Gemcitabine Sandoz 10 mg/mL Concentrate Solution for Infusion

Gemcitabine Injection is a nucleoside metabolic inhibitor indicated: in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. ( 1.1 ) in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. ( 1.2 ) in combination with cisplatin for the treatment of non-small cell lung cancer. ( 1.3 ) as a single agent for the treatment of pancreatic cancer. …

• Gemcitabine injection is for intravenous use only
• Ovarian Cancer: 1,000 mg/m 2 over 30 minutes on Days 1 and 8 of each 21-day cycle
• Breast Cancer: 1,250 mg/m 2 over 30 minutes on Days 1 and 8 of each 21-day cycle
• Non-Small Cell Lung Cancer: 1,000 mg/m 2 over 30 minutes on Days 1, 8, and 15 of each 28-day cycle or 1,250 mg/m 2 over 30 minutes on Days 1 and 8 of each 21-day cycle
• Pancreatic Cancer: 1,000 mg/m 2 over 30 minutes once weekly for the first 7 weeks, then one-week rest, then once weekly for 3 weeks of each 28-day cycle
• Ovarian Cancer Recommended Dose and Schedule The recommended dosage of gemcitabine injection is 1,000 mg/m 2 intravenously over 30 minutes on Days 1 and 8 of each 21-day cycle, in combination with carboplatin AUC 4 administered intravenously on Day 1 after gemcitabine injection administration
• Refer to carboplatin prescribing information for additional information
• Dosage Modifications Recommended dosage modifications for gemcitabine injection for myelosuppression are described in Tables 1 and 2 [see Warnings and Precautions ]
• Refer to the recommended dosage modifications for non-hematologic adverse reactions [see Dosage and Administration ] . …

Injection: 200 mg per 5.26 mL (38 mg per mL), 1 gram per 26.3 mL (38 mg per mL), and 2 grams per 52.6 mL (38 mg per mL) as a clear and colorless to light straw-colored solution in a single-dose vial. Injection: 200 mg per 5.26 mL (38 mg per mL), 1 gram per 26.3 mL (38 mg per mL), or 2 grams per 52.6 mL (38 mg per mL) in a single-dose vial. ( 3 )

• The safety and effectiveness of gemcitabine have not been established
• In pediatric patients
• The safety and pharmacokinetics of gemcitabine were evaluated in a trial
• In pediatric patients with refractory leukemia
• The maximum tolerated dose was 10 mg/m 2 /min for 360 minutes weekly for three weeks followed by a one-week rest period. …

In clinical studies which enrolled 979 patients with various malignancies who received single agent gemcitabine, no overall differences in safety were observed between patients aged 65 and older and younger patients, with the exception of a higher rate of Grade 3-4 thrombocytopenia in older patients as compared to younger patients. …

• Myelosuppression Advise patients of the risks of myelosuppression
• Instruct patients to immediately contact their healthcare provider should any signs or symptoms of infection, including fever, or if bleeding, or signs of anemia, occur [see Warnings and Precautions ]
• Severe Cutaneous Adverse Reactions (SCARs) Advise patients of the risks of SCARs, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). …

• Gemcitabine injection is contraindicated in patients with a known hypersensitivity to gemcitabine
• Reactions include anaphylaxis [see Adverse Reactions ]
• Patients with a known hypersensitivity to gemcitabine

Schedule-Dependent Toxicity: Increased toxicity with infusion time greater than 60 minutes or dosing more frequently than once weekly. ( 5.1 ) Myelosuppression: Monitor for myelosuppression prior to each cycle and reduce or withhold dose for severe myelosuppression. ( 5.2 ) Severe Cutaneous Adverse Reactions (SCARs) Permanently discontinue gemcitabine injection if SCARs occur. ( 5.3 ) Pulmonary Toxicity and Respiratory Failure: Discontinue gemcitabine injection for unexplained dyspnea or other evidence of severe pulmonary toxicity. ( 5.4 ) Hemolytic Uremic Syndrome (HUS): Monitor renal function prior to initiation and during treatment. …

The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity [see Contraindications ( 4 )] Schedule-Dependent Toxicity [see Warnings and Precautions ( 5.1 )] Myelosuppression [see Warnings and Precautions ( 5.2 )] Severe Cutaneous Adverse Reactions [see Warnings and Precautions ( 5.3 )] Pulmonary Toxicity and Respiratory Failure [see Warnings and Precautions ( 5.4 )] Hemolytic Uremic Syndrome [see Warnings and Precautions ( 5.5 )] Hepatic Toxicity [see Warnings and Precautions ( 5.6 )] Exacerbation of Radiation Therapy Toxicity [see Warnings and Precautions ( 5.8 )] Capillary Leak Syndrome [see Warnings and Precautions ( 5.9 )] Posterior Re …

8.1 Pregnancy Risk Summary Based on animal data and its mechanism of action, gemcitabine can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12.1 )] . There are no available data on the use of gemcitabine in pregnant women. In animal reproduction studies, gemcitabine was teratogenic, embryotoxic, and fetotoxic in mice and rabbits (see Data ) . …

There is no known antidote for overdoses of gemcitabine. Myelosuppression, paresthesias, and severe rash were the principal toxicities seen when a single dose as high as 5,700 mg/m 2 was administered by intravenous infusion over 30 minutes every 2 weeks to several patients in a dose-escalation study. In the event of suspected overdose, monitor with appropriate blood counts and provide supportive therapy, as necessary.

Prenez-le dès que vous y pensez, sauf s'il est presque l'heure de la dose suivante. Dans ce cas, sautez la dose oubliée. Ne prenez jamais deux doses à la fois pour compenser. Vérifiez votre notice, certains médicaments font exception.