Monograph Details
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Neoplasms
> Antimetabolites
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GEMZAR |
| Manufacturer |
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Lilly, Eli and Company |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Antimetabolite. |
| Generic Name |
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Gemcitabine HCl 200mg, 1g; per vial; pwd for IV infusion after reconstitution; contains mannitol. |
| Indications |
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Advanced ovarian cancer (in combination with carboplatin) that has relapsed at least 6 months after completion of platinum-based therapy. First-line treatment of metastatic breast cancer (in combination with paclitaxel) after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were contraindicated. First-line treatment of inoperable, locally advanced (Stage IIIA or IIIB), or metastatic (Stage IV) non-small cell lung cancer (NSCL) (in combination with cisplatin). First-line treatment of locally advanced (nonresectable Stage II or Stage III) or metastatic (Stage IV) pancreatic cancer. |
| Children |
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Not recommended. |
| Adults |
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Infuse over 30 minutes (increased toxicity if infusion goes beyond 60 minutes). Pancreatic cancer (as a single agent): 1000mg/m2 once weekly for up to 7 weeks, followed by a week of rest; subsequent cycles: infuse once weekly for 3 consecutive weeks out of every 4 weeks. NSCLC (in combination with cisplatin): 4-week schedule: 1000mg/m2 on Days 1, 8, and 15 of each 28 day cycle; or 3-week schedule: 1250mg/m2 on Days 1 and 8 of each 21 day cycle. Breast cancer (in combination with paclitaxel): 1250mg/m2 on Days 1 and 8 of each 21 day cycle. Ovarian cancer (in combination with carboplatin): 1000mg/m2 on Days 1 and 8 of each 21 day cycle. Adjust dose based on toxicity (see literature). |
| Precautions |
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Discontinue immediately if severe lung toxicity or hemolytic uremic syndrome occurs. Renal or hepatic impairment. Evaluate renal and hepatic function prior to therapy, then periodically thereafter. Monitor for myelosuppression; obtain CBCs, platelets prior to each dose. Elderly. Pregnancy (Cat.D), nursing mothers: not recommended. |
| Adverse Reactions |
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Myelosuppression, GI upset, elevated transaminases, proteinuria, hematuria, rash, pruritus, dyspnea, edema, flu-like symptoms, infection, alopecia, neurotoxicity, others; rare: renal or liver failure, hemolytic uremic syndrome. |
| How Supplied |
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Single-use vials—1 |
| Additional Resources |
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• Related Prescribing Note |
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