Notable New Meds of 2024

In this episode, TRC Healthcare editors, Sara Klockars, PharmD, BCPS, and Stephen Small, PharmD, BCPS, BCPPS, BCCCP, CNSC, discuss notable new meds of 2024. 

Listen in as our editors discuss several novel drugs approved in 2024...and highlight some medications now available in a new dosage form. They’ll review efficacy, safety, and considerations for use with these new treatment options.  

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

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

• On Demand Webinar: Notable New Meds of 2024
• Articles: 
  • Clarify the Role of Sofpironium for Hyperhidrosis
  • Watch for Ensifentrine for COPD
  • Don’t Rush to Aprocitentan for Resistant Hypertension
  • New Drug for Schizophrenia Targets Muscarinic Receptors
  • Be Familiar With Carbidopa/Levodopa Options
• New Drug Overviews:
  • Aprocitentan (Tryvio)
  • Epinephrine Nasal Spray (Neffy)
  • Xanomeline/Trospium (Cobenfy)
• FAQ: Emergency Epinephrine Devices
• Chart:

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Chapters

• 0:02 Introduction
• 1:02 CE Information
• 1:34 Lebrikizumab (Ebglyss)
• 5:35 Sofpironium (Sofdra)
• 8:21 Ensifentrine (Ohtuvayre)
• 12:02 Xanomeline - Trospium (Cobenfy)
• 14:55 Aprocitentan (Tryvio)
• 17:56 Aripiprazole oral film (Opipza)
• 18:55 Budesonide oral suspension (Eohilia)
• 20:18 Ethinyl estradiol/norethindrone acetate (Femlyv)
• 21:47 Sacubitril/valsartan sprinkle capsule (Entresto)
• 23:12 Clonidine ER oral suspension (Onyda XR)
• 24:26 Minocycline ER capsule (Emrosi)
• 25:27 Carbidopa/levodopa ER capsule (Crexont)
• 26:40 Epinephrine nasal spray (Neffy)

Transcript

This transcript is automatically generated. 

00:00:05 NARRATOR

Welcome to Medication Talk, the official podcast of TRC Healthcare, home of Pharmacist’s Letter, Prescriber Insights, RxAdvanced, and the most trusted clinical resources. 

00:00:14 NARRATOR

Proud to be celebrating 40 years of unbiased evidence and recommendations. 

00:00:20 NARRATOR

On today’s episode, listen in as our editors discuss several novel drugs approved in 2024...and highlight some medications now available in a new dosage form.  They’ll review efficacy, safety, and considerations for use with these new treatment options.

00:00:29 NARRATOR

 You'll hear from two of our pharmacist editors on our team at TRC Healthcare, associate editor Sarah Klockers and assistant editor Steven Small.

00:00:43 NARRATOR

This podcast is an excerpt from 1 of TRC's monthly live CE webinars. Each month, experts and frontline providers discuss and debate challenges in practice,

00:00:52 NARRATOR

evidence based practice recommendations, and other topics relevant to our subscribers.

00:00:58 NARRATOR

The full webinar originally aired on December 17, 2024.

00:01:03 NARRATOR

And now the CE information.

00:01:08 NARRATOR

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

00:01:15 NARRATOR

Please log into your pharmacist letter pharmacy technician's letter or prescriber insights account and look for the title of this podcast in the list of available CE.

00:01:24 NARRATOR

None of the speakers have anything to disclose.

00:01:30 NARRATOR

Now let's start our discussion.

00:01:34 Sara Klockars

I am going to start off reviewing the new monoclonal antibody LEBRIKIZUMAB or epist.

00:01:43 Sara Klockars

Lebrikizumab is approved for adults and children 12 years of age and older, weighing at least 40 kilograms with moderate to severe atopic dermatitis or eczema. When topical prescription meds aren't enough or aren't an option.

00:01:59 Sara Klockars

So it's a monoclonal antibody that targets select interleukin 13 receptors, which play a role in inflammation.

00:02:07 Sara Klockars

For eczema, the currently approved biologics target Interleukin 4 and interleukin 13, signaling pathways. And so lebrikizumab targets interleukin 13. And by binding to this protein, LEBROCHIZUMAB helps to block certain signals that can lead to inflammation and eczema.

