DAUNORUBICIN/CYTARABINE LIPOSOME - INJECTION

DAUNORUBICIN/CYTARABINE LIPOSOME - INJECTION

PHONETIC PRONUNCIATION: (DAW-noe-ROO-bi-sin/sye-TAR-abeen)

COMMON BRAND NAME(S): Vyxeos

GENERIC NAME(S): daunorubicin/cytarabine liposomal

Uses

USES: This medication is a combination product of daunorubicin and cytarabine liposome and is used to treat leukemia. It is a chemotherapy drug that works by slowing or stopping the growth of cancer cells.


How to use DAUNORUBICIN/CYTARABINE LIPOSOME - INJECTION

HOW TO USE: This medication is given by injection into a vein as directed by your doctor. It is given by a health care professional, usually over 90 minutes. The dosage and treatment schedule are based on your medical condition, body size, and response to treatment. Drink plenty of fluids while using this medication unless otherwise directed by your doctor. Doing so helps decrease the risk of certain side effects (such as increased uric acid).

Side Effects

SIDE EFFECTS: See also Warning section. Nausea, vomiting, constipation, diarrhea, and loss of appetite may occur. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Pain or sores in the mouth and throat may occur. Brush your teeth carefully/gently, avoid using mouthwash that contains alcohol, and rinse your mouth often with cool water mixed with baking soda or salt. It may also be best to eat soft, moist foods. Temporary hair loss may occur. Normal hair growth should return after treatment has ended. People using this medication may have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk. Tell your doctor right away if you have any serious side effects, including: unusual bleeding/bruising (such as small red spots on the skin, black/bloody stools, bloody urine, vomit that looks like coffee grounds). A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), trouble breathing, severe dizziness. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

PRECAUTIONS: See also Warning section. Before using this product, tell your doctor or pharmacist if you are allergic to daunorubicin, daunorubicin liposome, cytarabine, or cytarabine liposome; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood/bleeding problems (such as anemia), gout, heart problems (such as heart failure, irregular heartbeat), kidney disease, liver disease, radiation treatment (especially to the chest area), Wilson's disease. This medication can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details. Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose). To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports. This medication contains copper. Caution is advised if you have any condition (such as Wilson's disease) that requires you to limit/avoid copper. Talk to your doctor for details. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Children may be more sensitive to the side effects of this drug, especially heart problems. Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using this medication. Daunorubicin/cytarabine liposome may harm an unborn baby. Men and women should ask about reliable forms of birth control while using this medication and for 6 weeks after stopping treatment. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication. It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug and for 2 weeks after stopping treatment is not recommended. Consult your doctor before breast-feeding.

Interactions

DRUG INTERACTIONS: See also Warning section. Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Overdose

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

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Faq for DAUNORUBICIN/CYTARABINE LIPOSOME - INJECTION

Daunorubicin/Cytarabine Liposome - Injection is used to treat certain types of aggressive and recurrent acute myeloid leukemia (AML) in adults.

It combines two chemotherapy drugs, daunorubicin and cytarabine, encapsulated in liposomes. These liposomes help to deliver the drugs directly to cancer cells, increasing their effectiveness in killing the cancer cells.

Common side effects may include nausea, vomiting, diarrhea, mouth sores, hair loss, fatigue, fever, and a decreased number of blood cells.

It is typically administered by a healthcare professional through intravenous infusion over a period of about 90 minutes.

The treatment schedule is usually determined by your healthcare provider based on your specific condition. It is typically given for several days in a row, with cycles repeated every few weeks.

Yes, this medication may cause serious or potentially life-threatening heart problems. It may also increase the risk of infections and bleeding. It is important to discuss your medical history and any current medications with your healthcare provider before starting this treatment.

It is important to inform your healthcare provider about all the medications, supplements, and herbal products you are taking before starting this treatment. Some medications may interact with Daunorubicin/Cytarabine Liposome - Injection and affect its effectiveness or increase the risk of side effects.

It is not recommended to use this medication during pregnancy as it may harm the unborn baby. It is also not recommended while breastfeeding. It is important to discuss the potential risks and benefits with your healthcare provider.

The medication should be stored in the refrigerator at a temperature between 2°C to 8°C (36°F to 46°F), and it should be protected from light. It should not be frozen.


Warning

WARNING: This medication is not given the same way as similar products including daunorubicin, daunorubicin liposome, cytarabine, or cytarabine liposome. Do not use any of these similar products while using daunorubicin/cytarabine liposome injection. This medication may rarely cause serious (rarely fatal) heart problems (including heart failure). This effect may occur during treatment or months to years after treatment is completed. The risk of heart problems is increased if you have heart disease, or have had radiation treatment to the chest area, or use/have used drugs that can also cause heart problems. Tell your doctor right away if you notice symptoms such as irregular heartbeat, shortness of breath, swelling ankles/feet, unusual tiredness, or unusual/sudden weight gain. This medication decreases bone marrow function, an effect that may lead to a low number of blood cells such as red cells, white cells, and platelets. This effect can cause anemia, decrease your body's ability to fight an infection, or cause easy bruising/bleeding. Tell your doctor right away if you develop any of the following symptoms: unusual tiredness, pale skin, signs of infection (such as sore throat that doesn't go away, fever, chills), easy bruising/bleeding. This medication must be given only by injection into a vein. It must not be given by injection into a muscle or under the skin. If this medication accidentally leaks into the skin/muscle around the injection site, it may cause severe damage. Tell your doctor right away if you notice redness, pain, or swelling at or near the injection site.


Disclaimer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.