The toxicities of GEMZAR observed in pediatric patients were similar to those reported in adults.
GEMZAR clearance is affected by age as well as gender.
Patients receiving therapy with GEMZAR should be monitored closely by a physician experienced in the use of cancer chemotherapeutic agents.
Monitoring and Dosage Modifications
Dosage adjustments for hematologic toxicity may be required.
Serum creatinine, potassium, calcium, and magnesium should be monitored during combination therapy with cisplatin.
Patients should be assessed with a CBC, including differential and platelet count, prior to each dose of GEMZAR. Modify or suspend therapy according to the Dosage Reduction Guidelines in the full Prescribing Information.
Hepatic and renal function (including transaminases and serum creatinine) should be evaluated prior to therapy with GEMZAR and periodically thereafter.
Adverse Events
The most severe adverse events (grades 3/4) with GEMZAR plus paclitaxel for the treatment of patients with MBC were neutropenia (48%); alopecia (18%); leukopenia (11%); anemia (7%); fatigue (7%); thrombocytopenia (6%); ALT elevation (6%); and neuropathy-sensory (6%). The most common adverse events (all grades) were nausea (50%); fatigue (40%); myalgia (33%); and vomiting (29%). The most severe adverse events (grades 3/4) with GEMZAR for the first-line treatment of patients with pancreatic cancer were neutropenia (24%-26%); alkaline phosphatase elevation (16%-20%); AST elevation (12%-17%); nausea/vomiting (12%-13%); ALT elevation (10%-11%); anemia (10%); leukopenia (9%-10%); thrombocytopenia (8%-10%); bilirubin elevation (4%-8%); and pain (2%-7%). The most common adverse events (all grades) were AST (72%-78%); alkaline phosphatase (71%-77%); anemia (65%-73%); ALT (72%); leukopenia (64%-71%); nausea and vomiting (64%-71%); neutropenia (61%-62%); thrombocytopenia (36%-47%); pain (10%-42%); fever (30%-38%); proteinuria (10%-32%); constipation (10%-31%); diarrhea (24%-30%); rash (24%-28%); and bilirubin (16%-26%).
The most severe adverse events (grades 3/4) with GEMZAR plus cisplatin for the first-line treatment of patients with NSCLC were neutropenia (57%-64%); thrombocytopenia (50%-55%); leukopenia (29%-46%); anemia (22%-25%); nausea (27%); vomiting (23%); nausea/vomiting (39%); neuromotor (12%); hypomagnesemia (7%); neurohearing (6%); creatinine elevation (5%); alopecia (1%-13%); and dyspnea (1%-7%). The most common adverse events (all grades) were paresthesias (38%); hyperglycemia (30%); infection (18%-28%); and constipation (17%-28%).
The most severe adverse events (grades 3/4) with GEMZAR plus carboplatin for the treatment of patients with advanced ovarian cancer were neutropenia (71%), thrombocytopenia (35%), leukopenia (53%), anemia (28%), nausea (6%), vomiting (6%), and constipation (7%). The most common adverse events (all grades) were RBC transfusion (38%), alopecia (49%), neuropathy/sensory (29%), nausea (69%), fatigue (40%), vomiting (46%), diarrhea (25%), and constipation (42%).
See complete Warnings, Precautions, Adverse Reactions, and Dosage and Administration sections in the accompanying full Prescribing Information for safety and dosing guidelines.
About Lilly Oncology, a Division of Eli Lilly and Company
For more than four decades, Lilly Oncology has been collaborating with cancer researchers to deliver innovative treatment choices and valuable programs to patients and their physicians. Inspired by courageous patients living with cancer, Lilly Oncology is providing treatments that are considered global standards of care and developing a broad portfolio of novel targeted therapies to accelerate the pace and progress of cancer care. To learn more about Lilly's commitment to cancer, please visit www.LillyOncology.com.
About Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers - through medicines and information - for some of the world's most urgent medical needs.
P--LLY
ALIMTA(R) (pemetrexed for injection), Lilly
GEMZAR(R) (gemcitabine HCl for injection), Lilly
Taxol(R) (paclitaxel), Bristol-Meyers Squibb
Herceptin(R) (trastuzumab), Genentech
This press release contains forward-looking statements about the potential of GEMZAR for the treatment of breast cancer and reflects Lilly's current beliefs. However, as with any pharmaceutical product under development, there are substantial risks and uncertainties in the process of development, commercialization, and regulatory review. There is no guarantee that the product will receive additional regulatory approvals. There is also no guarantee that the product will continue to be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's filing with the United States Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.
(i) Sanchez-Munoz A, Duenos-Garcia R, et al. Neoadjuvant chemotherapy with a dose-dense sequential combination of epirubicin and cyclophosphamide followed by paclitaxel and gemcitabine +/- trastuzumab in stage II and III breast cancer. Correlation between pathologic complete response and biologic markers. Abstract #595, American Society of Clinical Oncology (ASCO) Annual Meeting 2007.
(ii) American Cancer Society, "What Are the Key Statistics for Breast Cancer?," American Cancer Society, www.cancer.org, (May 2, 2007).
(iii) Pan American Health Organization, "Guidelines for International Breast Health and Cancer Control," www.paho.org, (March 21, 2006).
(iv) American Cancer Society, "How is Breast Cancer Staged?," American Cancer Society, www.cancer.org (February 28, 2007).
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Gregory L. Clarke, Lilly, +1-317-276-5222 (office), +1-317-554-7119 (mobile), gregory.clarke@lilly.com; or Neil Hochman, CPR Worldwide, +1-212-453-2067 (office), +1-516-784-9089 (mobile), n.hochman@cprworldwideusa.com . NewsCom: http://www.newscom.com/cgi-bin/prnh/20070602/CLSA001 , PRN Photo Desk, photodesk@prnewswire.com
