gemcitabine hydrochloride

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.

See 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

See Stop infusion and notify prescriber immediately if patient has signs or symptoms of allergic reaction.

• Monitor liver and kidney function test results.

See 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.

See 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

See Instruct patient to stop taking drug and immediately report signs or symptoms of allergic reaction.

See Advise patient to immediately report signs or symptoms of infection (especially flulike symptoms).

See 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.