Ensifentrine (Ohtuvayre) for COPD

In this episode, TRC Healthcare editor, Sara Klockars, PharmD, BCPS, discusses a new drug for COPD, ensifentrine (Ohtuvayre). 

This is an excerpt from our September 2024 Pharmacy Essential Updates continuing education webinar series.

The clinical resources mentioned during the podcast are part of a subscription to Pharmacist’s Letter, Pharmacy Technician’s Letter, and Prescriber Insights: 

• Article: Watch for Ensifentrine (Ohtuvayre) for COPD
• Chart: Inhaled Medications for COPD

Don’t miss out! Subscribe to Pharmacist’s Letter today to stay ahead with trusted insights and tools. 

If you're a student, good news—students can access a free version of Pharmacist’s Letter.

If you’re not yet a subscriber, find out more about our product offerings at trchealthcare.com.

Follow, rate, and review this show in your favorite podcast app. Find the show on YouTube by searching for ‘TRC Healthcare’ or clicking here.

You can also reach out to provide feedback or make suggestions by emailing us at ContactUs@trchealthcare.com.

Transcript

This transcript is automatically generated. 

00:00:05 Narrator

Welcome to Clinical Capsules, where we bring you the same evidence-based insights you trust from TRC Healthcare, now in podcast form. We’re thrilled to launch this new series as we celebrate 40 years of keeping healthcare professionals ahead of critical medication updates and guidelines.

00:00:22 Narrator

Every 2nd and 4th Tuesday, our expert editors from Pharmacist’s Letter, Prescriber Insights, and Pharmacy Technician’s Letter will break down the most impactful clinical developments - giving you clear, actionable takeaways in just minutes.

00:00:36 Narrator

Today, you’ll hear an excerpt from our September 2024 Pharmacy Essential Updates continuing education webinar series. In this segment, Associate Editor and Pharmacist Sara Klockars examines a new drug for COPD, ensifentrine. With that, Let's get started…

00:01:00 Sara Klockars

Now let's discuss a new drug for COPD Ensifentrine, or Ohtuvayre.

00:01:06 Sara Klockars

As our article states, you'll get questions about inserting a new nebulized Med for 

COPD maintenance therapy in adults.

00:01:15 Sara Klockars

So how does Ensifentrine work?

00:01:17 Sara Klockars

Ensifentrine inhibits phosphodiesterase 3 and phosphodiesterase 4.

00:01:23 Sara Klockars

So, let's talk a little bit about what that means.

00:01:27 Sara Klockars

Phosphodiesterases are enzymes found throughout the body.

00:01:31 Sara Klockars

They breakdown cyclic amp and cyclic GMP which are cell messengers that impact 

many processes in the body and help keep things in balance.

00:01:42 Sara Klockars

They work in the lungs, the liver, immune system, heart and blood vessels, to name 

a few places.

00:01:50 Sara Klockars

But sometimes the phosphodiesterases or cell messengers get out of balance and 

cause different conditions or diseases that can be treated with phosphodiesterase 

inhibitors. You're likely familiar with some meds that inhibit certain 

phosphodiesterases.

00:02:05 Sara Klockars

For example, the phosphodiesterase 5 inhibitor sildenafil can affect sneez muscle to 

treat erectile dysfunction or pulmonary arterial hypertension.

00:02:17 Sara Klockars

Roflumilast is an oral PDE 4 inhibitor for severe COPD.

00:02:23 Sara Klockars

And we may see oral aprmolast or topical roflumilast or crisabol for different 

inflammatory skin conditions.

00:02:30 Sara Klockars

We also have some PDE 3 inhibitors such as celastazole or dipiridamol.

00:02:36 Sara Klockars

And then we have enzymes as the first dual phosphodiesterase 3 and 

phosphodiesterase 4 inhibitor.

00:02:43 Sara Klockars

So Enzo Venturin inhibits the phosphodiesterase 3 and 4, which prevents the 

breakdown of the cell messenger cyclic AMP which increases the levels of those 

cyclic amps in the lungs.

00:02:58 Sara Klockars

And the thought is, is that these higher levels of cyclic amp will bronchodilate or 

open up the Airways in the smooth muscle of the lungs.

00:03:08 Sara Klockars

Reduce airway swelling and inflammation.

00:03:12 Sara Klockars

It may also help reduce mucus in the lungs.

00:03:18 Sara Klockars

So for now, Ensifentrine is approved as a maintenance medication for adults with 

COPD.

00:03:26 Sara Klockars

To use this to prevent flare ups or worsening of COPD symptoms such as coughing 

or wheezing.

00:03:32 Sara Klockars

Studies show that giving insufficient via nebulizer twice daily improves lung function 

more than placebo.

00:03:39 Sara Klockars

And justice, to reiterate Ensifentrine is not a rescue medication for acute symptoms.

00:03:45 Sara Klockars

It's for twice daily use every day.

00:03:50 Sara Klockars

I do wanna note that over half of the patients in the clinical trials for insulin were 

also taking a LABA or long acting beta agonist or a llama or a long acting muscarinic 

antagonist with or without.

00:04:06 Sara Klockars

An inhaled corticosteroid.

00:04:09 Sara Klockars

What these initial trials did not include was patients on a combo lava llama or triple 

therapy of a lava llama with an inhaled steroid.

00:04:19 Sara Klockars

Plus, we don't have any data comparing and ensifentrine these treatments or to the 

oral PDE 4 inhibitor reflux.

00:04:29 Sara Klockars

You'll also hear ensifentrine reduces exacerbations and just want to note here that 

this is based on modeling data.

00:04:37 Sara Klockars

The exacerbations aren't a primary or secondary outcome and key studies.

