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Vyxeos Dosage

Generic name: CYTARABINE 100mg in 20mL, DAUNORUBICIN 44mg in 20mL
Dosage form: liposome injection, powder, lyophilized, for suspension

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Recommended Dosage

A full VYXEOS course consists of 1-2 cycles of Induction and up to 2 cycles of Consolidation at the dose and schedule listed in Table 1. Prior to initiating each cycle of VYXEOS, calculate the prior cumulative anthracycline exposure for the patient [see Warnings and Precautions (5.3)]. Administer prophylactic anti-emetics before treatment with VYXEOS.

Table 1: Dose and Schedule for VYXEOS

Cycle

VYXEOS Dose and Schedule

First Induction

(daunorubicin 44 mg/m2 and cytarabine 100 mg/m2) liposome days 1, 3, and 5

Second Induction a

(daunorubicin 44 mg/m2 and cytarabine 100 mg/m2) liposome days 1 and 3

Consolidation

(daunorubicin 29 mg/m2 and cytarabine 65 mg/m2) liposome days 1 and 3

a Only for patients failing to achieve a response with the first induction cycle.

For the first cycle of induction, the recommended dose of VYXEOS is (daunorubicin 44 mg/m2 and cytarabine 100 mg/m2) liposome administered via intravenous infusion over 90 minutes on days 1, 3, and 5. Prior to initiating induction, assess cardiac function and obtain liver and renal function studies. For patients who do not achieve remission with the first induction cycle, a second induction cycle may be administered 2 to 5 weeks after the first if there was no unacceptable toxicity with VYXEOS. The recommended dose for the second induction cycle of VYXEOS is (daunorubicin 44 mg/m2 and cytarabine 100 mg/m2) liposome administered via intravenous infusion over 90 minutes on days 1 and 3.

Administer the first consolidation cycle 5 to 8 weeks after the start of the last induction. The recommended dose for each cycle of consolidation therapy is VYXEOS (daunorubicin 29 mg/m2 and cytarabine 65 mg/m2) liposome administered via intravenous infusion over 90 minutes on days 1 and 3.

Assess cardiac function, complete blood counts, liver and renal function before each consolidation cycle. Do not start VYXEOS consolidation until the absolute neutrophil count recovers to greater than 0.5 Gi/L and the platelet count recovers to greater than 50 Gi/L in the absence of unacceptable toxicity. Administer the second consolidation cycle 5 to 8 weeks after the start of the first consolidation cycle in patients who do not show disease progression or unacceptable toxicity to VYXEOS.

Dosage Modification

Missed Doses of VYXEOS

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.

Hypersensitivity Reactions

For hypersensitivity reactions of any grade/severity, interrupt VYXEOS infusion immediately and manage symptoms. Reduce the rate of infusion or discontinue treatment as outlined below [see Warnings and Precautions (5.4)].

Mild symptoms: Once symptoms resolve, reinitiate infusion at half the prior rate of infusion. Consider premedication with antihistamines and/or corticosteroids for subsequent doses of VYXEOS.
Moderate symptoms: Do not reinitiate infusion. For subsequent doses of VYXEOS, premedicate with antihistamines and/or corticosteroids prior to initiating infusion at same rate.
Severe/life-threatening symptoms: Permanently discontinue VYXEOS treatment, treat according to the standard of care to manage symptoms, and monitor patient until symptoms resolve.

Cardiotoxicity

Discontinue VYXEOS in patients who exhibit impaired cardiac function unless the benefit of continuing treatment outweighs the risk [see Warnings and Precautions (5.3)].

Preparation and Handling Instructions

VYXEOS is a cytotoxic drug. Follow applicable special handling and disposal procedures.1 VYXEOS is supplied as a single-dose vial and does not contain any preservatives. Do not save any unused portions for later administration.

Preparation Instructions:

Calculate the VYXEOS dose based on daunorubicin and individual patient's BSA.
Calculate the number of vials of VYXEOS based on the 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 Injection using a 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 rest for 15 minutes.
The reconstituted product should be an opaque, purple, homogeneous dispersion, essentially free from visible particulates. After reconstitution (but before final dilution), each mL will contain 2.2 mg of daunorubicin and 5 mg of cytarabine.
Gently invert each vial 5 times prior to withdrawing the reconstituted product for further dilution. If the reconstituted product is not diluted into an infusion bag immediately, store in refrigerator at 2°C to 8°C for up to 4 hours.
Calculate the volume of reconstituted VYXEOS required using the following formula:
[volume required (mL) = dose of daunorubicin (mg/m2) X patient's BSA (m2) ÷ 2.2 (mg/mL)]
Aseptically withdraw the calculated volume of the reconstituted product from the vial(s) with a sterile syringe and transfer it to an infusion bag containing 500 mL of 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP. There may be residual product remaining in the vial. 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, free from visible particulates.
If the diluted infusion solution is not used immediately, store in refrigerator at 2°C to 8°C for up to 4 hours.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Only solutions without visible particles should be used.

Administration Instructions

For intravenous use only.
Do not mix VYXEOS with or administer as an infusion with other drugs.
Administer VYXEOS by constant intravenous infusion over 90 minutes via an infusion pump through a central venous catheter or a peripherally inserted central catheter. Do not use an in-line filter.
Flush the line after administration with 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP.
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