Notable New Meds of 2025

Listen in as our editors discuss several novel drugs approved in 2025, including two new eye drops, a new topical for chronic hand eczema, and an oral nonhormonal option for patients with menopausal hot flashes. They’ll review efficacy, safety, and considerations for use with these new treatment options.

• Aceclidine 1.44% Drops (Vizz) for Presbyopia
• Acoltremon 0.003% Drops (Tryptyr) for Dry Eye
• Delgocitinib (Anzupgo) 2% Cream for Chronic Hand Eczema
• Elinzanetant (Lynkuet) for Hot Flashes

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TRC Healthcare Editors: 

• Sara Klockars, PharmD, BCPS
• Stephen Small, PharmD, BCPS, BCPPS, BCCCP, CNSC 

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This podcast is an excerpt from one of TRC’s monthly live CE webinars, the full webinar originally aired in December 2025.

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CE Information:

None of the speakers have anything to disclose. 

TRC Healthcare offers CE credit for this podcast. Log in to your Pharmacist’s Letter, Pharmacy Technician’s Letter,or Prescriber Insights account and look for the title of this podcast in the list of available CE courses.

Claim Credit

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

• Article: Have Treatment Options in Sight for Dry Eye Disease
• Chart: Treatments for Dry Eyes
• Chart: Managing Eczema
• Article: Elinzanetant: Emerging Therapy for Menopausal Hot Flashes
• Chart: Managing Vasomotor Menopause Symptoms
• FAQ: Managing Genitourinary Menopausal Symptoms
• Chart: Menopausal Hormone Therapies

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The content of this podcast is not intended to be a substitute for professional medical advice, diagnosis, or treatment.

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Chapters

• 0:06 Introduction
• 1:00 CE Information
• 1:34 Aceclidine 1.44% Drops (Vizz) for Presbyopia
• 9:31 Acoltremon 0.003% Drops (Tryptyr) for Dry Eye
• 16:30 Audience Questions
• 17:50 Delgocitinib (Anzupgo) 2% Cream for Chronic Hand Eczema
• 24:22 Elinzanetant (Lynkuet) for Hot Flashes
• 33:30 Conclusion

Transcript

This transcript is automatically generated. 

00:00:07 Narrator

Welcome to Medication Talk, an official podcast of TRC Healthcare — home of Pharmacist’s Letter, Prescriber Insights, and our trusted clinical resources.

On this episode, listen in as our editors discuss several novel drugs approved in 2025.

00:00:21 Narrator

These include two new eye drops, a new topical for chronic hand eczema, and an oral nonhormonal option for patients experiencing menopausal hot flashes.

00:00:31 Narrator

They’ll review efficacy, safety, and key considerations for using these new treatment options.

00:00:37 Narrator

You’ll hear from two of our pharmacist editors at TRC Healthcare: Associate Editor Sara Klockars and Assistant Editor Steve Small.

00:00:47 Narrator

This podcast is an excerpt from one of TRC’s monthly live CE webinars.

Each month, experts discuss challenges in practice, evidence‑based recommendations, and topics relevant to our subscribers.

00:01:00 CE Narrator

And now, the CE information.

00:01:04 Narrator

This podcast offers continuing education credit for pharmacists, pharmacy technicians, physicians, and nurses.

Please log in to your Pharmacist’s Letter, Pharmacy Technician’s Letter, or Prescriber Insights account and look for the title of this podcast in the list of available CE courses.

00:01:20 Narrator

None of the speakers have anything to disclose.

00:01:26 Narrator

Now let’s join TRC editors Dr. Steve Small and Sara Klockars and start our discussion.

Aceclidine 1.44% Drops (Vizz) for Presbyopia

00:01:35 Steve Small

Let's start off by looking at several new eye drops.

00:01:39 Steve Small

First up is aceclidine eye drops or Vizz for presbyopia.

00:01:44 Steve Small

Before we dive into this med, it's worth talking about anatomy first, since we will be referencing several parts of the eye. Remember that the pupil at the front of the eye is the opening that allows light to come in and shine on the retina, which captures the image before sending it to our brain.

