Thank you, Ian and Multibilly, for your additional insights. Very well-received. I am a believer in off label use where it holds promise of adding a new benefit. My concern is that Granix manufacturers do not even claim to add anything new to Neupogen. I think the main benefit is the lower price. So if price/insurance coverage is not an issue for the patient, why push something else?
I admit these issues should ideally be sorted out between patient and provider and explained so the patient has a voice and a choice, where possible. Unfortunately there is obviously big pressure on transplant centers and it's a bit of an assembly line process out there. Once your main point of contact becomes the transplant coordinator, answers to medical questions and why certain things are done become difficult to get.
Thanks to this Forum for being there to share knowledge and experiences and shed light on some of these issues. We will assume that my nephew's Granix experience will go well and contribute to getting FDA approval and a cheaper option to Neupogen for everyone.
Forums
Re: Neupogen or Granix for stem cell mobilization?
From data at Medicare's website, Granix costs about 25 percent less than Neupogen. Given that competent regulatory authorities have deemed Granix equivalent to Neupogen, and given that competent doctors are comfortable using it, I'm having a hard time understanding why we should do anything but applaud this transplant center for trying to keep costs under control.
Of course, the same hospital is also recommending preventative use of Mozobil, which I really don't understand given the limited Revlimid exposure in this case, the cost of Mozobil, and the fact that Mozobil can be used on an as-needed basis. (I won't even go into the potential side effects of Mozobil.)
For what it's worth, there's actually a study that compared Granix to Neupogen for stem cell mobilization in patients undergoing autologous stem cell transplantation. It found that Granix was slightly more effective than Neupogen in mobilizing stem cells, although the difference was not even close to statistically significant:
MM Elayan et al, "Tbo-Filgrastim versus Filgrastim during Mobilization and Neutrophil Engraftment for Autologous Stem Cell Transplantation," Biology of Blood and Marrow Transplantation, Nov 2015 (link to abstract)
There's also another Neupogen biosimilar that has been approved in the U.S. – Zarxio (filgrastim-sndz), from the Sandoz subsidiary of Novartis. It was approved as an actual biosimilar, rather than as a new biologic agent, which (as Ian mentioned) was the route taken with Granix (related FDA press release).
Of course, the same hospital is also recommending preventative use of Mozobil, which I really don't understand given the limited Revlimid exposure in this case, the cost of Mozobil, and the fact that Mozobil can be used on an as-needed basis. (I won't even go into the potential side effects of Mozobil.)
For what it's worth, there's actually a study that compared Granix to Neupogen for stem cell mobilization in patients undergoing autologous stem cell transplantation. It found that Granix was slightly more effective than Neupogen in mobilizing stem cells, although the difference was not even close to statistically significant:
MM Elayan et al, "Tbo-Filgrastim versus Filgrastim during Mobilization and Neutrophil Engraftment for Autologous Stem Cell Transplantation," Biology of Blood and Marrow Transplantation, Nov 2015 (link to abstract)
There's also another Neupogen biosimilar that has been approved in the U.S. – Zarxio (filgrastim-sndz), from the Sandoz subsidiary of Novartis. It was approved as an actual biosimilar, rather than as a new biologic agent, which (as Ian mentioned) was the route taken with Granix (related FDA press release).
Re: Neupogen or Granix for stem cell mobilization?
Faith,
In answer to your question, my mom did four days of inpatient Cytoxan treatment at Northwestern in advance of her harvest to mobilize the stem cells. I'm not sure of the exact dosage of the Granix, but I do know it was three shots taken at the same time every night, preferably right before bed.
In answer to your question, my mom did four days of inpatient Cytoxan treatment at Northwestern in advance of her harvest to mobilize the stem cells. I'm not sure of the exact dosage of the Granix, but I do know it was three shots taken at the same time every night, preferably right before bed.
Re: Neupogen or Granix for stem cell mobilization?
Thanks, Cubs Fan! Wishing your mom a successful transplant and praying for her healing. My nephew is ready for his harvest next week and transplant a week or so later. God is in control. Will update on our progress from time to time. Thanks to all.
