#高警訊藥品

Metastatic breast cancer: As first-line therapy in combination with paclitaxel for patients previously treated with anthracycline-containing adjuvant chemotherapy or in whom anthracyclines are clinically contraindicated.
Non-small cell lung cancer: As first line therapy in combination with cisplatin for patients with inoperable, locally advanced (Stage IIIA or IIIB) or metastatic (Stage IV) disease.
Ovarian cancer, Advanced: In combination with carboplatin for patients who relapsed at least 6 months after platinum-based therapy.
Pancreatic cancer: As first line therapy in locally advanced (nonresectable stage II or stage III) or metastatic (stage IV) disease, or for patients previously treated with 5-fluorouracil.

Antimetabolite Antineoplastic Agent (Pyrimidine Analog)
Gemcitabine is a nucleoside metabolic inhibitor that exhibits antitumor activity which is cell phase-specific for the G1/S-phase boundary of cell division.

Absorption:
Tmax: 30 minutes.
Distribution:
1. Vd: (short infusion): 50 L/m2; (long infusion): 370 L/m2
2. Protein binding: negligible.
Metabolism:
Via nucleoside kinases; active metabolites: Diphosphate nucleoside (dFdCDP), Triphosphate nucleoside (dFdCTP); inactive metabolites: 2'-dexoxy-2',2'-difluororuidine (dFdU)
Excretion:
Renal: 92% to 98%, less than 10% unchanged.
Elimination Half Life:
1. Short infusion (less than 70 minutes): 42 to 94 minutes.
2. Long infusion (70 to 285 minutes): 245 to 638 minutes.
3. Gemcitabine triphosphate (active metabolite, dFdCTP): 1.7 to 19.4 hours.

Hypersensitivity to gemcitabine hydrochloride.

D [FDA]、[AUS]

Infant risk cannot be ruled out.

1. Cardiovascular: Peripheral edema
2. Dermatologic: Alopecia, Rash
3. Endocrine metabolic: Hyperglycemia, Hypomagnesemia
4. Gastrointestinal: Constipation, Diarrhea, Nausea and vomiting, Stomatitis
5. Hematologic: Anemia, Neutropenia, Thrombocytopenia
6. Hepatic: Alkaline phosphatase raised, ALT/SGPT level raised, AST/SGOT level raised
7. Immunologic: Infectious disease, Lymphocytopenia
8. Neurologic: Paresthesia, Peripheral motor neuropathy, Sensory neuropathy
9. Renal: Hematuria, Proteinuria, Serum creatinine raised
10. Respiratory: Dyspnea
11. Other: Fatigue, Fever

Breast cancer, metastatic:
1,250 mg/m2 over 30 minutes days 1 and 8; repeat cycle every 21 days (in combination with paclitaxel) until disease progression or unacceptable toxicity
Non-small cell lung cancer:
1,000 mg/m2 over 30 minutes days 1, 8, and 15; repeat cycle every 28 days (in combination with cisplatin)
or
1,250 mg/m2 over 30 minutes days 1 and 8; repeat cycle every 21 days (in combination with cisplatin)
Ovarian cancer, advanced:
1,000 mg/m2 over 30 minutes days 1 and 8; repeat cycle every 21 days (in combination with carboplatin)
Pancreatic cancer, locally advanced or metastatic:
1,000 mg/m2 over 30 minutes once weekly for 7 weeks followed by 1 week rest; then administer on days 1, 8, and 15 every 28 days

The safety and effectiveness of gemcitabine in pediatric patients have not been established.

1. Mild to severe renal impairment: No dosage adjustment necessary
2. ESRD (on hemodialysis): Hemodialysis should begin 6 to 12 hours after gemcitabine infusion

1. Transaminases elevated (with normal bilirubin): No dosage adjustment necessary
2. Serum bilirubin >1.6 mg/dL: Use initial dose of 800 mg/m2; may escalate if tolerated