Hi Phil,
Zenvita dasatinib is licensed for ALL, not CML ... though of course it's the exact same drug and as I understand it some hospitals in the UK are giving it to CML patients.
The active ingredient - dasatinib - is the same in generic drugs. But the "excipients" (coatings, fillers) are usually different between generic manufacturers. One person on this forum found that macrogol, when used as a filler even in small amounts in generic imatinib, given them bad GI issues. So people can be quite sensitive to small changes.
Here are the non-active ingredients in Zenvita dasatinib:
Tablet core:
- Lactose monohydrate (200)
- Cellulose, microcrystalline (101 and 102)
- Croscarmellose sodium
- Hydroxypropylcellulose (MW 80,000)
- Magnesium stearate
Film-coating:
- Lactose monohydrate
- Hypromellose (15 mPas)
- Titanium dioxide (E171)
- Triacetin
And here they are for the branded Sprycel:
Tablet core:
- lactose monohydrate
- microcrystalline cellulose
- croscarmellose sodium
- hydroxypropylcellulose
- magnesium stearate
Film-coating:
- hypromellose
- titanium dioxide (E171)
- macrogol 400
So without a complete interrogation of the quantities of each, the cores look very similar but the coatings not quit so similar.
All info taken from medicines.org.uk
David.