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VYXEOS is a brand name for Daunorubicin, supplied as a powder. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: VYXEOS® (daunorubicin and cytarabine liposome for injection) is indicated for: • treatment of adults with newly diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC). 1.1 Pediatrics Pediatrics (< 18 years): Newly Diagnosed t-AML or AML-MRC: The safety and…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • Treatment should be initiated and monitored under the supervision of a physician experienced in the use of chemotherapeutic medicinal products. • VYXEOS has a different posology than daunorubicin injection and cytarabine injection VYXEOS® (daunorubicin and cytarabine liposome for injection) Page 5 of 41 and it must not be interchanged with other daunorubicin and/or cytarabine containing products.
• Patients may be pre-medicated for nausea and vomiting. , allopurinol) prior to initiating VYXEOS. 2 Recommended Dose and Dosage Adjustment VYXEOS dosing is based on individual patient’s body surface area (BSA) according to the following schedule.
Adult Patients with Newly Diagnosed t-AML or AML-MRC Table 1:
Dose and Schedule for VYXEOS in Adult Patients with Newly Diagnosed t-AML or AML-MRC Therapy VYXEOS 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 Recommended Dosing Schedule for Induction of Remission The recommended dosing schedule of VYXEOS is daunorubicin 44 mg/m2 and cytarabine 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 cycle of induction may be administered 2 to 5 weeks after the first in patients who do not achieve remission and show no 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 a maximum of 2 induction courses.
Recommended Dosing Schedule for Consolidation The first consolidation course should be administered 5 to 8 weeks after the start of the last induction. The recommended dosing schedule of VYXEOS is daunorubicin 29 mg/m2 and cytarabine 65 mg/m2 administered intravenously over 90 minutes: • on days 1 and 3 as subsequent courses of consolidation therapy, if needed.
, Clinical Trial Adverse Reactions -Pediatrics]. 3 Reconstitution VYXEOS is a cytotoxic medicinal product. Applicable special handling and disposal procedures should be followed. The product is intended for single use only. Do not save any unused portions for later administration.
2 Recommended Dose and Dosage Adjustment. • Calculate the number of vials of VYXEOS based on daunorubicin dose. • Remove the appropriate number of vials of VYXEOS from the refrigerator and equilibrate to the room temperature for 30 minutes.
• Then, reconstitute each vial with 19 mL of sterile water for injections using a 20 mL sterile syringe, and immediately thereafter start a 5-minute timer. • Carefully swirl the contents of the vial for 5 minutes while gently inverting the vial every 30 seconds.
• Do not heat, vortex, or shake vigorously. • After reconstitution, let it rest for 15 minutes. • The reconstituted product should be an opaque, purple, homogeneous dispersion, essentially free from visible particles. • If the reconstituted product is not diluted into an infusion bag immediately, store in a refrigerator (2°C to 8°C) for up to 4 hours.
• Following the storage of reconstituted product in the vial for up to 4 hours at 2°C to 8°C, the reconstituted product must be immediately diluted into an infusion bag and run for the 90-minute infusion time. VYXEOS® (daunorubicin and cytarabine liposome for injection) Page 8 of 41 • The maximum combined storage time for reconstituted product in the vial and reconstituted product diluted into an infusion bag is up to 4 hours (not 4 hours each) at 2°C to 8°C.
2 (mg/mL)]. 2 mg/mL) daunorubicin and 100 mg/20 mL (5 mg/mL) cytarabine. • Gently invert each vial 5 times prior to withdrawing the concentrate for dilution. 9%) solution for injection, or 5% glucose. There may be residual product remaining in the vial.
]. 1 Dosing Considerations • Treatment should be initiated and monitored under the supervision of a physician experienced in the use of chemotherapeutic medicinal products. • VYXEOS has a different posology than daunorubicin injection and cytarabine injection VYXEOS® (daunorubicin and cytarabine liposome for injection) Page 5 of 41 and it must not be interchanged with other daunorubicin and/or cytarabine containing products.
• Patients may be pre-medicated for nausea and vomiting. , allopurinol) prior to initiating VYXEOS. 2 Recommended Dose and Dosage Adjustment VYXEOS dosing is based on individual patient’s body surface area (BSA) according to the following schedule.
Adult Patients with Newly Diagnosed t-AML or AML-MRC Table 1:
Dose and Schedule for VYXEOS in Adult Patients with Newly Diagnosed t-AML or AML-MRC Therapy VYXEOS 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 Recommended Dosing Schedule for Induction of Remission The recommended dosing schedule of VYXEOS is daunorubicin 44 mg/m2 and cytarabine 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 cycle of induction may be administered 2 to 5 weeks after the first in patients who do not achieve remission and show no 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 a maximum of 2 induction courses.
