREZZA (insulin human) Inhalation Powder: 90-8 unit cartridges and 2 inhalers
  • NDC 47918-891-90, AFREZZA (insulin human) Inhalation Powder: 90-12 unit cartridges and 2 inhalers
  • NDC 47918-898-18, AFREZZA (insulin human) Inhalation Powder: 180 cartridges; 90-8 unit cartridges and 90-12 unit cartridges and 2 inhalers
  • NDC 47918-880-18, AFREZZA (insulin human) Inhalation Powder: 180 cartridges; 90-4 unit cartridges and 90-8 unit cartridges and 2 inhalers (Titration Pack)
  • NDC 47918-902-18, AFREZZA (insulin human) Inhalation Powder; 180 cartridges; 60-4 unit cartridges, 60-8 unit cartridges and 60-12 unit cartridges and 2 inhalers (Titration Pack)

Drugs

Drug Countries
AFREZZA Brazil, United States
 
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