Generic name: olaratumab 10mg in 1mL
Dosage form: injection
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The recommended dose of LARTRUVO is 15 mg/kg administered as an intravenous infusion over 60 minutes on Days 1 and 8 of each 21-day cycle until disease progression or unacceptable toxicity. For the first 8 cycles, LARTRUVO is administered with doxorubicin, [see Clinical Studies (14)].
Refer to doxorubicin prescribing information for dosing, and dose modifications.
- Premedicate with diphenhydramine (25 to 50 mg intravenously) and dexamethasone (10 to 20 mg intravenously) prior to LARTRUVO on Day 1 of cycle 1.
- Permanently discontinue LARTRUVO for Grade 3 or 4 infusion-related reactions [see Dosage and Administration (2.2) and Warnings and Precautions (5.1)].
- Interrupt infusion of LARTRUVO for Grade 1 or 2 infusion-related reactions (IRR). After resolution, resume LARTRUVO infusion at 50% of the initial infusion rate. [see Warnings and Precautions (5.1)]
- For neutropenic fever/infection or Grade 4 neutropenia lasting longer than 1 week, discontinue administration of LARTRUVO until the absolute neutrophil count is 1,000 /microliter or greater and then permanently reduce the dose to 12 mg/kg.
Preparation and Administration
- Inspect vial contents for particulate matter and discoloration prior to dilution [see Description (11)]. Discard the vial if particulate matter or discolorations are identified.
- Withdraw calculated dose and further dilute with 0.9% Sodium Chloride Injection, USP to a final volume of 250 mL for intravenous infusion. Do not use dextrose-containing or other solutions.
- Gently invert but do not shake.
- DO NOT FREEZE the diluted solution.
- Store the diluted solution for up to 24 hours under refrigeration at 2°C to 8°C (36°F to 46°F) and for up to an additional 4 hours at room temperature (below 25°C [77°F]). Storage times include the duration of infusion. If refrigerated, allow the diluted solution to come to room temperature prior to administration.
- Discard vial with any unused portion of LARTRUVO.
- Do not administer LARTRUVO as an intravenous push or bolus. Do not co-infuse with electrolytes or other medications through the same intravenous line.
- Visually inspect the diluted solution for particulate matter and discoloration prior to administration. If particulate matter or discolorations are identified, discard the solution.
- Administer diluted solution as an intravenous infusion over 60 minutes. Flush the line with 0.9% Sodium Chloride Injection, USP at end of infusion.