HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use LARTRUVO safely and effectively. See full prescribing information for LARTRUVO.
LARTRUVO (olaratumab) injection, for intravenous use
Initial U.S. Approval: 2016
INDICATIONS AND USAGE
LARTRUVO™ is a platelet-derived growth factor receptor alpha (PDGFR-α) blocking antibody 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. ( 1)
This indication is approved under accelerated approval. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial. (14)
DOSAGE AND ADMINISTRATION
-
Administer LARTRUVO at 15 mg/kg as an intravenous infusion over 60 minutes on Days 1 and 8 of each 21-day cycle until disease progression or unacceptable toxicity. (2.1)
-
For the first 8 cycles, LARTRUVO is administered with doxorubicin. (2.1)
-
Premedicate with diphenhydramine and dexamethasone intravenously, prior to LARTRUVO on Day 1 of cycle 1. (2.2)
-
For intravenous infusion only. Do not administer as an intravenous push or bolus. (2.4)
DOSAGE FORMS AND STRENGTHS
Injection: 500 mg/50 mL (10 mg/mL) solution in a single-dose vial ( 3)
CONTRAINDICATIONS
None. ( 4)
WARNINGS AND PRECAUTIONS
-
Infusion-Related Reactions: Monitor for signs and symptoms during and following infusion. Discontinue LARTRUVO for Grade 3 or 4 infusion-related reactions. (2.2, 2.3, 5.1)
-
Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of potential risk to the fetus and to use effective contraception during treatment with LARTRUVO and for 3 months after the last dose. (5.2, 8.1, 8.3)
ADVERSE REACTIONS
The most common (≥20%) adverse reactions of LARTRUVO plus doxorubicin are nausea, fatigue, musculoskeletal pain, mucositis, alopecia, vomiting, diarrhea, decreased appetite, abdominal pain, neuropathy, and headache. (6.1)
The most common (≥20%) laboratory abnormalities were lymphopenia, neutropenia, thrombocytopenia, hyperglycemia, elevated aPTT, hypokalemia, and hypophosphatemia. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact El |
