Gemzar


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gemcitabine hydrochloride

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 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.

gemcitabine

(jem-site-a-been) ,

Gemzar

(trade name)

Classification

Therapeutic: antineoplastics
Pharmacologic: antimetabolites
Pregnancy Category: D

Indications

Pancreatic cancer (locally advanced or metastatic).Inoperable locally advanced/metastatic non–small-cell lung cancer (with cisplatin).Metastatic breast cancer (with paclitaxel).Advanced ovarian cancer that has relapsed 6 mo after completion of platinum-based therapy (with carboplatin).

Action

Interferes with DNA synthesis (cell-cycle phase–specific).

Therapeutic effects

Death of rapidly replicating cells, particularly malignant ones.

Pharmacokinetics

Absorption: IV administration results in complete bioavailability.
Distribution: Unknown.
Metabolism and Excretion: Converted in cells to active diphosphate and triphosphate metabolites; these are excreted primarily by the kidneys.
Half-life: 32–94 min.

Time/action profile (effect on blood counts)

ROUTEONSETPEAKDURATION
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Contraindications/Precautions

Contraindicated in: Hypersensitivity; Obstetric: Can cause fetal malformation; Lactation: Can expose infant to serious adverse effects. Bottle-feed if gemcitabine therapy is necessary.
Use Cautiously in: History of cardiovascular disease;Impaired hepatic or renal function (↑ risk of toxicity);Other chronic debilitating illness; Obstetric: Patients with child-bearing potential.

Adverse Reactions/Side Effects

Respiratory

  • pulmonary toxicity (life-threatening)
  • dyspnea (most frequent)
  • bronchospasm

Cardiovascular

  • arrhythmias (life-threatening)
  • capillary leak syndrome (life-threatening)
  • cerebrovascular accident (life-threatening)
  • mi (life-threatening)
  • edema (most frequent)
  • hypertension

Gastrointestinal

  • hepatotoxicity (life-threatening)
  • diarrhea (most frequent)
  • nausea (most frequent)
  • stomatitis (most frequent)
  • transient ↑ of liver enzymes (most frequent)
  • vomiting (most frequent)

Genitourinary

  • hemolytic uremic syndrome (life-threatening)
  • hematuria (most frequent)
  • proteinuria (most frequent)

Dermatologic

  • alopecia (most frequent)
  • rash

Hematologic

  • anemia (most frequent)
  • leukopenia (most frequent)
  • thrombocytopenia (most frequent)

Local

  • injection site reactions

Neurologic

  • paresthesias

Miscellaneous

  • flu-like symptoms (most frequent)
  • fever
  • anaphylactoid reactions

Interactions

Drug-Drug interaction

↑ bone marrow depression with other antineoplastics or radiation therapy.May ↓ antibody response to live virus vaccines and ↑ risk of adverse reactions.

Route/Dosage

Other regimens are used

Pancreatic Cancer

Intravenous (Adults) 1000 mg/m2 once weekly for 7 wk, followed by a week of rest. May be followed by cycles of once-weekly administration for 3 wk followed by a week of rest.

Non–Small-Cell Lung Cancer (with Cisplatin)

Intravenous (Adults) 1000 mg/m2 on days 1, 8, and 15 of each 28-day cycle (cisplatin is also given on day 1) or 1250 mg/m2 on days 1 and 8 of each 21-day cycle (cisplatin is also given on day 1).

Breast Cancer

Intravenous (Adults) 1250 mg/m2 on days 1 and 8 of each 21-day cycle (paclitaxel is also given on day 1).

Ovarian Cancer

Intravenous (Adults) 1000 mg/m2 on days 1 and 8 of each 21-day cycle.

Availability (generic available)

