Gemtabin Special Precautions

Prolongation of the infusion time beyond 60 minutes and more frequent than weekly dosing have been shown to increase toxicity.
This preparation is for intravenous use only. Patients receiving therapy with gemcitabine should be monitored closely by a physician experienced in the use of cancer chemotherapeutic agents. Gemcitabine can suppress bone marrow function as manifested by leukopenia, thrombocytopenia, and anemia, and myelosuppression is usually the dose-limiting toxicity. Patients should be monitored for myelosuppression during therapy.
Gemcitabine should be used with caution in patients with preexisting renal impairment or hepatic insufficiency as there is insufficient information from clinical studies to allow clear dose recommendation for these patient populations. Administration of gemcitabine in patients with concurrent liver metastases or a pre-existing medical history of hepatitis, alcoholism, or liver cirrhosis may lead to exacerbation of the underlying hepatic insufficiency.
The patient should be cautioned that driving automobile, operating hazardous machinery or engaging in hazardous activities should not be undertaken during receiving the drug.
Use in Pregnancy: Gemcitabine HCl can cause fetal harm when administered to a pregnant woman.
Gemcitabine HCl has been shown to cause malformations and embryotoxicity in mice and rabbits. Pregnant women or women of childbearing potential should be advised to avoid becoming pregnant during therapy with gemcitabine HCl.
Use in Nursing Mothers: It is not known whether gemcitabine HCl or its metabolites are excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions from gemcitabine HCl in nursing infants, the mother should be warned and a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother and the potential risk to the infant.
Use in Children: The effectiveness of gemcitabine in pediatric patients has not been demonstrated. Gemcitabine was evaluated in a Phase 1 trial in pediatric patients with refractory leukemia and determined that the maximum tolerated dose was 10 mg/m²/min for 360 minutes three times weekly followed by a one week rest period. Gemcitabine was also evaluated in a Phase 2 trial in patients with relapsed acute lymphoblastic leukemia (22 patients) and acute myelogenous leukemia (10 patients) using 10 mg/m²/min for 360 minutes three times weekly followed by a one week rest period. Toxicities observed included bone marrow suppression, febrile neutropenia, elevation of serum transaminases, nausea, and rash/desquamation, which were similar to those reported in adults. No meaningful clinical activity was observed in this Phase 2 trial.
Use in Elderly: Gemcitabine clearance is affected by age. There is no evidence, however, that unusual dose adjustments are necessary in patients over 65, and in general, adverse reaction rates in the single-agent safety database of 979 patients were similar in patients above and below 65. Grade 3/4 thrombocytopenia was more common in the elderly. In the randomized clinical trial of Gemcitabine in combination with carboplatin for recurrent ovarian cancer, 125 women treated with gemcitabine plus carboplatin were <65 years and 50 were ≥65 years. Similar effectiveness was observed between older and younger women. There was significantly higher Grade 3/4 neutropenia in women 65 years of age or older. Overall, there were no substantial differences in toxicity profile of gemcitabine plus carboplatin based on age.