Vyxeos

Vyxeos is a prescription medication used to treat acute myeloid leukemia (AML). It is a single product containing 2 medications: daunorubicin and cytarabine. Daunorubicin is part of a group of drugs called anthracyclines and cytarabine is classified as an antimetabolite. These two medications work together to slow or stop the growth of cancer.

Vyxeos is available in an injectable form to be given directly into a vein (IV)by a healthcare professional.

Common side effects include bleeding events, fevers, rash, or swelling.

Vyxeos is a prescription medication used to treat acute myeloid leukemia (AML) caused by other therapies. AML is a cancer of the blood and bone marrow that affects white blood cells. 

Vyxeos may be prescribed for other uses. Ask your doctor or pharmacist for more information. 

Serious side effects have been reported with Vyxeos. See the “Vyxeos Precautions” section.

Common side effects of Vyxeos include the following:

• bleeding
• fever with low white blood cell counts
• rash
• swelling
• nausea
• diarrhea
• constipation
• pain of the bones, muscles, tendons, and/or ligaments
• abdominal (stomach area) pain 
• difficulty breathing or shortness of breath
• cough
• loss of appetite
• headache
• changes in heart rate 
• vomiting
• chillls
• sleep disorders

Vyxeos can also cause tiredness. Do not drive or operate heavy machinery until you know how Vyxeos affects you.

This is not a complete list of Vyxeos side effects. Ask your doctor or pharmacist for more information. Tell your doctor if you have any side effects that bother you or that do not go away. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• medications that are toxic to the heart such as sotalol (Betapace), propranolol (Inderal), tricyclic antidepressants such as amitriptyline (Elavil), antibiotics such as levofloxacin (Levaquin), clarithromycin (Biaxin), antifungals such as ketoconazole (Nizoral), antidepressants such as fluoxetine (Prozac), antipsychotics such as chlorpromazine (Thorazine), quetiapine (Seroquel), migraine medications such as sumatriptan (Imitrex)
• medications that are toxic to the liver such as chlorpromazine (Thorazine), risperidone (Risperdal), amiodarone (Pacerone), clopidogrel (Plavix), acetaminophen (Tylenol), ibuprofen (Advil)

This is not a complete list of Vyxeos drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Vyxeos including the following:

• Bleeding events. Serious, life-threatening bleeding events may occur with Vyxeos. Your doctor may monitor blood counts and levels throughout Vyxeos treatment. Report any bleeding events to your doctor. 
• Cardiotoxicity. Vyxeos can cause damage to the heart. Talk to your doctor if you experience any changes in heart function including changes in blood pressure or heart rate, shortness of breath, swelling in arms or legs, or chest pain. 
• Hypersensitivity reaction. Severe allergic reaction can occur with Vyxeos. Your doctor may change the rate Vyxeos is administered depending on allergic reaction side effects.
• Copper overload. Vyxeos contains copper and can cause damage in high amounts. Vyxeos should be used with caution in patients with Wilson's disease and discontinued if copper toxicity is confirmed. 
• Tissue necrosis. Tissue damage and break down may occur at the site Vyxeos is administered. Vyxeos should only be administered directly into the vein (IV) by a healthcare professional. 
• Embryo-Fetal toxicity. Vyxeos can cause harm to unborn babies if administered to pregnant women. Contraception is recommended in women of reproductive age on Vyxeos therapy and for 6 months after completion.

Do not take Vyxeos if you are allergic to Vyxeos or to any of this medication’s ingredients.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Vyxeos, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Vyxeos, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Vyxeos or to any of its ingredients
• have to have had any other cancer treatments
• have or have had heart disease
• have any surgery dental surgery planned
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

There are no well-controlled studies that have been done in pregnant women. However, based on how Vyxeos works it may cause harm to unborn babies. Therefore Vyxeos should be given to pregnant women only if clearly needed. Contraception is recommended in women of reproductive age on Vyxeos therapy and for 6 months after completion.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Vyxeos crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Vyxeos.

Take Vyxeos exactly as prescribed.

Vyxeos is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

While taking Vyxeos, it is important to keep all appointments with your doctor and other healthcare professionals. 

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The Vyxeos dose you receive is based on your height and weight which is used to calculate your body surface area. It is usually injected 3 times within the first week followed by a period of time without an injection. If more cycles of Vyxeos are required it is injected only 2 times a week. Follow your doctor's instructions about your individual dosing schedule. It is important to keep all of your appointments to receive your Vyxeos doses.

Since Vyxeos is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if an overdose is suspected, seek emergency medical attention.

• Keep all appointments with your doctor and the laboratory.
• Your doctor will order certain lab tests to check your body's response to Vyxeos. 

WARNING: DO NOT INTERCHANGE WITH OTHER DAUNORUBICIN AND/OR CYTARABINE-CONTAINING PRODUCTS

Vyxeos has different dosage recommendations from other formulations including daunorubicin hydrochloride injection, cytarabine injection, daunorubicin citrate liposome injection, and cytarabine liposome injection. Verify drug name and dose prior to preparation and administration to avoid dosing errors.