00:02:29 Sara Klockars

Lebrikizumab comes in a 250 milligram per 2ML pre filled pen or syringe and is given by subcutaneous injection.

00:02:38 Sara Klockars

Into the abdomen, thigh or back of the upper arm.

00:02:42 Sara Klockars

The initial dose.

00:02:43 Sara Klockars

Is 500 milligrams, so that's two of those 250 milligram injections at week zero and then two weeks later and then it's followed by 250 milligrams every two weeks until week 16 or until patients see a response.

00:02:59 Sara Klockars

And then the maintenance dose IS250MG every four weeks.

00:03:04 Sara Klockars

And when may we see LeBron Kuzma for eczema?

00:03:09 Sara Klockars

Topicals are usually for treating mild to moderate eczema and if these don't do the trick or if patients have more severe eczema, they'll often use a systemic bed.

00:03:19 Sara Klockars

Patients will usually start with one of the injectable monoclonal antibodies if they need a systemic Med for more moderate to severe disease.

00:03:29 Sara Klockars

So think of dupilumab, Chala, Kannumab, and Lebrikizumab in the same bucket.

00:03:35 Sara Klockars

There aren't any head to head trials yet amongst these three monoclonal antibodies, and they all improve.

00:03:43 Sara Klockars

They're all specialty meds and are similar in cost at about 3300 to $3500 per month.

00:03:51 Sara Klockars

And there are some nuances amongst 3.

00:03:55 Sara Klockars

Trela, Kidiumab and Lebrikizumab are for patients 12 and older, whereas Depilium AB is currently for patients as young as six months with eczema and dipilumab also treats several other conditions.

00:04:06 Sara Klockars

Including asthma, nasal polyps or eosinophilic esophagitis.

00:04:12 Sara Klockars

One other difference is trala. Canumab and Dipilumab are self injected every other week versus LEBRIKIZUMAB, which is every four weeks.

00:04:23 Sara Klockars

And then just keep in mind that dupilumab has the longest track record and in most cases expect the choice to come down to pass meds tried or prescriber or a payer preferences.

00:04:35 Sara Klockars

Let's briefly review a few tips for leveraging ad use like other monoclonal antibodies for eczema patients on lebrikazumab should report any eye pain or vision changes since conjunctivitis can occur.

00:04:49 Sara Klockars

And injection site reactions are also common.

00:04:53 Sara Klockars

There are.

00:04:53 Sara Klockars

Few nuances I want to mention regarding storage and handling. If this pen is dropped on a hard surface, it should not be used because it actually contains glass parts.

00:05:05 Sara Klockars

Perhaps this is where it gets its trade name from, so remember that ebglis contains glass parts.

00:05:12 Sara Klockars

It should also be stored in the refrigerator and can be left at room temperature for up to seven days and then also just a reminder to give vaccines prior to starting this Med if possible and avoid live vaccines for weeks before starting the Med or during treatment we.

00:05:29 Sara Klockars

Don't have data for patients using this Med and getting live vaccines.

00:05:33 Sara Klockars

And that wraps up lebrikizumab.

00:05:36 Sara Klockars

So let's move along.

00:05:39 Sara Klockars

And discuss soft pronunciation.

00:05:42 Sara Klockars

Soft peronian jealous for patients 9 and older with primary axillary hyperhidrosis or excessive underarm sweating. It's a topical anticholinergic, so it blocks the actions of chemical messenger acetylcholine.

00:05:58 Sara Klockars

To reduce sweating.

00:06:00 Sara Klockars

And it comes as a 50 mill bottle containing 12.45% soft pronuncium gel, and the bottle has a pump and applicator. Patients can use to apply the product and patients should be instructed to apply one pump to each armpit once daily at bedtime.

00:06:18 Sara Klockars

They should also avoid shaving at least 8 hours before applying it, and then avoid bathing at least 30 minutes before and eight hours after applying it as well.

00:06:29 Sara Klockars

Soft cronium has been shown to benefit about one in six patients after six weeks of use. But.