00:04:44 Sara Klockars

And we do have.

00:04:45 Sara Klockars

Long term safety or efficacy data, yet either we just have a smaller subset of 

patients that were treated for 48 weeks in one trial.

00:04:54 Sara Klockars

So this may help you asking yourself what's the role of ensifentrine?

00:05:00 Sara Klockars

For now, expect specialists to save ensifentrine for patients as a last resort, or if 

they can't tolerate standard meds. We don't have enough evidence yet, but it's 

good to have another option for patients.

00:05:12 Sara Klockars

We need it.

00:05:15 Sara Klockars

Expect to continue to see a llama such as teatropium or a lava such as salmeterol 

burst lying from mild symptoms, or the combination of a lava lamba for patients 

with more severe symptoms.

00:05:31 Sara Klockars

And symptomatic patients with frequent or severe exacerbations may be even on 

triple therapy.

00:05:36 Sara Klockars

With that lava lama inhaled steroid combination.

00:05:42 Sara Klockars

If you get a prescription for insulin, be ready to handle prior.

00:05:46 Sara Klockars

It's a specialty medication and costs about $2900 per month.

00:05:53 Sara Klockars

For Medicare patients, you'll need to bill ensifentrineto Medicare Part B. Like most 

other nebs.

00:06:01 Sara Klockars

Be sure to check prescriptions closely to make sure they have the proper 

documentation, including that diagnosis code and exact directions for use.

00:06:11 Sara Klockars

And if you dispense sensor and we as pharmacists and techs are in a prime position 

to help ensure they know how to use it properly, there are a few nuances.

00:06:21 Sara Klockars

How should patients use ensifentrine?

00:06:25 Sara Klockars

Comes as an inhalation suspension in unit dose ampules and it's given twice daily 

via a standard nebulizer.

00:06:34 Sara Klockars

It's important to confirm that patients have a nebulizer machine before they leave 

the pharmacy.

00:06:39 Sara Klockars

There are some cases of patients drinking inhalation solutions, so we want to make 

sure that patients know this is not for oral use.

00:06:51 Sara Klockars

And since ensifentrine is a suspension, patients will need to shake the ampule well 

immediately before using it in the nebulizer.

00:06:59 Sara Klockars

And they.

00:07:00 Sara Klockars

Also need to be aware that it's normal for the Med to appear cloudy and yellow or 

pale yellow in color after shaking it.

00:07:09 Sara Klockars

And also patients should not mix ensifentrinewith other meds in the nebulizer.

00:07:18 Sara Klockars

And in regard to side effects, ensifentrine is well tolerated.

00:07:22 Sara Klockars

There are very rare reports of suicide related events with ensifentrine use, so 

patients should report any mood changes immediately and then be aware that 

ensifentrine.

00:07:35 Sara Klockars

Is back pain. Blood pressure increases and diarrhea.

00:07:42 Sara Klockars

And now for some practice pearls.

00:07:44 Sara Klockars

Be sure to check the prescription directions closely. As we said earlier, we want to 

make sure via nebulizer is in the SIG and then clarify any ambiguous or incomplete 

information. For instance, a quantity of 60 could mean 60 vials or 60 M LS.

00:08:01 Sara Klockars

And then make sure that there's a diagnosis code in exact directions, especially if 

you're billing Medicare Part B.

00:08:08 Sara Klockars

We also want to calculate the supply carefully.

00:08:12 Sara Klockars

Be aware, most payers require inputting the total number of MLS for the quantity, 

but using the number of bials or ampoules to determine the day's supply. So for 

example.

00:08:26 Sara Klockars

You would enter a quantity of 150 for a box of 60 2.5ML and suppentrin Neb.

00:08:36 Sara Klockars

And then you would enter a 30 day supply. If the patient is to use one of those 

ampoules.

00:08:42 Sara Klockars

Twice a day.

00:08:44 Sara Klockars

And also regarding storage in the pharmacy, you'll want to be sure to store it in its 

original packaging at room temperature and then tell patients to do the same at 

home. Once that pouch is opened.

00:08:56 Sara Klockars

Should be used right away.

00:09:00 Sara Klockars 

We mostly talked about ensifentrine today, but we have a great chart online called 

inhaled medications for COPD, which gives more detail about how the different 

treatment options stack up for instance.

00:09:13 Sara Klockars

Lamas and lavas we talked about, and then all the different combos.

00:09:17

Yeah.

00:09:18 Sara Klockars

The chart includes dosing specifics, Med costs and other considerations.

00:09:20 Narrator

We hope you enjoyed and gained practical insights from listening to this presentation! 

Be sure to follow or subscribe, rate, and review this show in your favorite podcast app. Or find the show on YouTube by searching for ‘TRC Healthcare’ or clicking the link in the show notes. While you’re there, check out our other TRC podcasts like Medication Talk and Rumor vs Truth.

Also in the show notes, we’ve linked directly to a few of the excellent resources mentioned today available to subscribers of Pharmacist’s Letter, Pharmacy Technician’s Letter, or Prescriber Insights. On those websites you’ll also find a lot more evidence-based, concise, yet comprehensive resources on this and other medication therapy topics. 

If you aren’t already a subscriber… don’t miss out on these resources! Sign up today to stay ahead with trusted insights and tools. We are an industry leading, non-biased source of information and continuing education.

And if you're a student, good news—students can access a free version of Pharmacist’s Letter, we’ve linked to that directly in the show notes as well… Check it out!

Find out more about our product offerings at trchealthcare.com.

You can also reach out to provide feedback or make suggestions by emailing us at ContactUs@trchealthcare.com. 

Thanks for listening to Clinical Capsules!