Gemcitabine

Gemcitabine

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Questions & Answers

Side Effects & Adverse Reactions

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Legal Issues

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FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

1.1 Ovarian Cancer

Gemcitabine for injection, USP 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.

1.2 Breast Cancer

Gemcitabine for injection, USP 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.

1.3 Non-Small Cell Lung Cancer

Gemcitabine for injection, USP is indicated in combination with cisplatin for the first-line treatment of patients with inoperable, locally advanced (Stage IIIA or IIIB), or metastatic (Stage IV) non-small cell lung cancer.

1.4 Pancreatic Cancer

Gemcitabine for injection, USP 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. Gemcitabine for injection is indicated for patients previously treated with 5-FU.

History

There is currently no drug history available for this drug.

Other Information


Gemcitabine for injection, USP is a nucleoside metabolic inhibitor that exhibits antitumor activity. Gemcitabine HCl is 2´-deoxy-2´,2´-difluorocytidine monohydrochloride (β-isomer). The structural formula is as follows:


chemical-structure-gemcitabine

The molecular formula for gemcitabine HCl is C9H11F2N3O4 • HCl. It has a molecular weight of 299.66.
 
Gemcitabine HCl is a white to off-white solid. It is soluble in water, slightly soluble in methanol, and practically insoluble in ethanol and polar organic solvents.
  
Gemcitabine for injection, USP is supplied in a sterile form for intravenous use only. Vials of gemcitabine for injection, USP contain either 200 mg or 1 g of gemcitabine HCl (expressed as free base) formulated with mannitol (200 mg or 1 g, respectively) and sodium acetate (12.5 mg or 62.5 mg, respectively) as a sterile lyophilized powder. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment.

Gemcitabine Manufacturers


  • Sun Pharma Global Fze
    Gemcitabine (Gemcitabine Hydrochloride) Injection, Powder, Lyophilized, For Solution [Sun Pharma Global Fze]
  • Sagent Pharmaceuticals
    Gemcitabine (Gemcitabine Hydrochloride) Injection, Powder, Lyophilized, For Solution [Sagent Pharmaceuticals]
  • Hospira, Inc.
    Gemcitabine (Gemcitabine Hydrochloride) Injection, Powder, Lyophilized, For Solution [Hospira, Inc.]
  • Hospira, Inc.
    Gemcitabine (Gemcitabine Hydrochloride) Injection, Powder, Lyophilized, For Solution [Hospira, Inc.]
  • Hospira, Inc.
    Gemcitabine (Gemcitabine Hydrochloride) Injection, Solution [Hospira, Inc.]
  • Hospira, Inc.
    Gemcitabine (Gemcitabine Hydrochloride) Injection, Solution [Hospira, Inc.]
  • Dr. Reddy’s Laboratories Limited
    Gemcitabine Injection, Powder, Lyophilized, For Solution [Dr. Reddy’s Laboratories Limited ]
  • Bedford Laboratories
    Gemcitabine Injection, Powder, Lyophilized, For Solution [Bedford Laboratories]

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