00:06:36 Sara Klockars

It costs about $1000 a month.

00:06:39 Sara Klockars

So where do we think soft pronunci?

00:06:42 Sara Klockars

Hydro Thunder.

00:06:43 Sara Klockars

Ation well, not first line. We're going to continue to start with antiperspirants. And if these aren't enough, we'll just have to consider patient preference cost side effects, since there's really no best option after failing the antibiotics.

00:06:59 Sara Klockars

Some patients may opt for generic.

00:07:02 Sara Klockars

Oral anticholinergics or even try a compounded glycopyrrolate solution which is often cheaper and maybe less irritant.

00:07:09 Sara Klockars

Meeting others may want to try prescription glycoprotein clots such as qbrexa. About one in three patients see improvement after four weeks of glycopyranum use, and it costs about $650 a month, which is a little less than soft peronium.

00:07:27 Sara Klockars

But insurers won't likely pay for either option.

00:07:31 Sara Klockars

It's important to point out that even the topical anticholinergics can cause systemic anticholinergic side effects.

00:07:39 Sara Klockars

Such as blurry vision or dry mouth, as well as local skin irritation.

00:07:44 Sara Klockars

And because of that, we also want to avoid soft cronium in patients with certain conditions that can be exaggerated by anticholinergics such as glaucoma or severe ulcerative colitis.

00:07:57 Sara Klockars

Also, if patients take other anticholinergic meds.

00:08:02 Sara Klockars

That can be a concern due to additive effects.

00:08:06 Sara Klockars

And then certain meds can also interact with soft proniam such as bupropion.

00:08:11 Sara Klockars

We want to be sure to check for interaction.

00:08:14 Sara Klockars

And lastly, these products are.

00:08:16 Sara Klockars

So advise patients to keep away from heat and flame, such as a burning candle.

00:08:22 Sara Klockars

Now let's move along and discuss ensuring or oduvir.

00:08:28 Sara Klockars

Antiphentron is approved as a maintenance Med for adults with COPD.

00:08:33 Sara Klockars

The goal is to use this to prevent flare ups or worsening of COPD symptoms such as coughing or wheezing.

00:08:40 Sara Klockars

So this is.

00:08:41 Sara Klockars

A Med that is used every day.

00:08:44 Sara Klockars

And Sophantrin is not a rescue Med for acute symptoms.

00:08:48 Sara Klockars

Studies show that giving enzymes nebulizer twice daily improves lung function more than placebo.

00:08:55 Sara Klockars

So how does enzymes work?

00:08:59 Sara Klockars

It inhibits phosphodiesterase 3 and phosphodiesterase 4.

00:09:04 Sara Klockars

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

00:09:07 Sara Klockars

Phosphodiesterases are enzymes found throughout the body and they breakdown. Cyclic amp and cyclic GMP which are cell messengers.

00:09:16 Sara Klockars

That impact many processes in the body and help keep things in balance and the liver, lungs, immune system.

00:09:22 Sara Klockars

And heart, just to name a few areas.

00:09:25 Sara Klockars

So in SYMPHON inhibits PDE 3 and PDE 4, which prevents the breakdown of the cell messenger cyclic amp, further increasing cyclic amp levels in the lung tissue.

00:09:38 Sara Klockars

And the thought is that these higher levels of cyclic amp will bronchodilate or open Airways and the smooth muscle of the lungs and reduce airway swelling and inflammation.

00:09:50 Sara Klockars

It may even help reduce mucus in the lungs.

00:09:54 Sara Klockars

And Sephentrine comes as an inhalation, suspension and unit dose ampuals, and it's given twice daily via standard nebulizer.

00:10:03 Sara Klockars

And it's just important to confirm that patients have a nebulizer machine and they know not to mix it with other meds in the nebulizer.

00:10:11 Sara Klockars

We also want to ensure patients know this is not for oral use.

00:10:15 Sara Klockars

There are cases of patients drinking inhalation solutions.

00:10:20 Sara Klockars

So what's the role of enzym?

00:10:24 Sara Klockars

Es Does improve lung function more than placebo.

