Kondreddy Naveen at 15:42, 2 November 2023

2023-11-02T15:42:35Z

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== '''What is Gemcitabine?''' ==

[[File:Gemcitabine.svg|thumb|Gemcitabine]]

* Gemcitabine ('''Gemzar'''; '''Infugem''') is '''a nucleoside metabolic inhibitor''' used in the therapy of several forms of advanced, pancreatic, lung, breast, ovarian and bladder cancer.

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== '''What are the uses of this medicine?''' ==

Gemcitabine ('''Gemzar'''; '''Infugem''') used alone or with other drugs to treat:
* [[Breast cancer]] that cannot be treated with or that did not respond to [[chemotherapy]] that included an [[Anthracyclines|anthracycline drug]]. It is used with [[paclitaxel]] as first-line therapy for cancer that has [[metastasized]] (spread to other parts of the body).
* [[Non-small cell lung cancer]] that is locally advanced or [[metastatic]] and cannot be removed by surgery. It is used with [[cisplatin]].
* [[Ovarian cancer]] that is advanced and has relapsed at least 6 months after treatment with [[platinum]] chemotherapy. It is used with [[carboplatin]].
* [[Pancreatic cancer]]. It is used alone in patients whose disease is locally advanced or [[metastatic]] and who have been treated with [[fluorouracil]].

== '''How does this medicine work?''' ==

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* Gemcitabine (jem sye' ta been), 2,,2.-difluoro deoxycytidine, '''is a pyrimidine analogue''' that is widely used in solid tumor chemotherapy. Intracellularly, '''it is metabolized to diphosphate and triphosphate forms''', both of which have [[antineoplastic]] activity '''inhibiting ribonucleotide reductase and competing with deoxycytidine triphosphate for incorporation into DNA'''.
* Gemcitabine is classified '''as an [[antimetabolite]]''' and is believed to '''act by inhibition of DNA synthesis in rapidly dividing cells'''.

== '''Who Should Not Use this medicine ?''' ==

This medicine cannot be used in patients:
* with a known [[hypersensitivity]] to gemcitabine.

[[File:Gemcitabine-hydrochloride-from-xtal-3D-balls.png|thumb|Gemcitabine-hydrochloride-from-xtal-3D-balls]]

== '''What drug interactions can this medicine cause?''' ==

* Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

[[File:Gemcitabine2DACS.svg|thumb|Gemcitabine2DACS]]

== '''Is this medicine FDA approved?''' ==

* Gemcitabine was approved for use in cancer [[chemotherapy ]]in the United States in 1996 and current indications include chemotherapy for advanced pancreatic, non-small cell lung, breast, ovarian and bladder cancers, either alone or in combination with other [[antineoplastic]] agents

== '''How should this medicine be used?''' ==

'''Recommended dosage:'''
* '''Ovarian Cancer:''' 1,000 mg/m 2 over 30 minutes on Days 1 and 8 of each 21-day cycle.
* '''Breast Cancer:''' 1,250 mg/m 2 over 30 minutes on Days 1 and 8 of each 21-day cycle.
* '''Non-Small Cell Lung Cancer:''' 1,000 mg/m 2 over 30 minutes on Days 1, 8, and 15 of each 28-day cycle or 1,250 mg/m 2 over 30 minutes on Days 1 and 8 of each 21-day cycle.
* '''Pancreatic Cancer:''' 1,000 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.

'''Administration:'''
* Gemcitabine comes as a powder to be mixed with liquid to be injected over 30 minutes [[intravenously]] (into a vein) by a doctor or nurse in a medical facility.

== '''What are the dosage forms and brand names of this medicine?''' ==

This medicine is available in fallowing doasage form:
'''As Injection:'''
* 200 mg per 5.26 mL (38 mg per mL), 1 gram per 26.3 mL (38 mg per mL), or 2 grams per 52.6 mL (38 mg per mL) in a single-dose vial
* 200 mg vial for injection
* 1 g vial for injection

This medicine is available in fallowing brand namesː
* '''Gemzar'''; '''Infugem'''

