Lartruvo Olaratumab 10mg

Description

LARTRUVO (Olaratumab 10mg)is indicated, in combination with doxorubicin, for the treatment of adult patients with soft tissue sarcoma (STS) with a histologic subtype for which an anthracycline-containing regimen is appropriate and which is not amenable to curative treatment with radiotherapy or surgery. This indication is approved under accelerated approval [see Clinical Studies]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial. DOSAGE AND ADMINISTRATION Recommended Dosage 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]. Refer to doxorubicin prescribing information for dosing, and dose modifications. Premedication Premedicate with diphenhydramine (25 to 50 mg intravenously) and dexamethasone (10 to 20 mg intravenously) prior to LARTRUVO on Day 1 of cycle 1. Dosing Modifications Infusion-Related Reactions Permanently discontinue LARTRUVO for Grade 3 or 4 infusion-related reactions [see Premedication and WARNINGS AND PRECAUTIONS]. 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] Neutropenia 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 Preparation Inspect vial contents for particulate matter and discoloration prior to dilution [see DESCRIPTION]. 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. Administration 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. HOW SUPPLIED Dosage Forms And Strengths Injection: 500 mg/50 mL (10 mg/mL) or 190 mg/19 mL (10 mg/mL) clear to slightly opalescent, colorless to slightly yellow solution in a single-dose vial.