VYXEOS is contraindicated in patients who are: • hypersensitive to this drug or to any ingredient in the formulation, including any non- medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Daunorubicin in Canada.
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5 x 109/L and the platelet count has recovered to greater than 50 x 109/L in the absence of unacceptable toxicity. A subsequent course of consolidation may be administered in patients who do not show disease progression or VYXEOS® (daunorubicin and cytarabine liposome for injection) Page 6 of 41 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 a maximum of 2 consolidation courses. Recommended Dose Adjustments Dosing should be delayed or permanently discontinued, if necessary, as described below.
Hypersensitivity Reactions For hypersensitivity reactions of any grade/severity, interrupt VYXEOS infusion immediately and manage symptoms. , mild flushing, rash, pruritus), the treatment should be stopped, and the patient should be supervised, including monitoring of vital signs.
Once the symptoms have resolved, the treatment should be restarted slowly at half the prior rate of infusion and intravenous antihistamines and/or corticosteroids should be considered. • For moderate hypersensitivity symptoms, do not reinitiate infusion.
For subsequent doses of VYXEOS, premedicate with antihistamines and/or corticosteroids prior to initiating infusion at the same rate [see 7 WARNINGS AND PRECAUTIONS, Immune]. • For severe or life-threatening symptoms, permanently discontinue VYXEOS treatment, treat according to the standard of care to manage symptoms.
Monitor the patient until symptoms resolve [see 7 WARNINGS AND PRECAUTIONS, Immune]. Cardiotoxicity Assessment of cardiac function prior to the initiation of each cycle of induction and consolidation is recommended, especially in patients with a high risk of cardiac toxicity.
VYXEOS treatment should be discontinued in patients who develop signs or symptoms of cardiomyopathy, unless the benefits outweigh the risks. 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), moderate (CrCL 30 mL/min to 59 mL/min) or severe (CrCL 15 mL/min to 29 mL/min)renal impairment.
There is no experience with VYXEOS in patients with end-stage renal disease managed with dialysis. Assessment of renal function prior to the initiation of each cycle of induction and consolidation is recommended. VYXEOS should only be used in patients with end-stage renal disease if the benefits outweigh the risks [see 7 WARNINGS AND PRECAUTIONS, Renal].
VYXEOS® (daunorubicin and cytarabine liposome for injection) Page 7 of 41 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 in patients with hepatic impairment resulting in a bilirubin level greater than 50 μmol/L.
Assessment of hepatic function prior to the initiation of each cycle of induction and consolidation is recommended. VYXEOS should only be used in patients with severe hepatic impairment if the benefits outweigh the [see 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary].
Elderly population No dosage adjustment is required in elderly patients (≥ 65 years). Pediatric population Based on the data submitted and reviewed by Health Canada, the safety and efficacy of VYXEOS in pediatric patients has not been […]
Discard unused portion. • Gently invert the bag to mix the solution. The dilution of the reconstituted product results in a deep purple, translucent, homogeneous dispersion. • If the diluted infusion solution is not used immediately, store in a refrigerator (2°C to 8°C) for up to 4 hours.
• Gently invert the bag to mix the solution after refrigeration. 4 Administration VYXEOS is for intravenous use only. It must not be administered via an intramuscular, intrathecal or subcutaneous route. VYXEOS is administered by intravenous infusion over a period of 90 minutes.
Care should be taken to ensure there is no extravasation to prevent the risk of tissue necrosis. Administration instructions: • Do not mix VYXEOS with, or administer as an infusion with, other medicinal products. • Administer VYXEOS by constant intravenous infusion over 90 minutes via an infusion pump through a central venous catheter or a peripherally inserted central catheter.
An in-line membrane filter may be used for the intravenous infusion of VYXEOS liposomal, provided the minimum pore diameter of the filter is greater than or equal to 15 μm. 9%) solution for injection. 5 Missed Dose If a planned dose of VYXEOS is missed, administer the dose as soon as possible and adjust the dosing schedule accordingly, maintaining the treatment interval.
5 OVERDOSAGE There is no specific experience in the management of overdose in patients. If overdose occurs, exacerbation of adverse reactions associated with VYXEOS are expected and supportive treatment (including anti-infectives, blood and platelet transfusions, colony-stimulating factors, and intensive care as needed) should be provided until the patient recovers.