00:10:27 Sara Klockars

But I also want to point out that over half of the patients in the trials were using another maintenance medication, such as a long acting beta agonist or a lava such as salmeterol or a long acting muscle antagonist or llama such as tiotropium.

00:10:45 Sara Klockars

With or without an inhaled corticosteroid, and we don't have any data yet. Comparing antiviral to standard treatments or to triple therapy.

00:10:54

Yeah.

00:10:55 Sara Klockars

We also don't have much long term safety or efficacy data either.

00:11:01 Sara Klockars

We just.

00:11:02 Sara Klockars

A smaller subset of patients that were treated for 48 weeks in one trial plus enzymes, a specialty Med that costs about $3000 a month.

00:11:13 Sara Klockars

So for.

00:11:13 Sara Klockars

Just expect specialist to save in sufficient for patients as a last resort or if they can't tolerate standard meds, it is good to have another option for patients with COPD.

00:11:24 Sara Klockars

So let's wrap up with a few tips.

00:11:28 Sara Klockars

Since Enso Fenton is a suspension, patients will need to shake the ampule well immediately before using it in the nebulizer, and be aware that it's normal for the Med to appear cloudy and yellow or pale yellow in color. After shaking this suspension.

00:11:43 Sara Klockars

And in regard to side effects and suppent run is pretty well tolerated.

00:11:47 Sara Klockars

It may rarely cause back pain.

00:11:50 Sara Klockars

Blood pressure increases in diarrhea.

00:11:53 Sara Klockars

But do advise patients to report any mood changes or suicidal thoughts. There are very rare reports of suicide related events of entering.

00:12:02 Stephen Small

Excellent. Let's switch gears to discuss a novel antipsychotic Sonoma Leen with Trospium known as Copenhor.

00:12:11 Stephen Small

It's a proof for schizophrenia in adult patients, but unlike traditional antipsychotics that we know inhibit dopamine activity in the brain, this new Med inhibits a different receptor, the muscarinic receptors. Trospium is added here to limit adverse effects from cinomoli.

00:12:29 Stephen Small

Look at that closer.

00:12:31 Stephen Small

Sonoma County works by stimulating muscarinic receptors in the brain, which can then help increase things like verbal learning and memory.

00:12:38 Stephen Small

While decreasing some main schizophrenia symptoms we're worried about.

00:12:42 Stephen Small

Like hallucinations and delusions, however, zenormaline could also stimulate muscarinic receptors throughout the body and Causeway things like vomiting, salivation and sweating.

00:12:53 Stephen Small

Thankfully, that added tropium actually blocks these receptors systemically to limit those effects, but allows anomalies to work in the brain and have those beneficial effects.

00:13:06 Stephen Small

This comes in several strengths. Since this Med should actually be titrated when it started. For example when starting.

00:13:12 Stephen Small

It's important to begin with the 50 milligram 20 milligram strength given as one capsule twice daily.

00:13:18 Stephen Small

After at least two days, then it can be increased to 100MG20MG twice daily for at least five days if needed for patient response. It can then be increased and maintained at 125 milligram, 30 milligrams.

00:13:33 Stephen Small

These doses should be taken one hour before or two hours after meals, and that's to help improve absorption.

00:13:39 Stephen Small

And it's important to avoid opening the capsule, since the effect on absorption really isn't known.

00:13:44 Stephen Small

So it must be taken whole.

00:13:47 Stephen Small

Were this novel antipsychotic may help is for patients with moderate to severe schizophrenia when traditional antipsychotics have been tried but don't work or the side effects are intolerable, it's important to avoid this Med, though, with significant liver impairment, since it does rely on the liver to be met.

00:14:06 Stephen Small

Also use this with caution and patience with existing urinary retention and slow stomach emptying since trospium can actually make these worse.

00:14:15 Stephen Small

So for pharmacists, I think it's important here to emphasize good.

00:14:19 Stephen Small

Schizophrenia can make sticking to a medication regimen very difficult, and this Med has to be taken twice daily and be prepared for patients to ask if there's a long acting injectable formulation like other antipsychotics that we know.

