Gemcitabine

What is Gemcitabine?

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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.

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 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?

• 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.

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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.

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:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

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
• 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).

Alphabetic list of antineoplastic agents - 0-9 - A1 - A2 - A3 - A4 - A5 -A6 - B - C - D - E - F - G - H - I - JK - L - M - NO - PQ - R - S - T - UVW - XYZ

 

• Dailymed label info on Gemcitabine
• FDA Gemcitabine

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