Commercial Narrator (4:15)

Boy, do I hate being right all the time.

Dr. Chapa (4:18)

Well, I mean that in all humility. No, but it's true. The data was there and I said on various podcast episodes in the past, the label will change. We just gotta wait for it.

Commercial Narrator (4:30)

Boy, do I hate being right all the time.

Dr. Chapa (4:32)

And now it has happened. So in this episode, very quickly, we're gonna show you the pre existing D data from the peer reviewed clinical communities that showed maybe this thing should be five years. Then we're gonna discuss the official FDA extender trial that looked at this. So we'll give you that clinical trial information. It was clinical trial registration number NCT 0462-6596. Very impressive. Including in patients who had BMIs greater than 30, no drop in efficacy. So again, just having fun with this. Nobody be upset. Just being a little sarcastic.

Commercial Narrator (5:13)

Boy, I hate being right all the time.

Dr. Chapa (5:15)

Oh boy, I hate being right all the time. So in this episode, we're gonna cover this data, take a look at the FDA approval, that quick assessment. So if a patient asks you, is it safe? Can I go to five years? You go, yep. If you choose to, you can. I think I've set it up enough and now we will be right back.

Brooklyn Adams (5:33)

Eczema is unpredictable, but you can flare less with EB gl, a once monthly treatment for moderate to severe eczema after an initial four month or longer dosing phase. About four in ten people taking Epglis achieved itch relief in clear or almost clear skin at 16 weeks, and most of those people maintain skin that's still more clear at one year with monthly dosing.

Commercial Narrator (5:52)

Epglis Lebricizumab, a 250mg per 2ml injection, is a prescription medicine used to treat adults and children 12 years of age and older who weigh at least 88 pounds or 40 kilograms with moderate to severe eczema, also called atopic dermatitis that is not well controlled with prescription therapies used on the skin or topicals or who cannot use topical therapies. EBGLIS can be used with or without topical corticosteroids. Don't use if you're allergic to ebglis. Allergic reactions can occur that can be severe. Eye problems can occur. Tell your doctor if you have new or worsening eye problems. You should not receive a live vaccine when treated with Eglis before starting Ebglis. Tell your doctor if you have a parasitic infection.

Brooklyn Adams (6:26)

Ask your doctor about Eglis and Visit or call 1-800-LILYRX or 1-800-545-5979.

Commercial Narrator (6:33)

Boy, do I hate being right all the time.

Dr. Chapa (6:36)

Foreign. This is Dr. Chapa's obgyn no spin podcast. Yeah, Implanons had kind of a long history. It's had a long pedigree. I mean, I actually trained with Norplant that was kind of kind of a bear. That was multiple capsules put into the arm. Putting them in was one thing. Taking them out was a beast. Then came Implanon, which was in 2006. Then it got revamped as Implanon 2.0, which was this radiopaque version. Had a nice little applicator that was Nexplanon in 2010 again, originally approved for three years duration. But a lot of data was circulating in print that this thing actually works for five, and some sites were actually advertising it for five years, though it was clearly at that time off label. But yeah, I did receive multiple messages every time I mentioned that, you know, you can use this for five. Some were like, I can't believe I'm saying I'm promoting something off label. Honey, we do things off label all the time. It's all right. Especially when there's data behind it. So very quickly, let me just show you some of the data we'll get into the, the, the clinical trial that the FDA used and what you need to know about this. Because in February 2026, if you are currently a nexplanon registered user, meaning you have an account with the manufacturer to get the device and use it, you may have to re register with them because they are launching a new REMS database for this. All right, so that's why you gotta know about this. Cause these tests can go, oh great. Things are gonna continue as is. Well, yes and no. Because you've gotta be re registered through the and mitigation strategy. That's rams anytime that there's an extension unlabel. This is not unique. This is not anything to be concerned about. This is what the FDA does because they have to make sure that no one's going to be harmed by this. So it's not a worrisome thing. It's just one more thing we have to do. And you got to register by the end of February, actually February 23, 2026, according to the manufacturer, so you don't lose the account. All right, so it is a part of the FDA label change is that this will now have a REMS program, a risk evaluation and mitigation strateg. That's all right. It's not nothing to worry about. That's what Oregon is required to do as part of the label agreement. All right. It's all right. This is nothing concerning that's expected. But we've had this data for a while now, even before this label change. All right, so there was a prospective study that looked at 390 women who used the implant beyond three years and those who went all the way up to five years. And the overall five year, the Kaplan Meier cumulative pregnancy rate was 0.6 per 100 woman years. In other words, that was statistically a blip when there was no pregnancies which occurred in the additional two years of follow up beyond the FDA approved duration. So in those patients who actually completed follow up, which was 200 women actually completing the five year Spanish, there was no additional pregnancies recorded. It was phenomenal. There's also data from the Contraceptive Choice Project. We've covered this. This was in close to 300 implant users who again use this beyond the original FDA label of three years. And it was 0 per 100 woman years in both years four and five, meaning no additional pregnancies. Now there's two things to look at here, whenever something is looked at for duration of use, you want to look at clinical pregnancy, which we've just discussed. And if that is supported by the pharmacological data, in other words, was it because they didn't have sex, Was it because something else happened, or was it in fact attributed to the agent? Well, we do have the pharmacological support for this because each andorgestrel levels do remain well above ovulation suppressive zone at years four and five. All right, so they didn't really differ much after the three year span. Yes, it kind of dropped a little bit, but clinically they're still above the ovulation suppression threshold. In general, you need around 90 picograms per milliliter of this hormone for suppression. And in year four and five, there were well over 150. Okay. So short of it is we have clinical data that says no pregnancy in year four and five. And that is also supported by the pharmacological data both in bench and in patients. This led to a multicenter single arm, open label study involving patients who already were wearing the implant and said, do you want to continue this joker for four or five years? We know it should work, but do you want to be officially part of this NCT registered trial? And they said, yes. Fine. Let me give you the key data here, and then we're going to wrap this up. This is just a quick awareness of what's out now and so you can be aware as of the end of February, before you get to the end of February 2026, contact your. And if you do this displacement, you got to re register with their REMS protocol. And again, or I just want to be clear, not a direct sponsor. I'm doing this on my own initiative. And so anyway, I just thought I'd throw that out there. So this key study finding had several remarkable things. Number one, no pregnancies were recorded in years four and five. None. No pregnancies recorded in years four or five. Not one, not two. No pregnancies. Amazing. That's a pearl index, y'. All. Listen to this. This is the official Pearl index of 0.0 pregnancies per 100 woman years. What? I mean, it's insane. So, yes, it's still one of the best methods of contraception out there, even in patients with a BMI over 30. Because there was about 38% who had a BMI over 30 in this study and about 10% who had a BMI over 40. It is pretty darn phenomenal. Okay, so the new label change is up to five years. You do have to register with the REMS protocol and this data is now accepted by the FDA as proof of efficacy. Now we don't have to do it off label. You will have protection if the patient wants to use it for five years to go, no problem, y'. All. This is very similar to the Mirena story. Remember, Mirena was like five years and then miraculously went to seven years and then a competitor came about and miraculously went to eight years. Nothing changed that that information was there, guys. They just didn't seek label change. So these are all good things. The patient does win with this because if she wants to extend its use, she should not fear pregnancy with this device because the Pearl index was 0.0 per 100 woman years in the official FDA trial. Phenomenal. Anyway, this is very quick. Just want to let you know what is up and out with the eternorgestrel implant 68 milligram contraceptive device. Now FDA approves for five years duration. Podcast family, as always, we're thankful for you. We're glad you're part of our podcast community. This was a short one. Now that we've done all that, let's take it home.