00:14:32 Stephen Small

Are formulated to help with adherence, but sadly there isn't one for this medication at this time, so it would be good to clarify that for patients.

00:14:41 Stephen Small

For technicians anticipate prior authorization paperwork with these scripts. Since insurance companies are unlikely to cover this at first and the current price tag is quite steep at over $1800 per month.

00:14:55 Sara Klockars

Now I will move on to our last novel, drug of the day.

00:14:59 Sara Klockars

And it is apresentantan.

00:15:02 Sara Klockars

Or trivia.

00:15:04 Sara Klockars

It is approved for.

00:15:05 Sara Klockars

Use in patients with blood pressures above goal despite being optimally managed on other antihypertensives.

00:15:11 Sara Klockars

It's a dual endotheline antagonist for resistant hypertension and the mechanism may sound familiar as we have drugs of this class approved for pulmonary arterial hypertension such as bothentin.

00:15:24 Sara Klockars

So let's see how Uppercintantin works.

00:15:27 Sara Klockars

Endothelin usually binds to the endothelin A and B receptors, leading to many effects.

00:15:33 Sara Klockars

Including vasoconstriction, endothelial dysfunction, vascular hypertrophy and remodeling, and increased aldosterone as an endothelin receptor antagonist, apris.

00:15:48 Sara Klockars

Inhibits the binding of endotheline to those endothelin A and B receptors, impacting the downstream effects and ultimately improving blood pressure.

00:15:57 Sara Klockars

It's available as a 12.5 milligram oral tablet dosed 1 tablet orally once daily. This Med is only available through the trivial Rams program due to embryo fetal toxicity prescribers and pharmacies must be certified.

00:16:14 Sara Klockars

With the trivial remedy by enrolling and completing training.

00:16:18 Sara Klockars

For the pharmacy crews listening that may be dispensing this and authorization must be obtained prior to dispensing each prescription tan 12.5 milligram tablet once daily decreases systolic blood pressure by about 4mm of mercury.

00:16:36 Sara Klockars

Versus placebo, after four weeks in patients with resistant hypertension not controlled when taking at least three antihypertensives.

00:16:44 Sara Klockars

We don't have safety and efficacy data past 48 weeks.

00:16:48 Sara Klockars

I do want to point out that this Med can be used with spironolactone.

00:16:53 Sara Klockars

It does not cause hyperkalemia or have any significant drug interactions. So generally think of apricotintan as another add on option when blood pressures are above goal on an optimized regimen or if other.

00:17:09 Sara Klockars

An option.

00:17:11 Sara Klockars

Be aware that adverse effects include fluid retention, anemia and liver toxicity, so we'll want to monitor weights and also some labs recommend checking baseline liver function and blood counts, and then check periodically during treatment.

00:17:27 Sara Klockars

We don't want to start this Med in patients with severe anemia or elevated liver function tests.

00:17:34 Sara Klockars

We want to take extra caution for patients of childbearing age and follow the trivial REMS to ensure benefits of this Med outweigh the possible risks.

00:17:46 Sara Klockars

So this wraps up our novel drugs for 2024.

00:17:52 Sara Klockars

Let's talk.

00:17:52 Sara Klockars

Some interesting new dosage forms from this year.

00:17:57 Sara Klockars

First up is.

00:17:59 Sara Klockars

Brazil is now available as Opexa, which is an oral film.

00:18:04 Sara Klockars

This atypical antipsychotic is indicated for treatment of schizophrenia and patients ages 13 and older.

00:18:11 Sara Klockars

And as an adjunct treatment of major depressive disorder in adults, and then for pediatric patients age 6 and older, it's approved for irritability associated with autistic disorder and treatment of Tourette's disorder.

00:18:25 Sara Klockars

Doses vary based on indication.

00:18:28 Sara Klockars

These oral films should be dissolved on top of the tongue once daily, with or without food.

00:18:35 Sara Klockars

And these films may reach peak concentrations in about 1 1/2 hours, versus about three to five hours for oral tablets.

00:18:42 Sara Klockars

But the price tag is hefty around $2000.00 for 30 oral films.

00:18:49 Sara Klockars

So the oral solution tablets or orally disintegrating tablets may be more affordable alternatives.

