Gemita

Gemita

gemcitabine

Manufacturer:

Fresenius Kabi

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Gemcitabine HCl
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult Administer as a 30-min IV infusion. Non-small cell lung cancer Monotherapy: 1,000 mg/m2 repeated once wkly for 3 wk, followed by 1 wk rest period. Combination w/ cisplatin: 3-wk schedule using gemcitabine 1,250 mg/m2 on days 1 & 8 of each 21-day cycle; or 4-wk schedule using gemcitabine 1,000 mg/m2 on days 1, 8, 15 of each 28-day cycle. Pancreatic cancer 1,000 mg/m2 repeated once wkly for up to 7 wk, followed by 1 wk rest period. Subsequent cycles: Once wkly inj for 3 consecutive wk out of every 4 wk. Breast cancer Combination w/ paclitaxel: Paclitaxel (175 mg/m2) on day 1 over a 3 hr IV infusion, followed by gemcitabine (1,250 mg/m2) on days 1 & 8 of each 21-day cycle. Bladder cancer Combination w/ cisplatin: Gemcitabine (1,000 mg/m2) on days 1, 8 & 15 of each 28-day cycle, combined w/ cisplatin (70 mg/m2) on day 1 following gemcitabine or day 2 of each 28-day cycle. Ovarian cancer Monotherapy: 800-1,250 mg/m2 given on days 1, 8 & 15 of each 28-day cycle. Combination w/ carboplatin: Gemcitabine (1,000 mg/m2) on days 1 & 8 of each 21-day cycle, combined w/ carboplatin on day 1 following gemcitabine consistent w/ AUC 4 mg/mL/min. Biliary tract cancer Monotherapy: 1,000 mg/m2 repeated once wkly for 3 wk, followed by 1-wk rest period. Combination w/ cisplatin: Cisplatin (70 mg/m2) on day 1, followed by gemcitabine 1,250 mg/m2 on days 1 & 8 of each 21-day cycle. Cervical cancer Combination w/ radiation & cisplatin: Cisplatin (40 mg/m2) on day 1, followed by gemcitabine (125 mg/m2) on day 1, 8, 15, 22 & 36 (6 wkly) then concurrent pelvic radiation of 50.4 Gγ, 28 fractions (1.8 Gγ/day) 5 day/wk followed by 2 adjuvant cisplatin (50 mg/m2) on day 1 gemcitabine (1,000 mg/m2) on day 1 & day 8 of each 21-day cycle.
Special Precautions
Monitor CBC, bone marrow, renal & hepatic function. Pregnancy & lactation.
Adverse Reactions
Myelosuppression, anemia, leucopenia or thrombocytopenia. Nausea, vomiting, diarrhea, stomatitis. Transient elevation of liver enzymes, proteinuria, hematuria. Fever, rash, pruritus. Dyspnea, edema, flu like symptoms, infections, alopecia. Mild paresthesia.
ATC Classification
L01BC05 - gemcitabine ; Belongs to the class of antimetabolites, pyrimidine analogues. Used in the treatment of cancer.
Presentation/Packing
Form
Gemita infusion 200 mg
Packing/Price
1's
Form
Gemita infusion 1.4 g
Packing/Price
1's
Form
Gemita infusion 1 g
Packing/Price
1's
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