| GEMCITABINE HYDROCHLORIDE
Classifications: antineoplastic agent; antimetabolite, pyrimidine; Therapeutic: antineoplastic; antimetabolite
Pregnancy Category: D
20 mg/mL injection
Pyrimidine analog with cell phase specificity by affecting rapidly dividing cells in S phase (DNA synthesis). It also blocks
the progression of cells from G1 phase to S phase of cell cycle. Gemcitabine interferes with DNA synthesis by inhibiting ribonucleotide reductase, which results
in a reduction in the concentration of deoxynucleotides. In addition, if gemcitabine is incorporated into the DNA strand,
it inhibits further growth of the DNA strand.
Gemcitabine induces DNA fragmentation in dividing cells, resulting in the cell death of tumor cells.
Locally advanced or metastatic adenocarcinoma of the pancreas, non-small cell lung cancer, breast cancer.
Hypersensitivity to gemcitabine, severe thrombocytopenia, acute infection, pregnancy (category D), lactation.
Myelosuppression, renal or hepatic dysfunction, older adults; neutropenia; history of bleeding disorders, infection, previous
cytotoxic or radiation treatment. Safety and effectiveness in children are not established.
Route & Dosage
Adult: IV 1000 mg/m2 once weekly for up to 7 wk, followed by 1 wk rest from treatment; may repeat once weekly for 3 of every 4 wk
Non-Small Cell Lung Cancer
Adult: IV 1000 mg/m2 on days 1, 8, 15 of 28-d cycle OR 1250 mg/m2 on days 1 and 8 of 21 d cycle. Given with cisplatin.
Adult: IV 1250 mg/m2 on days 1 and 8 of 21 d cycle. Given with paclitaxel.
PREPARE: IV Infusion: ??Dilute with NS without preservatives by adding 5 mL or 25 mL to the 200 mg or 1 g vial, respectively, to yield 38 mg/mL.??Shake to dissolve.??Dilute further if necessary with NS to concentrations as low as 0.1 mg/mL.
ADMINISTER: IV Infusion: Infuse over 30 min. Infusion time >60 min is associated with increased toxicity.
INCOMPATIBILITIES Y-site: Acyclovir, amphotericin B, cefoperazone, cefotaxime, furosemide, ganciclovir, imipenem/cilastatin, irinotecan, methotrexate, methylprednisolone, mitomycin, piperacillin, piperacillin/tazobactam, prochlorperazine.
- Store reconstituted solutions unrefrigerated at 20°25° C (68°77° F). Use within 24 h
Adverse Effects (≥1%)CNS: Fever, flu-like syndrome (anorexia, headache, cough, chills, myalgia),
paresthesias. GI: Nausea, vomiting, diarrhea, stomatitis
, transient elevations of liver transaminases. Hematologic: Myelosuppression (anemia, leukopenia, neutropenia, thrombocytopenia)
Bullous skin eruption, desquamation. Urogenital:
Mild proteinuria and hematuria. Other: Dyspnea, edema, peripheral edema, infection
, elevated liver function tests.
May increase effect of warfarin
or oral anticoagulants
Peak concentrations reached 30 min after infusion; lower clearance in women and older adult results in higher concentrations
at any given dose. Distribution:
Crosses placenta, distributed into breast milk. Metabolism:
Intracellularly by nucleoside kinases to active diphosphate and triphosphate nucleosides. Elimination:
9298% recovered in urine within 1 wk. Half-Life:
Assessment & Drug Effects
- Lab tests: Monitor CBC with differential and platelet count prior to each dose. Monitor baseline and periodic renal and hepatic
Patient & Family Education
- Learn about common adverse effects and measures to control or minimize when possible. Notify physician immediately of any
distressing adverse effects.
- Note: Fever with flu-like symptoms, rash, and GI distress are very common.