Active Ingredient: Imetelstat
Imetelstat is indicated as monotherapy for the treatment of adult patients with transfusion-dependent anaemia due to very low, low or intermediate risk myelodysplastic syndromes (MDS) without an isolated deletion 5q cytogenetic (non-del 5q) abnormality and who had an unsatisfactory response to or are ineligible for erythropoietin-based therapy.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intravenous, 7.1 milligrams imetelstat per kilogram of body weight, once every 4 weeks.
Complete blood cell count and liver function tests are recommended before administration of each dose. Additionally, weekly blood cell counts are recommended following the first two doses.
A pregnancy test should be performed before administration of the first dose of imetelstat for females of reproductive potential.
The recommended dose of imetelstat is 7.1 mg/kg body weight administered as an intravenous infusion once every 4 weeks. Imetelstat should be discontinued if patients do not experience a reduction in red blood cell (RBC) transfusion burden after 24 weeks of treatment (6 doses) or if unacceptable toxicity occurs at any time.
Patients should be premedicated with diphenhydramine (25 to 50 mg) and hydrocortisone (100 to 200 mg), or equivalent, at least 30 minutes before dosing with imetelstat. Premedication should be administered before any doses of imetelstat, to prevent or reduce potential infusion-related reactions.
Recommended dose reductions for all Grade 3 and Grade 4 adverse reactions are found in the table below.
The management of Grade 3 and Grade 4 adverse reactions may require a dose delay, dose reduction, or treatment discontinuation. Treatment with imetelstat should be permanently discontinued if the patient cannot tolerate the lowest dose level of 4.4 mg/kg.
Recommended dose reduction for all Grade 3 and Grade 4 adverse reactions:
| Dose reduction | Current dose | Decreased dose |
|---|---|---|
| First dose reduction | 7.1 mg/kg | 5.6 mg/kg |
| Second dose reduction | 5.6 mg/kg | 4.4 mg/kg |
If a planned dose is missed, the patient should be administered imetelstat as soon as possible and dosing continued as prescribed with 4 weeks between doses.
Administer the intravenous infusion over 2 hours (i.e., 250 mL/h). Do not administer as an intravenous push or bolus.
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