Powder for injection: 200 mg/vial, 1 g/vial, 2 g/vial

Nursing implications

Nursing assessment

  • Monitor vital signs before and frequently during therapy.
  • Assess injection site during administration. Although gemcitabine is not considered a vesicant, local reactions may occur.
  • Monitor for bone marrow depression. Assess for bleeding (bleeding gums, bruising, petechiae; guaiac stools, urine, and emesis) and avoid IM injections and taking rectal temperatures if platelet count is low. Apply pressure to venipuncture sites for 10 min. Assess for signs of infection during neutropenia. Anemia may occur. Monitor for increased fatigue, dyspnea, and orthostatic hypotension.
  • Monitor intake and output, appetite, and nutritional intake. Mild to moderate nausea and vomiting occur frequently. Antiemetics may be used prophylactically.
  • Assess for signs and symptoms of capillary leak syndrome (severe hypotension, hypoalbuminemia, hemoconcentration). Discontinue therapy if symptoms occur.
  • Lab Test Considerations: Monitor CBC, including differential and platelet count, before each dose. Dose guidelines are based on the CBC. For single-agent use: If the absolute granulocyte count is >1000 and platelet count is >100,000, the full dose may be administered. If the absolute granulocyte count is 500–999 or platelet count is 50,000–99,000, 75% of the dose may be given. If the absolute granulocyte count is <500 or the platelet count is <50,000, withhold further doses. For gemcitabine with paclitaxel (breast cancer): If the absolute granulocyte count is >1200 and platelet count is >75,000, the full dose may be administered. If the absolute granulocyte count is 1000–1199 or platelet count is 50,000–75,000, 75% of the dose may be given. If the absolute granulocyte count is 700–999 or platelet count is ≥50,000, 50% of the dose may be given. If the absolute granulocyte count is <700 or the platelet count is <50,000, withhold further doses.
    • Monitor serum creatinine, potassium, calcium, and magnesium in patients taking cisplatin with gemcitabine. For gemcitabine with carboplatin (ovarian cancer): If the absolute granulocyte count is >1500 and platelet count is >100,000, the full dose may be administered. If the absolute granulocyte count is 1000–1499 or platelet count is 75,000–99,000, 75% of the dose may be given. If the absolute granulocyte count is <1000 or the platelet count is <75,000, withhold further doses.
    • Monitor hepatic and renal function before and periodically during therapy. May cause transient ↑ in serum AST, ALT, alkaline phosphatase, and bilirubin concentrations.
    • May also cause ↑ BUN and serum creatinine concentrations, proteinuria, and hematuria.

Potential Nursing Diagnoses

Risk for infection (Adverse Reactions)

Implementation

  • high alert: Fatalities have occurred with incorrect administration of chemotherapeutic agents. Before administering, clarify all ambiguous orders; double-check single, daily, and course-of-therapy dose limits; have second practitioner independently double-check original order, calculations, and infusion pump settings.
  • Solution should be prepared in a biologic cabinet. Wear gloves, gown, and mask while handling IV medication. Discard IV equipment in specially designated containers.
  • Intravenous Administration
  • Intermittent Infusion: To reconstitute, add 5 mL of 0.9% NaCl without preservatives to 200-mg vial or 25 mL of 0.9% NaCl to the 1-g vial of gemcitabine for a concentration of 40 mg/mL. Incomplete dissolution may result in concentrations greater than 40 mg/mL. Diluent: May be further diluted with 0.9% NaCl. Solution is colorless to light straw color. Do not administer solutions that are discolored or contain particulate matter. Solution is stable for 24 hr at room temperature. Discard unused portions. Do not refrigerate; crystallization may occur.Concentration: 0.1–38 mg/mL.
  • Rate: Administer dose over 30 min. Infusions longer than 60 min have a greater incidence of toxicity.
  • Y-Site Compatibility: alemtuzumab, alfentanil, allopurinol, amifostine, amikacin, aminocaproic acid, aminophylline, amiodarone, ampicillin, ampicillin/sulbactam, anidulafungin, argatroban, atracurium, azithromycin, aztreonam, bivalirudin, bleomycin, bumetanide, buprenorphine, butorphanol, calcium acetate, calcium chloride, calcium gluconate, carboplatin, carmustine, caspofungin, cefazolin, cefotetan, cefoxitin, ceftazidime, ceftriaxone, cefuroxime, chlorpromizine, ciprofloxacin, cisatracurium, cisplatin, clindamycin, cyclophosphamide, cyclosporine, cytarabine, dactinomycin, daunorubicin, dexamethasone, dexmedetomidine, dexrazoxane, digoxin, diltiazem, diphenhydramine, dobutamine, docetaxel, dolasetron, dopamine, doripenem, doxacurium, doxorubicin, doxycycline, droperidol, enalaprilat, ephedrine, epinephrine, epirubicin, ertapenem, erythromycin, esmolol, etoposide, etoposide phosphate, famotidine, fenoldopam, fentanyl, floxuridine, fluconazole, fludarabine, fluorouracil, foscarnet, fosphenytoin, gentamicin, glycopyrrolate, granisetron, haloperidol, heparin, hydralazine, hydrocortisone, hydromorphone, idarubicin, ifosfamide, insulin, isoproterenol, labetalol, leucovorin, levofloxacin, lidocaine, linezolid, lorazepam, magnesium sulfate, mannitol, meperidine, meropenem, mesna, metaraminol, methyldopate, metoclopramide, metoprolol, metronidazole, midazolam, milrinone, mitoxantrone, morphine, moxifloxacin, nalbuphine, naloxone, nesiritide, nicardipine, nitroglycerin, nitroprusside, norepinephrine, octreotide, ondansetron, oxaliplatin, paclitaxel, palinosetron, pamidronate, pancuronium, pentamidine, pentazocine, pentobarbital, phenobarbital, phentolamine, potassium acetate, potassium chloride, potassium phosphates, procainamide, promethazine, propranolol, quinupristin/dalfopristin, ranitidine, remifentanil, rituxumab, rocuronium, sodium acetate, sodium bicarbonate, sodium phosphates, streptozocin, succinylcholine, sufentanil, tacrolimus, teniposide, thiotepa, ticarcillin/clavulanate, tigecycline, tirofiban, tobramycin, topotecan, trastuzumab, trimethoprim/sulfamethoxazole, vancomycin, vasopressin, vecuronium, verapamil, vinblastine, vincristine, vinorelbine, voriconazole, zidovudine, zoledronic acid
  • Y-Site Incompatibility: acyclovir, amphotericin B colloidal, amphotericin B lipid complex, amphotericin B liposome, cefepime, cefoperazone, cefotaxime, chloramphenicol, dantrolene, daptomycin, diazepam, doxorubicin liposomal, furosemide, ganciclovir, imipenem-cilastatin, irinotecan, ketorolac, methotrexate, methoprednisolone, mitomycin, nafcillin, pantoprazole, pemetrexed, phenytoin, piperacillin/tazobactam, prochlorperazine, thiopental

