Parenteral Manual

Gemcitabine

Disclaimer: Official controlled document is the CHEO online copy. It is the responsibility of user to ensure that any paper copy version is the same as the online version before use.

Alternate Name(s): 
Gemzar, dFdC
Classification: 
Antimetabolite antineoplastic - CYTOTOXIC
Original Date: 
October 2006
Revised Date: 
April 2023
Indications: 
  • Locally advanced and metastatic non-small cell lung cancer and bladder carcinoma (alone or in combination with cisplatin)
  • Locally advanced or metastatic adenocarcinoma of the pancreas
  • Unresectable, locally recurrent or metastatic breast cancer (in combination with paclitaxel)
  • Recurrent or refractory Hodgkin disease

THIS MEDICATION IS TO BE ADMINISTERED BY A CHEMO-TRAINED NURSE. IF THE NURSE IS NOT CHEMO-TRAINED, THEY ARE TO CONTACT THE UNIT NURSE EDUCATOR OR ADVANCED PRACTICE NURSE.

Reconstitution and Stability: 
  • Solution for injection: Store vials in the refrigerator (2-8 ◦C) 
  • Gemcitabine solution for injection may be available in various concentrations (38 and 40 mg/mL); verify product carefully prior to admixture to ensure appropriate dose preparation. 
  • Further dilute with NS or D5W to a concentration greater than 0.1mg/mL 
  • Solutions further diluted in NS or D5W are stable for 24 hours at room temperature  
Compatibility: 
  • Solutions Compatible: NS, D5W
  • Y-site compatible: amifostine, bleomycin, carboplatin, carmustine, cisplatin, cyclophosphamide, cytarabine, dactinomycin, daunorubicin, dexamethasone, dexrazoxane, diphenhydramine, docetaxel, dopamine, doxorubicin, etoposide, fludarabine, fluorouracil, granisetron, heparin, hydrocortisone, hydromorphone, idarubicin, ifosfamide, leucovorin, lorazepam, mannitol, meperidine, mesna, metoclopramide, mitoxantrone, morphine, ondansetron, paclitaxel, potassium chloride, ranitidine, sodium bicarbonate, teniposide, thiotepa, topotecan, vinblastine, vincristine, vinorelbine
  • Incompatible: furosemide, irinotecan, methotrexate, methylprednisolone, prochlorperazine
Administration: 

(For approved routes of administration by nursing personnel, refer to Policy for the Administration of Intravenous Medications.)

SC NO
IM NO
IV Push NO
IV Intermittent Infusion

Yes

Infusion Time: 30-60 minutes
IV Continuous Infusion NO
Dosage: 

(For neonatal dosages, refer to Neonatal IV Drug Manual.)

  • Relapsed or refractory Hodgkin disease: 1000 mg/m2 on days 1 and 8 of a 21 day cycle
  • Refer to protocol for patient specific dosing
  • Use with caution in patients with renal or hepatic impairment although no specific dosage recommendations exist
Potential hazards of parenteral administration: 

  • Common:

    • Immediate: nausea, vomiting, fever, rash, constipation, pain, dyspnea

    • Prompt: Myelosuppression, elevated AST/ALT/alkaline, phosphatase, proteinuria, hematuria 

    • Late: rash 

  • Occasional 

    • Immediate: Somnolence (L), diarrhea, itching, flu-like syndrome (fever, asthenia, anorexia, headache, cough, chills, and myalgia), peripheral edema 

    • Prompt: Mucositis/stomatitis, elevated bilirubin,  elevated BUN/creatinine, hemorrhage, infection, alopecia (L) 

    • Delayed: paresthesia

  • Rare 

    • Immediate: anaphylaxis, bronchospasm, phlebitis, hypertension 

    • Prompt: Hemolytic uremic syndrome, renal failure, thrombotic microangiopathy (L), cardiovascular events (myocardial  infarction, cerebrovascular accident, arrhythmia, CHF and hypertension primarily in patients with pre-existing cardiac disease) (L), severe rashes (L)

    • Delayed: radiation recall reactions, interstitial pneumonitis, pulmonary fibrosis, pulmonary edema, and ARDS, sepsis, liver failure 

Notes: 
  • Hemolytic uremic syndrome- infrequently reported and is characterized by microangiopathic haemolytic uremia, thrombocytopenia & renal failure.  The onset of the syndrome has been reported to occur during and shortly after gemcitabine therapy.  If not treated promptly, the syndrome can result in irreversible renal failure requiring dialysis.
  •  Severe pulmonary toxicity-pulmonary edema, interstitial pneumonitis and adult respiratory distress syndrome have been rarely reported.  Pulmonary toxicity may occur as early as the first cycle but usually occur after several cycles of gemcitabine.  Risk factors include prior radiation to the mediastinum.  Management of pulmonary toxicities consists of discontinuation of gemcitabine and early supportive care with bronchodilators, corticosteroids, diuretics and/or oxygen.
  • Patients receiving concurrent radiation while receiving full dose gemcitabine should be closely monitored for reactions. Potentially life-threatening esophagitis and pneumonitis, particularly in patients receiving large volumes of radiation have been observed. Gemcitabine should be discontinued if pneumonitis occurs.
  • Infusion duration/frequency: Prolongation of the infusion duration >60 minutes or more frequent than weekly dosing have been shown to alter the half-life and increase toxicity (hypotension, flu-like symptoms, myelosuppression, weakness). 
References: 
  1. Gemcitabine solution for injection. Product Monograph. Hospira Canada. Accessed 23Mar15 
  2. Gemcitabine solution for injection. Product Monograph. Pfizer Canada. Version 16Mar2021, Accessed 4Nov2022 
  3. Gemcitabine. Lexi-Drugs. Accessed online 5nov2022 
  4. Gemcitabine. Drug Information For Commercial Agents Used by the Children’s Oncology Group. Version Number 14.1. Version Date 25 May 2022  
  5. Telephone communication, Medical Information Hospira Canada, 23Mar15

The information contained on this website is provided for informational purposes only, as a guide to assist physicians, nurses and other healthcare providers in deciding on the appropriate care required for a particular patient. At all times, physicians, nurses and other healthcare providers must exercise their independent clinical judgment, based on their knowledge, training and experience, taking into account the specific facts and circumstances of each patient, when deciding on the appropriate course of investigation and/or treatment to recommend in a particular clinical situation.

CHEO has made every effort to ensure that the information contained on this website is as current and accurate as possible. However, changes can occur due to ongoing research and the constant influx of new information. Where possible, hospitals and healthcare practitioners should verify the information before acting on it.

Reliance on any information in this website is at the user's own risk. CHEO is not responsible or liable for any harm, loss or other consequences from the use or misuse of the information on this website.