Vyxeos

What is Vyxeos used for?

• Vyxeos is used to treat a type of leukemia.

Before taking Vyxeos, tell your doctor:

• If you are allergic to this medicine (Vyxeos); any part of this medicine (Vyxeos); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have heart problems like heart failure.
• If you have taken any drugs like this one.
• If you are breast-feeding. Do not breast-feed while you take this medicine (Vyxeos) and for 2 weeks after your last dose.

This is not a list of all drugs or health problems that interact with this medicine (Vyxeos).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine (Vyxeos) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Vyxeos?

• Tell all of your health care providers that you take this medicine (Vyxeos). This includes your doctors, nurses, pharmacists, and dentists.
• Allergic reactions have happened with this medicine (Vyxeos). Rarely, some reactions can be very bad or life-threatening. Talk with the doctor.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• You will need to have your heart checked before starting this medicine (Vyxeos) and while taking it. This includes an ECG. Talk with your doctor.
• Heart failure has happened with this medicine (Vyxeos), as well as heart failure that has gotten worse in people who already have it. Tell your doctor if you have heart disease. Call your doctor right away if you have shortness of breath, a big weight gain, a heartbeat that is not normal, or swelling in the arms or legs that is new or worse.
• You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor. Rarely, some bleeding problems have been deadly.
• You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
• Talk with your doctor before getting any vaccines. Use of some vaccines with this medicine (Vyxeos) may either raise the chance of an infection or make the vaccine not work as well.
• This medicine may cause tissue damage if the drug leaks from the vein. Tell your nurse if you have any redness, burning, pain, swelling, blisters, skin sores, or leaking of fluid where the drug is going into your body.
• If you are 65 or older, use this medicine (Vyxeos) with care. You could have more side effects.
• This medicine may affect being able to father a child. Talk with the doctor.
• This medicine may cause harm to an unborn baby. A pregnancy test will be done before you start this medicine (Vyxeos) to show that you are NOT pregnant.
• Women must use birth control while taking this medicine (Vyxeos) and for some time after the last dose. Ask your doctor how long to use birth control. If you get pregnant, call your doctor right away.
• Men with a partner who may get pregnant must use birth control while taking this medicine (Vyxeos) and for some time after the last dose. Ask your doctor how long to use birth control. If your partner gets pregnant, call the doctor right away.

How is Vyxeos best taken?

Use this medicine (Vyxeos) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as an infusion into a vein over a period of time.
• Other drugs may be given before this medicine (Vyxeos) to help avoid side effects.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are the side effects of Vyxeos that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of bleeding like throwing up or coughing up blood; vomit that looks like coffee grounds; blood in the urine; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a cause or that get bigger; or bleeding you cannot stop.
• Signs of electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, seizures, not hungry, or very bad upset stomach or throwing up.
• Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
• Signs of high or low blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• Swelling.
• Chest pain.
• Anxiety.
• Change in eyesight, eye pain, or very bad eye irritation.
• Hearing loss.
• Feeling very tired or weak.

What are some other side effects of Vyxeos?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Mouth irritation or mouth sores.
• Muscle pain.
• Feeling dizzy, sleepy, tired, or weak.
• Stomach pain.
• Headache.
• Not hungry.
• Trouble sleeping.
• Signs of a common cold.
• Constipation, diarrhea, throwing up, and upset stomach are common with this medicine (Vyxeos). If these happen, talk with your doctor about ways to lower these side effects. Call your doctor right away if any of these effects bother you, do not go away, or get very bad.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Vyxeos?

• If you need to store this medicine (Vyxeos) at home, talk with your doctor, nurse, or pharmacist about how to store it.

Consumer information use and disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine (Vyxeos), please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine (Vyxeos) or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine (Vyxeos). It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine (Vyxeos). This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine (Vyxeos).