Patient/Family Teaching

  • Instruct patient to notify health care professional if fever; chills; sore throat; signs of infection; bleeding gums; bruising; petechiae; or blood in urine, stool, or emesis occurs. Caution patient to avoid crowds and persons with known infections. Instruct patient to use soft toothbrush and electric razor. Patient should be cautioned not to drink alcoholic beverages or take products containing aspirin or NSAIDs.
  • Instruct patient to inspect oral mucosa for erythema and ulceration. If ulceration occurs, advise patient to use sponge brush and rinse mouth with water after eating and drinking. Stomatitis pain may require management with opioid analgesics.
  • Instruct patient to notify health care professional if flu-like symptoms (fever, anorexia, headache, cough, chills, myalgia), swelling of the feet or legs, or shortness of breath occurs.
  • Discuss with patient the possibility of hair loss. Explore methods of coping.
  • Advise patient that this medication may have teratogenic effects. Contraception should be used during therapy.
  • Instruct patient not to receive any vaccinations without advice of health care professional.
  • Emphasize the need for periodic lab tests to monitor for side effects.

Evaluation/Desired Outcomes

  • Palliative, symptomatic improvement in patients with pancreatic cancer.
  • Decrease in size and spread of malignancy in lung, ovarian, and breast cancer.

Gemzar

A brand name for GEMCITABINE.
References in periodicals archive ?
cell lung cancer in combination with GEMZAR (gemcitabine HCl for
The Court's ruling invalidates Lilly's '826 patent, or method-of-use patent, for Gemzar (gemcitabine HCI for injection) which had been set to expire in 2013.
Shaye was again treated with Gemzar which was interrupted for a week due to serious depression of his neutrophils (white blood count).
This press release contains forward-looking statements about the potential of ALIMTA and GEMZAR for the treatment of non-small cell lung cancer and reflects Lilly's current beliefs.
Tokyo, Japan, July 11, 2006 - (JCN) - Eli Lilly Japan announced o June 4 that it has obtained additional approval for Gemzar Injection (gemcitabine HC1), its proprietary anti-cancer agent, from the Ministry of Health, Labor and Welfare.
Importantly, one-year survival for the patient group treated with AVICINE plus Gemzar was significantly better than either treatment alone.
s Gemzar is the first new treatment for pancreatic cancer in 30 years.
Food and Drug Administration (FDA) recently gave its "fast track" approval, initially reserved for new AIDS drugs, to Eli Lilly and Company's experimental anticancer drug, Gemzar.
Contraindication GEMZAR is contraindicated in patients with a known hypersensitivity to gemcitabine.
When Gemzar was first tested, the Oncologic Drugs Advisory Committee strongly recommended against its approval.
GlobalData's pharmaceuticals report, Gemzar (Pancreatic cancer) - Analysis and Forecasts to 2020 provides Gemzar sales forecasts for US, EU5 and Japan.