Gemzar contains the active ingredient gemcitabine hydrochloride, which is a nucleoside metabolic inhibitor. It is available in the form of a lyophilized powder for injection, with dosage strengths of 200 mg and 1 g, administered intravenously. Key inactive ingredients include mannitol and sodium acetate trihydrate.

How should I use this medication?

This medication is injected into a vein. It is given by your care team in a hospital or clinic setting.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

Keep appointments for follow-up doses. It is important not to miss your dose. Call your care team if you are unable to keep an appointment.

Where should I keep my medication?

This medication is given in a hospital or clinic. It will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Capillary leak syndrome—stomach or muscle pain, unusual weakness or fatigue, feeling faint or lightheaded, decrease in the amount of urine, swelling of the ankles, hands, or feet, trouble breathing
• Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Low red blood cell level—unusual weakness or fatigue, dizziness, headache, trouble breathing
• Lung injury—shortness of breath or trouble breathing, cough, spitting up blood, chest pain, fever
• Stomach pain, bloody diarrhea, pale skin, unusual weakness or fatigue, decrease in the amount of urine, which may be signs of hemolytic uremic syndrome
• Sudden and severe headache, confusion, change in vision, seizures, which may be signs of posterior reversible encephalopathy syndrome (PRES)
• Unusual bruising or bleeding

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Diarrhea
• Drowsiness
• Hair loss
• Nausea
• Pain, redness, or swelling with sores inside the mouth or throat
• Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Blood disorders
• Infection
• Kidney disease
• Liver disease
• Lung or breathing disease, such as asthma or COPD
• Recent or ongoing radiation therapy
• An unusual or allergic reaction to gemcitabine, other medications, foods, dyes, or preservatives
• If you or your partner are pregnant or trying to get pregnant
• Breast-feeding

What may interact with this medication?

Interactions have not been studied.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Your condition will be monitored carefully while you are receiving this medication.

This medication may make you feel generally unwell. This is not uncommon, as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your care team tells you to stop.

In some cases, you may be given additional medications to help with side effects. Follow all directions for their use.

This medication may increase your risk of getting an infection. Call your care team for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

This medication may increase your risk to bruise or bleed. Call your care team if you notice any unusual bleeding.

Be careful brushing or flossing your teeth or using a toothpick because you may get an infection or bleed more easily. If you have any dental work done, tell your dentist you are receiving this medication.

Avoid taking medications that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your care team. These medications may hide a fever.

Talk to your care team if you or your partner wish to become pregnant or think you might be pregnant. This medication can cause serious birth defects if taken during pregnancy and for 6 months after the last dose. A negative pregnancy test is required before starting this medication. A reliable form of contraception is recommended while taking this medication and for 6 months after the last dose. Talk to your care team about effective forms of contraception. Do not father a child while taking this medication and for 3 months after the last dose. Use a condom while having sex during this time period.

Do not breastfeed while taking this medication and for at least 1 week after the last dose.

This medication may cause infertility. Talk to your care team if you are concerned about your fertility.