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Cancer
    Home > Cancer > Celgem (Gemcitabine)
 

Celgem (Gemcitabine)
Select Ref Description Manufacturer Pack Size Strength Our Price
P1285 Celgem (Gemcitabine) Alkem 1 injection 200 mg $ 92.07
P1286 Celgem (Gemcitabine) Alkem 1 injection 1gm $ 280.41
Price is per pack & not per tab.. eg: if pack size is 10 tabs & price is $2.75 then for 100 tabs the price would be $27.50

What is gemcitabine?


Gemcitabine is a cancer medication that interferes with the growth and spread of cancer cells in the body.

Gemcitabine is used to treat cancers of the pancreas, lung and breast. Gemcitabine is also used in combination with carboplatin to treat ovarian cancer.

Gemcitabine may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about gemcitabine?


Do not receive this medication without telling your doctor if you are pregnant. It could cause harm to the unborn baby. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

Gemcitabine is given as an injection through a needle placed into a vein. You will receive this injection in a clinic or hospital setting. Gemcitabine is usually given once a week for several weeks. The medicine must be given slowly through an IV infusion, and can take up to 30 minutes to complete.

Gemcitabine can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Your kidney and liver function may also need to be checked. Do not miss any scheduled visits to your doctor.

Do not receive a "live" vaccine while you are being treated with gemcitabine, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you.

If any of this medicine accidentally gets on your skin, wash the area thoroughly with soap and warm water.

What should I discuss with my healthcare provider before receiving gemcitabine?


Do not use this medication if you are allergic to gemcitabine.

Before receiving gemcitabine, tell your doctor if you are allergic to any drugs, or if you have:

kidney disease;

liver disease; or

if you are receiving radiation treatment.

If you have any of these conditions, you may not be able to use gemcitabine, or you may need a dosage adjustment or special tests during treatment.

FDA pregnancy category D. This medication can cause harm to an unborn baby. Do not receive gemcitabine without telling your doctor if you are pregnant. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment. It is not known whether gemcitabine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.


How is gemcitabine used?


Gemcitabine is given as an injection through a needle placed into a vein. You will receive this injection in a clinic or hospital setting. The medicine must be given slowly through an IV infusion, and can take up to 30 minutes to complete.

Gemcitabine is usually given once a week for up to 7 weeks.

Gemcitabine can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Your kidney and liver function may also need to be checked. Do not miss any scheduled visits to your doctor.

If any of this medicine accidentally gets on your skin, wash the area thoroughly with soap and warm water.

What happens if I miss a dose?


Contact your doctor if you miss a miss an appointment to receive your gemcitabine infusion.

What happens if I overdose?


Seek emergency medical attention if you think you have received too much of this medicine.

Symptoms of a gemcitabine overdose may include numbness or tingly feeling, severe skin rash, fever, chills, flu symptoms, or any signs of infection.

What should I avoid while using gemcitabine?


Avoid contact with people who have colds, the flu, or other contagious illnesses. Contact your doctor immediately if you develop signs of infection.

Do not receive a "live" vaccine while you are being treated with gemcitabine, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you.

Gemcitabine side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

pale skin, easy bruising or bleeding, unusual weakness;

urinating less than usual or not at all;

nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

sudden numbness or weakness, especially on one side of the body;

sudden headache, confusion, problems with vision, speech, or balance;

fever, chills, body aches, flu symptoms;

white patches or sores inside your mouth or on your lips;

pain, swelling, or skin changes where the needle was placed;

hearing problems;

blood in your urine; or

breathing problems.

Less serious side effects may be more likely to occur, such as:

mild nausea, vomiting, upset stomach;

diarrhea or constipation;

swelling in your hands, ankles, or feet;

skin rash;

numbness or tingly feeling;

drowsiness; or

hair loss.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

Gemcitabine Dosing Information


Usual Adult Dose for Pancreatic Cancer:

For the first-line treatment of 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 5-FU.)

1000 mg/m² intravenously one time over 30 minutes. May repeat at weekly intervals for up to 7 weeks, followed by one week of rest. If toxicity occurs, a dose should be held. Subsequent cycles should consist of weekly cycles for 3 consecutive weeks, out of every 4 weeks.

Dosage Modifications, Decreases: Doses may need to be adjusted, based upon the degree of hematologic toxicity experienced by the patient. If marrow suppression is detected, therapy should be modified or suspended according to the following guidelines: Absolute granulocyte count 500,000,000-999,000,000/L or Platelet count 50,000,000,000-99,000,000,000 give 75% of the full dose. Absolute granulocyte count < 500,000,000 or Platelet count < 50,000,000,000, then hold the dose.

Dosage Modifications, Increases: Patients who complete an entire seven week initial cycle of therapy or subsequent three week cycle at a dose of 1000 mg/m² may have the dose for subsequent cycles increased by 25%, provided that the absolute granulocyte count (AGC) > 1,500,000,000/L, platelet nadirs > 1,000,000,000,000 and nonhematologic toxicity has not been > WHO Grade 1. If patients tolerate the subsequent course of gemcitabine at the increased dose, the dose for the next cycle can be further increased by 20%, provided again that the AGC and platelet nadirs exceed 1500,000,000/L and 100,000,000,000/L, respectively, and that nonhematologic toxicity has not been greater than WHO grade 1.

Usual Adult Dose for Non-Small Cell Lung Cancer:

In combination with cisplatin for the first-line treatment of patients with inoperable, locally advanced (Stage IIIA or IIIB) or metastatic (Stage IV) non-small cell lung cancer:

Two schedules have been investigated and the optimum schedule has not been determined. With the 4 week schedule, gemcitabine should be administered intravenously at 1000 mg/m2 over 30 minutes on days 1, 8, and 15 of each 28 day cycle. With the 3 week schedule, gemcitabine should be administered intravenously at 1250 mg/m2 over 30 minutes on days 1 and 8 of each 21 day cycle.

