TM Owner Jazz Pharmaceuticals
Vyxeos 44mg/100mg Powder for injection (liposomal), lyophilised
Global Shipping : Reliable Global Distribution Network
Express Delivery : Priority Shipping for Every Order
Secure Payments : Trusted Payment Protection System
Disclaimer
Secure Handling
24/7 Worldwide Support
Global Access
Worldwide Access to Health
Cold-Chain Expert
Excellence in Cold-Chain
Trusted Supply
Certified Medical Supply
Indications & Clinical Uses
- Vyxeos 44 mg/100 mg is a lyophilised powder for intravenous infusion in which 44 mg of daunorubicin (an anthracycline) and 100 mg of cytarabine (an antimetabolite) are encapsulated together in liposomes in a fixed ratio.
- In the US it is approved for newly diagnosed therapy-related acute myeloid leukaemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in adults and children aged 1 year and older; the EU authorisation (now named Vyxeos liposomal) covers adults only.
- It is a hospital-administered cancer treatment given over 90 minutes on days 1, 3 and 5 for the first induction cycle, then days 1 and 3 for a second induction or consolidation.
- Boxed warning: do not interchange with other daunorubicin and/or cytarabine-containing products because dosing differs substantially.
Side Effects
- Very common side effects (at least 25% of patients) include haemorrhagic events (70%), febrile neutropenia (68%), rash (54%), oedema (51%), nausea, mouth sore or mucositis, diarrhoea, constipation, musculoskeletal pain, fatigue and abdominal pain.
- Serious risks include serious or fatal bleeding, heart toxicity from the anthracycline, severe allergic reactions and, if the drug leaks outside the vein, severe local tissue damage.
- Boxed warning: Vyxeos has different dosing from other daunorubicin and cytarabine products and must not be interchanged; verify the drug name and dose before preparing and giving it.
- Tell your care team at once about bleeding, fever, chest pain, breathlessness, swelling, rash or pain at the infusion site.
Precautions & Warnings
- Because of the boxed warning, the drug name and dose must be verified before preparation and administration.
- Do not use with a history of serious hypersensitivity to daunorubicin, cytarabine or any component.
- Blood counts, heart function (before treatment and with attention to cumulative anthracycline exposure) and liver function are monitored.
- The reconstituted product contains copper, so people with Wilson's disease need specialist advice and copper monitoring.
- Vyxeos can harm an unborn baby: use effective contraception during treatment and for 6 months afterwards (women and men), and do not breastfeed during treatment or for 2 weeks after the last dose.
- Give intravenously only, after confirming the vein is patent, because extravasation causes tissue necrosis.
- Store unopened vials upright at 2°C to 8°C in the carton, protected from light.
Avoid Interactions
- Increase effect or toxicity: other cardiotoxic agents (heart function should be assessed more often), hepatotoxic medicines (monitor liver function more often), and other anthracycline or cytarabine products, which must never be used in place of, or interchanged with, Vyxeos.
- Reduce efficacy: no specific medicines are named on the label.
- Tell your healthcare provider about all medicines, herbal products and supplements before treatment.
- Pharmacy point: reconstitute each vial with 19 mL of Sterile Water for Injection, swirl for 5 minutes without vortexing or shaking, then dilute in 500 mL of sodium chloride 0.9% or dextrose 5%; the reconstituted and diluted product should be used within 4 hours when refrigerated.
References
Frequently Asked Questions
Vyxeos (daunorubicin and cytarabine liposome) treats newly diagnosed therapy-related acute myeloid leukaemia and AML with myelodysplasia-related changes. The US label covers adults and children aged 1 and over; the EU authorisation, now called Vyxeos liposomal, covers adults only. It is given in hospital.
Vyxeos (daunorubicin and cytarabine liposome) is given in hospital as an infusion into a vein over 90 minutes. First induction is on days 1, 3 and 5, and a second induction, if needed, is on days 1 and 3. Consolidation is also given on days 1 and 3.
Common Vyxeos side effects include bleeding, fever with low white cells (febrile neutropenia), rash, swelling, nausea, mouth sores, diarrhoea, constipation, pain and tiredness. Serious risks are fatal bleeding, heart damage and severe allergic reactions. Tell staff at once about bleeding, fever, chest pain or breathlessness.
Vyxeos (daunorubicin and cytarabine liposome) has a boxed warning: it must not be interchanged with other daunorubicin or cytarabine products, because the dosing is substantially different. Staff must verify the drug name and dose before preparing and giving it. It is never a like-for-like substitute.
During a Vyxeos infusion, staff give it into a vein over 90 minutes and check the vein first, because leakage can badly damage tissue. They monitor for allergic reactions and check blood counts and heart function around treatment. Report pain, burning or swelling at the site immediately.
No. Vyxeos (daunorubicin and cytarabine liposome) can harm an unborn baby. Women and men should use effective contraception during treatment and for 6 months after the last dose. Do not breastfeed during treatment or for 2 weeks after the last dose.
Trusted & Reliable – Your Partner in Global Distribution.
We provide comprehensive lines of pharmaceutical products to support all your healthcare distribution needs.