00:18:57 Sara Klockars

Next, we have a new budesonide oral suspension eohelia.

00:19:03 Sara Klockars

This is for eosinophilic esophagitis, which is a chronic immune mediated condition where patients may have difficulty swallowing or narrowing of the esophagus.

00:19:13 Sara Klockars

Many of us are used to seeing patients swallowing inhaled corticosteroids for this condition, or possibly using the budesonide nebulized.

00:19:22 Sara Klockars

Solution orally.

00:19:24 Sara Klockars

But this formulation of Budapest and I'd comes in a 2 milligram per 10 milliliter single dose stick pack and it's dosed 2 milligrams twice daily for up to 12 weeks.

00:19:39 Sara Klockars

And as we know, steroid use long term can lead to a whole slew of.

00:19:44 Sara Klockars

It has some specific instructions for use, including shaking it well for 10 seconds before using it.

00:19:51 Sara Klockars

Swallowing all of the suspension and then not eating or drinking for 30 minutes after taking it.

00:19:58 Sara Klockars

And then after that 30 minutes, patients need to rinse their mouth out with water and spit out the contents, not swallow.

00:20:06 Sara Klockars

Oral Candidiasis, or thrush, is a common side effect.

00:20:11 Sara Klockars

Plus, it costs about $1900 a month.

00:20:15

So.

00:20:15 Sara Klockars

Anticipate payer rejects.

00:20:20 Sara Klockars

And Next up we have Femliv which is our first orally disintegrating tablet for contraception.

00:20:28 Sara Klockars

It's ethanol. Estradiol, 20 micrograms and norethindrone acetate, 1 milligram.

00:20:35 Sara Klockars

In a 24 day active tablet pill pack, there are also 4 placebo pills in each blister pack. So for 28 days total comes as a box of three blister cards for about $600.

00:20:49 Sara Klockars

And one thing to point out with this is how it's given.

00:20:53 Sara Klockars

Patients should put 1 tablet on the tongue, allow it to disintegrate and then drink 8 ounces of water.

00:21:01 Sara Klockars

So perhaps this is an option for someone who can't swallow or chew, but generally I think.

00:21:09 Sara Klockars

I would recommend one of the many other 24 day options of ethanol estradiol, 20 micrograms, norethindrone acetate, 1 milligram instead.

00:21:20 Sara Klockars

These costs closer to $160.00 for three of those 28 day packs, or the quantity of 84.

00:21:28 Sara Klockars

So those might be.

00:21:30

A less costly.

00:21:31 Sara Klockars

Option, but just know that this oral disintegrating tablet does exist.

00:21:38 Sara Klockars

And now I'm going to turn it over to you, Steve, to talk about a few.

00:21:41 Sara Klockars

New dosage forms.

00:21:43 Stephen Small

Yeah, very interesting, Sarah, with all those new options and Next up we have is a new sprinkle capsule version of Entresto or Sacubitrile del Sartin.

00:21:54 Stephen Small

We know this is indicator for heart failure, but it can be used in kids down to one year old.

00:21:59 Stephen Small

So as you can guess, the tablet version is difficult for kids to take, and even though these tabs can be compounded into an oral suspension that has a really short expiration of only about 15 days.

00:22:11 Stephen Small

So sprinkles make administration easier without worrying about expiring drug. It has 2 available strengths and has dosing for patients 13 kilos to less than 50 kilos.

00:22:23 Stephen Small

But these patients may need to use two to four capsules per dose based on weight.

00:22:29 Stephen Small

With twice daily dosing, this could mean up to 8 capsules per day, so keep that in mind.

00:22:34 Stephen Small

It's important to open the capsule and sprinkle the pellets on up to two teaspoons of soft food.

00:22:39 Stephen Small

I'm thinking things like applesauce, yogurt or pudding and remind patients that you cannot take the capsule by.

00:22:46 Stephen Small

It must be opened and the patient should not chew or crush the roll pellets, since it could change the taste.

00:22:54 Stephen Small

These pellets can also clog feeding tubes like nasogastric tubes, so avoid giving it by this route.