Dose Modifications: Dosage adjustments for hematologic toxicity may be required for gemcitabine and for cisplatin. Gemcitabine dosage adjustment for hematological toxicity is based on the granulocyte and platelet counts taken on the day of therapy. Patients receiving gemcitabine should be monitored prior to each dose with a complete blood count (CBC), including differential and platelet counts. If marrow suppression is detected, therapy should be modified or suspended according to the guidelines below:

Dosage Modifications, Decreases: Doses may need to be adjusted, based upon the degree of hematologic toxicity experienced by the patient. If marrow suppression is detected, therapy should be modified or suspended according to the following guidelines: Absolute granulocyte count 500,000,000-999,000,000/L or Platelet count 50,000,000,000-99,000,000,000/L give 75% of the full dose. Absolute granulocyte count < 500,000,000 or Platelet count < 50,000,000,000/L, then hold the dose.

In general, for severe (grade 3 or 4) nonhematologic toxicity, except alopecia and nausea/vomiting, therapy with gemcitabine plus cisplatin should be held or decreased by 50% depending on the judgment of the treating physician. During combination therapy with cisplatin, serum creatinine, serum potassium, serum calcium, and serum magnesium should be carefully monitored.

Usual Adult Dose for Breast Cancer:

In combination with paclitaxel as first-line therapy in the treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy (unless anthracyclines were clinically contraindicated):

Gemcitabine 1250 mg/m2 intravenously over 30 minutes on days 1 and 8 of each 21 day cycle. Gemcitabine is given in combination with paclitaxel. Paclitaxel should be administered at 175 mg/m2 on day 1 as a 3 hour intravenous infusion before gemcitabine administration.

Patients should be monitored prior to each dose with a complete blood count, including differential counts. Patients should have an absolute granulocyte count greater than or equal to 1,500,000,000/L and a platelet count greater than or equal to 100,000,000,000/L prior to each cycle.

Dosage adjustments for hematologic toxicity are based on the granulocyte and platelet counts taken on day 8 of therapy. If marrow suppression is detected, the dosage of gemcitabine should be modified as follows:

If the absolute granulocyte count is greater than or equal to 1,200,000,000/L and the platelet count is greater than 75,000,000,000/L, than give 100% of the full dose.

If the absolute granulocyte count is between 1,000,000,000/L and 1,199,000,000/L or the platelet count is between 50,000,000,000/L and 75,000,000,000/L, than give 75% of the full dose.

If the absolute granulocyte count is between 700,000,000/L and 999,000,000/L and the platelet count is greater than or equal to 50,000,000,000/L, than give 50% of the full dose.

If the absolute granulocyte count is less than 700,000,000/L or the platelet count is less than 50,000,000,000/L, than the dose should be held.

In general, for severe (grade 3 or 4) nonhematologic toxicity, except alopecia and nausea/vomiting, therapy with gemcitabine plus cisplatin should be held or decreased by 50% depending on the judgment of the treating physician.

Usual Adult Dose for Ovarian Cancer:

In combination with carboplatin for the treatment of patients with advanced ovarian cancer that has relapsed at least six months after completion of platinum-based therapy:

1000 mg/m2 intravenously over 30 minutes on days 1 and 8 of each 21 day cycle. Carboplatin should be administered intravenously on day 1 after gemcitabine administration. Patients should be monitored prior to each dose with a complete blood count, including differential counts. Patients should have an absolute granulocyte count greater than or equal to 1,500,000,000/L and a platelet count greater than or equal to 100,000,000,000/L prior to each cycle.

Dose Modifications: Gemcitabine dosage adjustments for hematologic toxicity within a cycle of treatment is based on the granulocyte and platelet counts taken on day 8 of therapy.

If marrow suppression is detected, gemcitabine dosage should be modified according to guidelines below.

Dosage Reduction Guidelines for Gemcitabine in Combination with Carboplatin:

If the absolute granulocyte count is greater than or equal to 1,500,000,000/L and the platelet count is greater than 100,000,000,000/L, than give 100% of the full dose.

If the absolute granulocyte count is between 1,000,000,000/L and 1,499,000,000/L and/or the platelet count is between 75,000,000,000/L and 99,999,000,000/L, than give 50% of the full dose.

If the absolute granulocyte count is less than 1,000,000,000/L and/or the platelet count is less than 75,000,000,000/L, than the dose should be held.

In general, for severe (Grade 3 or 4) nonhematologic toxicity, except nausea/vomiting, therapy with gemcitabine should be held or decreased by 50% depending on the judgment of the treating physician.

Dose adjustment for gemcitabine in combination with carboplatin for subsequent cycles is based upon observed toxicity. The dose of gemcitabine in subsequent cycles should be reduced to 800 mg/m2 on days 1 and 8 in case of any of the following hematologic toxicities:

Absolute granulocyte count less than 500,000,000/L for more than five days
Absolute granulocyte count less than 100,000,000/L for more than three days
Febrile neutropenia
Platelets less than 25,000,000,000/L
Cycle delay of more than one week due to toxicity

If any of the above toxicities recur after the initial dose reduction, for the subsequent cycle, gemcitabine should be given on day 1 only at 800 mg/m2.

Gemcitabine may be administered on an outpatient basis.

What other drugs will affect gemcitabine?


There may be other drugs that can affect gemcitabine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?


Your healthcare provider may have additional information about gemcitabine that you may read.

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