Daunorubicin and cytarabine liposome (Intravenous)

Daunorubicin and cytarabine injection is used to treat therapy-related acute myeloid leukemia (AML) or AML with myelodysplasia-related changes (AML-MRC).

Daunorubicin and cytarabine liposome works by interfering with the growth of cancer cells, which are eventually destroyed by the body. Because it can also affect the growth of normal body cells, there may be other unwanted side effects. Some of these side effects could be serious and should be reported to your doctor.

This medicine is to be given only by or under the supervision of your doctor.

It is very important for your doctor to check your progress at regular visits to ensure that this medicine is working properly. Blood, heart, kidney, and liver tests are needed to check for unwanted effects before starting each cycle of treatment with this medicine.

Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control to avoid getting pregnant during treatment and for at least 6 months after the last dose of this medicine. Men should use an effective form of birth control during treatment and for at least 6 months after the last dose to prevent pregnancy in a sexual partner. If you become pregnant while using this medicine, tell your doctor right away.

Talk to your doctor before using this medicine if you plan to have children. Some men who use this medicine have become infertile (unable to have children).

Check with your doctor right away if you have any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, headache, dizziness, or weakness, pain, swelling, or discomfort in a joint, pinpoint red spots on your skin, unusual nosebleeds, or unusual vaginal bleeding that is heavier than normal. These may be signs of bleeding problems.

If you are rapidly gaining weight, having chest pain or discomfort, extreme tiredness or weakness, irregular breathing, irregular heartbeat, excessive swelling of the hands, wrists, ankles, or feet, or trouble breathing, check with your doctor right away. These may be symptoms of a heart problem or your body retaining too much water.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving this medicine.

This medicine contains copper gluconate. Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, yellow eyes or skin, changes in mood, blurred or double vision, difficulty walking, headache, numbness or tingling in your fingers and toes, or trouble sleeping. These could be symptoms of copper toxicity.

This medicine may cause tissue damage at the injection site where this medicine has leaked. Talk to your doctor if you have any concerns.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor need to consider the risks and benefits of the medicine. Here are some important points to think about:

Allergies

Let your doctor know if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also inform your health care professional about any other allergies you may have, such as allergies to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Studies have not shown any specific problems in children 1 year of age and older that would limit the usefulness of daunorubicin and cytarabine injection. Safety and effectiveness have been confirmed.

Geriatric

Studies have not shown any specific problems in the elderly that would limit the usefulness of daunorubicin and cytarabine injection. However, older patients are more likely to have bleeding issues, which may require caution when using this medicine.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if an interaction could happen. In these cases, your doctor may adjust the dose or take other precautions. When you are receiving this medicine, it is very important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are significant but may not include all possible interactions.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Tasonermin
• Varicella Virus Vaccine, Live
• Zoster Vaccine, Live

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or frequency of one or both medicines.

• Adenovirus Vaccine
• Bacillus of Calmette and Guerin Vaccine, Live
• Cedazuridine
• Cholera Vaccine, Live
• Dengue Tetravalent Vaccine, Live
• Influenza Virus Vaccine, Live
• Margetuximab
• Pertuzumab
• Poliovirus Vaccine, Live
• Smallpox Vaccine
• Trastuzumab
• Typhoid Vaccine, Live
• Yellow Fever Vaccine

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken at the same time as eating or with certain types of food because interactions may happen. Using alcohol or tobacco with some medicines may also cause interactions. Talk to your healthcare professional about how to use your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect how you use this medicine. Make sure to tell your doctor if you have any other medical conditions, especially:

• Bleeding problems or
• Heart disease or
• Kidney disease or
• Liver disease or
• Wilson's disease (high levels of copper in the body)—Use with caution. May worsen these conditions.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do, they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

• Bleeding gums
• blood in the urine or stools
• blurred vision
• body aches or pain
• chest pain, discomfort, or tightness
• chills
• confusion about time, place, or person
• cough
• coughing up blood
• deafness
• decreased frequency or amount of urine
• diarrhea
• difficulty breathing or swallowing
• dizziness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• ear congestion
• facial swelling
• fainting
• fast, slow, or irregular heartbeat
• fever
• general feeling of discomfort or illness
• headache
• holding false beliefs that cannot be changed by fact
• increased blood pressure
• increased menstrual flow or vaginal bleeding
• increased thirst
• itching of the genitals or other skin areas
• loss of appetite
• loss of voice
• lower back or side pain
• nausea
• nervousness
• nosebleeds
• painful or difficult urination
• pale skin
• paralysis
• pinpoint red spots on the skin
• pounding in the ears
• prolonged bleeding from cuts
• rapid, shallow breathing
• red or black, tarry stools
• red or dark brown urine
• runny or stuffy nose
• scaling
• seeing, hearing, or feeling things that are not there
• skin rash
• sneezing
• sore throat
• stomach cramps or pain
• sweating
• swelling
• swelling of the face, fingers, feet, or lower legs
• tenderness
• thickening of the bronchial secretions
• trouble breathing
• ulcers, sores, or white spots in the mouth
• unusual bleeding or bruising
• unusual excitement, nervousness, or restlessness
• unusual tiredness or weakness
• vomiting
• watery or bloody diarrhea
• weakness
• weight gain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Anxiety
• belching
• bleeding after having a bowel movement
• bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• bone and muscle pain
• burning, dry, or itching of the eyes
• changes in vision
• constipation
• cracked lips
• decreased appetite
• discharge, excessive tearing
• heartburn
• indigestion
• redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
• small red or purple spots on the skin
• stomach discomfort or upset
• trouble sleeping
• uncomfortable swelling around the anus

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

In the U.S.

• Vyxeos

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Antimetabolite

Chemical Class: Anthracycline

Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

A nurse or other trained health professional will give you this medicine in a hospital or cancer treatment center. This medicine is given through a needle placed into one of your veins. It must be given slowly, so the needle will have to remain in place for over 90 minutes.

You may receive other medicines to help prevent vomiting before starting treatment with this medicine.

Missed Dose

This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

• How is Vyxeos administered and how long do you take it for?
• Why does Vyxeos have a polymer coating?