=='''What side effects can this medication cause?'''==

The most common side effects of this medicine include:
* nausea/vomiting
* [[anemia]]
* hepatic [[transaminitis]]
* [[neutropenia]]
* increased [[alkaline phosphatase]]
* [[proteinuria]]
* fever
* [[hematuria]]
* [[rash]]
* [[thrombocytopenia]]
* [[dyspnea]]
* [[peripheral edema]]

==''' What special precautions should I follow?''' ==

* Increased toxicity with infusion time greater than 60 minutes or dosing more frequently than once weekly.
* [[Myelosuppression]] manifested by [[neutropenia]], [[thrombocytopenia]], and [[anemia]] occurs with gemcitabine for injection as a single agent and the risks are increased when gemcitabine for injection is combined with other [[cytotoxic]] drugs. Monitor for myelosuppression prior to each cycle and reduce or withhold dose for severe myelosuppression.
* Pulmonary toxicity, including [[interstitial pneumonitis]], [[pulmonary fibrosis]], [[pulmonary edema]], and [[adult respiratory distress syndrome]] (ARDS), has been reported. Discontinue gemcitabine for injection immediately for unexplained new or worsening [[dyspnea]] or evidence of severe pulmonary toxicity.
* [[Hemolytic Uremic Syndrome]] to include fatalities from renal failure or the requirement for [[dialysis]] can occur in patients treated with gemcitabine for injection. Monitor renal function prior to initiation and during therapy. Discontinue gemcitabine for injection for HUS or severe renal impairment.
* Drug-induced liver injury, including liver failure and death, has been reported in patients receiving gemcitabine for injection alone or in combination with other potentially hepatotoxic drugs. Monitor hepatic function prior to initiation and during therapy. Discontinue gemcitabine for injection for severe hepatic toxicity.
* Gemcitabine for injection is not indicated for use in combination with radiation therapy. May cause severe and life-threatening toxicity when administered during or within 7 days of radiation therapy.
* Gemcitabine Can cause fetal harm. Advise women of potential risk to the fetus.
* [[Capillary leak syndrome]] (CLS) with severe consequences has been reported in patients receiving gemcitabine for injection as a single agent or in combination with other chemotherapeutic agents. Discontinue gemcitabine for injection if CLS develops during therapy.
* [[Posterior reversible encephalopathy syndrome]] (PRES) has been reported in patients receiving gemcitabine for injection as a single agent or in combination with other chemotherapeutic agents. Confirm the diagnosis of PRES with [[magnetic resonance imaging]] (MRI) and discontinue gemcitabine for injection if PRES develops during therapy.

== '''What to do in case of emergency/overdose?''' ==

Symptoms of overdosage may include:
* [[Myelosuppression]]
* [[paresthesias]]
* severe rash

'''Management of overdosage:'''
* {{overdose}}

== '''Can this medicine be used in pregnancy?''' ==

* Pregnancy Category D.
* Gemcitabine for injection can cause fetal harm when administered to a pregnant woman.

=='''Can this medicine be used in children?'''==

* The safety and effectiveness of gemcitabine for injection have not been established in pediatric patients.

== '''What are the active and inactive ingredients in this medicine?''' ==

'''Active ingredient:'''
* gemcitabine hydrochloride

'''Inactive ingredients:'''
* mannitol
* sodium acetate

== '''Who manufactures and distributes this medicine?''' ==

'''Manufactured by:'''
* [[Dr. Reddy's Laboratories Limited|Dr. Reddy’s Laboratories Limited]]
* Visakhapatnam -INDIA

'''Distributed by:'''
* Bedford Laboratories
* TM Bedford, OH

'''Manufactured for:'''
* Dr. Reddy’s Laboratories Limited
* BachupallY – INDIA

'''Distributed by:'''
* Bedford LaboratoriesTM
* Bedford, OH
* Made in India

== '''What should I know about storage and disposal of this medication?''' ==

* Unopened vials of gemcitabine for injection are stable until the expiration date indicated on the package when stored at 20° to 25°C (68° to 77°F).

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[[Category:Eli Lilly and Company brands]]
[[Category:Pyrimidine antagonists]]
[[Category:Organofluorides]]
[[Category:Pyrimidones]]
[[Category:Fluoropyrimidines]]
[[Category:Hydroxymethyl compounds]]

Gemcitabine - Revision history

Kondreddy Naveen at 15:42, 2 November 2023