Gemzar

DRUG DESCRIPTION

Gemzar (gemcitabine for injection, USP) is a nucleoside metabolic inhibitor that exhibits antitumor activity. Gemcitabine HC1 is 2'-deoxy-2',2'-difluorocytidine monohydrochloride (?-isomer).

The structural formula is as follows:

GEMZAR
  (gemcitabine for injection) Powder  Structural Formula Illustration

The empirical formula for gemcitabine HC1 is C9H11F2N3O4·HCI It has a molecular weight of 299.66.

Gemcitabine HC1 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 (gemcitabine hcl) contain either 200 mg or 1 g of gemcitabine HC1 (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.

What are the possible side effects of gemcitabine (Gemzar)?

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...

Read All Potential Side Effects and See Pictures of Gemzar »

What are the precautions when taking gemcitabine hcl (Gemzar)?

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: bone marrow problems (e.g., leukopenia, thrombocytopenia, anemia), heart problems (e.g., irregular heartbeat, heart failure), kidney problems, liver problems, radiation therapy.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine.

Wash your hands well to prevent the spread of infections.

To lower the chance...

Read All Potential Precautions of Gemzar »


Gemzar Consumer (continued)

SIDE EFFECTS: Nausea, vomiting, diarrhea, pain/redness at the injection site, and flu-like symptoms (e.g., fever, muscle aches) may occur. Nausea and vomiting can be severe. In some cases, drug therapy may be needed to prevent or relieve nausea and vomiting. Changes in diet and lifestyle, such as eating several small meals or limiting activity, may help lessen some of these effects. If any of these effects persist or worsen, contact your doctor or pharmacist promptly.

Temporary hair loss may occur. Normal hair growth should return after treatment has ended.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: dizziness, fainting, mouth sores, numbness/tingling of hands/feet, swelling of ankles/feet, severe stomach/abdominal pain, easy bleeding/bruising, cough, difficulty catching your breath (shortness of breath, wheezing), unusual tiredness, fast/irregular heartbeat, change in amount of urine, dark urine, yellowing of the eyes/skin.

Get medical help right away if any of these rare but very serious side effects occur: chest pain, jaw/left arm pain, weakness on one side of the body, slurred speech, vision changes, confusion.

This medication can lower your ability to fight an infection (bone marrow depression). Notify your doctor promptly if you develop any signs of infection (e.g., high fever, chills, persistent sore throat).

An allergic reaction to this drug is unlikely, but get medical help right away if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: 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: bone marrow problems (e.g., leukopenia, thrombocytopenia, anemia), heart problems (e.g., irregular heartbeat, heart failure), kidney problems, liver problems, radiation therapy.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine.

Wash your hands well to prevent the spread of infections.

To lower the chance of getting cut, bruised or injured, use caution with sharp objects like safety razors or nail cutters, and avoid activities such as contact sports. Use a soft-bristle toothbrush to lessen the risk of bleeding gums.

This medication is not recommended for use during pregnancy. Consult your doctor for more details and to discuss reliable forms of birth control. It is recommended that men and women use two effective forms of birth control (e.g., condoms and birth control pills) while taking this medication and for some time afterwards.

It is not known whether this medication passes into breast milk. Because of the potential harm to the nursing infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.


Gemzar Patient Information Including Side Effects

Brand Names: Gemzar

Generic Name: gemcitabine (Pronunciation: jem SYE ta been)

  • What is gemcitabine (Gemzar)?
  • What are the possible side effects of gemcitabine (Gemzar)?
  • What is the most important information I should know about gemcitabine (Gemzar)?
  • What should I discuss with my healthcare provider before receiving gemcitabine (Gemzar)?
  • How is gemcitabine used (Gemzar)?
  • What happens if I miss a dose (Gemzar)?
  • What happens if I overdose (Gemzar)?
  • What should I avoid while using gemcitabine (Gemzar)?
  • What other drugs will affect gemcitabine (Gemzar)?
  • Where can I get more information?

What is gemcitabine (Gemzar)?

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 may also be used for other purposes not listed in this medication guide.

What are the possible side effects of gemcitabine (Gemzar)?

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 include:

  • 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.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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

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.

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