00:02:00 Steve Small

And the amount of light is adjusted by opening and closing the iris. The lens, on the other hand, sits behind the pupil. Muscles around the lens can help it change shape and help it focus the image onto the retina so we can interpret it.

00:02:17 Steve Small

With that in mind, what is presbyopia? It's what we call a refractive error, where patients have difficulty seeing closer objects.

00:02:26 Steve Small

It typically starts occurring after our 40s as our lenses become stiff and less flexible over time, and it starts having trouble changing shape to help us focus on those close objects. So those close objects become blurry.

00:02:40 Steve Small

And presbyopia is considered a typical part of normal aging, and there's no way to stop or reverse it.

00:02:48 Steve Small

And it is common. About one in eight adults in the US who are 50 years or older have near‑vision impairment because of presbyopia that is not corrected.

00:02:59 Steve Small

Although we don't have a cure per se for presbyopia, we do have treatment options. A common one for most people is to use reading glasses, including those that are available over the counter, and some patients may need bifocals if they already use glasses to see distant objects. Plus, contact lenses are alternative options.

00:03:16 Steve Small

And keep in mind that surgery is another option, but as you can guess, it's more invasive. We also have pilocarpine 0.4% and 1.25% eye drops as an FDA‑approved pharmacologic treatment option.

00:03:30 Steve Small

These address presbyopia by constricting the pupil to better focus the image, also known as the pinhole effect, and can be used daily for mild cases.

00:03:40 Steve Small

But pilocarpine has side effects such as headaches, eye redness, things like that, and the lower 0.4% concentration was developed in order to decrease some of these effects.

00:03:53 Steve Small

Now we have aceclidine as another pharmacologic option, and it works similarly to pilocarpine as a muscarinic agonist, but it has a longer duration of action, which allows for less frequent dosing. And like pilocarpine, it constricts the pupil to better focus images on the retina. However, aceclidine is considered more pupil‑selective than pilocarpine.

00:04:13 Steve Small

Let's talk about why that's important in terms of possible adverse effects.

00:04:21 Steve Small

We talked about how images in presbyopia are focused behind the eye because of lens rigidity, making close objects blurry. Pilocarpine constricts the pupil to adjust for this, but pilocarpine also causes lens muscles to constrict, changing the lens shape and image focus, and as a result, you may have fixed the problem — blurry close objects.

00:04:41 Steve Small

But now you have issues with seeing distant objects, known as myopic shift. Quite the trade‑off there.

00:04:48 Steve Small

Aceclidine's pupil selectivity is intended to fix this issue by not affecting the lens muscles. It's thought that the selectivity helps patients maintain vision of those distant objects. But keep in mind this benefit over pilocarpine hasn't been proven in head‑to‑head trials.

00:05:06 Steve Small

If patients are prescribed aceclidine, there are some important administration points for prescribers and pharmacists to share. Patients should remove their contact lenses before administration and should wait at least 10 minutes after administration before putting them back in.

00:05:21 Steve Small

Now the dose for aceclidine is two drops in each eye one time daily. Now patients may want to rush through to get these drops in, but clarify that they need to be patient to get the best effect. Explain that patients should give one drop in each eye first, then wait two minutes, and then they can instill another drop in each eye again.

00:05:42 Steve Small

And also, patients may be taking other eye drops. They'll need to space these at least five minutes after using aceclidine.

00:05:50 Steve Small

And as we know, it's important to think about possible side effects here. Although rare, medications in this class can rarely cause retinal detachment, where the retina actually separates from the back of the eye. And this is an emergency and requires immediate medical help, since it can lead to permanent blindness. But again, this is rare.

00:06:10 Steve Small

Similarly, this class can also cause iris inflammation, or iritis, especially in patients who've had this issue before.

00:06:17 Steve Small

But there are also some minor side effects that are more common, but are temporary and thankfully usually go away on their own.

