What is the recommended dosage and administration of Gemtasa (gemcitabine) for cancer treatment?

From the Guidelines

Gemtasa (gemcitabine) should be administered intravenously at a dose of 1000 mg/m² over 30 minutes, weekly for 3 weeks every 28 days, as this is the recommended regimen for metastatic pancreatic adenocarcinoma, according to the NCCN guidelines 1. The specific dosage and schedule of gemcitabine may vary depending on the type of cancer being treated and whether it is used alone or in combination with other chemotherapy agents. Some key points to consider when administering gemcitabine include:

• For patients with good performance status, combination chemotherapy regimens such as gemcitabine + erlotinib, FOLFIRINOX, or gemcitabine + nab-paclitaxel may be considered 1.
• Fixed-dose rate gemcitabine (10 mg/m²/min) may be used as an alternative to standard infusion of gemcitabine over 30 minutes, as it has been shown to maximize intracellular concentrations of the phosphorylated forms of gemcitabine 1.
• Dose adjustments are necessary based on blood counts, with reductions recommended for patients experiencing significant myelosuppression.
• Patients should be monitored for common side effects including myelosuppression, flu-like symptoms, nausea, and elevated liver enzymes during treatment. It's worth noting that the most recent guidelines from 2017 recommend gemcitabine as a single agent or in combination with other chemotherapy agents for the treatment of pancreatic adenocarcinoma, with the specific regimen depending on the patient's performance status and other factors 1.

From the FDA Drug Label

2 DOSAGE AND ADMINISTRATION 2.1 Ovarian Cancer Recommended Dose and Schedule The recommended dosage of Gemcitabine Injection is 1000 mg/m2 intravenously over 30 minutes on Days 1 and 8 of each 21-day cycle, in combination with carboplatin AUC 4 administered intravenously on Day 1 after Gemcitabine Injection administration. 2.2 Breast Cancer Recommended Dose and Schedule The recommended dosage of Gemcitabine Injection is 1250 mg/m2 intravenously over 30 minutes on Days 1 and 8 of each 21-day cycle in combination with paclitaxel 175 mg/m2 administered as a 3-hour intravenous infusion on Day 1 before Gemcitabine Injection administration. 2.3 Non-Small Cell Lung Cancer Recommended Dose and Schedule 28-day schedule The recommended dosage of Gemcitabine Injection is 1000 mg/m2 intravenously over 30 minutes on Days 1,8, and 15 of each 28-day cycle in combination with cisplatin 100 mg/m2 administered intravenously on Day 1 after Gemcitabine Injection administration 2.4 Pancreatic Cancer Recommended Dose and Schedule The recommended dose of Gemcitabine Injection is 1000 mg/m2 over 30 minutes intravenously.

The recommended dosage and administration of Gemcitabine (Gemtasa) for cancer treatment varies depending on the type of cancer:

• Ovarian Cancer: 1000 mg/m2 on Days 1 and 8 of each 21-day cycle, in combination with carboplatin.
• Breast Cancer: 1250 mg/m2 on Days 1 and 8 of each 21-day cycle, in combination with paclitaxel.
• Non-Small Cell Lung Cancer: 1000 mg/m2 on Days 1,8, and 15 of each 28-day cycle, in combination with cisplatin.
• Pancreatic Cancer: 1000 mg/m2 weekly for the first 7 weeks, followed by one week of rest, then weekly on Days 1,8, and 15 of 28-day cycles. 2

From the Research

Recommended Dosage and Administration of Gemtasa (Gemcitabine)

The recommended dosage and administration of Gemtasa (gemcitabine) for cancer treatment vary depending on the type of cancer and the stage of the disease.

• For locally advanced and metastatic pancreatic cancer, the recommended dosage is 1000 mg/m2 (as the hydrochloride salt) i.v. given over 30 minutes weekly for seven weeks, followed after one week of rest by 1000 mg/m2 i.v. given over 30 minutes weekly for three weeks every four weeks 3.
• In clinical studies, gemcitabine has shown activity against non-small-cell lung cancer, particularly when combined with cisplatin or ifosfamide, and has also shown modest activity against advanced ovarian and breast cancer 3, 4.
• The ESPAC-4 trial compared adjuvant gemcitabine and capecitabine with gemcitabine monotherapy in patients with resected pancreatic cancer, and found that the combination of gemcitabine and capecitabine resulted in a median overall survival of 28.0 months, compared to 25.5 months with gemcitabine alone 5.
• A retrospective analysis of patients with stage IV transitional cell carcinoma (TCC) found that a 3-week schedule of gemcitabine and cisplatin was comparable to a 4-week schedule in terms of overall survival, but had less toxicity 6.
• A randomized trial found that gemcitabine as first-line therapy for patients with advanced pancreas cancer resulted in a clinical benefit response in 23.8% of patients, compared to 4.8% with fluorouracil (5-FU), and also conferred a modest survival advantage over treatment with 5-FU 7.

Administration Schedules

• Weekly administration for seven weeks, followed by a week of rest, and then weekly administration for three weeks every four weeks 3.
• A 3-week schedule of gemcitabine and cisplatin has been found to be comparable to a 4-week schedule in terms of overall survival, but with less toxicity 6.
• Six cycles of gemcitabine alone or with capecitabine, administered over 21 days followed by 7 days' rest 5.