gemcitabine hydrochloride
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gemcitabine hydrochloride
Pharmacologic class: Antimetabolite (pyrimidine analog)
Therapeutic class: Antineoplastic
Pregnancy risk category D
Action
Kills malignant cells undergoing DNA synthesis; arrests progression of cells at G1/S border
Availability
Powder for injection: 200 mg in 10-ml vial, 1 g in 50-ml vial
Indications and dosages
➣ Pancreatic cancer
Adults: 1,000 mg/m2 I.V. q week for 7 weeks, followed by 1 week of rest. May continue with cycles of once-weekly administration for 3 weeks, followed by 1 week of rest.
➣ Non-small-cell lung cancer (given with cisplatin)
Adults: 1,000 mg/m2 I.V. on days 1, 8, and 15 of 28-day cycle; or 1,250 mg/m2 on days 1 and 8 of 21-day cycle. Cisplatin also given on day 1.
➣ Breast cancer (combined with paclitaxel after failure of anthracylinecontaining adjuvant chemotherapy, unless anthracyclines were contraindicated)
Adults: 1,250 mg/m2 I.V. over 30 minutes on days 1 and 8 of 21-day cycle, with paclitaxel given on day 1 before gemcitabine
➣ Advanced ovarian cancer after 6-month failure on platinum-based therapy (combined with carboplatin)
Adults: 1,000 mg/m2 I.V. over 30 minutes on days 1 and 8 of each 21-day cycle, with carboplatin given on day 1 after gemcitabine administration.
Dosage adjustment
• Bone marrow depression
Off-label uses
• Bladder cancer
Contraindications
• Hypersensitivity to drug
Precautions
Use cautiously in:
• hepatic or renal impairment
• females of childbearing age
• pregnant or breastfeeding patients.
Administration
• Follow facility policy for preparing, handling, and administering carcinogenic, mutagenic, and teratogenic drugs.
• Add 5 ml of preservative-free normal saline solution to 200-mg vial, or add 25 ml of this solution to 1-g vial. Shake vial to dissolve drug.
• Reconstitute drug to a concentration of 40 mg/ml. If necessary, dilute further to a concentration of 1 mg/ml.
☞ Infuse each dose over 30 minutes. (Infusions lasting longer than 1 hour increase toxicity risk.)
Adverse reactions
CNS: paresthesia
GI: nausea, vomiting, diarrhea, stomatitis
GU: hematuria, proteinuria, hemolytic uremic syndrome, renal failure
Hematologic: anemia, leukopenia, thrombocytopenia
Respiratory: dyspnea, bronchospasm
Skin: alopecia, rash, cellulitis
Other: flulike symptoms, fever, edema, injection site reactions, anaphylactoid reactions
Interactions
Drug-drug. Live-virus vaccines: decreased antibody response to vaccine, increased risk of adverse reactions
Other antineoplastics: additive bone marrow depression
Drug-diagnostic tests. Alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, bilirubin: transient increases
Blood urea nitrogen, serum creatinine: increased levels
Patient monitoring
☞ Stop infusion and notify prescriber immediately if patient has signs or symptoms of allergic reaction.
• Monitor liver and kidney function test results.
☞ Monitor CBC with white cell differential (particularly neutrophil and platelet counts) before each dose.
• Assess degree of bone marrow depression. Expect dosage changes based on blood counts.
☞ Watch for signs and symptoms of infection and bleeding tendencies, even after drug therapy ends.
• Evaluate respiratory status regularly.
• Monitor temperature, especially during first 12 hours of therapy.
Patient teaching
☞ Instruct patient to stop taking drug and immediately report signs or symptoms of allergic reaction.
☞ Advise patient to immediately report signs or symptoms of infection (especially flulike symptoms).
☞ Instruct patient to report unusual bleeding or bruising, change in urination pattern, or difficulty breathing.
• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration and alertness.
• Advise patient to avoid activities that can cause injury. Tell him to use soft toothbrush and electric razor to avoid gum and skin injury.
• Tell patient to minimize GI upset by eating frequent, small servings of healthy food.
• Inform patient that he'll undergo blood testing periodically throughout therapy.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and tests mentioned above.