Adverse reactions occurring in ≥10% (all grades) of patients in the LARTRUVO + doxorubicin arm and at a higher incidence than in the doxorubicin alone arm (between arm difference of ≥5% for all grades or ≥2% for Grades 3 and 4)
*Abdominal pain includes: abdominal pain, lower abdominal pain, and upper abdominal pain.
†Fatigue includes: asthenia and fatigue.
‡Musculoskeletal pain includes: arthralgia, back pain, bone pain, flank pain, groin pain, musculoskeletal chest pain, musculoskeletal pain, myalgia, muscle spasms, neck pain, and pain in extremity.
The most common (≥20%) adverse reactions of LARTRUVO + doxorubicin were nausea, fatigue, musculoskeletal pain, mucositis, alopecia, vomiting, diarrhea, decreased appetite, abdominal pain, neuropathy, and headache.
Laboratory abnormalities worsening from baseline in >10% (all grades) of patients in the LARTRUVO + doxorubicin arm and occurring at a higher incidence than in the doxorubicin arm (between arm difference ≥5% for all grades and ≥2% for Grades 3 and 4)
*The incidence is based on the number of patients who had both baseline and at least one on-study laboratory measurement: LARTRUVO + doxorubicin arm (range 60 to 63 patients) and doxorubicin arm (range 39 to 62 patients).
†aPTT=activated partial thromboplastin time.
Febrile neutropenia: 13% for the LARTRUVO + doxorubicin-treated patients vs 12% for the doxorubicin-treated patients.
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LARTRUVO 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. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial.
Please see full Prescribing Information for LARTRUVO.
OR HCP ISI 19OCT2016