00:06:24 Steve Small

For example, despite aceclidine’s theoretical advantages, blurry vision is still possible, so it's best to advise patients to see how aceclidine affects their vision first, especially at night, before they try to drive while on this medication.

00:06:39 Steve Small

It's also expected that patients may have dimmer vision, since after all, we are constricting the pupil, so it's going to let less light into the eye. And similar to pilocarpine, patients can have headaches, likely due to patients’ eyes needing to adapt to focusing, which can be exhausting.

00:06:56 Steve Small

In terms of role of therapy, expect aceclidine to be used for patients where non‑drug interventions such as glasses or contact lenses aren't enough to improve their presbyopia, or perhaps when these options are inconvenient.

00:07:09 Steve Small

It can also be an option if patients have tried pilocarpine but had trouble tolerating or adhering to the regimen. Plus, the Vuity version contains benzalkonium chloride as a preservative, which might increase irritation for some patients taking pilocarpine. Aceclidine may decrease this risk since it's actually preservative‑free.

00:07:29 Steve Small

But don't always expect significant financial benefits to using aceclidine. A monthly supply costs about the same as pilocarpine options depending on whether pilocarpine is used once or twice daily.

00:07:43 Steve Small

There are some other unique pearls about this med to think about. For example, each aceclidine plastic vial is intended for single use because it doesn't have preservatives. Open vials shouldn't touch other surfaces or the eye, since that could cause contamination and potentially infections.

00:07:59 Steve Small

But clarify that one vial should be used to administer doses in both eyes. Patients don't need to use one vial for each eye — otherwise that will increase cost and waste.

00:08:11 Steve Small

And the dispense quantity is also interesting here. Aceclidine comes in cartons of 25 vials, which is five foil pouches, each containing five vials. So essentially a 25‑day supply and not exactly a month.

00:08:26 Steve Small

So technicians should check with their pharmacy before opening up another carton to get patients to a full 30 days.

00:08:34 Steve Small

Thankfully, if you do open a carton, each unopened foil pack can be stored until its expiration date on the packaging. But keep in mind unopened aceclidine foil pouches should be refrigerated. Use auxiliary stickers as a helpful reminder to staff and patients to ensure the med is stored properly.

00:08:51 Steve Small

And once the foil pouches are open, they can be stored at room temp and used within 30 days. Ideally advise patients to write the opening date on the foil packs to help them keep track.

00:09:02 Steve Small

Now let's say that an aceclidine shipment was left out in your pharmacy at room temp for a day after delivery. 

00:09:10 Steve Small

Now you might first think to just throw that supply away, but that's not always the case with this med. The manufacturer notes that the med can actually tolerate temps up to 104°F for up to eight days, so that might help you save supply and money. And we know it's always good to keep an eye out for cost savings.

00:09:28 Steve Small

With that, I'll hand it over to you, Sara.

Acoltremon 0.003% Drops (Tryptyr) for Dry Eye

00:09:32 Sara Klockars

Thanks Steve. You know, when it comes to eye care, I'm also not afraid to drop some knowledge.

00:09:39 Sara Klockars

Next we have acoltremon or Tryptyr drops for dry eye disease.

00:09:46 Sara Klockars

So dry eye disease occurs when there is decreased tear production or increased tear evaporation, and when tears can't adequately lubricate the eyes. That leads to inflammation and surface damage.

00:09:58 Sara Klockars

Where patients can have burning, stinging, irritation — that sense of sand or grit in the eye. So let's briefly review what happens with tears to help us understand how the meds can help.

00:10:10 Sara Klockars

So with normal tear production, the lacrimal glands continuously produce watery tear fluid to moisturize the surface of your eyes every time you blink.

00:10:20 Sara Klockars

And the small glands on the edge of your eyelids, called meibomian glands, secrete an oil which then coats that watery tear and helps prevent tears from evaporating. So then tears will drain out of your eyes and into your nose through the tear ducts in the inner corner.

