Gemcitabine is a member of a group of chemotherapy drugs known as anti-metabolites. It prevents cells from making DNA, which stops cell growth and causes the cells to die.
GEMZAR (gemcitabine for injection) Powder, Lyophilized , For Solution For Intravenous Use Initial U.S. Approval: 1996
RECENT MAJOR CHANGES
Dosage and Administration: Dose Modifications for Non-Hematologic Adverse Reactions (2.5) 05 /2014 Warnings and Precautions : Capillary Leak Syndrome (5. 8) 05/2013 Posterior Reversible Encephalo pathy Syndrome (5.9) 05 /2014
INDICATIONS AND USAGE
Gemzar ® 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
- 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.
- in combination with cisplatin for the treatment of non-small cell lung cancer
- as a single agent for the treatment of pancreatic cancer
DOSAGE AND ADMINISTRATION
Gemzar is for intravenous use only.
- Ovarian Cancer : 1000 mg/m 2 over 30 minutes on Days 1 and 8 o f each 21 day cycle
- Breast Cancer : 1250 mg/m 2 over 30 minutes on Days 1 and 8 of each 21 day cycle
- Non-Small Cell Lung Cancer : 1000 mg/m 2 over 30 minutes on Days 1, 8, and 15 of each 28 day cycle or 1250 mg/m 2 over 30 minutes on Days 1 and 8 of each 21 day cycle
- Pancreatic Cancer : 1000 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
DOSAGE FORMS AND STRENGTHS
- 200 mg / single-use vial (3)
- 1 g/ single - use vial
CONTRAINDICATIONS
Patients with a known hypersensitivity to gemcitabine
WARNINGS AND PRECAUTIONS
- Schedule-dependent toxicity : Increased toxicity with infusion time greater than 60 minutes or dosing more frequently than once weekly .
- Myelosuppression : Monitor for myelosuppression prior to each cycle and reduce or withhold dose for severe myelosuppression .
- Pulmonary Toxicity and Respiratory Failure : Discontinue Gemzar immediately for unexplained new or worsening dyspnea or evidence of severe pulmonary toxicity .
- Hemolytic-Uremic Syndrome (HUS) : Monitor renal function prior to initiation and during therapy . Discontinue G emzar f or HUS or severe renal impairment .
- Hepatic Toxicity : Monitor hepatic functi on prior to initiation and during therapy . Discontinue Gemzar for severe hepatic toxicity.
- Embryofetal Toxicity : C an cause fetal harm . Advise women of potential risk to the fetus.
- Exacerbation of Radiation Therapy Toxicity : May cause severe and life-threatening toxicity when administered during or within 7 days of radiation therapy .
- Capillary Leak Syndrome: Discontinue Gemzar .
- Posterior reversible encephalopathy syndrome (PRES) : Discontinue G emzar .
ADVERSE REACTIONS
The most common adverse reactions for the single agent ( ≥ 20%) are nausea / vomiting, anemia, hepatic transaminitis , neutropenia, increased alkaline phosphatase, proteinuria, fever, hematuria, rash, thrombocytopenia, dyspnea , and peripheral edema
Sources: FDA / American Cancer Society