Observe the patient carefully over time for signs of cardiotoxicity and provide appropriate supportive therapy as clinically indicated. For management of a suspected drug overdose, contact your regional poison control centre. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 3: Dosage Forms, Strengths, Composition and Packaging VYXEOS is a sterile, preservative-free, purple, lyophilized cake for reconstitution supplied in a single-dose clear glass vial.
Each pack size contains 1 vial, 2 vials or 5 vials. Not all pack sizes may be marketed. 7 WARNINGS AND PRECAUTIONS General Other Daunorubicin and/or Cytarabine-containing Products VYXEOS must not be substituted or interchanged with other daunorubicin and/or cytarabine- containing products.
Due to substantial differences in the pharmacokinetic parameters, the Route of Administration Dosage Form/ Strength/Composition Non-medicinal Ingredients Intravenous infusion Powder. Each vial contains 44 mg of daunorubicin and 100 mg of cytarabine.
2 mg/mL daunorubicin and 5 mg/mL cytarabine encapsulated in liposomes in a fixed combination in a 1:5 molar ratio. Cholesterol, copper gluconate, distearoylphosphatidylcholine, distearoylphosphatidylglycerol, sucrose, triethanolamine (for pH adjustment).
VYXEOS® (daunorubicin and cytarabine liposome for injection) Page 10 of 41 dose and schedule recommendations for VYXEOS are different from those for daunorubicin hydrochloride injection, cytarabine injection, daunorubicin citrate liposome […]
Recommended Dosing Schedule for Consolidation The first consolidation course should be administered 5 to 8 weeks after the start of the last induction. The recommended dosing schedule of VYXEOS is daunorubicin 29 mg/m2 and cytarabine 65 mg/m2 administered intravenously over 90 minutes: • on days 1 and 3 as subsequent courses of consolidation therapy, if needed.
5 x 109/L and the platelet count has recovered to greater than 50 x 109/L in the absence of unacceptable toxicity. A subsequent course of consolidation may be administered in patients who do not show disease progression or VYXEOS® (daunorubicin and cytarabine liposome for injection) Page 6 of 41 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 a maximum of 2 consolidation courses. Recommended Dose Adjustments Dosing should be delayed or permanently discontinued, if necessary, as described below.
Hypersensitivity Reactions For hypersensitivity reactions of any grade/severity, interrupt VYXEOS infusion immediately and manage symptoms. , mild flushing, rash, pruritus), the treatment should be stopped, and the patient should be supervised, including monitoring of vital signs.
Once the symptoms have resolved, the treatment should be restarted slowly at half the prior rate of infusion and intravenous antihistamines and/or corticosteroids should be considered. • For moderate hypersensitivity symptoms, do not reinitiate infusion.
For subsequent doses of VYXEOS, premedicate with antihistamines and/or corticosteroids prior to initiating infusion at the same rate [see 7 WARNINGS AND PRECAUTIONS, Immune]. • For severe or life-threatening symptoms, permanently discontinue VYXEOS treatment, treat according to the standard of care to manage symptoms.
Monitor the patient until symptoms resolve [see 7 WARNINGS AND PRECAUTIONS, Immune]. Cardiotoxicity Assessment of cardiac function prior to the initiation of each cycle of induction and consolidation is recommended, especially in patients with a high risk of cardiac toxicity.
VYXEOS treatment should be discontinued in patients who develop signs or symptoms of cardiomyopathy, unless the benefits outweigh the risks. 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), moderate (CrCL 30 mL/min to 59 mL/min) or severe (CrCL 15 mL/min to 29 mL/min)renal impairment.
There is no experience with VYXEOS in patients with end-stage renal disease managed with dialysis. Assessment of renal function prior to the initiation of each cycle of induction and consolidation is recommended. VYXEOS should only be used in patients with end-stage renal disease if the benefits outweigh the risks [see 7 WARNINGS AND PRECAUTIONS, Renal].
VYXEOS® (daunorubicin and cytarabine liposome for injection) Page 7 of 41 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 in patients with hepatic impairment resulting in a bilirubin level greater than 50 μmol/L.
Assessment of hepatic function prior to the initiation of each cycle of induction and consolidation is recommended. VYXEOS should only be used in patients with severe hepatic impairment if the benefits outweigh the [see 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary].
Elderly population No dosage adjustment is required in elderly patients (≥ 65 years). Pediatric population Based on the data submitted and reviewed by Health Canada, the safety and efficacy of VYXEOS in […]