Cytarabine Liposome (sye-TARE-a-been LYE-poh-some), Daunorubicin Liposome (daw-noe-ROO-bi-sin LYE-poh-some)

Treats acute myeloid leukemia (AML) or AML with myelodysplasia-related changes (AML-MRC).

Brand Name(s):

Vyxeos

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through an IV placed in a vein. 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.
• You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you 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.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how daunorubicin/cytarabine works. Tell your doctor about all other medicines that you are using.

Warnings While Using This Medicine:

• This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant. Use an effective form of birth control during treatment with this medicine and for at least 6 months after your last dose. Male patients with female partners should use an effective form of birth control during treatment and for at least 6 months after the last dose.
• Do not breastfeed during treatment with this medicine and for at least 2 weeks after the last dose.
• Tell your doctor if you have kidney disease, liver disease, heart disease, bleeding problems, or Wilson's disease (high levels of copper in the body).
• This medicine may cause the following problems:
  • Bleeding problems, which may be life-threatening
  • Heart problems (including heart failure)
  • Tissue damage at the injection site where the medicine has leaked
• 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.
• Talk with your doctor before receiving this medicine if you plan to have children. Some men who receive this medicine have become infertile (unable to have children).
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Changes in mood, blurred or double vision, difficulty in walking, headache, numbness or tingling in your fingers and toes, trouble sleeping
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Rapid weight gain, swelling in your hands, ankles, or feet
• Tiredness, trouble breathing, uneven heartbeat
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Cough
• Decreased appetite
• Diarrhea, constipation
• Pain, itching, burning, swelling, or a lump under your skin where the needle is placed

If you notice other side effects that you think are caused by this medicine, tell your doctor

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