00:10:35 Sara Klockars

So when we get dry eyes, we don't produce enough tears — possibly due to aging or medications — or we experience increased tear evaporation when those meibomian glands become clogged or don't secrete enough oil, possibly due to staring at screens and blinking less, or maybe makeup or bacteria gets in there.

00:10:56 Sara Klockars

So to manage that decreased tear production or increased tear evaporation, we want to first emphasize starting with non‑drug measures — things like humidifiers, sitting away from a blowing air duct, quitting smoking, and then trying to limit that screen time with the 20/20/20 rule, where you shift the eyes’ focus from the computer or phone every 20 minutes to something 20 feet away for 20 seconds.

00:11:19 Sara Klockars

We also want to look at meds that may contribute to dry eyes. We want to look for anticholinergics like tricyclic antidepressants, or amitriptyline. We also have overactive bladder meds like oxybutynin. And then before we go to prescription meds, we want to recommend trying OTC ophthalmic lubricants first such as artificial tears, gels, or ointments.

00:11:43 Sara Klockars

And when all of that isn't enough and patients still have symptoms, we have prescription meds. So we have our cyclosporine options such as Restasis to help decrease inflammation and increase natural tear production. We also have lifitegrast, or Xiidra, which targets inflammation due to reduced tear production.

00:12:03 Sara Klockars

We have perfluorohexyloctane, or Miebo, often for patients with meibomian gland dysfunction to help stabilize tears and reduce evaporation.

00:12:13 Sara Klockars

We also have varenicline, or Tyrvaya, which is a nasal spray to treat eye symptoms. Yeah, you heard me right — it helps increase tear production. And then we have the new med acoltremon or Tryptyr, which stimulates tear production.

00:12:30 Sara Klockars

So acoltremon is the first drug in a new class for dry eye disease. It's a transient receptor potential melastatin 8, or TRPM8, thermoreceptor agonist. So acoltremon binds to these temperature‑sensitive receptors and activates nerve signaling, which leads to increased tear production.

00:12:50 Sara Klockars

And it may also cause a cooling sensation to relieve discomfort.

00:12:57 Sara Klockars

If a patient is prescribed acoltremon, there are some important administration points. We want to be sure patients remove their contact lenses before a dose.

00:13:07 Sara Klockars

Then instill one drop in each eye twice daily, trying to space it out about 12 hours apart.

00:13:13 Sara Klockars

And note that there is enough solution in the single‑dose vial for both eyes.

00:13:19 Sara Klockars

And then wait at least 15 minutes after a dose before inserting contacts. If patients are using other eye drops, we want to be sure to separate them by at least five minutes.

00:13:31 Sara Klockars

And when it comes to side effects, the most common side effect was instillation‑site pain or burning sensation, which occurred in about half of the patients in clinical trials. So this could be more of that cooling sensation that it may cause when these drops are instilled in the eye. Some patients say it may feel like menthol or mint in their eye.

00:13:52 Sara Klockars

So the good news is that it's usually mild, short‑lasting, and tolerable, since less than 1% of patients stopped the med due to this sensation in clinical trials.

00:14:05 Sara Klockars

So let's see where acoltremon fits into the bigger picture of managing dry eyes.

00:14:10 Sara Klockars

Here you can see the current prescription options, how they work, and their approximate cost for a month's supply.

00:14:17 Sara Klockars

And one of these is usually started after optimizing those non‑drug measures, limiting meds that may be worsening dry eye symptoms, and treating with those OTC eye lubricants.

00:14:28 (Unidentified Speaker — short interjection)

Yes.

00:14:29 Sara Klockars

When it comes to choosing one of the prescription eye drops, the choice is definitely individualized, so it's based on symptom severity, patient and payer preference. And many of us are used to seeing cyclosporine tried first with its long track record, and it's the only generic option for now as well.

00:14:49 Sara Klockars

So don't expect to see a lot of acoltremon or Tryptyr yet. There's no proof it's any better, comparative data are lacking, plus it's pricey — so anticipate prior auths.

00:15:01 Sara Klockars

It may have a role when patients have tried and failed other options for dry eye, and it does seem to work fairly quickly, which is a plus as well.

