- 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 (in combination with vinorelbine in COG study AHOD0321)
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.
· Store vials at room temperature (250C)
· Supplied as a 200 mg or 1000 mg vial of powder for reconstitution
· Reconstitute 200 mg vial with 5 mL 0.9% NaCl (without preservative) for a 38 mg/mL solution
· Reconstitute 1000 mg vial with 25 mL 0.9% NaCl (without preservative) for a 38 mg/mL solution
· Further dilute with NS to a concentration of 0.1-10 mg/mL
· Reconstituted solution is stable 35 days at room temperature and for 7 days refrigerated (crystals may develop when solution is refrigerated for longer)
Solutions further diluted in NS stable 35 days at room temperature or refrigerated
- 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
(For approved routes of administration by nursing personnel, refer to Policy for the Administration of Intravenous Medications.)
|IV Intermittent Infusion||
Infusion Time: 30-60 minutes (over 100 minutes in AHOD0321)
|IV Continuous Infusion||NO|
(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 (AHOD0321)
· Pancreatic carcinoma (initial cycle): 1000 mg/m2 IV once weekly for up to 7 weeks, followed by a one week rest period
· Pancreatic carcinoma (subsequent cycles): 1000 mg/m2 IV on days 1, 8, 15 of a 28 day cycle
· Non-small cell carcinoma: 1000 mg/m2 IV on days 1, 8, 15 of a 28 day cycle or 1250 mg/m2 on days 1, 8 of a 21 day cycle
· Bladder carcinoma: 1000-1200 mg/m2 IV on days 1, 8, 15 of a 28 day cycle
Use with caution in patients with renal or hepatic impairment although no specific dosage recommendations exist
· Common: nausea, vomiting, fever, phlebitis, edema, flu-like symptoms (fever, chills, asthenia, myalgia), rash, mild diarrhea or constipation, myelosuppression (neutrophils, hemoglobin, platelets), liver function abnormalities (increased bilirubin, transient elevation of serum transaminases), proteinuria, hematuria
· Occasional: somnolence, dyspnea, mucositis, weakness (late), alopecia, paresthesias, itching
· Rare: hypotension, hemolytic uremic syndrome, renal dysfunction, confusion, seizure (late), coma (late), pulmonary edema-noncardiogenic & potentially fatal
· Radiosensitizer (increases mucositis and pneumonitis)
· 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.