00:23:01 Stephen Small

The cost is about $688 per 60 capsules, which means we could be looking at over $2500 per month for patients needing 8 capsules per day.

00:23:13 Stephen Small

Then we have a new extended release Clonidine oral suspension.

00:23:17 Stephen Small

Indicated for ADHD.

00:23:19 Stephen Small

We already have extended release tablets of quantity on the market, but we know some kids have trouble swallowing tabs just like we saw with our last map.

00:23:26 Stephen Small

And these Clonidine tabs can't be crushed or split because they're extended release with clomidine.

00:23:33 Stephen Small

It's available as a .1 milligram per mil suspension in bottles ranging from sizes of 30 mills up to 120 mills in size, and I'm also glad to hear that these come with bottle adapters and oral syringes, and I'd argue we want to make sure that.

00:23:49 Stephen Small

Are placed on the bottle before we give them to the family because even.

00:23:53 Stephen Small

A small Clonidine overdose in a child can be deadly and we need to keep these out of reach of kids.

00:23:59 Stephen Small

Similarly, we can't simply switch a patient from uh, tabs or even a compounded Clonidine suspension.

00:24:05 Stephen Small

To an identical milligram dose of this new extended release formulation.

00:24:10 Stephen Small

The pharmacokinetics are just two different and we have not an update at this point to make that sort of conversion.

00:24:16 Stephen Small

So patients will need to start at a .1 milligram dose by mouth at bed time and then titrate up from there. And it should be good to explain to families so they know what to expect.

00:24:26 Stephen Small

Another new extended release formulation is Minocycline indicated for rosacea.

00:24:32 Stephen Small

Other extended release tetracyclines like doxycycline have been used to treat the papulopustular lesions at a low dose of only 40 milligrams daily.

00:24:41 Stephen Small

We also have a 1.5% Minocycline topical foam already on the market, but it can cause temporary skin pigmentation.

00:24:50 Stephen Small

I was also surprised to find out it's flammable, which is concerning for patients.

00:24:53 Stephen Small

Smoke the new.

00:24:55 Stephen Small

40MG uh capsules given once daily, just like the doxycycline version.

00:25:00 Stephen Small

But trials showed Minocycline at higher lesion count improvement and more treatment success based on severity scores compared to doxycycline.

00:25:09 Stephen Small

This new formulation, though, is quite expensive, and doxycycline 100 milligram immediate release capsules are way less expensive than all of these.

00:25:17 Stephen Small

But these capsules that are immediate release may have more side effects, since it's a higher dose, and that could increase also bacterial resistance.

00:25:27 Stephen Small

Last but not least of our extended release formulations, we have another.

00:25:31 Stephen Small

This time it's for carbidopa levodopa.

00:25:33 Stephen Small

For Parkinson's disease, as a new formulation crexont, we have quite a few carbidopa, levodopa versions on the market, including capsules with immediate and extended release beads.

00:25:45 Stephen Small

Crecstone is similar that it has immediate and extend release beads.

00:25:49 Stephen Small

But its extended release beads have a new muco adhesive component that helps make it sticky so it stays at the absorption site longer to maintain levels.

00:25:59 Stephen Small

This is where the immediate release extended release capsule Rytary, already on the market and the new ER capsule that we're talking about today are not interchangeable.

00:26:11 Stephen Small

The Rytary version can be open and sprinkled on food, but the new ER capsule must be swallowed whole for that muco adhesive action to work.

00:26:20 Stephen Small

Like most carbidopa levodopa products, the package insert gives recommendations on how to convert patients to kreaxon from other versions, including a media release and the combination immediate extended release version that we talked about before.

00:26:34 Stephen Small

It also costs $521.00 for a bottle of 120 capsules.

00:26:40 Stephen Small

And now for the grand finale epinephrine nasal spray for anaphylaxis.

00:26:45 Stephen Small

And we know that injectable epinephrine products have been the go to for decades.

00:26:49 Stephen Small

This new route is probably going to spark some questions at your pharmacy.

00:26:53 Stephen Small

Each carton of epinephrine nasal spray comes with two nasal spray devices.