00:15:10 Sara Klockars

There are a few nuances with acoltremon. It comes in a carton of 60 for a 30‑day supply, and inside that carton there are 12 foil pouches. Each foil pouch contains five single‑dose vials. So similar to this, these are single‑use vials and do not contain preservatives, so they should not be saved once they're open.

00:15:33 Sara Klockars

Also, if your pharmacy carries this, it should be kept in the refrigerator while it's in the pharmacy before it's dispensed.

00:15:42 Sara Klockars

And then patients can store an open carton at room temp or in the fridge. But be sure to review beyond‑use dating with them.

00:15:52 Sara Klockars

An open carton is only good for 30 days if it's stored at room temperature.

00:15:57 Sara Klockars

So point to the place on the side of the carton to write the opening dates to help patients.

00:16:03 Sara Klockars

Also remind patients to record the opening date on the foil as well, since once the foil packet is open, they should use it within seven days. So keep the unopened vials in that foil until they're ready to be used as well.

00:16:20 Sara Klockars

To help keep all of the dry eye meds — along with their dosing and cost — straight, be sure to see our Treatments for Dry Eyes chart on our website.

00:16:30 Sara Klockars

Steve, are there any audience questions we can answer for folks?

00:16:35 Steve Small

Sure. Let's see what we have here. Here's a question about aceclidine. They asked, “Can aceclidine be used in kids?” And this is a good question. So presbyopia by definition only occurs in adults, since it's associated with aging after the 40s.

00:16:52 Steve Small

So aceclidine doesn't have an FDA‑approved pediatric indication for kids. And this is a good reason to double‑check your patient’s age and the indication when verifying or dispensing this med.

00:17:03 Steve Small

And here's one for you, Sara. One audience member asks, “How long does it take Tryptyr to start working?”

00:17:12 Sara Klockars

Oh, good question. Yeah. So patients report that it starts working as early as the first day.

00:17:18 Sara Klockars

Usually it takes at least two weeks to see significant improvement, and so that two‑week mark is along the lines of when you see improvements with the lifitegrast and perfluorohexyloctane drops, though all of these seem to be quicker than what we're used to seeing with cyclosporine, which may take six weeks to see some improvements and three to six months to see those full effects.

00:17:43 Sara Klockars

So, this one does work pretty quickly.

00:17:47 Steve Small

Yeah, great context there.

Delgocitinib (Anzupgo) 2% Cream for Chronic Hand Eczema

00:17:50 Sara Klockars

OK, let's move along to our next drug, which is delgocitinib or Anzupgo. It's the first topical cream approved specifically for chronic hand eczema in adults.

00:18:04 Sara Klockars

So briefly, chronic hand eczema is an inflammatory skin disorder on the hands, and it gets its name “chronic” because it's lasting for more than three months or it relapses and comes back at least twice a year.

00:18:19 Sara Klockars

And it causes itching, drying, cracking of the skin, as well as redness. It can be pretty painful.

00:18:27 Sara Klockars

It's usually treated in a stepwise manner — so factoring in those patient preferences, costs, and severity — and that just means starting by identifying and avoiding triggers such as frequent handwashing, irritants such as fragrances or soaps, and then extremely hot water.

00:18:49 Sara Klockars

We also want to encourage regular use of moisturizing ointments and creams, and suggesting those fragrance‑ and dye‑free options. And then if more is needed, topical steroids tend to be the mainstay of treatment, and we may or may not see them used with topical calcineurin inhibitors like tacrolimus.

00:19:08 Sara Klockars

So in severe cases, we’ll see patients on that UV light therapy or oral meds such as acitretin or cyclosporine.

00:19:19 Sara Klockars

So now we have this new topical pan‑Janus kinase inhibitor delgocitinib. And this blocks multiple types of those JAK enzymes to reduce inflammation and symptoms. So it's a bit different than the other topical JAK inhibitor you may see — Opzelura or ruxolitinib. 

