How is gemcitabine administered

Therefore, dosing may vary from protocol to protocol. If questions arise, clinicians should consult the appropriate references to verify the dose.

Baseline Hepatic Impairment: Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

Treatment-Related Hepatotoxicity: Severe hepatotoxicity: Permanently discontinue gemcitabine. Baseline Renal Impairment: Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed. Treatment-Related Nephrotoxicity: Severe renal impairment: Permanently discontinue gemcitabine therapy. For storage information, see the specific product information within How Supplied section. Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit.

Gemcitabine is available as a powder for injection, which requires reconstitution, and a solution for injection. Both formulations require further dilution prior to administration. It is also available as a premixed bag for IV infusion which does not require further dilution.

Reconstitution powder for injection mg vial: Add 5 mL of 0. Complete withdrawal of the vial contents will provide mg of gemcitabine. Shake to dissolve. Complete withdrawal of the vial contents will provide 1 g of gemcitabine. Storage after reconstitution: Reconstituted gemcitabine solutions are stable for 24 hours at room temperature 20 to 25 degrees Celsius or 68 to 77 degrees Fahrenheit.

Do not refrigerate, as crystallization may occur. Discard unused portion. Mix by gentle inversion. Do not shake. Storage after dilution: Store the diluted solution at a controlled room temperature 20 to 25 degrees Celsius or 68 to 77 degrees Fahrenheit for up to 24 hours from reconstitution. In clinical trials where the infusion time was more than 60 minutes, or the frequency was more than once weekly, there was an increased incidence of clinically significant hypotension, severe flu-like symptoms, myelosuppression, and asthenia.

Do not dilute prior to administration. Do not remove or add medication. If two premixed infusion bags are required to achieve the prescribed dose, infuse the total volume of both bags over 30 minutes.

Generic: - Discard product if it contains particulate matter, is cloudy, or discolored - Discard unused portion. Do not store for later use. Myelosuppression, including neutropenia, thrombocytopenia, and anemia, has occurred with gemcitabine therapy; the risk is increased when used in combination with other chemotherapeutic agents.

Monitor a CBC plus differential prior to each dose of gemcitabine; a dose reduction or interruption of therapy may be necessary. Patients with an active infection should be treated prior to receiving gemcitabine. Patients should immediately report any symptoms of severe myelosuppression such as fever, sore throat, or abnormal bleeding.

Gemcitabine is not recommended for use in combination with radiation therapy due to the risk of excessive toxicity. In a clinical trial of patients with non-small cell lung cancer NSCLC receiving concurrent given together or 7 days or less apart gemcitabine and thoracic radiation therapy, life-threatening mucositis, esophagitis, and pneumonitis were reported. Excessive toxicity has not been observed when gemcitabine is administered more than 7 days before or after radiation nonconcurrent ; however, radiation recall has occurred in patients who have received gemcitabine after prior radiation.

Gemcitabine should be used cautiously in patients with pre-existing hepatic disease, as treatment in patients with concurrent liver metastases or a history of hepatitis, alcoholism, or liver cirrhosis may lead to exacerbation of the underlying hepatic insufficiency. Treatment-related hepatotoxicity has occurred with gemcitabine use, either as monotherapy or in combination with other potentially hepatotoxic drugs; some cases resulted in liver failure and death.

Assess liver function tests prior to initiation of gemcitabine therapy and periodically during treatment; permanently discontinue gemcitabine in patients that develop severe hepatotoxicity. Prolonged infusion times beyond 60 minutes, as well as more frequent than once weekly administration, has been associated with infusion-related reactions and increased toxicity, including clinically significant hypotension, severe flu-like symptoms, myelosuppression, and asthenia.

The half-life of gemcitabine is also prolonged and volume of distribution increased with longer infusions. Use caution if administration of gemcitabine lasts beyond 60 minutes.

Pneumonitis interstitial lung disease, ILD , pulmonary edema, acute respiratory distress syndrome ARDS , and pulmonary fibrosis have been observed in patients treated with gemcitabine in clinical studies; some cases have been fatal, despite discontinuation of therapy.