00:26:58 Stephen Small

Each device is a single use only product and contains enough Med for one dose, which is 2 milligrams.

00:27:05 Stephen Small

It's only approved for patients who weigh 30 kilos or 66 lbs. Or more, so this strength won't be an option for many young children.

00:27:13 Stephen Small

But do know that the FDA is reviewing a 1MG dose option for those kids that weigh 15 to 30 kilos.

00:27:21 Stephen Small

Patients should talk about risks and benefits with their prescriber if they have a history of nasal conditions like nasal polyps, nasal surgery, or things similar, since those may affect the sprays absorption.

00:27:32 Stephen Small

Clinical studies suggests that the epinephrine 2 milligram nasal spray achieves the same or similar blood levels as injectable epinephrine and also increases blood pressure and heart rate similarly as well.

00:27:44 Stephen Small

But these studies were done in healthy patients.

00:27:47 Stephen Small

Not experiencing anaphylaxis, right?

00:27:49 Stephen Small

So real.

00:27:50 Stephen Small

Use of the nasal sprays limited for now, and we'll await more data on that.

00:27:56 Stephen Small

The single use device is the same design as you may have seen with Narcan or Imitrex nasal sprays, and again, it contains enough Med for one dose.

00:28:05 Stephen Small

Going to emphasize the device should not be primed or tested, since this will discharge the dose and you.

00:28:10 Stephen Small

The Med.

00:28:12 Stephen Small

It's held with a thumb on the bottom of the plunger and a finger on each side of the nozzle.

00:28:17 Stephen Small

Then the nozzle is inserted fully into one nostril.

00:28:20 Stephen Small

Either nostril can be used, and then the plunger's pressed to give a dose.

00:28:25 Stephen Small

A second dose of the nasal spray can be given in the same nostril 5 minutes after the first dose if needed.

00:28:31 Stephen Small

In that direction, we're using the same nostril comes from the manufacturer, based on how it's studied. Cost is also an important.

00:28:38 Stephen Small

Here we found that a 2 pack of Nephi cost about $710. On the other hand, it's $620.00 for the talking obique injector, and only $300.00 for the generic EpiPen.

00:28:52 Stephen Small

But thankfully, most manufacturers have copay cards or patient assistance programs, so most patients will hopefully pay less than these prices with savings or discounts.

00:29:03 Stephen Small

Now for few reminders when you get epinephrine scripts in general, ask for and document the patients weight to double check doses, especially as children grow and remind patients to check the expiration date of their device.

00:29:17 Stephen Small

This new product, Nephi, has a shelf life of 30 months, compared to the 15 to 20 month shelf life we see with epinephrine injection devices.

00:29:25 Stephen Small

And what's nice is this nasal spray also is less sensitive to temperature excursions.

00:29:30 Stephen Small

It can with stand temperatures up to 122°F for a couple days, and it can even be thought if you accidentally freeze it, which we don't recommend you do, but just in case.

00:29:39 Stephen Small

And it does not have a window to view the contents to look at the expiration date like you may be familiar with epinephrine injectors.

00:29:45 Stephen Small

You're just going to find that expiration date on the box.

00:29:50 Stephen Small

And make a note on the patient's calendar or their phones to refill it before it expires.

00:29:55 Stephen Small

In the pharmacy, we can also continue following good inventory control practices.

00:30:00 Stephen Small

Check those expiration dates and rotate stock.

00:30:03 Stephen Small

Read our emergency Epinephrine devices chart online For more information about intranasal epinephrine and to compare that to our injectable epidemic for anaphylaxis.

00:30:12 Stephen Small

And be sure to watch our.

00:30:13 Stephen Small

We've written about several of these meds and we're excited to be writing about more of these in several months as they become available.

00:30:21 NARRATOR

We hope you enjoyed and gained practical insights from listening to this discussion. Now that you've listened, pharmacists, pharmacy technicians, physicians and nurses can receive CE credit.

00:30:32 NARRATOR

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00:30:37 NARRATOR

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00:30:41 NARRATOR

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00:30:46 NARRATOR

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00:30:56 NARRATOR

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00:31:10 NARRATOR

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