cytarabine and daunorubicin (liposomal)

What is the most important information I should know about cytarabine and daunorubicin liposomal?

What is cytarabine and daunorubicin liposomal?

Cytarabine and daunorubicin liposomal is a combination medicine used to treat acute myeloid leukemia that is newly diagnosed in adults and children at least 1 year old.

Cytarabine and daunorubicin liposomal may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before receiving cytarabine and daunorubicin liposomal?

Tell your doctor if you have ever had:

• heart disease;
• liver or kidney disease;
• radiation treatment of your chest area; or
• Wilson's disease (a rare genetic disorder).

You may need to have a negative pregnancy test before starting this treatment.

Keep using birth control for at least 6 months after your last dose. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using this medicine.

It may be harder for you to get a woman pregnant while you are using this medicine. You should still use birth control to prevent pregnancy because the medicine can harm an unborn baby.

How is cytarabine and daunorubicin liposomal given?

The liposomal combination of cytarabine and daunorubicin is not given in the same doses or on the same schedule as other forms of cytarabine or daunorubicin. If you have used either of these medicines before, your dose schedule of cytarabine and daunorubicin liposomal may be different.

Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using this medicine.

Cytarabine and daunorubicin liposomal is given as an infusion into a vein. A healthcare provider will give you this injection.

This medicine must be given slowly, and the infusion can take at least 90 minutes to complete.

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when the medicine is injected.

Cytarabine and daunorubicin liposomal is usually given every other day for up to 3 infusions in a 5-day treatment cycle. If you need additional treatment cycles, you will need to wait 5 to 8 weeks before you receive the medicine again.

Cytarabine and daunorubicin liposomal doses are based on body surface area (height and weight). Your dose needs may change if you gain or lose weight or if you are still growing.

Your doctor will determine how long to treat you with this medicine.

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while receiving cytarabine and daunorubicin liposomal?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of cytarabine and daunorubicin liposomal?

• easy bruising, unusual bleeding (nose, mouth, vagina, rectum), or any bleeding that will not stop;
• signs of bleeding in your digestive tract --feeling very weak or dizzy, severe stomach pain, black or bloody stools, coughing up blood or vomit that looks like coffee grounds; or
• signs of bleeding in the brain --sudden numbness or weakness (especially on one side of the body), sudden severe headache, problems with vision or balance.

• severe or ongoing diarrhea;
• sores or white patches in or around your mouth, trouble swallowing or talking, dry mouth, bad breath, altered sense of taste;
• fast, slow, or uneven heart rate;
• pain, burning, irritation, or skin changes where the injection was given;
• heart problems --swelling, rapid weight gain, feeling short of breath; or
• signs of infection --fever, chills, swollen gums, skin sores, cold or flu symptoms, cough with mucus, chest pain, wheezing, trouble breathing, rapid heart rate, fainting.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

• bleeding (especially nosebleeds);
• fever, chills;
• irregular heartbeats;
• nausea, vomiting, stomach pain, loss of appetite;
• diarrhea, constipation;
• mouth sores;
• cough, trouble breathing;
• rash;
• muscle or joint pain;
• headache, feeling tired;
• swelling anywhere in your body; or
• sleep problems (insomnia).

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 other drugs will affect cytarabine and daunorubicin liposomal?

Other drugs may affect cytarabine and daunorubicin liposomal, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about cytarabine and daunorubicin liposomal.