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Olaratumab (Lartruvo)

Trade Name : LARTRUVO

Eli Lilly and Company

INJECTION, SOLUTION

Strength 10 mg/mL

OLARATUMAB

Delivery Process

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Olaratumab (Lartruvo) which is also known as LARTRUVO and Manufactured by Eli Lilly and Company. It is available in strength of 10 mg/mL per ml. Read more

Olaratumab (Lartruvo) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • LARTRUVOu2122 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.n
  • 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.n
  • LARTRUVOu2122 is a platelet-derived growth factor receptor alpha (PDGFR-u03b1) 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. ()n
  • 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. ()n
  • No data
  • Administer LARTRUVO at 15u00a0mg/kg as an intravenous infusion over 60 minutes on Days 1 and 8 of each 21-day cycle until disease progression or unacceptable toxicity. ()n
  • For the first 8 cycles, LARTRUVO is administered with doxorubicin. ()n
  • Premedicate with diphenhydramine and dexamethasone intravenously, prior to LARTRUVO on Day 1 of cycle 1. ()n
  • For intravenous infusion only
  • Injection: 500u00a0mg/50u00a0mL (10u00a0mg/mL) or 190u00a0mg/19u00a0mL (10u00a0mg/mL) clear to slightly opalescent, colorless to slightly yellow solution in a single-dose vial.n
  • Injection: 500u00a0mg/50u00a0mL (10u00a0mg/mL) or 190u00a0mg/19u00a0mL (10u00a0mg/mL) solution in a single-dose vial ()n
  • None.n
  • None. ()n
  • No data
  • Infusion-Related Reactions
  • Embryo-Fetal Toxicity
  • The following adverse drug reactions are described elsewhere in the labeling:n
  • The most common (u226520%) adverse reactions of LARTRUVO plus doxorubicin are nausea, fatigue, musculoskeletal pain, mucositis, alopecia, vomiting, diarrhea, decreased appetite, abdominal pain, neuropathy, and headache. ()n
  • The most common (u226520%) laboratory abnormalities were lymphopenia, neutropenia, thrombocytopenia, hyperglycemia, elevated aPTT, hypokalemia, and hypophosphatemia. ()n
  • To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • Lactation: Advise women not to breastfeed. ()n
  • Olaratumab is a recombinant human IgG1 monoclonal blocking antibody that binds specifically to human platelet-derived growth factor receptor alpha (PDGFR-u03b1). LARTRUVO has an approximate molecular weight of 154u00a0kDa. LARTRUVO is produced in genetically engineered mammalian NS0 cells.n
  • LARTRUVO is a sterile, preservative-free, clear to slightly opalescent, and colorless to slightly yellow solution. LARTRUVO injection is supplied in single-dose vials for intravenous use following dilution. Each vial contains 500u00a0mg LARTRUVO in 50u00a0mL (10u00a0mg/mL) or 190u00a0mg LARTRUVO in 19u00a0mL (10u00a0mg/mL). Each mL contains 10u00a0mg olaratumab, glycine (7.5u00a0mg), L-histidine (0.3u00a0mg), L-histidine monohydrochloride (1.7u00a0mg), mannitol (13.7u00a0mg), polysorbate 20 (0.2u00a0mg), sodium chloride (2.9u00a0mg), and water for injection, USP, pH 5.2 to 5.8.n
  • No data
  • No studies have been performed to assess the potential of olaratumab for carcinogenicity or genotoxicity.n
  • Fertility studies have not been performed with olaratumab; however, in animal knockout models, loss of PDGFR-u03b1 pathway signaling resulted in progressive reduction in testicular size, Leydig cell loss, and spermatogenic arrest.n
