Hetero Labs


Medicell Pharma
Concise Prescribing Info
Gemcitabine HCl
In combination w/ paclitaxel for 1st-line treatment in metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically CI. In combination w/ cisplatin for 1st-line treatment of locally advanced (stage IIIA or IIIB) or metastatic (stage IV) non-small cell lung cancer. Locally advanced or metastatic adenocarcinoma of the pancreas in adults; patients w/ 5-FU refractory pancreatic cancer.
Dosage/Direction for Use
IV Breast cancer 1,250 mg/m2 over 30 min infusion on days 1 & 8 of each 21-day cycle. Administer paclitaxel 175 mg/m2 on day 1 as a 3-hr infusion prior to gemcitabine inj. Non-small cell lung cancer 4-wk schedule: 1,000 mg/m2 over 30 min infusion on days 1, 8 & 15 of each 28-day cycle, administer cisplatin 100 mg/m2 on day 1 after gemcitabine infusion. 3-wk schedule: 1,250 mg/m2 over 30 min infusion on days 1 & 8 of each 21-day cycle, administer cisplatin 100 mg/m2 on day 1 after gemcitabine infusion. Pancreatic cancer 1,000 mg/m2 over 30 min infusion once wkly for up to 7 wk (or until toxicity necessitates reducing or holding a dose), followed by a wk of rest from treatment. Subsequent cycles should consist of infusions once wkly for 3 consecutive wk out of every 4 wk.
Special Precautions
Increased risk of toxicity in prolonged (>60 min) & frequent (more than wkly dosing) infusion time. Monitor patients for myelosuppression during therapy. Perform a complete blood count including differential & platelet count prior to each dose. Consider possibility of cumulative bone marrow suppression. Immediately discontinue use in case of severe lung toxicity. Discontinue at the 1st signs indicative of hemolytic uremic syndrome development eg, any evidence of microangiopathic hemolytic anemia (eg, rapidly falling Hb w/ concomitant thrombocytopenia, elevation of serum bilirubin & creatinine, BUN, or LDH). Patients w/ preexisting renal impairment. Potential serious hepatotoxicity. Preexisting or exacerbation of underlying hepatic insufficiency. Perform renal & hepatic lab evaluation prior to initiation & periodically thereafter. May affect ability to drive & use machines. Pregnancy & lactation. Childn. Elderly.
Adverse Reactions
Myelosuppression; nausea, vomiting, diarrhea, stomatitis; mild proteinuria & hematuria; fever; rash; dyspnea (may be accompanied by bronchospasm); peripheral & generalized edema; flu syndrome; infection; alopecia; neurotoxicity; extravasation; bronchospasm; MI, CVA, arrhythmia, HTN. Potentially, serious hepatotoxicity, including liver failure & death; hemolytic uremic syndrome.
MIMS Class
Cytotoxic Chemotherapy
ATC Classification
L01BC05 - gemcitabine ; Belongs to the class of antimetabolites, pyrimidine analogues. Used in the treatment of cancer.
Gemtero 1 g infusion
Gemtero 200 mg infusion
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