A generic version of Velcade is now available in the USA:
"Fresenius Kabi Introduces Bortezomib For Injection," Fresenius Kabi press release, January 12, 2018.
Let's hope there will soon be more generic alternatives for myeloma patients.
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Multibilly - Name: Multibilly
- Who do you know with myeloma?: Me
- When were you/they diagnosed?: Smoldering, Nov, 2012
Re: Generic Velcade now available in the USA
Hi Multibilly,
The Fresenius Kabi bortezomib, which was launched about a year ago, is not quite the same as Velcade. The difference is that the bortezomib in Velcade is suspended in mannitol, while the Fresenius Kabi bortezomib is in boric acid and glycine, as noted in its U.S. prescribing information: "Each single-dose vial [of Fresenius Kabi bortezomib] contains 3.5 mg of bortezomib, 10.5 mg boric acid, 25 mg glycine as a sterile lyophilized powder."
The Velcade U.S. prescribing information says: "Each single-use vial contains 3.5 mg of bortezomib as a sterile lyophilized powder. It also contains the inactive ingredient: 35 mg mannitol, USP."
Apparently this difference matters, because you are only supposed to administer Fresenius Kabi bortezomib by intravenous infusion, as emphasized in the drug's prescribing information: "Bortezomib for Injection is for intravenous use only. Do not administer Bortezomib for Injection by any other route."
The comparable statement for Velcade reads: "Velcade is for intravenous or subcutaneous use only. Velcade should not be administered by any other route."
I believe I read someplace that the mannitol plays a role in making subcutaneous injection of Velcade possible, but I can't find a link to what I read.
Here are links to the U.S. prescribing information ("package inserts") for the two versions of bortezomib:
Fresenius Kabi bortezomib:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205004s002lbl.pdf
Velcade (bortezomib):
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021602s043lbl.pdf
The Fresenius Kabi bortezomib, which was launched about a year ago, is not quite the same as Velcade. The difference is that the bortezomib in Velcade is suspended in mannitol, while the Fresenius Kabi bortezomib is in boric acid and glycine, as noted in its U.S. prescribing information: "Each single-dose vial [of Fresenius Kabi bortezomib] contains 3.5 mg of bortezomib, 10.5 mg boric acid, 25 mg glycine as a sterile lyophilized powder."
The Velcade U.S. prescribing information says: "Each single-use vial contains 3.5 mg of bortezomib as a sterile lyophilized powder. It also contains the inactive ingredient: 35 mg mannitol, USP."
Apparently this difference matters, because you are only supposed to administer Fresenius Kabi bortezomib by intravenous infusion, as emphasized in the drug's prescribing information: "Bortezomib for Injection is for intravenous use only. Do not administer Bortezomib for Injection by any other route."
The comparable statement for Velcade reads: "Velcade is for intravenous or subcutaneous use only. Velcade should not be administered by any other route."
I believe I read someplace that the mannitol plays a role in making subcutaneous injection of Velcade possible, but I can't find a link to what I read.
Here are links to the U.S. prescribing information ("package inserts") for the two versions of bortezomib:
Fresenius Kabi bortezomib:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205004s002lbl.pdf
Velcade (bortezomib):
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021602s043lbl.pdf
Re: Generic Velcade now available in the USA
Thanks Cheryl,
This is really good to know.
This is really good to know.
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Multibilly - Name: Multibilly
- Who do you know with myeloma?: Me
- When were you/they diagnosed?: Smoldering, Nov, 2012
Re: Generic Velcade now available in the USA
For what it's worth, this FDA document has the FDA review of the Fresenius product, including extensive discussion of boric acid.
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Foundry738 - Name: Biclonal
- Who do you know with myeloma?: Me
- When were you/they diagnosed?: 2016
- Age at diagnosis: 67
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