Gemcitabine Intravenous

Before using gemcitabine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, radiation treatment, heart problems (such as irregular heartbeat, heart failure).

This drug may make you drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Gemcitabine can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using gemcitabine. Gemcitabine may harm an unborn baby. Women should ask about reliable forms of birth control while using this medication and for 6 months after stopping treatment. Men should ask about reliable forms of birth control while using this medication and for 3 months after stopping treatment. If you or your partner becomes pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug and for 1 week after stopping treatment is not recommended. Consult your doctor before breast-feeding.

More frequently reported side effects include: signs and symptoms of injection site. See below for a comprehensive list of adverse effects.

Applies to gemcitabine: intravenous powder for solution, intravenous solution

Along with its needed effects, gemcitabine 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 while taking gemcitabine:

• Bleeding gums
• blood in urine or stools
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chest pain
• cloudy urine
• coughing up blood
• cough or hoarseness
• diarrhea
• difficult or labored breathing
• difficulty in moving
• difficulty in swallowing
• dizziness
• fever or chills
• general feeling of discomfort or illness
• headache
• increased menstrual flow or vaginal bleeding
• joint pain
• lack or loss of strength
• loss of appetite
• lower back or side pain
• muscle aching or cramping
• muscle pains or stiffness
• nausea
• nosebleeds
• painful or difficult urination
• pale skin
• paralysis
• pinpoint red spots on skin
• prolonged bleeding from cuts
• red or black, tarry stools
• red or dark brown urine
• runny nose
• shivering
• shortness of breath
• sores, ulcers, or white spots on lips or in mouth
• sore throat
• sweating
• swelling of hands, ankles, feet, or lower legs
• swollen glands
• swollen joints
• tightness in chest
• troubled breathing with exertion
• trouble sleeping
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting
• weight loss
• wheezing

• Blurred vision
• chest discomfort
• fainting
• fast, slow, or irregular heartbeat
• headache (sudden and severe)
• inability to speak
• nervousness
• noisy breathing
• pain or discomfort in arms, jaw, back or neck
• pounding in the ears
• seizures
• slurred speech
• temporary blindness
• weakness in arm and/or leg on one side of the body (sudden and severe)

• Confusion
• lightheadedness
• rapid, shallow breathing

• Hives
• itching
• puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
• skin rash

Some side effects of gemcitabine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Difficulty having a bowel movement (stool)
• hair loss
• pain
• sleepiness or unusual drowsiness
• swelling or inflammation of the mouth
• thinning of hair

• Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at site

1000 mg/m2 IV one time over 30 minutes.
-Weeks 1 through 8: Weekly dosing for the first 7 weeks, followed by one week of rest. If toxicity occurs, a dose should be held.
-After week 8: Weekly dosing on Days 1, 8, and 15 of 28 day cycles

Comments:
-Patients should be monitored prior to each dose with a complete blood count (CBC), including differential and platelet count.
-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.
-Dose modifications due to hematological toxicity in subsequent cycles, for all indications:
The gemcitabine dose should be reduced to 75% of the original cycle initiation dose, in the case of the following hematological toxicities:
1) Absolute granulocyte count less than 500,000,000/L for more than 5 days
2) Absolute granulocyte count less than 100,000,000/L more than 3 days
3) Febrile neutropenia
4) Platelets less than 25,000,000,000/L
5) Cycle delay of more than 1 week due to toxicity
-Withhold therapy or reduce dose by 50% for other severe (Grade 3 or 4) nonhematological toxicity until resolved. No dose modifications are recommended for alopecia, nausea, or vomiting.

Use: Pancreatic cancer (as first-line treatment for patients with locally advanced (nonresectable Stage II or Stage III) or metastatic (Stage IV) adenocarcinoma of the pancreas. This drug is indicated for patients previously treated with 5-FU).

1250 mg/m2 IV over 30 minutes on days 1 and 8 of each 21 day cycle that includes paclitaxel. Paclitaxel should be administered at 175 mg/m2 IV on day 1 as a 3 hour IV infusion before gemcitabine administration
Dose reduction with each cycle or within a cycle may be applied based upon the grade of toxicity experienced by the patient. Patients should have an absolute granulocyte count of at least 1,500,000,000/L prior to initiation of gemcitabine plus paclitaxel combination.

Comments:
-Patients should be monitored prior to each dose with a complete blood count (CBC), including differential and platelet count.
-Doses may need to be adjusted, based upon the degree of hematologic toxicity experienced by the patient. -Dose Modifications for Non-Hematologic Adverse Reactions
Permanently discontinue therapy for any of the following:
1) Unexplained dyspnea or other evidence of severe pulmonary toxicity
2) Severe hepatic toxicity
3) Hemolytic-Uremic Syndrome
4) Capillary Leak Syndrome
5) Posterior reversible encephalopathy syndrome
-Withhold therapy or reduce dose by 50% for other severe (Grade 3 or 4) non-hematological toxicity until resolved. No dose modifications are recommended for alopecia, nausea, or vomiting.

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

Data not available

Data not available

AU and UK: Use is contraindicated. US: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Unknown