00:19:37 Sara Klockars

And this med only blocks two enzymes and is approved for mild to moderate atopic dermatitis. It is currently in trials for chronic hand eczema as well.

00:19:48 Sara Klockars

The thought is that this broader mechanism with delgocitinib may be more effective, but we don't have head‑to‑head trials yet to know.

00:19:59 Sara Klockars

If patients get delgocitinib, they should apply a thin layer twice daily to affected areas of the hands and wrists only. They also shouldn't use more than 30 grams per two weeks or 60 grams in one month. Also, it seems to have minimal systemic absorption which may be why it doesn't have the same serious boxed warnings for clots or mortality that oral JAK inhibitors and the topical ruxolitinib have.

00:20:30 Sara Klockars

But be aware, it is still linked to reports of shingles, rare infections, and non‑melanoma skin cancer. So patients should watch for infections during and after treatment, still get periodic skin checks, limit sun exposure, use sunscreen. It's not recommended to use this topical with oral JAK inhibitors or other potent immunosuppressants like oral cyclosporine, since there isn't any evidence that it's safe to do this.

00:21:02 Sara Klockars

Also, side effects were rare in the initial trials but you could see pain, itching, redness at that application site.

00:21:13 Sara Klockars

So let's see where delgocitinib fits for treating chronic hand eczema. I know you're itching to know.

00:21:20 Sara Klockars

Thinking back to that stepwise approach — first limiting those triggers, using moisturizers — and then prescription‑med‑wise, we don't have a lot of options. We would probably continue to start with topical steroids with or without that calcineurin inhibitor. And then that leaves delgocitinib basically as a last resort.

00:21:41 Sara Klockars

So expect to see delgocitinib when other topicals aren't enough and when patients want to avoid oral options or using that UV light therapy.

00:21:50 Sara Klockars

Plus, just a reminder that it's only for patients age 18 and older, and it will likely need a prior auth, partially due to that price tag of about $2000 per month for a 30‑gram tube. But it is good to have another option available for patients with severe symptoms.

00:22:11 Sara Klockars

I do briefly want to mention the JAK inhibitors approved for atopic dermatitis, as these may be used in some patients who have both atopic dermatitis and chronic hand eczema. And as I mentioned Opzelura cream, or ruxolitinib, is in trials for chronic hand eczema.

00:22:32 Sara Klockars

Plus, there are other oral JAK inhibitors used for conditions such as moderate to severe rheumatoid arthritis, ulcerative colitis, psoriatic arthritis — such as baricitinib. These are important because patients shouldn't use delgocitinib if they're on another JAK inhibitor or a med ending in “‑nib.”

00:22:53 Sara Klockars

So we need to ensure patient profiles are current, and since most of these are specialty meds, remember to ask patients if they're getting prescriptions from other pharmacies.

00:23:04 Sara Klockars

Also, if you get delgocitinib prescriptions, clarify that “use as directed” SIG.

00:23:10 Sara Klockars

It's usually used twice daily, but don't be surprised if it gets changed to PRN BID once patients get their symptoms controlled. There is a 52‑week open‑label trial where it was used safely like this.

00:23:25 Sara Klockars

And then watch quantities and refill histories. Patients shouldn't get more than 60 grams in one month.

00:23:35 Sara Klockars

And also note that it is stored at room temperature.

00:23:38 Sara Klockars

And remember, I mentioned rare cases of shingles with delgocitinib use, so I'll use this as a reminder to try and complete those age‑appropriate vaccines prior to starting this med.

00:23:50 Sara Klockars

And if patients need live vaccines, wait to give them about a week after finishing this drug, because patients should not get live vaccines right before starting, during, or right after treatment.

00:24:04 Sara Klockars

To get answers about many more FAQs about treating eczema, see our chart online called Managing Eczema. It includes everything from prevention and non‑drug measures we discussed to the role of systemic meds like cyclosporine for more severe eczema, and then everything in between.

Elinzanetant (Lynkuet) for Hot Flashes

00:24:24 Sara Klockars

So now I'm going to switch gears and talk about elinzanetant or Lynkuet for moderate to severe vasomotor symptoms — or hot flashes and night sweats — due to menopause.

