Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: Geron Netherlands B.V., Naritaweg 165, 1043 BW Amsterdam, Netherlands
Rytelo 47 mg powder for concentrate for solution for infusion.
Rytelo 188 mg powder for concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
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Powder for concentrate for solution for infusion (powder for concentrate). White to off-white or slightly yellow lyophilised powder. |
Rytelo 47 mg powder for concentrate for solution for infusion: Each vial contains imetelstat sodium equivalent to 47 mg imetelstat. After reconstitution, 1 mL of the solution contains 31.4 mg imetelstat.
Rytelo 188 mg powder for concentrate for solution for infusion: Each vial contains imetelstat sodium equivalent to 188 mg imetelstat. After reconstitution, 1 mL of the solution contains 31.4 mg imetelstat.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Imetelstat |
Imetelstat is an oligonucleotide telomerase inhibitor that binds to the template region of the RNA component of human telomerase (hTR), which prevents telomere binding. Telomerase activity and human telomerase reverse transcriptase (hTERT) RNA expression are known to be significantly increased in MDS and malignant stem and progenitor cells. Imetelstat treatment leads to reduction of telomere length, inhibition of malignant stem and progenitor cell proliferation and induction of apoptotic cell death leading to reduction of malignant clones. |
| List of Excipients |
|---|
|
Sodium carbonate (for pH-adjustment) |
Rytelo 47 mg powder for concentrate for solution for infusion is a clear, 8 mL Type 1 glass vial with a chlorobutyl rubber stopper and an aluminium flip-off seal with a dark green plastic cap.
Pack size: 1 vial.
Rytelo 188 mg powder for concentrate for solution for infusion is a clear, 10 mL Type 1 glass vial with a chlorobutyl rubber stopper and an aluminium flip-off seal with a royal blue plastic cap.
Pack size: 1 vial.
Geron Netherlands B.V., Naritaweg 165, 1043 BW Amsterdam, Netherlands
EU/1/24/1894/001
EU/1/24/1894/002
| Drug | Countries | |
|---|---|---|
| RYTELO | United States |
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