  • The efficacy of LARTRUVO was demonstrated in Trial 1, an open-label, randomized, active-controlled study. Eligible patients were required to have soft tissue sarcoma not amenable to curative treatment with surgery or radiotherapy, a histologic type of sarcoma for which an anthracycline-containing regimen was appropriate but had not been administered, ECOG PS of 0-2, and tumor specimen available for assessment of PDGFR-u03b1 expression by an investigational use assay. Patients were randomized (1:1) to receive LARTRUVO in combination with doxorubicin or doxorubicin as a single agent. PDGFR-u03b1 expression (positive versus negative), number of previous lines of treatment (0 versus 1 or more), histological tumor type (leiomyosarcoma versus synovial sarcoma versus all others), and ECOG PS (0 or 1 versus 2) were used to allocate patients in the randomization. LARTRUVO was administered at 15u00a0mg/kg as an intravenous infusion on Days 1 and 8 of each 21-day cycle until disease progression or unacceptable toxicity. All patients received doxorubicin 75u00a0mg/m as an intravenous infusion on Day 1 of each 21-day cycle for a maximum of eight cycles and were permitted to receive dexrazoxane prior to doxorubicin in Cycles 5 to 8. Patients randomized to receive doxorubicin as a single agent were offered LARTRUVO at the time of disease progression. The efficacy outcome measures were overall survival (OS), and progression-free survival (PFS) and objective response rate (ORR) as assessed by investigator and by independent review according to RECIST v1.1.n
  • A total of 133 patients were randomized, 66 patients to the LARTRUVO plus doxorubicin arm and 67 patients to the doxorubicin arm. Baseline demographics and disease characteristics were: median age of 58 years (range 22 to 86); 44% men; 86% White, 8% Black, 3% Asian, and 2% Other; 56% ECOG PS 0 and 39% ECOG PS 1; 65% no prior chemotherapy (excluding adjuvant and neoadjuvant therapy); 38% leiomyosarcoma, 1.5% synovial sarcoma, and 61% other histologies [17% liposarcoma (8% dedifferentiated, 4% myxoid, 3% well-differentiated, 1.5% pleomorphic, 1% liposarcoma not otherwise specified (NOS)), 11% undifferentiated pleomorphic sarcoma, 5% angiosarcoma, 5% undifferentiated sarcoma NOS, 3% extraskeletal myxoid chondrosarcoma, 2% malignant peripheral nerve sheath tumor, 2% myxofibrosarcoma, 2% malignant solitary fibrous tumor, 2% endometrial stromal sarcoma, 1.5% chondrosarcoma, 1.5% epithelioid sarcoma, 1.5% fibrosarcoma, 1.5% low-grade fibromyxoid sarcoma, and 5% other histologies with one patient each]. All patients had metastatic disease and were enrolled at U.S. sites. Among patients randomized to doxorubicin, 30 (45%) patients received LARTRUVO as a single agent at the time of disease progression.n
  • Trial 1 demonstrated a significant improvement in overall survival. The efficacy results are summarized in and .n
  • Figure 1: Kaplan-Meier Curves of Overall Survival
  • LARTRUVO is supplied in single-dose vials as a sterile, preservative-free, clear to slightly opalescent and colorless to slightly yellow solution.n
  • Store vials in a refrigerator at 2u00b0C to 8u00b0C (36u00b0F to 46u00b0F) until time of use. Keep the vial in the outer carton to protect from light. the vial.n
  • No data
  • PACKAGE CARTON u2013 LARTRUVO 500 mg/50 mL single-use vial
  • NDC 0002-8926-01n
  • Rx onlyn
  • LARTRUVOn
  • (olaratumab)n
  • Injectionn
  • 500 mg/50 mLn
  • (10 mg/mL)n
  • For Intravenous Infusion Onlyn
  • Must Dilute Prior to Usen
  • Single-Dose Vialn
  • Discard Unused Portionn
  • Keep Refrigeratedn
  • www.lilly.comn
  • Lillyn
  • PACKAGE CARTON u2013 LARTRUVO 190 mg/19 mL single-use vial
  • NDC 0002-7190-01n
  • Rx onlyn
  • LARTRUVOn
  • (olaratumab)n
  • Injectionn
  • 190 mg/19 mLn
  • (10 mg/mL)n
  • For Intravenous Infusion Onlyn
  • Must Dilute Prior to Usen
  • Single-Dose Vialn
  • Discard Unused Portionn
  • Keep Refrigeratedn
  • www.lilly.comn
  • Lillyn

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