00:24:35 Sara Klockars

So managing menopausal hot flashes: systemic hormone therapy has been the mainstay, especially for healthy patients under age 60, or if patients are within 10 years of their last period.

00:24:48 Sara Klockars

And these replace that estrogen the body stops making during menopause.

00:24:53 Sara Klockars

But hormone therapy is not an option for everyone, such as patients with blood clots, breast cancer, or with a history of a stroke.

00:25:02 Sara Klockars

Or perhaps there are patients who want a non‑hormonal med. So for these patients we can usually try meds such as an SSRI like paroxetine, an SNRI like venlafaxine, gabapentin, or in 2023 fezolinetant, or Veozah, was approved.

00:25:20 Sara Klockars

And even though they're not as effective as estrogen, they may still all offer some relief — but overall, more options are needed.

00:25:30 Sara Klockars

Which brings us to the latest non‑hormonal option, elinzanetant. So before menopause, usually there is a balance between estrogen and the chemicals in the brain, which keeps the internal temperature of the body in check.

00:25:44 Sara Klockars

But during menopause, estrogen levels decrease — disrupt this balance — increasing substance P and neurokinin B causing the estrogen‑sensitive kisspeptin/neurokinin/dynorphin — or KNDy — neurons in the hypothalamus to tell the body it's overheating, which leads to hot flashes and night sweats.

00:26:07 Sara Klockars

But elinzanetant blocks neurokinin‑1 and neurokinin‑3 receptors to reduce substance P and neurokinin B, which reduces the overactivation of the KNDy neurons. So ultimately it will lead to a reduction in vasomotor symptoms.

00:26:26 Sara Klockars

So think of elinzanetant as similar to fezolinetant but fezolinetant only blocks NK3 receptors.

00:26:34 Sara Klockars

So is elinzanetant more effective since it blocks two different receptors? And how do these two meds compare?

00:26:41 Sara Klockars

Well, patients can expect about three fewer hot flashes per day with elinzanetant compared to placebo.

00:26:48 Sara Klockars

And studies with fezolinetant report about two or three fewer hot flashes per day when compared to placebo.

00:26:56 Sara Klockars

Both of these options seem to work within four weeks, with some seeing benefit as early as one week, but we don't have direct comparison trials to say one is better than the other. But the thought is that elinzanetant may impact sleep better than fezolinetant, and studies are ongoing.

00:27:14 Sara Klockars

If patients get elinzanetant, we'll need to take steps to ensure it's used appropriately. Most patients getting elinzanetant will take two 60 mg capsules — or 120 mg — orally once daily at bedtime. It can be taken with or without food.

00:27:32 Sara Klockars

And just be aware that patients taking some interacting meds such as fluconazole or diltiazem may need a lower dose and should only take one 60 mg capsule at bedtime.

00:27:45 Sara Klockars

And they'll need to carefully peel the foil to save that second capsule for the next dose.

00:27:52 Sara Klockars

We also want to watch for other interactions where elinzanetant should be avoided, such as with strong CYP3A4 inhibitors such as itraconazole or ketoconazole, or inducers such as rifampin. Patients should also avoid grapefruit juice while on elinzanetant.

00:28:11 Sara Klockars

It's also important to think about possible side effects. This med can cause headache, fatigue, somnolence, and dizziness — especially at first. And that extreme tiredness does seem to improve with time, but that is why it's important to take it at bedtime.

00:28:29 Sara Klockars

This med should also be avoided in pregnancy.

00:28:32 Sara Klockars

And use this med with caution in patients with a history of seizures — one patient with a history of epilepsy had a seizure in the trials.

00:28:42 Sara Klockars

And also note that elinzanetant can cause photosensitivity in some patients.

00:28:48 Sara Klockars

There are also some other considerations. For example, it's costly — about $625 a month.

00:28:55 Sara Klockars

So anticipate prior auths and that patients may need to try those other non‑hormonal options first.

