Every pharmacy student has been told during their education that this profession is a forever learning field. For example, every pharmacist must obtain continuing education hours in order to renew their license. I do not think I fully understood how often or how much the world of pharmacy changes and one important thing pharmacists must stay on top of are new drug approvals. I would hate to be working in a pharmacy and get a new prescription for a drug I have never heard of. Therefore, I sometimes browse the FDA’s website to look at newly approved drugs and last week I saw a new approval that captured my attention.
According to the American Diabetes Association, there were 29.1 million Americans (9.3% of the population) with diabetes in 2012.1 This number has risen from 2010, when there were 25.8 million Americans with diabetes.1 Although, Type 1 diabetes can only be controlled with insulin, there are many different types of medications that can be used to control Type 2 diabetes.7 Insulin and some other Type 2 approved medications require a patient to inject themselves with a needle and personally I would not want to inject myself every day. Therefore, there has always been talk about trying to deliver insulin to patients by a different route of administration. This had been done before in 2006, when Pfizer made a drug called Exubera, which was the first inhaled form of insulin.2 But then in 2007 Pfizer took Exubera off the market due to lack of sales of the product.2
The FDA’s approval of Afrezza, an inhaled form of insulin,3 on June 27, 2014, is what caught my attention. Afrezza is manufactured by MannKind Corporation and approved for adult diabetic patients.3 This inhaled form of insulin is only to be used as a short acting control of glucose levels,3 and was approved with a Risk Evaluation and Mitigation Strategy (REMS).3
Now let’s dive into more specifics about Afrezza; it is a synthetic insulin that is inhaled by the patient.4 It comes in two different strengths, four units and eight units, which are dosed at mealtimes.4 Each strength comes as a different colored cartridge, the four units are blue and the eight units are green.4 Each cartridge must always be used with the Afrezza inhaler and the inhaler should be replaced every 15 days.4 Listed below are the steps to proper usage of the Afrezza inhaler.
Steps to Using Afrezza According to the Medication Guide4:
1.) Select the correct number of cartridges needed based on your individual dose required. Some patients may need to use more than one cartridge of different or the same strengths.
- There will be a foil package that contains blister cards of the cartridges, so remove the correct number cartridges from the blister card by pressing the clear side.
- Important: Inhaler and cartridges must be at room temperature for 10 minutes before use.
2.) Load the cartridge by holding the inhaler in one hand (white mouthpiece on top and purple base on bottom) and open the inhaler by lifting the mouthpiece with the other hand.
- Place the cartridge with the cup facing down and the pointed end of the cartridge should align with the pointed end of the inhaler.
- Close the mouthpiece and a snap should be heard when the inhaler is fully closed.
- Important: Make sure the cartridge lies flat within the inhaler and once in this flat position do not turn, point, or shake the inhaler as the drug powder may be lost.
3.) Inhaling the powder requires multiple steps.
- First, remove the mouthpiece cover while still keeping the inhaler level.
- Exhale while the inhaler is away from your mouth.
- Put the mouthpiece in your mouth and tilt the inhaler down toward your chin, then close your lips to form a seal.
- Inhale deeply and hold your breath while removing the inhaler, then continue to hold your breath for as long as comfortable.
4.) Remove the used cartridge by placing the mouthpiece back on the inhaler, then open the white mouthpiece, remove the cartridge, and then throw away the cartridge in the trash.
- Important: If you need to use more than one cartridge for your dose repeat steps two through four.
- Important: You can tell the difference of a new and used cartridge by the placement of the white cup. If the white cup is in the middle it is used and if it is to one side it is new.
Afrezza should be stored based on whether it has been opened or not.4 If the sealed foil packages have not been opened they should be stored within a refrigerator and can be used up to the expiration date.4 If the sealed foil package or the clear strips from the blister card have been opened they can be stored at room temperature.4 Although, the blister cards can last for 10 days, if removed from the foil package, and the clear strips only last for three days if they have been opened.4 The inhaler can be kept in the refrigerator, but do not keep the cartridges left in the inhaler.4 The inhaler can be cleaned by wiping it with a clean, dry cloth, but do not get the inhaler wet or wash it.4
Afrezza does come with a boxed warning of acute bronchospasms in patients with COPD or asthma.3 Therefore, it should not be used in patients with chronic lung conditions, such as COPD or asthma.4 It cannot be used in children under the age of 18.4 Patients should be informed to not operate heavy machinery, drink alcohol, or smoke while using Afrezza.4 The most common side effects seen with this new medication is hypoglycemia, cough, and sore throat.4 A list of warnings and precautions include: acute bronchospasm, change in insulin regimen, hypoglycemia, decline in pulmonary function, lung cancer, diabetic ketoacidosis, hypersensitivity reactions, hypokalemia, and fluid retention and heart failure with concomitant use of thiazolidinediones .5 Finally, Afrezza is pregnancy category C and there have not been studies on whether it is safe in lactating women.6
From this information it looks like Afrezza may have complicated steps to use and difficult storage directions, but it does provide the benefit of no needle sticks. Adherence is something pharmacists should worry about in their patients and Afrezza may provide an advantage as it is considered a painless route of administration when compared to injections. The FDA is requiring post-marketing studies to research safety and efficacy in pediatrics, pulmonary malignancy risks, and pharmacokinetic and pharmacodynamic studies.3 Currently, Afrezza is not yet available in pharmacies,5 but only time will tell if patients accept Afrezza or if it has the same fate as Exubera.
But I will leave you with a quote from the CEO of MannKind Corporation, Alfred Mann, the “approval of AFREZZA is an important milestone for MannKind, as today’s FDA action validates the years of clinical research and commitment that powered the development of this unique therapy.”5
UMKC School of Pharmacy at MU
PharmD Candidate 2015
MPA Rotation Student, July 2014
1Statistics about diabetes. (2014, June 10). Retrieved from http://www.diabetes.org/diabetes-basics/statistics/
2Hitti, M. (n.d.). Sales of inhaled insulin exubera halted. Retrieved from http://www.webmd.com/diabetes/news/20071018/pfizer-quits-inhaled-insulin-exubera
3FDA approves afrezza to treat diabetes. (2014, June 30). Retrieved from http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm403122.htm
4Medication guide afrezza ® (uh-FREZZ-uh) (insulin human) inhalation powder. (2014, June). Retrieved from http://www.mannkindcorp.com/Collateral/Documents/English-US/Afrezza_MedGuide-IFU.pdf
5Mannkind corporation announces FDA approval of afrezza(R); a novel, rapid-acting inhaled insulin for the treatment of diabetes. (2014, June 27). Retrieved from http://www.news.mannkindcorp.com/phoenix.zhtml?c=147953&p=irol-newsArticle&ID=1943390&highlight=
6Label. (2014, June). Retrieved from http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022472lbl.pdf
7Medication. (n.d.). Retrieved from http://www.diabetes.org/living-with-diabetes/treatment-and-care/medication/