Any experience with Nubeqa or Darolutamide?

[wat380bjw]

Happy New year Y'all. My Dr is planning to put me on Darolutamide (Nubeqa) after the first of the year. I had been on Xtandi but the side effects were to much for me. Any one have any experience with this relatively new drug? My concerns are side effects and cost. Thanks Brad

[wat380bjw]

Thank you for your input. Your response is well respected. I APPRECIATE IT. Thank you

[Tall_Allen]

Nubeqa is only approved, so far, for non-metastatic castration-resistant PC (which is also one of the indications for Xtandi and Erleada). If that is your situation, insurance may approve it. Otherwise, it is incredibly expensive.

The FDA approved it based on its ability to prevent first detectable metastases. Because they did not follow subjects long enough, we have no idea if it extends survival, the way Xtandi has been proven to in metastatic situations. But in lab studies, it seems to do everything Xtandi does plus it prevents overexpression of the androgen receptor (AR), and it prevents one type of AR ligand resistance. So there's every hope that it works at least as well as Xtandi. This is true for Erleada as well.

As for side effects, it has never been tested against Xtandi. In lab tests, it doesn't activate GABAB receptors, which may be responsible for the fatigue experienced with Xtandi and others. It is also believed to not penetrate the blood/brain barrier, so things like seizures may be reduced.

Here's what Bayer says about side effects of Nubeqa:

"Serious adverse reactions occurred in 25% of patients receiving NUBEQA and in 20% of patients receiving placebo. Serious adverse reactions in ≥ 1 % of patients who received NUBEQA were urinary retention, pneumonia, and hematuria. Overall, 3.9% of patients receiving NUBEQA and 3.2% of patients receiving placebo died from adverse reactions, which included death (0.4%), cardiac failure (0.3%), cardiac arrest (0.2%), general physical health deterioration (0.2%), and pulmonary embolism (0.2%) for NUBEQA.

Adverse reactions occurring more frequently in the NUBEQA arm (≥ 2% over placebo) were fatigue (16% vs. 11%), pain in extremity (6% vs. 3%) and rash (3% vs. 1%).

Clinically significant adverse reactions occurring in ≥ 2% of patients treated with NUBEQA included ischemic heart disease (4.0% vs. 3.4% on placebo) and heart failure (2.1% vs. 0.9% on placebo)."

[wat380bjw in reply to Tall_Allen]

Thank you Tall Allen. I am NMCRPC at the moment, I am due for scans next week to be sure. I was offered Erleada but since it has a similar SE profile to Xtandi I passed. If the scans show anything should I push for Zytiga? Thank you for your help

[Tall_Allen in reply to wat380bjw]

Will your insurance cut you off from Nubeqa if you have any metastases on the bone scan/CT? Does insurance require you to get the new bone scan? If not required for insurance, you might want to discuss with your oncologist delaying the next scan until you've at least shown signs of PSA progression or symptoms. I'd hate to see you get cut off from a drug you like on a technicality.

If required and it shows something, next steps depend on what kind of met and where it is. Zytiga, Xofigo, Provenge, Docetaxel, and targeted radiation are all possible, depending. Plus there are loads of clinical trials you may qualify for.

Have you discussed estrogen patches with your oncologist? It may have a more agreeable side effect profile.

[wat380bjw in reply to Tall_Allen]

Thanks Tall Allen. My MO is insisting on the scans....my psa is low at 0.533 and is rising, I have been on Degarelix since 2/16. I keep telling her it will not show anything but she is persistent. I have not had scan since 7/2018...no evidence of mets. I will know more after my January appt.

[Tall_Allen in reply to wat380bjw]

Maybe you can discuss the insurance implications with her - some doctors live in an ivory tower.

[Danielgreer]

Hi wat380bjw, I’ve been taking Darolutamide for about 2 1/2 months. I originally took Abiraterone but had high liver enzymes. Regarding side effects, I get a little tired for about 2 hours after taking it. I try to make time to be able to relax during that time. The fatigue isn’t extreme. My liver enzymes and blood pressure have been normal with Daro. Also, I don’t think I’ve had any balance or cognitive issues. Regarding cost, I’m guessing it’s priced similar to Zytiga and Erleada. Generic Zytiga may be a bit lower in cost. My health plan is covering Daro. I currently have mHSPC and the insurance company still paid for it!

[wat380bjw]

Thank you Danielgreer. Sounds like you are doing well with it. When on Xtandi I had sever vitago and falling issues as well as fatigue, even with a lower dose. But it did bring my PSA down....so it was working well.