I first wrote about inhaled insulin in 2014. I have yet to run across a patient using it. In fact, I thought it may have been taken off the market for a while. In any case, it’s back:
“MannKind Corporation (Nasdaq:MNKD) (TASE:MNKD) announced it is now distributing MannKind-branded Afrezza® (insulin human) Inhalation Powder directly to major wholesalers and that Afrezza is available by prescription from retail pharmacies nationwide. The MannKind-branded product is associated with new National Drug Code (NDC) numbers, as noted in the table below. With distribution channels now stocked, the Company announced several key programs to promote access, adoption and adherence to Afrezza therapy.”
Source: MannKind Corporation – Mannkind Assumes Responsibility for Distribution of Afrezza® and Launches Patient Reimbursement and Adherence Support Programs
Well, it’s not really new. It’s our old friend insulin, soon to be available via inhalation with the brand name Afrezza. The U.S. Food and Drug Administration approved it in July, 2014. Click for the package insert.
Who Can Use It?
Adults with either type 1 or 2 diabetes.
Who Should Avoid It Or Not Use It?
- those with chronic lung disease such as asthma or chronic obstructive lung disease (COPD)
- pregnant or lactating women
- those in diabetic ketoacidosis (DKA)
- users who see a significant deterioration in lung function over time
Common Side Effects:
Hypoglycemia, cough, throat pain.
What’s the Dose?
It comes in 4 and 8 unit cartridges. See the package insert for dosing details. Afrezza is a rapid-acting insulin taken at the start of meals, so you’re looking at two or three doses a day. Type 1 diabetics still need to take a basal (long-acting) insulin once or twice daily. As far as I can tell, the type 2 diabetics in the pre-approval clinical studies were all taking one or more oral diabetic drugs in addition to the Afrezza; the inhaled insulin was an add-on drug. The average time to maximum effect of the drug is 50 minutes with the 8 unit dose; blood levels of insulin are back to baseline after three hours.
Anything Else Interesting About It?
The manufacturer recommends a test of lung function before starting the drug, to identify folks with lung disease who shouldn’t inhale insulin. The test is called spirometry or FEV-1 (forced expiratory volume in 1 second). Moreover, spirometry should be repeated six months after start of the drug, then yearly thereafter.
Another form of inhaled insulin—Exubera—was on the U.S. market in 2006 and discontinued by the manufacturer the next year. The problem may have been poor sales or a concern about lung cancer.
You can’t get it at your pharmacy yet. Maybe later this year or the next.
Steve Parker, M.D.