Vyxeos

What is Vyxeos?

Vyxeos is a prescription medicine that is used to treat a type of leukemia.

Description

VYXEOS (daunorubicin and cytarabine) liposome for injection is a combination of daunorubicin and cytarabine in a 1:5 molar ratio encapsulated in liposomes for intravenous administration. The liposome membrane is composed of distearoylphosphatidylcholine (DSPC), distearoylphosphatidylglycerol (DSPG), and cholesterol in a 7:2:1 molar ratio.

Daunorubicin is an anthracycline topoisomerase inhibitor. The chemical name for daunorubicin is (1S,3S)-3-acetyl-1,2,3,4,6,11-hexahydro-3,5,12-trihydroxy-10-methoxy-6,11-dioxo-1-naphthacenyl-3-amino-2,3,6-trideoxy-α-L-lyxo-hexopyranoside; its molecular weight is 527.52. Daunorubicin has the following structural formula:

Cytarabine is a nucleoside metabolic inhibitor. The chemical name of cytarabine is 4-amino-1-β-D-arabinofuranosyl-2(1H)-pyrimidinone; its molecular weight is 243.22. Cytarabine has the following structural formula:

VYXEOS liposome for injection is supplied as a sterile, preservative-free, purple, lyophilized cake, in a single-dose vial. Each vial contains 44 mg daunorubicin and 100 mg cytarabine, and the following inactive ingredients: distearoylphosphatidylcholine 454 mg, distearoylphosphatidylglycerol 132 mg, cholesterol HP 32 mg, copper gluconate 100 mg, triethanolamine 4 mg, and sucrose 2054 mg.

Mechanism of Action

VYXEOS (daunorubicin and cytarabine) liposome for injection is a liposomal formulation of daunorubicin and cytarabine at a fixed 1:5 molar ratio. The 1:5 molar ratio of daunorubicin:cytarabine has been shown to have synergistic effects at killing leukemia cells in vitro and in murine models. Daunorubicin has antimitotic and cytotoxic activity, which is achieved by forming complexes with DNA, inhibiting topoisomerase II activity, inhibiting DNA polymerase activity, affecting regulation of gene expression, and producing DNA-damaging free radicals. Cytarabine is a cell cycle phase-specific antineoplastic agent, affecting cells only during the S-phase of cell division. Cytarabine acts primarily through inhibition of DNA polymerase. Based on animal data, the liposomes enter and persist in the bone marrow, where they are taken up intact by bone marrow cells. In leukemia-bearing mice, the liposomes are taken up by leukemia cells to a greater extent than by normal bone marrow cells. After cellular internalization, liposomes undergo degradation releasing cytarabine and daunorubicin within the intracellular environment.

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.

Label

PACKAGE/LABEL DISPLAY PANEL

 

SRC: NLM .