gemcitabine hydrochloride

gemcitabine hydrochloride Warning - Hazardous drug!

Gemzar

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 anthracyline-containing 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

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.)

Route	Onset	Peak	Duration
I.V.	Unknown	Unknown	Unknown

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.