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Vyxeos Liposomal (Previously Vyxeos) is a brand name for Daunorubicin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Vyxeos liposomal is indicated for the treatment of adults with newly diagnosed, therapy-related acute myeloid leukaemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC).
Verbatim from this product's EMA label. Tap a section to expand.
Vyxeos liposomal treatment should be initiated and monitored under the supervision of a physician experienced in the use of chemotherapeutic medicinal products. 4). Posology Vyxeos liposomal dosing is based on the patient’s body surface area (BSA) according to the following schedule: Table 1: Dose and schedule for Vyxeos liposomal Therapy Dosing schedule First induction daunorubicin 44 mg/m2 and cytarabine 100 mg/m2 on days 1, 3, and 5 Second induction daunorubicin 44 mg/m2 and cytarabine 100 mg/m2 on days 1 and 3 Consolidation daunorubicin 29 mg/m2 and cytarabine 65 mg/m2 on days 1 and 3 3 Recommended dosing schedule for induction of remission The recommended dosing schedule of Vyxeos liposomal 44 mg/100 mg/m2, administered intravenously over 90 minutes: • on days 1, 3, and 5 as the first course of induction therapy.
• on days 1 and 3 as subsequent course of induction therapy, if needed. A subsequent course of induction may be administered in patients who do not show disease progression or unacceptable toxicity. The attainment of a normal-appearing bone marrow may require more than one induction course.
Evaluation of the bone marrow following recovery from the previous course of induction therapy determines whether a further course of induction is required. Treatment should be continued as long as the patient continues to benefit or until disease progression up to maximum of 2 induction courses.
Recommended dosing schedule for consolidation The first consolidation cycle should be administered 5 to 8 weeks after the start of the last induction. The recommended dosing schedule of Vyxeos liposomal is 29 mg/65 mg/m2, administered intravenously over 90 minutes: • on days 1 and 3 as subsequent courses of consolidation therapy, if needed.
Consolidation therapy is recommended for patients achieving remission who have recovered to absolute neutrophil count (ANC) > 500/μL and the platelet count has recovered to greater than 50,000/μL in the absence of unacceptable toxicity.
A subsequent course of consolidation may be administered in patients who do not show disease progression or unacceptable toxicity within the range of 5 to 8 weeks after the start of the first consolidation. Treatment should be continued as long as the patient continues to benefit or until disease progression, up to maximum of 2 consolidation courses.
7%). 1%). Tabulated list of adverse reactions ADRs have been included under the appropriate category in the table below according to the highest frequency observed in any of the main clinical studies. Frequencies are defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000); not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. For classification of ADRs which occur at Grades 3-5, a comprehensive listing is available from the NCI at NCI CTCAE. Toxicity is graded as mild (Grade 1), moderate (Grade 2), severe (Grade 3), or life-threatening (Grade 4), with specific parameters according to the organ system involved.
Death (Grade 5) is used for some of the criteria to denote a fatality. 3) a Arrhythmia group terms includes atrial fibrillation, bradycardia, and the most commonly reported arrhythmia was tachycardia Description of selected adverse reactions Infections Due to the neutropenia experienced with Vyxeos liposomal, infections of various types were very common ADRs.
Pneumonia, sepsis and bacteriaemia were the most frequently seen serious infection ADRs in the clinical studies population. 5%. 9%. 4). Haemorrhage Due to the thrombocytopenia experienced with Vyxeos liposomal a variety of haemorrhagic events were seen in clinical studies.
1%). 6%; the incidence of haemorrhage which led to discontinuation is 0. 1%. 4). Cardiotoxicity Cardiotoxicities were seen in Vyxeos liposomal clinical studies. The most frequently reported serious ADRs were decreased ejection fraction and congestive cardiac failure.
Cardiotoxicity is a known risk of anthracycline treatment. 1%; the […]
Other daunorubicin and/or cytarabine-containing products Vyxeos liposomal must not be substituted or interchanged with other daunorubicin and/or cytarabine containing products. Due to substantial differences in the pharmacokinetic parameters, the dose and schedule recommendations for Vyxeos liposomal are different from those for daunorubicin hydrochloride injection, cytarabine injection, daunorubicin citrate liposome injection, and cytarabine 5 liposome injection.
The medicinal product name and dose should be verified prior to administration to avoid dosing errors. Severe myelosuppression Severe myelosuppression (including fatal infections and haemorrhagic events) has been reported in patients after administration of a therapeutic dose of Vyxeos liposomal.
Serious or fatal haemorrhagic events, including fatal central nervous system (CNS) haemorrhages, associated with severe thrombocytopenia, have occurred in patients treated with Vyxeos liposomal. Baseline assessment of blood counts should be obtained, and patients should be carefully monitored during treatment with Vyxeos liposomal for possible clinical complications due to myelosuppression.
Due to the long plasma half-life of Vyxeos liposomal, time to recovery of ANC and platelets may be prolonged and require additional monitoring. Prophylactic anti-infectives (including anti-bacterial, anti-virals, anti-fungals) may be administered during the period of profound neutropenia until ANC returns to 500/μL or greater.
, anti-infectives, colony-stimulating factors, transfusions. 8). Cardiotoxicity Cardiotoxicity is a known risk of anthracycline treatment. Prior therapy with anthracyclines (including patients who have previously received the recommended maximum cumulative doses of doxorubicin or daunorubicin hydrochloride), pre-existing cardiac disease (including impaired cardiac function), previous radiotherapy of the mediastinum, or concomitant use of cardiotoxic products may increase the risk of daunorubicin-induced cardiac toxicity.
