Tag: epinephrine

Options During the Epinephrine Shortage

Of the medicines that you would hope that we would never run out of, epinephrine is probably on the top of the list for many people.

Unfortunately, many parents are still stuck dealing with shortages and delays of epinephrine injectors.

Why?

“The purpose of this letter is to inform you that in a very small number of cases, some EpiPen® 0.3 mg and EpiPen Jr® 0.15 mg Auto-Injectors, and their authorized generic versions, may not easily slide out of their carrier tube, which could delay or potentially prevent use of the device during an emergency.”

Dear Healthcare Provider Letter for Potential Label Defect of EpiPen Auto-Injectors and its Authorized Generic

For EpiPens, there was a problem with the labels on the injectors so that “in a very small number of cases, labels were not fully adhered to the surface of the auto-injector such that the device label may become stuck to the inside of the carrier tube.”

And for the Adrenaclick generic injectors, “Some lots of Epinephrine Injection auto-injector have passed all levels of inspection and met product specifications at the manufacturing facility, but have been found to contain particles upon further inspection.”

So both are now suffering from manufacturing delays after fixing these issues.

Luckily, most still have options for their kids with severe allergies.

Options During the Epinephrine Shortage

Can’t get your child’s prescription for epinephrine filled?

“Currently, EpiPen, EpiPen Jr and Adrenaclick remain in either a spot shortage or constrained supply.”

Alert – Epinephrine Shortage Update September 17, 2019

One of the first things to keep in mind is that the FDA has allowed for temporary extensions of expiration dates:

So check the NDC number and the original expiration date and see if you even need a refill yet.

The FDA has allowed for temporary extensions of expiration dates for some epinephrine injectors.

Next, know that many more versions of epinephrine are available than ever before!

If you can’t refill your child’s prescription because your pharmacy doesn’t have it, you might ask them which form of epinephrine they do have in stock, and then ask your pediatrician if you can use that version.

There are now six forms of epinephrine injectors available (with three that may be hard to find), including:

  • EpiPen, EpiPen Jr coupon – the auto-injector with the notorious reputation for the $670 retail price tag
  • Epinephrine injection (EpiPen, EpiPen Jr authorized generics) – coupon
  • Epineprhine injection (EpiPen, EpiPen Jr Teva manufactured generics) – coupon
  • Adrenaclick Adult, Child authorized genericcoupon – this is the epinephrine auto-injector that is available for $109.99 at CVS
  • SYMJEPI 0.3mg, 0.15mg – coupon – a new epinephrine pre-filled, ready-to-use device – not an auto-injector!
  • Auvi-Q – financial support – the epinephrine auto-injector that talks to you and has the notorious reputation for the $5,000 retail price tag

Whichever version you get, if you have commercial insurance without a high deductible, the coupon will likely cover your copay.

There are now six versions of epinephrine injectors available for children and adults with severe allergic reactions.
Can your pharmacy get you the Teva manufactured generic EpiPen or EpiPen, Jr?

And in a worst case scenario, if necessary, use an expired epinephrine injector, even if it is out of range of an extension, and seek immediate medical attention.

“If an in-date auto-injector is not available, it is better to use an expired auto-injector than to not give epinephrine.

Expired Epinephrine Can Still Save Lives

Still confused?

Hopefully you won’t be when you need to use your child’s epinephrine injector!

One very big issue with so many different types of epinephrine injectors is that their instructions for use are a little different.

“There are several different epinephrine auto-injectors available – Mylan EpiPen and Mylan Generic, Auvi-Q, and Adrenaclick; these auto-injectors have different steps for use.”

How to Use an Epinephrine Auto-Injector

We can also hope that once the shortages are resolved, a little competition will bring down the prices of all of these drugs, as even the generic EpiPens are at least $300!

More on Options During the Epinephrine Shortage

Have Questions About the First Generic Version of EpiPen?

Have you heard the news that the FDA has approved the first generic version of the EpiPen?

“The U.S. Food and Drug Administration today approved the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector for the emergency treatment of allergic reactions, including those that are life-threatening (anaphylaxis), in adults and pediatric patients who weigh more than 33 pounds.”

FDA Press Announcement on FDA approves first generic version of EpiPen

That’s likely surprising news to all of those folks who have been prescribing and using generic epinephrine injectors this past year.

Is This Really the First Generic Version of EpiPen?

Many remember that we all talk about EpiPens so much because their cost jumped from about $100 in 2006 to over $600 in recent years.

The current generic epinephrine injectors are authorized generics, so didn't need FDA approval.
The current generic epinephrine injectors are authorized generics, so didn’t need extra FDA approval.

That prompted Mylan, the company that makes the EpiPen 2-Pak and EpiPen Jr 2-Pak, to come out with a half-price authorized generic version last year.

“An authorized generic is made under the brand name’s existing new drug application using the same formulation, process and manufacturing facilities that are used by the brand name manufacturer.”

An authorized generic Adrenaclick injector also became available for a cash price of $109.99 CVS pharmacies. Combined with a $50 coupon, that’s often your best deal on an epinephrine injector if you don’t have insurance.

How Much Will the First Generic Version of EpiPen Cost?

And now we have a true generic version of the EpiPen 2-Pak and EpiPen Jr 2-Pak, from Teva Pharmaceuticals USA.

“The reduction in upfront research costs means that, although generic medicines have the same therapeutic effect as their branded counterparts, they are typically sold at substantially lower costs.”

FDA on Generic Drug Facts

Will it be cheaper than current EpiPens?

“When multiple generic companies market a single approved product, market competition typically results in prices about 85% less than the brand-name.”

FDA on Generic Drug Facts

It should be, but how much cheaper will it be?

“A company spokeswoman declined to say when it would be available, or how much it would cost.”

F.D.A. Approves Generic EpiPen That May Be Cheaper

While most folks would be happy with a $90 EpiPen and a tier 1 generic copay, I wouldn’t count on it. For one thing, we technically don’t have multiple generic EpiPens competing against the TEVA EpiPen yet.

And looking at drug prices of some of TEVA’s other medications, you can get a clue about their pricing plan:

  • Airduo generic (similar to Advair, but about 1/4 the price) – $98
  • Qvar (similar to Flovent) – $200
  • ProAir (albuterol inhaler) – $71
  • Budesonide Inhalation Suspension (generic Pulmicort Respules) – $176
  • Levalbuterol Inhalation Solution, USP (generic Xopenex) – $121
  • Clindamycin Phosphate and Tretinoin Gel (generic Ziana) – $600
  • Cefdinir oral suspension (generic Omnicef) – $45
  • Syprine (generic trientine hydrochloride) – $18,375

Their drugs typically ain’t cheap…

Will the first generic version of the EpiPen simply be a little cheaper than the authorized generic or can we expect TEVA to offer it at substantially lower cost?

What’s your guess?

More on the First Generic Version of EpiPen