Active Ingredient: Olaratumab
Olaratumab is indicated in combination with doxorubicin for the treatment of adult patients with advanced soft tissue sarcoma who are not amenable to curative treatment with surgery or radiotherapy and who have not been previously treated with doxorubicin.
For this indication, competent medicine agencies globally authorize below treatments:
Intravenous
15 - 15 mg per kg of body weight
From 15 To 15 mg per kg of body weight once every 7 day(s)
The recommended dose of olaratumab is 15 mg/kg administered by intravenous infusion on days 1 and 8 of each 3 week cycle until disease progression or unacceptable toxicity. Olaratumab is administered in combination with doxorubicin for up to 8 cycles of treatment, followed by olaratumab monotherapy in patients whose disease has not progressed. Doxorubicin is given on day 1 of each cycle following the olaratumab infusion.
Premedication with an H1 antagonist (e.g., diphenhydramine) and dexamethasone (or equivalent medicinal products) should be given, intravenously, 30–60 minutes prior to the olaratumab doses on days 1 and 8 of cycle 1 in all patients. For subsequent cycles, premedication with an H1 antagonist (e.g., diphenhydramine) should be given intravenously 30–60 minutes prior to each dose of olaratumab.
For patients who experience Grade 1 or 2 IRR, the infusion should be interrupted and paracetamol, H1 antagonist and dexamethasone (or equivalent medicinal products) administered as needed. For all subsequent infusions, premedication with the following (or equivalent medicinal products) diphenhydramine hydrochloride (intravenously), paracetamol, and dexamethasone, should be given.
In the event that intravenous administration of an H1 antagonist is not possible, equivalent alternative premedication should be given (e.g. oral diphenhydramine hydrochloride at least 90 minutes prior to the infusion).
Olaratumab is administered as an intravenous infusion over approximately 60 minutes.
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