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Gemcitabine Hcl

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(Treatment for intravenous)

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CAS: 22111-03-9

Chemical Name: 1-(2-oxo-4-amino-1,2-dihydropyrimidin-1-yl)-2- deoxy-2,2-difluororibose

Gemcitabine HCl is a nucleoside analogue that exhibits antitumor activity. Gemcitabine HCl is 2'-deoxy-2',2'-difluorocytidine monohydrochloride ((beta)-isomer). The structural formula is as follows:

The empirical formula for gemcitabine HCl is C9H11 F2N3O4¡¤HCl.

Molecular weight: 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.

The clinical formulation is supplied in a sterile form for intravenous use only. Vials of Gemzar 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.

Detail information about the pharmacology, please find in Drugs.com

Side Effects of Gemcitabine?

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common
Shortness of breath

Less common
Cough or hoarseness (accompanied by fever or chills); fever or chills; headache (sudden and severe); lower back or side pain (accompanied by fever or chills); painful or difficult urination (accompanied by fever or chills); pain in chest, arm, or back; pressure or squeezing in chest; slurred speech or inability to speak; troubled breathing, tightness in chest, and/or wheezing; weakness in arm and/or leg on one side of the body (sudden and severe)

Rare
Coughing; noisy or rattling breathing

The following side effects may mean that you are having a serious allergic reaction to this medicine, especially if they occur together with breathing problems. Check with your doctor immediately if any of them occur:

Rare
Change in skin color of the face; skin rash, hives, and/or itching; swelling or puffiness of the face, especially the eyelids or area around the eyes

Also, check with your doctor as soon as possible if any of the following side effects occur:

More common
Black, tarry stools; blood in urine or stools; cloudy urine; fever; pinpoint red spots on skin; skin rash, with or without itching; swelling of fingers, feet, or lower legs; unusual bleeding or bruising ; unusual tiredness or weakness

Less common
Fast or irregular heartbeat; high blood pressure

Rare
Increased or decreased urination; yellow eyes or skin

Some of the above side effects may occur, or continue to occur, after treatment with gemcitabine has ended. Check with your doctor if you notice any of them after you stop receiving the medicine.

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

More common
Constipation; diarrhea; general feeling of illness; loss of appetite; muscle pain; nausea and vomiting; runny nose; sweating; trouble in sleeping

Less common
Drowsiness (severe); irritation, pain, or redness at place of injection; numbness or tingling of hands or feet; sores, ulcers, or white spots on lips and in mouth

Gemcitabine may also cause a temporary loss of hair in some people. After treatment with gemcitabine has ended, normal hair growth should return.

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

DOSAGE AND ADMINISTRATION

Gemzar is for intravenous use only.

Adults

Single-Agent Use:

Pancreatic Cancer -- Gemzar should be administered by intravenous infusion at a dose of 1000 mg/m 2 over 30 minutes once weekly for up to 7 weeks (or until toxicity necessitates reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles should consist of infusions once weekly for 3 consecutive weeks out of every 4 weeks.

Dose Modifications -- Dosage adjustment is based upon the degree of hematologic toxicity experienced by the patient. Clearance in women and the elderly is reduced and women were somewhat less able to progress to subsequent cycles.

References:

  1. Recommendations for the safe handling of parenteral antineoplastic drugs. NIH publication No. 83-2621. US Government Printing Office, Washington, DC 20402.
  2. Council on Scientific Affairs: Guidelines for handling parenteral antineoplastics. JAMA 1985;253:1590.
  3. National Study Commission on Cytotoxic Exposure -- Recommendations for handling cytotoxic agents, 1987. Available from Louis P Jeffrey, ScD, Director of Pharmacy Services, Rhode Island Hospital, 593 Eddy Street, Providence, Rhode Island 02902.
  4. Clinical Oncological Society of Australia: Guidelines and recommendations for safe handling of antineoplastic agents. Med J Aust 1983;1:426.
  5. Jones RB, et al. Safe handling of chemotherapeutic agents: A report from the Mount Sinai Medical Center. CA 1983;33(Sept/Oct):258.
  6. American Society of Hospital Pharmacists: Technical assistance bulletin on handling cytotoxic drugs in hospitals. Am J Hosp Pharm 1990;47:1033.
  7. Controlling Occupational Exposure to Hazardous Drugs, OSHA Work Practice Guidelines. Am J Health-Sys Pharm 1996;53:1669-1685.
  8. ONS Clinical Practice Committee. Cancer Chemotherapy Guidelines and Recommendations for Practice. Pittsburg, PA: Oncology Nursing Society; 1999:32-41.

Literature revised May 19, 2004