gemcitabine injection powder 1GM, 200MG Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use GEMCITABINE FOR INJECTION safely and effectively. See full prescribing information for GEMCITABINE FOR INJECTION.

GEMCITABINE for injection, for intravenous use
Initial U.S. Approval: 1996

RECENT MAJOR CHANGES

Warnings and Precautions,

Severe Cutaneous Adverse Reactions (5.3)

5/2024

INDICATIONS AND USAGE

Gemcitabine 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. (1.4)

DOSAGE AND ADMINISTRATION

Gemcitabine is for intravenous use only.

•
Ovarian Cancer: 1,000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle. (2.1)
•
Breast Cancer: 1,250 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle. (2.2)
•
Non-Small Cell Lung Cancer: 1,000 mg/m2 over 30 minutes on Days 1, 8, and 15 of each 28-day cycle or 1,250 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle. (2.3)
•
Pancreatic Cancer: 1,000 mg/m2 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. (2.4)

DOSAGE FORMS AND STRENGTHS

For Injection: 200 mg or 1 gram lyophilized powder in single-dose vials for reconstitution. (3)

CONTRAINDICATIONS

Patients with a known hypersensitivity to gemcitabine. (4)

WARNINGS AND PRECAUTIONS

•
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, 5.7)
•
Severe Cutaneous Adverse Reactions (SCARs): Permanently discontinue gemcitabine injection if SCARs occur. (5.3)
•
Pulmonary Toxicity and Respiratory Failure: Discontinue gemcitabine for 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. Discontinue gemcitabine for injection for HUS or severe renal impairment. (5.5)
•
Hepatic Toxicity: Monitor hepatic function prior to initiation and during treatment. Discontinue gemcitabine for injection for severe hepatic toxicity. (5.6)
•
Embryo-Fetal Toxicity: Can cause fetal harm. Advise females and males of reproductive potential to use effective contraception. (5.7, 8.1)
•
Exacerbation of Radiation Therapy Toxicity: May cause severe and life-threatening toxicity when administered during or within 7 days of radiation therapy. (5.8)
•
Capillary Leak Syndrome: Discontinue gemcitabine for injection. (5.9)
•
Posterior Reversible Encephalopathy Syndrome (PRES): Discontinue gemcitabine for injection. (5.10)

ADVERSE REACTIONS

The most common adverse reactions for the single-agent (≥20%) are nausea/vomiting, anemia, increased aspartate aminotransferase (AST), increased alanine aminotransferase (ALT), neutropenia, increased alkaline phosphatase, proteinuria, fever, hematuria, rash, thrombocytopenia, dyspnea, and edema. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc. at 1-800-441-4100 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

USE IN SPECIFIC POPULATIONS

Lactation: Advise not to breastfeed. (8.2)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 8/2024

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Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use GEMCITABINE FOR INJECTION safely and effectively. See full prescribing information for GEMCITABINE FOR INJECTION.

GEMCITABINE for injection, for intravenous use
Initial U.S. Approval: 1996

RECENT MAJOR CHANGES

Warnings and Precautions,

Severe Cutaneous Adverse Reactions (5.3)

5/2024

INDICATIONS AND USAGE

Gemcitabine 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. (1.4)

DOSAGE AND ADMINISTRATION

Gemcitabine is for intravenous use only.

•
Ovarian Cancer: 1,000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle. (2.1)
•
Breast Cancer: 1,250 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle. (2.2)
•
Non-Small Cell Lung Cancer: 1,000 mg/m2 over 30 minutes on Days 1, 8, and 15 of each 28-day cycle or 1,250 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle. (2.3)
•
Pancreatic Cancer: 1,000 mg/m2 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. (2.4)

DOSAGE FORMS AND STRENGTHS

For Injection: 200 mg or 1 gram lyophilized powder in single-dose vials for reconstitution. (3)

CONTRAINDICATIONS

Patients with a known hypersensitivity to gemcitabine. (4)

WARNINGS AND PRECAUTIONS

•
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, 5.7)
•
Severe Cutaneous Adverse Reactions (SCARs): Permanently discontinue gemcitabine injection if SCARs occur. (5.3)
•
Pulmonary Toxicity and Respiratory Failure: Discontinue gemcitabine for 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. Discontinue gemcitabine for injection for HUS or severe renal impairment. (5.5)
•
Hepatic Toxicity: Monitor hepatic function prior to initiation and during treatment. Discontinue gemcitabine for injection for severe hepatic toxicity. (5.6)
•
Embryo-Fetal Toxicity: Can cause fetal harm. Advise females and males of reproductive potential to use effective contraception. (5.7, 8.1)
•
Exacerbation of Radiation Therapy Toxicity: May cause severe and life-threatening toxicity when administered during or within 7 days of radiation therapy. (5.8)
•
Capillary Leak Syndrome: Discontinue gemcitabine for injection. (5.9)
•
Posterior Reversible Encephalopathy Syndrome (PRES): Discontinue gemcitabine for injection. (5.10)

ADVERSE REACTIONS

The most common adverse reactions for the single-agent (≥20%) are nausea/vomiting, anemia, increased aspartate aminotransferase (AST), increased alanine aminotransferase (ALT), neutropenia, increased alkaline phosphatase, proteinuria, fever, hematuria, rash, thrombocytopenia, dyspnea, and edema. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc. at 1-800-441-4100 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

USE IN SPECIFIC POPULATIONS

Lactation: Advise not to breastfeed. (8.2)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 8/2024
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