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Gemcitabine for Injection, USP

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How does Gemcitabine for Injection, USP work? What will it do for me?

Gemcitabine belongs to the group of cancer-fighting medications known as antineoplastics, and specifically to the group of antineoplastics known as antimetabolites. Gemcitabine fights cancer by preventing the growth of cancer cells, which eventually results in their destruction. It is used to treat certain types of lung cancer, bladder cancer, breast cancer, and cancer of the pancreas.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are receiving this medication, speak to your doctor. Do not stop receiving this medication without consulting your doctor.

What form(s) does Gemcitabine for Injection, USP come in?

Powder for Solution

200 mg
Each vial contains 200 mg of gemcitabine (as the hydrochloride salt). Nonmedicinal ingredients: mannitol, sodium acetate, and hydrochloric acid and sodium hydroxide (for pH adjustment).

Each vial contains 1 g of gemcitabine (as the hydrochloride salt). Nonmedicinal ingredients: mannitol, sodium acetate, and hydrochloric acid and sodium hydroxide (for pH adjustment).

2 g
Each vial contains 2 g of gemcitabine (as the hydrochloride salt). Nonmedicinal ingredients: mannitol,sodium acetate, and hydrochloric acid and sodium hydroxide (for pH adjustment).

Intravenous Solution

Each mL of solution contains 38 mg of gemcitabine. Nonmedicinal ingredients: hydrochloric acid and sodium chloride (for pH adjustment).

How should I use Gemcitabine for Injection, USP?

Gemcitabine is available as an intravenous (into the vein) injection. It is usually injected through a specially prepared site on the skin. The recommended dose varies according to body size. Gemcitabine is usually given once a week by an intravenous infusion that usually takes about 30 minutes. Initially, it may be given weekly for up to 7 weeks followed by a 1-week rest period. After the first cycle of treatment, intravenous infusions are given weekly for 3 weeks followed by a rest period of 1 week.

Many things can affect the schedule and dose of medication that a person needs, such as body weight, other medical conditions, and other medications. Very careful handling of this medication is required. It is always administered in a hospital or similar setting, where there is access to sterile equipment for preparation.

As well as interfering with the genetic material DNA of cancer cells, gemcitabine can interfere with some of your normal cells. This may cause a number of side effects such as nausea and vomiting. Keep track of any side effects and report them to your doctor as suggested in the section, "What side effects are possible with this medication?"

It is important this medication be given exactly as recommended by your doctor. If you miss an appointment to receive gemcitabine, contact your doctor as soon as possible to reschedule your appointment.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take Gemcitabine for Injection, USP?

Gemcitabine should not be used by anyone who is allergic to gemcitabine or to any of the ingredients of the medication.

What side effects are possible with Gemcitabine for Injection, USP?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • constipation (mild)
  • diarrhea
  • fatigue
  • flu-like symptoms (most commonly after the first dose of gemcitabine) including:
    • chills
    • cough
    • difficulty sleeping
    • feeling of illness
    • fever (not associated with infection)
    • headache
    • muscle pain
    • runny nose
    • sweating
    • weakness
  • nausea and vomiting (for less than 24 hours)
  • numbness or tingling of hands or feet
  • temporary hair loss (minimal)

Although most of these side effects listed below don’t happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • fast or irregular heartbeat
  • high blood pressure
  • pain at site of injection
  • severe constipation for 3 days that has not been relieved by laxatives
  • severe diarrhea (3 or more watery bowel movements per day lasting more than 24 hours)
  • signs of clotting problems (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood,  bleeding gums, cuts that don’t stop bleeding)
  • signs of kidney problems (e.g., increased urination at night, decreased urine production, blood in the urine, change of urine colour)
  • signs of  liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
  • skin rash
  • sores on mouth or lips
  • swelling of fingers, feet, or lower legs
  • symptoms of anemia (i.e., shortness of breath, paleness, tiredness, fast heart rate, yellowing of the skin or eyes, dark urine)
  • symptoms of infection (i.e., fever, cough, chills, difficult or painful urination, pain in the side or lower back)
  • vision changes
  • vomiting lasting more than 24 hours after treatment

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • signs of bleeding in the stomach (e.g., bloody, black, or  tarry stools, spitting up of blood, vomiting blood or material that looks like coffee grounds)
  • signs of breathing problems (e.g., shortness of breath, troubled breathing, wheezing, or tightness in chest, fast or irregular breathing)
  • signs of posterior reversible encephalopathy syndrome (e.g., headache, seizures, weakness, confusion, high blood pressure, vision changes, difficulty thinking clearly)
  • signs of a severe skin reaction such as blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for Gemcitabine for Injection, USP?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Blood clotting: This medication can reduce the number of platelet cells in the blood. Your doctor will monitor the number of platelets in your blood with regular blood tests while you are using this medication. Platelets help the blood to clot, and a shortage could make you bleed more easily. Tell your doctor of any signs that your blood is not clotting as quickly. Such symptoms may include black and tarry stools, nosebleeds, bleeding gums, blood in the urine, easy bruising, or cuts that won’t stop bleeding.

Fever and flu-like symptoms: Gemcitabine can cause a fever and flu-like symptoms (chills, feeling unwell) that are not associated with an infection. Your doctor may prescribe acetaminophen to help treat this reaction.

Infection: As well as killing cancer cells, this medication can reduce the number of cells that fight infection in the body (white blood cells). Avoid contact with people who have contagious infections and tell your doctor if you begin to notice signs of an infection, such as fever or chills. Your doctor will monitor the number of white blood cells in your blood with regular blood tests while you are using this medication.

Kidney problems: Rarely, gemcitabine can cause a rapid breakdown of red blood cells that can be associated with kidney failure and may be fatal. Your doctor will monitor you for this while you are receiving this medication. People who have kidney problems should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Liver problems: Gemcitabine may reduce liver function and can cause liver failure. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Lung inflammation: Lung inflammation, causing difficulty breathing has occurred rarely in some people taking this medication. This complication can be serious and sometimes fatal. If you experience new or worsening shortness of breath or cough (with or without fever) at any time while you are taking gemcitabine contact your doctor immediately.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS): This is a rare disease of the brain that may occur when using medications like gemcitabine. If you have had a previous episode of RPLS, gemcitabine may not be an appropriate medication for you. If you experience signs and symptoms of RPLS, such as headache, seizures, change in awareness or consciousness or vision changes, contact your doctor immediately.

Pregnancy: Gemcitabine should not be used during pregnancy. Effective birth control should be used while receiving this medication. Gemcitabine may harm the baby if used during pregnancy. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if gemcitabine passes into breast milk. Women receiving gemcitabine should not breast-feed.

Children: The safety and effectiveness of using this medication have not been established for children.

What other drugs could interact with Gemcitabine for Injection, USP?

There may be an interaction between gemcitabine and any of the following:

  • acetylsalicylic acid (ASA)
  • amphotericin B
  • bleomycin
  • other cancer medications
  • clozapine
  • deferiprone
  • denosumab
  • digoxin
  • dipyrone
  • echinacea
  • fingolimod
  • fluorouracil
  • leflunomide
  • natalizumab
  • nivolumab
  • pimecrolimus
  • roflumilast
  • tacrolimus
  • tofacitinib
  • trastuzumab
  • vaccines
  • warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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