00:29:03 Sara Klockars

We do have some safety data after a year of use.

00:29:07 Sara Klockars

Elinzanetant doesn't have that boxed warning for liver injury like fezolinetant does, but advise checking those baseline and three‑month follow‑up liver function tests until we have more long‑term safety data.

00:29:22 Sara Klockars

It's also important to note that elinzanetant doesn't impact hormone levels or cause endometrial hyperplasia after a year of use.

00:29:34 Sara Klockars

So will we see a lot of elinzanetant? Probably not yet. You know, expect to continue to see systemic hormone therapy in eligible patients — especially for those healthy patients under age 60 or if they're within 10 years of their last period.

00:29:51 Sara Klockars

If patients can't take hormone therapy or prefer not to, then think of the non‑hormonal options.

00:29:58 Sara Klockars

It may be worthwhile to consider a generic SSRI like paroxetine or an SNRI like venlafaxine before we consider that neurokinin‑receptor antagonist — fezolinetant or elinzanetant.

00:30:13 Sara Klockars

So this is a good reminder to make sure patient profiles are up to date with current meds and medical conditions when dispensing elinzanetant.

00:30:22 Sara Klockars

And that's to help identify patients at risk of seizures, ensure patients are not pregnant, and to catch potential interactions.

00:30:30 Sara Klockars

Also, even though this med doesn't seem to cause liver injury, labeling advises not to start elinzanetant if baseline serum transaminase concentrations are two times the upper limit of normal or greater.

00:30:45 Sara Klockars

Another thing to stay alert for: look‑alike, sound‑alike errors. Not only do elinzanetant and fezolinetant look similar, but then we have the neurokinin‑1 antagonists that we often see as antiemetics, such as aprepitant.

00:30:59 Sara Klockars

And for the pharmacy folks, be sure to use those proper auxiliary labels when dispensing this. Do not chew or crush these soft gelatin capsules — patients will need to swallow them whole. Patients should also avoid grapefruit, and since this may cause photosensitivity, it's good to remind patients of sun‑protective measures.

00:31:21 Sara Klockars

So to close this topic out, be sure to search our website for some helpful menopausal resources. We have a chart on managing vasomotor symptoms, and we're in the process of updating this to provide more information on the non‑hormonal options. And then I also see a few questions on how to manage vaginal symptoms of menopause.

00:31:42 Sara Klockars

So please search our website for our chart Managing Genitourinary Menopausal Symptoms for answers to many of your questions — we have info on vaginal lubricants and moisturizers as well as vaginal estrogen products. I think you'll find it really helpful.

00:31:59 Sara Klockars

And then if you start to get more questions — or if you've already gotten more questions — on menopausal hormone therapies with the labeling changes, we have an interactive printable chart with brand names, dosage forms, and so much more.

00:32:13 Sara Klockars

Steve, any more audience questions we can try to answer quick?

00:32:18 Steve Small

Yes, we do. Here's a question about elinzanetant. Can elinzanetant be used in patients who've had breast cancer?

00:32:26 Sara Klockars

Good question. The short answer to that is yes.

00:32:31 Sara Klockars

The longer answer is that there's actually evidence in a recent OASIS‑4 trial that elinzanetant can be used safely in patients with hot flashes and a history of breast cancer, or if they're taking endocrine therapy for breast‑cancer prevention. And so after four weeks of use, patients experienced about three and a half fewer hot flashes a day with elinzanetant compared to placebo.

00:32:59 Sara Klockars

So this is an option for patients. I know anecdotally fezolinetant has been used in this population as well, but there isn't robust published data in this population for fezolinetant.

00:33:12 Sara Klockars

But I do think we'll start to see more data on using these agents in patients with a history of breast cancer or having hot flashes on endocrine therapy for breast‑cancer prevention. That's a great question.

00:33:27 Steve Small

Great to have that data in mind.

Conclusion

00:33:30 Narrator

We hope you enjoyed and gained practical insights from listening to this discussion.

00:33:35 Narrator

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00:34:40 Narrator

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