Usual Adult Dose for Acute Nonlymphocytic Leukemia

Remission Induction in Combination:
Under 60 years:
45 mg/m2 IV once daily on days 1, 2, and 3 of the first course and on days 1 and 2 of subsequent courses AND cytosine arabinoside (ara-C) 100 mg/m2 IV once daily for 7 days for the first course and 5 days for subsequent courses

Duration of therapy: The attainment of a normal-appearing bone marrow may require up to 3 courses of induction.

Comments:

• The doses presented here are manufacturer suggested; consult local and institutional protocol for further guidance.

Use: For remission induction in acute nonlymphocytic leukemia (myelogenous, monocytic, erythroid) in adults

Usual Adult Dose for Acute Lymphocytic Leukemia

Remission Induction in Combination:
45 mg/m2/day IV on days 1, 2, and 3 AND vincristine 2 mg IV on days 1, 8, and 15; prednisone 40 mg/m2/day orally on days 1 through 22, then tapered between days 22 to 29; L-asparaginase 500 IU/kg/day IV on days 22 through 32

Comments:

• The doses presented here are manufacturer suggested; consult local and institutional protocol for further guidance.

Use: For remission induction in acute lymphocytic leukemia in adults

Usual Geriatric Dose for Acute Nonlymphocytic Leukemia

Remission Induction in Combination:
60 years and older:
30 mg/m2 IV once daily on days 1, 2, and 3 of the first course and on days 1 and 2 of subsequent courses AND cytosine arabinoside (ara-C) 100 mg/m2 IV once daily for 7 days for the first course and 5 days for subsequent courses

Duration of therapy: The attainment of a normal-appearing bone marrow may require up to 3 courses of induction.

Comments:

• The doses presented here are manufacturer suggested; consult local and institutional protocol for further guidance.
• This daunorubicin dose-reduction is based on a single study and may not be appropriate if optimal supportive care is available.

Use: For remission induction in acute nonlymphocytic leukemia (myelogenous, monocytic, erythroid) in adults

Usual Pediatric Dose for Acute Lymphocytic Leukemia

Remission Induction in Pediatric Acute Lymphocytic Leukemia:
In Combination:
LESS THAN 2 YEARS OR LESS THAN 0.5 M2:
1 mg/kg IV on day 1 every week, vincristine 1.5 mg/m2 IV on day 1 every week, prednisone 40 mg/m2 orally daily; complete remission will usually be obtained within 4 courses of therapy; however, if after 4 courses the patient is in partial remission, an additional 1 or 2 courses may be given to obtain complete remission
GREATER THAN 2 YEARS OR GREATER THAN 0.5 M2:
25 mg/m2 IV on day 1 every week, vincristine 1.5 mg/m2 IV on day 1 every week, prednisone 40 mg/m2 orally daily; complete remission will usually be obtained within 4 courses of therapy; however, if after 4 courses the patient is in partial remission, an additional 1 or 2 courses may be given to obtain complete remission

Comments:

• The doses presented here are manufacturer suggested; consult local and institutional protocol for further guidance.

Use: For remission induction in acute lymphocytic leukemia in children

Renal Dose Adjustments

Serum creatinine greater than 3 mg/dL: Reduce dose by 50%

Liver Dose Adjustments

Serum bilirubin 1.2 to 3 mg/dL: Reduce dose by 25%
Serum bilirubin greater than 3 mg/dL: Reduce dose by 50%

Precautions

US BOXED WARNINGS:

• This drug should be given as a rapidly flowing IV infusion, never by the IM or subcutaneous route. Severe local tissue necrosis will occur if there is extravasation during administration.
• Myocardial toxicity manifested in its most severe form by potentially fatal congestive heart failure may occur either during therapy or months to years after. The incidence increases after a total cumulative dose exceeding 400 to 550 mg/m2 in adults, 300 mg/m2 in children more than 2 years of age, or 10 mg/kg in children less than 2 years of age.
• Severe myelosuppression occurs when used in therapeutic doses; this may lead to infection or hemorrhage.
• This drug should be administered only by physicians who are experienced in leukemia chemotherapy and in facilities with laboratory and supportive resources adequate to monitor drug tolerance and protect and maintain a patient compromised by drug toxicity. The physician and institution should be capable of responding rapidly to severe hemorrhagic conditions and/or overwhelming infection.
• The dose of this drug should be reduced in patients with impaired hepatic or renal function.

CONTRAINDICATIONS:

• Hypersensitivity to the active component or any of the ingredients

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• This drug is for IV use only and should not be administered by intramuscular or subcutaneous routes, as severe tissue necrosis will result.
• This drug should be given into a rapidly flowing IV infusion of 0.9% sodium chloride or 5% dextrose injection.
• The tubing should be connected to a butterfly needle, inserted preferably

into a large vein. The dose and the size of the vein will determine the rate of administration, which should not be less than 3 to 5 minutes. Erythematous streaking and facial flushing are indications of too rapid administration.

• A direct push injection is not recommended due to the risk of extravasation, which may occur even in the presence of adequate blood return upon needle aspiration.

Storage requirements:

• Store unopened vials in refrigerator at 2C to 8C (36F to 46F).
• Store prepared solution for infusion at room temperature at 15C to 30C (59F to 86F) for up to 24 hours.
• Protect from light.

Reconstitution/preparation techniques:
Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published. There is no general agreement that procedures recommended in the guidelines are necessary or appropriate.

General:

• Contains no preservative.
• Discard unused portion.
• If this drug contacts the skin or mucous membranes wash the area thoroughly with soap and water.

Monitoring:

• Blood counts
• Cardiac function
• Renal function
• Hepatic function
• Blood uric acid levels

Patient advice:

• Immediately report any stinging or burning as these indicate possible extravasations.
• This drug may transiently cause a red discoloration to the urine after administration.
• Complete alopecia is common but reversible on withdrawal of therapy.
• Notify the doctor if fever, sore throat, or unusual bleeding or bruising occurs.

Frequently asked questions

• What drugs are contained in Vyxeos?