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

Vyxeos may also be used for purposes not listed in this medication guide.

Vyxeos can make it easier for you to bleed. Contact your doctor or seek emergency medical attention if you have easy bruising, unusual bleeding, or any bleeding that will not stop. You may also have bleeding on the inside of your body, such as in your stomach or intestines, or in your brain.

Call your doctor at once if you have: signs of bleeding in your digestive tract--feeling very weak or dizzy, severe stomach pain, black or bloody stools, or if you cough 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, or problems with vision or balance.

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 Vyxeos.

Vyxeos 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.

Vyxeos 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.

You may be given other medications to help prevent serious side effects or allergic reaction. Keep taking these medicines for as long as your doctor has prescribed.

Vyxeos 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.

This medicine can make it easier for you to bleed. Contact your doctor or seek emergency medical attention if you have easy bruising, unusual bleeding, or any bleeding that will not stop.

You should not be treated with this medicine if you are allergic to cytarabine or daunorubicin.

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.

Both men and women using this medicine should use effective birth control to prevent pregnancy. Vyxeos can harm an unborn baby if the mother or father is using this medicine.

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.

You should not breastfeed while using this medicine and for at least 2 weeks after your last dose.

Call your doctor for instructions if you miss an appointment for your Vyxeos liposomal injection.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Vyxeos can make it easier for you to bleed. Call your doctor or seek emergency medical attention if you have:

• 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.

Vyxeos may cause serious side effects. Call your doctor at once if you have:

• 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 of Vyxeos 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.

Other drugs may affect Vyxeos, 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.