Update and Besremi associated Ads

[gjh8733]

Hi all - thought I would give an update from my last note regarding platelet crash while on Besremi 500 ug. Also add some thoughts re AEs I feel associated with Besremi

With platelets dropping Nov 3rd 2023 to 86 while on Besremi 500 ug, my hematologist stopped medication. By Nov 20 platelets had rebounded back up to 226 and I restarted Besremi at 100 ug./2 weeks dose. The platelets staying staple over the last month.

I experienced frequent episodes of emotional upset following abrupt cessation of Besremi in November. The anxiety/irritability/depression have remained even when I restarted Besremi at 100 ug. Now after 6 weeks at the 100 ug dose, the frequency has dropped, especially over the last week as if the body is adjusting to the lower levels of Besremi. In looking at my diary, I did note in the initial Besremi dose escalation during Sep- Dec 2022 from a starting dose of 100 ug to the 500 ug dose, that I again experienced a period of emotional upset. It was obvious to me from Nov when dose was at 300 ug for the following 2 months approx. when the dose was at 500 ug. In retrospect it does seem like it was again my body adjustment to Besremi. I am mentioning these in this excellent forum as over the last 18 months or so I don't recall any comments/discussion about the mental AEs that are associated with Besremi even though it is noted in the label. I am assuming therefore it is not common and maybe as in my case driven by the high dose and/or change in exposure.

Other side effects in looking back is that I suffered frequent very uncomfortable facial flushing, headache and feeling of nausea from mid 2023. While NSAIDs were typically effective in reducing these AEs (thankfully!), their frequency/intensity was requiring me to take them once or twice daily. With the cessation and now reintroduction of Besremi at the lower100 ug dose, these AEs are markedly reduced and require only infrequent NSAID treatment. i am hoping they will disappear soon

Happy Holidays to all!

Gerry

[hunter5582]

Thank you for sharing your thoughts and experience with Besremi. It is very valuable to hear about what we each experience. We are each different in how we respond to Besremi and the other treatment options for MPNs. There is great wisdom and value in our shared experiences.

I am a proponent of the low and slow approach to Besremi. I believe that we should be using the lowest dose necessary for the desired hematologic response. We should not take a higher dose than we can readily tolerate. The benefits do not justify the risks and actual adverse effects.

PharmaEssentia is studying the accelerated dosing schedule in the Eclipse PV clinical trial. This is good news for the MPN community. The decision about recommended dosing schedules needs to be based on verified data. I am predicting that the outcome of this study may not be what is hoped for by those who support the more aggressive doing. The risks associated with the more aggressive dosing strategy are likely to be too much higher than the low and slow approach.

My experience with Besremi using the low and slow approach has been very positive. My quality of life has improved and I am maintaining a hematologic response, with only one phlebotomy in a year. However, 175mcg appears to be my maximum tolerated dose. The neutropenia is the primary concern. A higher dose would likely compromise my immune system too negatively.

In regards to your experience, your response is fairly common. Thrombocytopenia is one of the more common adverse effects of Besremi, at about 19%. Depression was found in about 20%. besremihcp.com/peginvera-pr...

While I believe that Besremi is one of the best treatment options we have for MPNs, I would never contend that it is without risks. This is true for all of our treatment options. The medications we use to treat MPNs make fundamental alterations in how our bodies function. It would be inaccurate to think that these interventions come without potential negative consequences. It is always a balancing act between benefits and risks. We each respond differently and need an individualized approach to treatment.

Hopefully the data from the research will lead to better information to guide individualized care. This is what we all need when dealing with MPNs.

Wishing you all the best and success in the next stage of your journey.

[gjh8733 in reply to hunter5582]

Thanks Hunter. The plan for now is stay at the 100 ug and check CBC every month. If stable then steady as she goes, but if HCT over 45 then phlebotomy and up the dose.

[KLCTJC]

I think Hunter is so right. Luckily Dr V at MDA before he left was already of the low slow plan. So I told my local oncologist this is how I was going to do it. So, we only increased every 4-6 weeks. And my first question when I go back to MDA is when can I go to once a month as I think Besremi will continue to work as I keep going. It wouldn’t surprise me that dose adjusting up or down happens the longer you are on this drug. And I am like Hunter I feel great. I am on 225mcg. I think your body needs time to adjust either up or down on this drug. It is long lasting so I think abrupt changes can really affect us. I know they needed to cut you back but doesn’t surprise me you felt bad with an abrupt stop. I am glad you are feeling some better. And thanks for sharing. Merry Christmas

[Solyesh]

Thank you for sharing! One of the most important aspects of this wonderful forum is sharing each of our real world experiences - it is always welcome and provides everyone with additional information and can make us feel less alone.