A liposomal formulation containing a fixed combination of the antineoplastic agents cytarabine and daunorubicin in a 5:1 molar ratio, Daunorubicin hydrochloride and cytarabine liposome have been designed to provide optimal delivery of a specific ratio of cytarabine to daunorubicin, one that is synergistic in vitro. The antimetabolite cytarabine competes with cytidine for incorporation into DNA, inhibiting DNA synthesis. This agent also inhibits DNA polymerase, resulting in a decrease in DNA replication and repair. Daunorubicin, an intercalator, and a topoisomerase II inhibitor prevents DNA replication and inhibits protein synthesis. This agent also generates oxygen free radicals, resulting in the cytotoxic lipid peroxidation of cell membrane lipids.
Daunorubicin hydrochloride and cytarabine liposome are approved to treat:
- Acute myeloid leukemia (AML) that is newly diagnosed. It is used in adults with therapy-related AML (tAML) or AML with myelodysplasia-related changes (AML-MRC).
HOW DAUNORUBICIN AND CYTARABINE IS GIVEN
- Daunorubicin and cytarabine (liposomal) is given as an infusion into the vein (intravenous or IV) over 90 minutes.
- You will be given anti-nausea medications approximately 30 minutes before the infusion to reduce the risk of chemotherapy-induced nausea or vomiting.
The amount of daunorubicin and cytarabine (liposomal) that you will receive depends on many factors, including your height and weight and your general health or other health problems. Your doctor will determine your exact dosage and schedule.
Important – Daunorubicin hydrochloride and cytarabine liposome (liposomal) have different dosage recommendations than other daunorubicin- and cytarabine-containing medications. Do not interchange daunorubicin and cytarabine (liposomal) with other daunorubicin- and/or cytarabine-containing medications.
The following side effects are common (occurring in greater than 30%) for patients taking daunorubicin and cytarabine (liposomal):-
- Low blood counts. Your white and red blood cells and platelets may temporarily decrease. This can put you at increased risk for infection, anemia, and/or bleeding.
- Diarrhea (within the first week of therapy)
- Nausea and Vomiting
- Mouth sores (in the first week after therapy)
- Skin rash
- Muscle pain
- Heart rhythm changes
These are less common side effects (occurring in 10-29%) for patients receiving daunorubicin and cytarabine (liposomal):-
- Loss of appetite
- Sleep problems
- High or low blood pressure
- Chest pain
These are rare but serious side effects of daunorubicin and cytarabine (liposomal):-
(a) Cardiac toxicity
- A serious, but uncommon side effect of daunorubicin and cytarabine (liposomal) can be interference with the pumping action of the heart. The chance of heart problems may be raised if you are using other drugs that may cause heart problems if you have ever had heart problems, if you have had radiation to the chest area, or if you have ever had this drug or other anthracyclines similar to this drug before.
- Your chance of heart problems depends on your dose of this drug and your health condition.
- Your doctor will check your heart function before you may take any daunorubicin and cytarabine (liposomal) and will monitor your heart closely during your treatment.
- Dose-related heart problems can occur as late as 7 or 8 years after treatments have ended.
(b) Hypersensitivity reactions
- Some individuals will experience certain side effects during the infusion such as back pain, flushing, and tightness of their chest and throat. The chance of having an infusion reaction is very low and generally only happens during the first 5 minutes of the first infusion.
- Tell your doctors right away if you experience any of these side effects during the infusion. The side effects go away upon stopping the infusion and typically do not reoccur when the infusion is restarted at a slower rate.
Not all side effects are listed above. But you should always inform your health care provider if you experience any unusual symptoms.
WHEN TO CONTACT YOUR DOCTOR OR HEALTHCARE PROVIDER
Contact your health care provider immediately, day or night, if you should experience any of the following symptoms:-
- Fever of 100.4º F (38º C) or higher, chills (possible signs of infection)
The following symptoms require medical attention but are not an emergency. Contact your health care provider within 24 hours of noticing any of the following:-
- Nausea (interferes with the ability to eat and unrelieved with prescribed medication)
- Vomiting (vomiting more than 4-5 times in a 24-hour period)
- Diarrhea (4-6 episodes in a 24-hour period)
- Unusual bleeding or bruising
- Black or tarry stools, or blood in your stools
- Blood in the urine
- Pain or burning with urination
- Extreme fatigue (unable to carry on self-care activities)
- Mouth sores (painful redness, swelling, or ulcers)
Always inform your health care provider if you experience any unusual symptoms.
- Before starting Daunorubicin hydrochloride and cytarabine liposome (liposomal) treatment, make sure you tell your doctor about any other medications you are taking (including prescription, over-the-counter, vitamins, herbal remedies, etc.). Do not take aspirin, products containing aspirin unless your doctor specifically permits this.
- People who have had a serious allergic reaction with daunorubicin, cytarabine, or any component of this medication cannot take daunorubicin and cytarabine (liposomal).
- Do not receive any kind of immunization or vaccination without your doctor’s approval while taking daunorubicin and cytarabine (liposomal).
- Inform your health care professional if you are pregnant or may be pregnant prior to starting this treatment. Pregnancy category D (daunorubicin and cytarabine [liposomal] may be hazardous to the fetus. Women who are pregnant or become pregnant must be advised of the potential hazard to the fetus).
- For both men and women: Use contraceptives, and do not conceive a child (get pregnant) while taking daunorubicin and cytarabine (liposomal). Barrier methods of contraception, such as condoms, are recommended for up to 6 months after the last dose of daunorubicin and cytarabine (liposomal).
- Do not breastfeed while taking daunorubicin and cytarabine (liposomal) and for at least 2 weeks after the last dose.
- Drink at least two to three quarts of fluid every 24 hours, unless you are instructed otherwise.
- You may be at risk of infection so try to avoid crowds or people with colds, and report fever or any other signs of infection immediately to your health care provider.
- Wash your hands often.
- To help treat/prevent mouth sores, use a soft toothbrush, and rinse three times a day with 1 teaspoon of baking soda mixed with 8 ounces of water.
- Use an electric razor and a soft toothbrush to minimize bleeding.
- Avoid contact sports or activities that could cause injury.
- To reduce nausea, take-anti-nausea medications as prescribed by your doctor, and eat small, frequent meals.
- Follow a regimen of anti-diarrhea medication as prescribed by your health care professional.
- In general, drinking alcoholic beverages should be kept to a minimum or avoided completely. You should discuss this with your doctor.
- Get plenty of rest.
- Maintain good nutrition.
- Remain active as you are able. Gentle exercise is encouraged such as a daily walk.
- If you experience symptoms or side effects, be sure to discuss them with your health care team. They can prescribe medications and/or offer other suggestions that are effective in managing such problems.