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Recommended dose adjustments during treatment Patients should be monitored for haematologic response and toxicities. Dosing should be delayed or permanently discontinued, if necessary, as described below. Patients may be pre-medicated for nausea and vomiting.
, allopurinol) prior to initiating Vyxeos liposomal. , mild flushing, rash, pruritus), the treatment should be stopped, and the patient should be supervised, including monitoring of vital signs. The treatment should be restarted slowly once the symptoms have resolved, by halving the rate of infusion and intravenous diphenhydramine (20-25 mg) and intravenous dexamethasone (10 mg) should be given.
, moderate rash, flushing, mild dyspnoea, chest discomfort) the treatment should be stopped. Intravenous diphenhydramine (20-25 mg or equivalent) and intravenous dexamethasone (10 mg) should be given. The infusion should not be restarted.
When the patient is retreated, Vyxeos liposomal should be given at the same dose and rate and with premedication. , hypotension requiring vasopressor therapy, angioedema, respiratory distress requiring bronchodilation therapy, generalised urticaria), the treatment should be stopped.
Intravenous diphenhydramine (20-25 mg) and dexamethasone (10 mg) should be given, and an epinephrine (adrenaline) or bronchodilators should be added if indicated. Do not reinitiate infusion, and do not retreat. Treatment with Vyxeos liposomal should be permanently discontinued.
8). 4 Cardiotoxicity Assessment of cardiac function prior to start of treatment is recommended, especially in patients with a high risk of cardiac toxicity. 4). Missed dose If a planned dose of Vyxeos liposomal is missed, the dose should be administered as soon as possible and the dosing schedule adjusted accordingly, maintaining the treatment interval.
Special populations Renal impairment Dose adjustment is not required for patients with mild (creatinine clearance [CrCL] 60 mL/min to 89 mL/min by Cockcroft Gault equation [C-G]), moderate (CrCL 30 mL/min to 59 mL/min) or severe (CrCL<30 mL/min) renal impairment.
There is no experience with Vyxeos liposomal in patients with end-stage renal disease managed with dialysis. 2). Hepatic impairment Dose adjustment is not required for patients with a bilirubin level less than or equal to 50 μmol/L. There is no experience with Vyxeos liposomal in patients with hepatic impairment resulting in a bilirubin level greater than 50 μmol/L.
4). 2). Paediatric population Outside its authorised indications Vyxeos liposomal has been studied in paediatric and young adult patients aged 1-21 years with relapsed AML. Due to the limited size of these studies, it is not possible to conclude that the benefits of the use outweigh the […]
In two single arm studies of 65 anthracycline pre-treated children with relapsed or refractory AML treated with a single induction cycle (Cycle 1) of Vyxeos liposomal, cardiac disorders (including sinus tachycardia, QT prolongation and ejection fraction decreased) were observed.
8). Total cumulative doses of non-liposomal daunorubicin greater than 550 mg/m2 have been associated with an increased incidence of treatment-induced congestive heart failure. This limit appears lower (400 mg/m2) in patients who received radiation therapy to the mediastinum.
The relationship between cumulative Vyxeos liposomal dose and the risk of cardiac toxicity has not been determined. Total cumulative exposure of daunorubicin has been described in the table below.
Table 2:
Cumulative exposure of daunorubicin per course of Vyxeos liposomal Therapy Daunorubicin per dose Number of doses per course Daunorubicin per course First induction 44 mg/m2 3 132 mg/m2 Second induction 44 mg/m2 2 88 mg/m2 Each consolidation 29 mg/m2 2 58 mg/m2 A baseline cardiac evaluation with an electrocardiogram (ECG) and a multi-gated radionuclide angiography (MUGA) scan or an echocardiography (ECHO) is recommended, especially in patients with risk factors for increased cardiac toxicity.
Cardiac function should be closely monitored. 8). 6 Contraception and Pregnancy Patients should be advised to avoid becoming pregnant while receiving Vyxeos liposomal. 6). Hypersensitivity reactions Serious hypersensitivity reactions, including anaphylactic reactions, have been reported with daunorubicin and cytarabine.
, moderate rash, flushing, mild dyspnoea, chest discomfort) the treatment should be stopped. Intravenous diphenhydramine (20-25 mg or equivalent) and intravenous dexamethasone (10 mg) should be given. The infusion should not be restarted.
When the patient is retreated, Vyxeos liposomal should be given at the same dose and rate and with premedication. , hypotension requiring vasopressor therapy, angioedema, respiratory distress requiring bronchodilation therapy, generalised urticaria), the treatment should be stopped.
Intravenous diphenhydramine (20-25 mg) and dexamethasone (10 mg) should be given, and an epinephrine (adrenaline) or bronchodilators should be added if indicated. Infusion should not be reinitiated, and retreatment should not be attempted.
Treatment with Vyxeos liposomal should be permanently discontinued. 8). Tissue necrosis Daunorubicin has been associated with local tissue necrosis at the site of medicinal product extravasation. In clinical studies with Vyxeos liposomal, one event of extravasation occurred, but no necrosis was observed.
Care should be taken to ensure that there is no extravasation of medicinal product when Vyxeos liposomal is administered. Vyxeos liposomal should be administered intravenously only. 2). Evaluation of hepatic and renal function Hepatic impairment may increase the risk of toxicity associated with daunorubicin and […]