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Faith
Re: Neupogen or Granix for stem cell mobilization
I promised to come back with an update.
My nephew proceeded with stem cell harvest using Granix and Mozobil. It worked well without major problems. He harvested some 22 million cells in 3.5 days. His doctors wanted enough for 4 transplants. They got it. He took Claritin to prevent bone pain and did not have much pain at all. Thanks for that suggestion from this forum. We asked his doctor who cleared the use of Claritin. Nephew needed a platelets transfusion at the end of mobilization. Apparently this is a known side effect of Mozobil, and the levels recovered quickly.
Two weeks or so later he got melphalan chemo followed by infusion of his stem cells (5 million) and is now at Day +12. The white count and neutrophils bottomed out at zero on Day +8 and begun to recover 2 days later. Granix was reintroduced on Day +5 as a daily injection of 300 mg. He may go home in the next day or 2.
He has felt the lethargy and some diarrhea and cramping but otherwise relatively few problems. He has done a lot of walking and biking while on admission, maintaining a high level of activity. He has had no mouth sores or throat irritation although the medical team basically assured us that he would develop them, which kept us very nervous!! We are thankful, and convinced that sucking on ice during infusion of melphalan helped. We took that very seriously following the advice of many on this forum – thank you! – and my nephew continued the ice therapy from 30 minutes before till one hour after the melphalan.
Overall his progress is well beyond the doctors' expectation – even for his young age (51). The medical team has also taken a proactive approach and have kept my nephew on Zofran since his chemo. That must have helped to prevent nausea because he did not develop any. He has however needed a couple of blood transfusions and a lot of IV hydration to restore electrolytes. This is all coupled with a lot of day-to-day in-patient medical care and monitoring by a highly qualified and experienced team.
Since we have been encouraged by the accounts of others on this forum, I just wanted to share this experience with those yet to undergo the transplant process. Be encouraged and know your journey may be different from others. Plan for the worst but be assured that so much progress is being made in this field, making better experiences increasingly possible.
Blessing each of your journeys, with faith.
My nephew proceeded with stem cell harvest using Granix and Mozobil. It worked well without major problems. He harvested some 22 million cells in 3.5 days. His doctors wanted enough for 4 transplants. They got it. He took Claritin to prevent bone pain and did not have much pain at all. Thanks for that suggestion from this forum. We asked his doctor who cleared the use of Claritin. Nephew needed a platelets transfusion at the end of mobilization. Apparently this is a known side effect of Mozobil, and the levels recovered quickly.
Two weeks or so later he got melphalan chemo followed by infusion of his stem cells (5 million) and is now at Day +12. The white count and neutrophils bottomed out at zero on Day +8 and begun to recover 2 days later. Granix was reintroduced on Day +5 as a daily injection of 300 mg. He may go home in the next day or 2.
He has felt the lethargy and some diarrhea and cramping but otherwise relatively few problems. He has done a lot of walking and biking while on admission, maintaining a high level of activity. He has had no mouth sores or throat irritation although the medical team basically assured us that he would develop them, which kept us very nervous!! We are thankful, and convinced that sucking on ice during infusion of melphalan helped. We took that very seriously following the advice of many on this forum – thank you! – and my nephew continued the ice therapy from 30 minutes before till one hour after the melphalan.
Overall his progress is well beyond the doctors' expectation – even for his young age (51). The medical team has also taken a proactive approach and have kept my nephew on Zofran since his chemo. That must have helped to prevent nausea because he did not develop any. He has however needed a couple of blood transfusions and a lot of IV hydration to restore electrolytes. This is all coupled with a lot of day-to-day in-patient medical care and monitoring by a highly qualified and experienced team.
Since we have been encouraged by the accounts of others on this forum, I just wanted to share this experience with those yet to undergo the transplant process. Be encouraged and know your journey may be different from others. Plan for the worst but be assured that so much progress is being made in this field, making better experiences increasingly possible.
Blessing each of your journeys, with faith.
-
Faith
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