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Gemcitabine

Generic Name
Gemcitabine
Brand Names
Gemzar
Drug Type
Small Molecule
Chemical Formula
C9H11F2N3O4
CAS Number
95058-81-4
Unique Ingredient Identifier
B76N6SBZ8R

Overview

Gemcitabine is a nucleoside analog and a chemotherapeutic agent. It was originally investigated for its antiviral effects, but it is now used as an anticancer therapy for various cancers. Gemcitabine is a cytidine analog with two fluorine atoms replacing the hydroxyl on the ribose. As a prodrug, gemcitabine is transformed into its active metabolites that work by replacing the building blocks of nucleic acids during DNA elongation, arresting tumour growth and promoting apoptosis of malignant cells. The structure, metabolism, and mechanism of action of gemcitabine are similar to cytarabine, but gemcitabine has a wider spectrum of antitumour activity. Gemcitabine is marketed as Gemzar and it is available as intravenous injection. It is approved by the FDA to treat advanced ovarian cancer in combination with carboplatin, metastatic breast cancer in combination with paclitaxel, non-small cell lung cancer in combination with cisplatin, and pancreatic cancer as monotherapy. It is also being investigated in other cancer and tumour types.

Background

Gemcitabine is a nucleoside analog and a chemotherapeutic agent. It was originally investigated for its antiviral effects, but it is now used as an anticancer therapy for various cancers. Gemcitabine is a cytidine analog with two fluorine atoms replacing the hydroxyl on the ribose. As a prodrug, gemcitabine is transformed into its active metabolites that work by replacing the building blocks of nucleic acids during DNA elongation, arresting tumour growth and promoting apoptosis of malignant cells. The structure, metabolism, and mechanism of action of gemcitabine are similar to cytarabine, but gemcitabine has a wider spectrum of antitumour activity. Gemcitabine is marketed as Gemzar and it is available as intravenous injection. It is approved by the FDA to treat advanced ovarian cancer in combination with carboplatin, metastatic breast cancer in combination with paclitaxel, non-small cell lung cancer in combination with cisplatin, and pancreatic cancer as monotherapy. It is also being investigated in other cancer and tumour types.

Indication

Gemcitabine is a chemotherapeutic agent used as monotherapy or in combination with other anticancer agents. In combination with carboplatin, it is indicated for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. Gemcitabine 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. In combination with cisplatin, gemcitabine 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). Dual therapy with cisplatin is also used to treat patients with Stage IV (locally advanced or metastatic) transitional cell carcinoma (TCC) of the bladder. Gemcitabine 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 is indicated for patients previously treated with fluorouracil.

Associated Conditions

  • Advanced Ovarian Cancer
  • Bladder Transitional Cell Carcinoma Stage IV
  • Carcinoma of the Head and Neck
  • Cervical Cancer
  • Cutaneous T-Cell Lymphoma (CTCL)
  • Hodgkins Disease (HD)
  • Mesothelioma
  • Metastatic Breast Cancer
  • Pancreatic Adenocarcinoma Locally Advanced
  • Small Cell Lung Cancer (SCLC)
  • Stage IIIA Non Small Cell Lung Cancer
  • Stage IIIB Non-Small Cell Lung Cancer
  • Stage IV Non-small Cell Lung Cancer (NSCLC)
  • Stage 4 Pancreatic adenocarcinoma

FDA Approved Products

GEMCITABINE HYDROCHLORIDE
Manufacturer:Cipla USA Inc.
Route:INTRAVENOUS
Strength:200 mg in 5 mL
Approved: 2020/09/14
NDC:69097-313
GEMCITABINE
Manufacturer:Accord Healthcare Inc.
Route:INTRAVENOUS
Strength:100 mg in 1 mL
Approved: 2022/11/05
NDC:16729-419
GEMCITABINE
Manufacturer:NorthStar Rx LLC
Route:INTRAVENOUS
Strength:1 g in 1 1
Approved: 2019/01/30
NDC:16714-930
GEMCITABINE
Manufacturer:Accord Healthcare Inc.
Route:INTRAVENOUS
Strength:100 mg in 1 mL
Approved: 2022/11/05
NDC:16729-391
Gemcitabine
Manufacturer:Hikma Pharmaceuticals USA Inc.
Route:INTRAVENOUS
Strength:200 mg in 1 1
Approved: 2021/06/28
NDC:0143-9394

Singapore Approved Products

GEMITA LYOPHILISED POWDER FOR SOLUTION FOR INJECTION 200 mg/vial
Manufacturer:Fresenius Kabi Oncology Limited
Form:INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Strength:200 mg/vial
Online:Yes
Approved: 2016/01/25
Approval:SIN14925P
GEMZAR 200mg Powder for Solution for Infusion
Manufacturer:Vianex S.A. - Plant C (Bulk Manufacturer and Primary Packager)
Form:INJECTION, POWDER, FOR SOLUTION
Strength:200mg
Online:Yes
Approved: 1997/07/23
Approval:SIN09416P
FONKO-GEMCITABINE LYOPHILIZED POWDER FOR SOLUTION FOR INFUSION 200MG/VIAL
Manufacturer:PT Fonko International Pharmaceuticals
Form:INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Strength:200mg/vial
Online:Yes
Approved: 2023/05/03
Approval:SIN16771P
GEMZAR 1gm POWDER FOR SOLUTION FOR INFUSION
Manufacturer:Vianex S.A. - Plant C (Bulk Manufacturer and Primary Packager)
Form:INJECTION, POWDER, FOR SOLUTION
Strength:1000mg
Online:Yes
Approved: 2006/12/22
Approval:SIN13229P
GEMIBINE-200 POWDER FOR SOLUTION FOR INFUSION 200 MG VIAL
Manufacturer:INTAS PHARMACEUTICALS LTD.
Form:INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Strength:200 mg
Online:Yes
Approved: 2018/09/28
Approval:SIN15554P

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