Gemtero

Gemtero

gemcitabine

Manufacturer:

Amarox
Concise Prescribing Info
Contents
Gemcitabine
Indications/Uses
In combination w/ cisplatin as 1st line treatment of locally advanced (inoperable stage IIIA & IIIB) or metastatic (stage IV) non-small cell lung cancer. 1st line treatment of locally advanced (non-resectable stage II or III) or metastatic (stage IV) adenocarcinoma of the pancreas. Pancreatic cancer in patients previously treated w/ 5-FU. In combination w/ cisplatin for advanced bladder cancer (muscle invasive stage IV tumours w/ or w/o metastases). In combination w/ paclitaxel for unresectable, locally recurrent or metastatic breast cancer that has relapsed following adjuvant/neoadjuvant anthracycline-containing chemotherapy. As monotherapy or in combination for recurrent epithelial ovarian carcinoma that has relapsed following platinum-based therapy. As monotherapy or in combination for advanced breast & ovarian cancer. Palliative treatment of adults w/ locally advanced or metastatic non-small cell lung cancer.
Dosage/Direction for Use
Adult Non-small cell lung cancer In combination w/ cisplatin: Regimen 1 (3-wk schedule): 1,250 mg/m2 as 30-min IV infusion on days 1, 8 of each 21-day cycle + 75-100 mg/m2 cisplatin after gemcitabine administration on day 1. Regimen 2 (4-wk schedule): 1,000 mg/m2 as 30-min IV infusion on days 1, 8, & 15 of each 28-day cycle + 75-100 mg/m2 cisplatin after gemcitabine administration on day 1. Monotherapy: 1,000 mg/m2 as 30-min IV infusion, repeated once wkly for 3 wk, followed by 1 wk rest period; repeat 4-wk cycle. Pancreatic cancer 1,000 mg/m2 as 30-min IV infusion, repeated once wkly for up to 7 wk, followed by a wk of rest. Subsequent cycles should consist of inj once wkly for 3 consecutive wk out of every 4 wk. Bladder cancer In combination w/ cisplatin: 1,000 mg/m2 as 30-min infusion on days 1, 8 & 15 of each 28-day cycle + 70 mg/m2 cisplatin on day 1 following gemcitabine or day 2 of each 28-day cycle; repeat 4-wk cycle. Breast cancer In combination w/ paclitaxel: 175 mg/m2 paclitaxel as IV infusion approx 3 hr on day 1 followed by 1,250 mg/m2 gemcitabine as 30-min IV infusion on days 1 & 8 of each 21-day cycle. Ovarian cancer Monotherapy: 800-1,250 mg/m2 as 30-min IV infusion on days 1, 8 & 15 of each 28-day cycle; repeat 4-wk cycle. In combination w/ carboplatin: 1,000 mg/m2 as 30-min IV infusion on days 1 & 8 of each 21-day cycle + carboplatin on day 1 consistent w/ a target AUC of 4 mg/mL·min.
Contraindications
Special Precautions
Increased toxicity w/ prolonged infusion time & increased dosing frequency. Discontinue treatment at 1st signs of any evidence of microangiopathic hemolytic anemia eg, rapidly falling Hb w/ concomitant thrombocytopenia, elevation of serum bilirubin, creatinine, BUN or LDH & if hemolytic uremic syndrome, capillary leak syndrome, adult resp distress syndrome & posterior reversible encephalopathy syndrome, other severe pulmonary effects eg, interstitial pneumonitis & pulmonary edema develop during therapy. Consider suspension of therapy if drug-induced marrow depression is detected. Patients w/ compromised bone marrow function; concurrent liver metastases or preexisting medical history of hepatitis, alcoholism, or liver cirrhosis. Monitor platelet, leucocyte & granulocyte counts prior to each dose. Causes mild to moderate somnolence which may affect ability to drive & use machines. Hepatic insufficiency or impaired renal function. Avoid in pregnant or nursing women. Childn.
Adverse Reactions
Fever, headache, back pain, chills, myalgia, asthenia & anorexia. Anemia, leucopenia, thrombocytopenia, myelosuppression, febrile neutropenia; nausea w/ vomiting; mild proteinuria & hematuria; bronchospasm, dyspnoea; abnormalities of liver transaminases (AST & ALT) & alkaline phosphatase; radiation toxicity & recall; MI, CHF & arrhythmia; rash w/ pruritus; cough, rhinitis, malaise, sweating & insomnia; oedema, peripheral &/or facial oedema; alopecia, somnolence, diarrhea, oral toxicity (mainly soreness & erythema) & constipation.
Drug Interactions
Concurrent use w/ radiotherapy.
ATC Classification
L01BC05 - gemcitabine ; Belongs to the class of antimetabolites, pyrimidine analogues. Used in the treatment of cancer.
Presentation/Packing
Form
Gemtero lyo powd for inj 1 g
Packing/Price
1's
Form
Gemtero lyo powd for inj 200 mg
Packing/Price
1's
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