Use gemcitabine with caution in patients with pre-existing pulmonary disease or a history of interstitial pneumonitis or pulmonary fibrosis. Permanently discontinue therapy for unexplained dyspnea with or without bronchospasm or other evidence of severe pulmonary toxicity. The onset of pulmonary symptoms may occur up to 2 weeks after the last dose of gemcitabine. Hemolytic-uremic syndrome HUS has been reported in patients treated with gemcitabine, including some cases requiring dialysis and fatalities due to renal failure; most gemcitabine-related cases of fatal renal failure in clinical trials were due to HUS.

Permanently discontinue gemcitabine in patients with HUS or severe renal impairment. Assess renal function prior to initiation of therapy with gemcitabine and periodically during treatment.

Renal failure may not be reversible, even after discontinuation of therapy. Posterior reversible encephalopathy syndrome PRES , also known as reversible posterior leukoencephalopathy syndrome RPLS , has been reported in patients treated with gemcitabine, either as monotherapy or in combination with other chemotherapeutic agents.

Permanently discontinue gemcitabine in patients suspected of developing PRES. Patients with headache, lethargy, seizures, confusion, blindness, and other visual or neurologic disturbances should be evaluated for RPLS with magnetic resonance imaging MRI. Mild to severe hypertension may also be present. The safety and efficacy of gemcitabine have not been established in children. No meaningful clinical activity was observed in this trial.

Gemcitabine toxicity may occur earlier on therapy or with a higher frequency in geriatric patients and females, as a result of slower drug clearance leading to higher plasma and intracellular concentrations of gemcitabine and increased half-life at any dose.

These patients require close monitoring during gemcitabine therapy and dose modification may be necessary. Additionally, in studies of gemcitabine monotherapy, women especially older women were less likely to proceed to subsequent cycles of treatment, and were more likely to experience grade 3 or 4 neutropenia and thrombocytopenia.

Although there are no adequate and well-controlled studies in pregnant women, gemcitabine is expected to cause fetal harm based on animal data and its mechanism of action.

If gemcitabine is used during pregnancy or if a woman becomes pregnant during therapy, the patient should be apprised of the risk to the fetus.

In one case, a woman with lung cancer was administered gemcitabine and carboplatin at 25 weeks gestation. The baby was delivered at 28 weeks by elective cesarean. Gemcitabine is also sometimes used to treat bladder cancer and cancer of the biliary tract cancer in the organs and ducts that make and store bile, the liquid made by the liver.

Talk to your doctor about the risks of using this medication for your condition. This medication may be prescribed for other uses; ask your doctor or pharmacist for more information. Gemcitabine may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

In case of overdose, call the poison control helpline at If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests before and during your treatment to check your body's response to gemcitabine. It is important for you to keep a written list of all of the prescription and nonprescription over-the-counter medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements.

You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies. Gemcitabine Injection pronounced as jem sit' a been. Why is this medication prescribed? How should this medicine be used? Other uses for this medicine What special precautions should I follow? However, you should always inform your health care provider if you experience any unusual symptoms. Contact your health care provider immediately, day or night, if you should experience any of the following symptoms:.

The following symptoms require medical attention, but are not emergency situations. Contact your health care provider within 24 hours of noticing any of the following:. You will be checked regularly by your doctor while you are taking Gemcitabine, to monitor side effects and check your response to therapy. Periodic blood work will be obtained to monitor your complete blood count CBC as well as the function of other organs such as your kidneys and liver will also be ordered by your doctor.

Cancerous tumors are characterized by cell division, which is no longer controlled as it is in normal tissue. Cancerous cells lose this ability. Cancer cells no longer have the normal checks and balances in place that control and limit cell division.

The process of cell division, whether normal or cancerous cells, is through the cell cycle. The cell cycle goes from the resting phase, through active growing phases, and then to mitosis division. The ability of chemotherapy to kill cancer cells depends on its ability to halt cell division. If the cells are unable to divide, they die.