Orgovyx dosage when on Erleada

[Atlpapa]

I've been on 3 month Eligard shots for almost 2 years. I started with Xtandi at the same time but switched to Erleada in September of this year (due to what I thought were side effects from Xtandi). Now I'm trying to switch the Eligard shots to Orgovyx and the urologists office is working with the insurance company. I was just talking the person in the UR office and they said the insurance denied the claim and she is applying for an appeal with a lot of documentation. She said when taking Orgovyx and Erleada the dosage of Orgovyx is 2 pills a day not the usual 1 pill and that is why the insurance company denied it (she said it is FDA approved for 2 pills when taking Erleada) I'm curious if those taking Orgovyx and Erleada are you taking 2 Orgovyx pills?

[JamesAtlanta]

My dosage of Orgovyx is 1 tablet per day (120mg) and 4 tablets of Erleada (60 mg each - 240 mg total). This was prescribed by my oncologist at MD Anderson.

Hope this helps.

James

[Atlpapa in reply to JamesAtlanta]

Thanks, I just posted some additional info I found.

[JamesAtlanta in reply to Atlpapa]

Did your oncologist say why they want you to take 2 pills per day instead of just one?

As for insurance, both my local MO and my MO at MD Anderson said it always takes a few weeks to get insurance approval. Apparently it is normally denied first and then may be approved with additional documentation. In my case they recommended it for two reasons. First, it is supposedly easier on the heart. I have a pacemaker and some other heart issues, potentially caused by chemo and/or radiation to my T8 vertebra. Second, it is supposed to be the fastest at allowing T levels to rise after treatment, which will help since I am doing intermittent ADT.

Good luck in your quest to figure this out. Again, I’d really want to know WHY a “double dose”.

Best,

James

[Atlpapa in reply to JamesAtlanta]

The back office did say it is often denied at first and they have sent in an appeal with additional documentation. As for the double dose my understanding from reading about Erleada it is a 'combined P-gp and strong CYP3A4 Inducer' and the Orgovyx website says when combining Orgovyx with a 'P-gp and strong CYP3A Inducer' the dosage is 240 mg.

I will definitely mention that your MO from MD Anderson has prescribed just one 120 mg pill. I don't like the idea of taking 2 pills and seriously considering an orchiectomy in the near future. Thanks.

[Atlpapa in reply to JamesAtlanta]

I saw this on the wellrx website: wellrx.com/ORGOVYX/monographs/ it corresponds to what I saw on the Orgovyx website under "full prescription informatiom". I will probably start out with the 240 mg a day until I get my next PSA and T blood test and then go down to the 1 dose like you are taking and monitor it. I'd be curious if you showed this to your MO's what they would say.

Apalutamide: (Major) Avoid concurrent use of relugolix and apalutamide. Concurrent use may decrease relugolix exposure and compromise the efficacy of relugolix therapy. If concurrent use is unavoidable, increase the relugolix maintenance dose to 240 mg once daily. If apalutamide is discontinued resume the recommended relugolix treatment dose of 120 mg once daily. Relugolix is a P-glycoprotein (P-gp) and CYP3A substrate and apalutamide is a P-gp and strong CYP3A inducer. Concurrent use of another P-gp and strong CYP3A inducer decreased relugolix overall exposure by 55%.

[CENTIPEDE in reply to JamesAtlanta]

DID YOUR TESTOSTERONE LEVEL START TO RISE WHEN THE TWO DRUGS WE CO-ADMINISTERED?

[JamesAtlanta in reply to CENTIPEDE]

No. Testosterone levels have been and remain below 10 since starting. No issues with T levels rising.

Best,

James

[Atlpapa]

I did some digging and I'm a little confused because it is getting technical. On the Orgovyx website link for full prescription information (myovant.com/wp-content/uplo... )

I see the below Drug interaction that indicates Combined P-gp and Strong CYP3A Inducers need to have the Orgovyv dose increased. and on drugs.com it says Apalutamide (Erleada) is potent inducer of CYP3A4 and 2C19 and weak inducer of CYP2C9, P-gp, BCRP, and OATP1B1 in humans.

Is CYP3A the same as CYP3A4? I may need to call a phone number on the Orgovyx site to help understand this although they may not want to get into the weeds with a lay person.

ORGOVYX DRUG INTERACTIONS:

P-gp Inhibitors: Avoid co-administration. If unavoidable, take

ORGOVYX first, separate dosing by at least 6 hours, and monitor patients more frequently for adverse reactions (2.2, 7.1).

Combined P-gp and Strong CYP3A Inducers: Avoid co-administration. If unavoidable, increase the ORGOVYX dose to 240 mg once daily

(2.3, 7.1).

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling

[Atlpapa]

Thanks, I just posted some additional info I found.

[Psychmed]

I started with an RP in 2016. Since there was some extracapsular spread I then had 40 EBRT. About a year later I had a couple high power shots to a met on a vertebra. In between I was started on Eligard every three months. My PSA throughout was 0. I was on it for three years. The worst side effects were fatigue, brain fog and weakness. I reduced my psychiatric practice from 8 to 5 to 9 to 4 and later from 4 days a week to 3. Didn't make much in 2020. The stress of working from home, having a hard time thinking, carrying a pager for 50 years, and preauthorizations, and my wife's urging got me to retire end of June. I have been off Eligard for a little over a year and my brain fog, fatigue and weakness are slowly improving. I still tire easily and need 9 or 10 hours of sleep. The whole experience was awful. but a whole lot better than the alternative. I was happy to follow my uro's advice, with a second opinion at the Seattle Cancer Care Alliance and being also followed by a MO. I didn't study the biochemistry of it. I was happy to find this forum which provided a lot of support. A bunch of guys battling a common foe. I read it most every day although I don't contribute much. I figure if what you are doing is working stay with it. You never know what horrors an alternative will bring.All the best, Mike

[MateoBeach in reply to Psychmed]

Congratulations on your retirement and your improving symptoms. Good luck in 2022.

[j-o-h-n]

Tell that "go between insurance person" that you actually place two in your mouth but only swallow one.....

Good Luck, Good Health and Good Humor.

j-o-h-n Thursday 12/30/2021 6:43 PM EST

[MateoBeach]

You can verify adequacy of treatment by measuring testosterone level on the one pill. If less than 20 ng/dl then it is sufficient. LH level should also be very low if you want to add that.