HIGHLIGHTS OF PRESCRIBING INFORMATION

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

GEMCITABINE HYDROCHLORIDE (UNII: U347PV74IL) (GEMCITABINE - UNII:B76N6SBZ8R)

Available from:

Sun Pharmaceutical Industries, Inc.

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

INFUGEM in combination with carboplatin is indicated for the treatment of patients with advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. INFUGEM in combination with paclitaxel is indicated for the first-line treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. INFUGEM in combination with cisplatin is indicated for the first-line treatment of patients with inoperable, locally advanced (Stage IIIA or IIIB) or metastatic (Stage IV) non-small cell lung cancer (NSCLC). INFUGEM is indicated as first-line treatment for patients with locally advanced (nonresectable Stage II or Stage III) or metastatic (Stage IV) adenocarcinoma of the pancreas. INFUGEM is indicated for patients previously treated with fluorouracil. INFUGEM is contraindicated in patients with a known hypersensitivity to gemcitabine. Reactions include anaphylaxis [see Adverse

Product summary:

INFUGEM (gemcitabine in 0.9% sodium chloride injection) is a clear, colorless, sterile solution in a single-dose, premixed intravenous infusion bag with an aluminum overwrap. The container closure is not made with natural rubber latex and is tamper evident. It is available in presentations as described in Table 22. Table 22: INFUGEM Available Presentations 1200 mg in 120 mL 1 single-dose bag per carton 62756-073-60 1300 mg in 130 mL 1 single-dose bag per carton 62756-008-60 1400 mg in 140 mL 1 single-dose bag per carton 62756-102-60 1500 mg in 150 mL 1 single-dose bag per carton 62756-219-60 1600 mg in 160 mL 1 single-dose bag per carton 62756-321-60 1700 mg in 170 mL 1 single-dose bag per carton 62756-438-60 1800 mg in 180 mL 1 single-dose bag per carton 62756-533-60 1900 mg in 190 mL 1 single-dose bag per carton 62756-614-60 2000 mg in 200 mL 1 single-dose bag per carton 62756-746-60 2200 mg in 220 mL 1 single-dose bag per carton 62756-974-60 INFUGEM is a cytotoxic drug. Follow applicable special handling and disposal procedures.1 Unopened infusion bags of INFUGEM are stable until the expiration date indicated on the package when stored at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). [see USP Controlled Room Temperature]. Do not freeze as crystallization can occur.

Authorization status:

New Drug Application

Summary of Product characteristics

INFUGEM- GEMCITABINE INJECTION, SOLUTION
SUN PHARMACEUTICAL INDUSTRIES, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
INFUGEM SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR INFUGEM.
INFUGEM (GEMCITABINE IN SODIUM CHLORIDE INJECTION), FOR INTRAVENOUS
USE
INITIAL U.S. APPROVAL: 1996
RECENT MAJOR CHANGES
Warnings and Precautions, Hemolytic Uremic Syndrome (5.4) 1/2020
INDICATIONS AND USAGE
INFUGEM is a nucleoside metabolic inhibitor indicated: (1)
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DOSAGE AND ADMINISTRATION
INFUGEM is for intravenous infusion only. (2)
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DOSAGE FORMS AND STRENGTHS
Injection: single-dose premixed infusion bags containing 10 mg/mL of
gemcitabine in 0.9% sodium chloride: (3)
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CONTRAINDICATIONS
Patients with a known hypersensitivity to gemcitabine. (4) (4)
WARNINGS AND PRECAUTIONS
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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)
Ovarian Cancer: 1000 mg/m over 30 minutes on Days 1 and 8 of each
21-day cycle. (2.1)
2
Breast Cancer: 1250 mg/m over 30 minutes on Days 1 and 8 of each 21
day cycle. (2.2)
2
Non-Small Cell Lung Cancer: 1000 mg/m over 30 minutes on Days 1, 8,
and 15 of each 28-day cycle or 1250 mg/m
over 30 minutes on Days 1 and 8 of each 21-day cycle. (2.3)
2
2
Pancreatic Cancer: 1000 mg/m 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)
2
1200 mg in 120 mL (3)
1300 mg in 130 mL (3)
1400 mg in 140 mL (3)