Gemcitabine, in combination with cisplatin, is indicated as
a first-line treatment of patients with locally advanced or metastatic
non-small cell lung cancer. It is also indicated for the palliative treatment
of patients with NSCLC. Gemcitabine is indicated for the treatment of adult
patients with locally advanced or metastatic adenocarcinoma of the pancreas,
including patients with 5-FU refractory pancreatic cancer. It is indicated for
treatment of advanced bladder cancer in combination with cisplatin therapy.
Gemcitabine, in combination with paclitaxel, is indicated for the treatment of
patients with metastatic breast cancer who have relapsed following adjuvant or
neoadjuvant chemotherapy. Prior chemotherapy should have included an
anthracycline, unless clinically contraindicated. Gemcitabine, in combination
with carboplatin, is indicated for the treatment of patients with recurrent
epithelial ovarian carcinoma who have relapsed following platinum-based
therapy.
Gemcitabine is contraindicated in patients with a known
hypersensitivity to the medicine or any excipients in the product.
The most common toxicities include hematological suppression
such as anemia, leukopenia, thrombocytopenia, and neutropenia. Hepatic
abnormalities such as elevated transaminases, alkaline phosphatase, and
bilirubin may occur. Gastrointestinal adverse events include nausea, vomiting,
diarrhea, and stomatitis. Mild proteinuria and hematuria have been reported.
Pulmonary toxicities include dyspnea and rarely interstitial pneumonitis.
Allergic reactions such as rash and pruritus are common. Other adverse effects
include flu-like symptoms, edema, alopecia, mild somnolence, and asthenia.
Severe but rare events include hemolytic-uremic syndrome, renal failure,
hepatic failure, severe skin reactions, and radiation recall.
Pregnancy Category D. Gemcitabine can cause fetal harm when
administered to a pregnant woman. It is embryotoxic and teratogenic in animal
studies. There are no studies in pregnant women. Gemcitabine should not be used
during pregnancy unless clearly necessary. It is unknown whether Gemcitabine or
its metabolites are excreted in human milk; therefore, breastfeeding should be
discontinued during treatment.
Patients should be monitored closely by a physician
experienced in chemotherapy. Blood counts and hepatic and renal function should
be assessed before each dose. Most adverse events are reversible and do not
necessitate discontinuation. Dose adjustments should be made for hematologic or
other toxicities. Caution should be used in patients with hepatic or renal impairment.
Elderly patients may be more susceptible to toxicities. Gemcitabine may have
radiosensitizing activity and concurrent use with radiotherapy should be
managed carefully.
There is no known antidote for Gemcitabine overdose.
Symptoms include severe myelosuppression, paresthesias, and severe rash.
Patients should receive supportive treatment with appropriate blood count
monitoring.
Store below 25°C in a dry place, protected from light and
moisture. Do not freeze.
