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Vidaza Dosage

Generic name: AZACITIDINE 100mg
Dosage form: injection, powder, lyophilized, for solution
Drug class: Miscellaneous antineoplastics

Medically reviewed by Drugs.com. Last updated on May 20, 2022.

2.1 Important Administration Information

Do not substitute VIDAZA for oral azacitidine. The indications and dosing regimen for VIDAZA differ from that of oral azacitidine [see Warnings and Precautions (5.1)]

First Treatment Cycle for Adults

The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m2 subcutaneously or intravenously, daily for 7 days. Premedicate patients for nausea and vomiting.

Obtain complete blood counts, liver chemistries and serum creatinine prior to the first dose.

Subsequent Treatment Cycles for Adults

Repeat cycles every 4 weeks. The dose may be increased to 100 mg/m2 if no beneficial effect is seen after 2 treatment cycles and if no toxicity other than nausea and vomiting has occurred. It is recommended that patients be treated for a minimum of 4 to 6 cycles. However, complete or partial response may require additional treatment cycles. Treatment may be continued as long as the patient continues to benefit.

Monitor patients for hematologic response and renal toxicities [see Warnings and Precautions (5.4)], and delay or reduce dosage if necessary [see Dosage and Administration (2.6)].

2.4 Pediatric Patients with JMML

Table 1: Dosage and Administration for Pediatric Patients (JMML)

Pediatric Patients with JMML

Recommended Dose

Age 1 month to less than 1 year OR

weighing less than 10 kg

2.5 mg/kg

Age 1 year and older AND weighing 10 kg

or greater

75 mg/m2

The recommended dosage for pediatric patients with JMML is provided in Table 1. VIDAZA is administered as an intravenous infusion daily for 7 days in a 28-day cycle. Patients should be treated for a minimum of 3 cycles and maximum of 6 cycles.

A delay in dose not exceeding 14 days can be considered for non-hematologic toxicities.

Monitor patients for hematologic response and renal toxicities [see Warnings and Precautions (5.4)], and delay or reduce dosage if necessary. Treatment may be continued up to six cycles as long as the patient continues to benefit.

Dosage Adjustment Based on Hematology Laboratory Values

For adult patients with baseline (start of treatment) WBC greater than or equal to 3 x109/L, ANC greater than or equal to 1.5 x109/L, and platelets greater than or equal to 75 x109/L, adjust the dose as follows, based on nadir counts for any given cycle:

Nadir Counts

% Dose in the Next
Course

ANC (x109/L)
Less than 0.5
0.5 –1.5
Greater than 1.5

Platelets (x109/L)
Less than 25
25-50
Greater than 50


50%
67%
100%

For adult patients whose baseline counts are WBC less than 3 x109/L, ANC less than 1.5 x109/L, or platelets less than 75 x109/L, base dose adjustments on nadir counts and bone marrow biopsy cellularity at the time of the nadir as noted below, unless there is clear improvement in differentiation (percentage of mature granulocytes is higher and ANC is higher than at onset of that course) at the time of the next cycle, in which case continue the current dose.

WBC or Platelet
Nadir
% decrease in
counts
from baseline

Bone Marrow
Biopsy Cellularity at Time of Nadir
(%)

30-60

15-30

Less than 15


% Dose in the Next Course

50 - 75

100

50

33

Greater than 75

75

50

33

If a nadir as defined in the table above has occurred, give the next course 28 days after the start of the preceding course, provided that both the WBC and the platelet counts are greater than 25% above the nadir and rising. If a greater than 25% increase above the nadir is not seen by day 28, reassess counts every 7 days. If a 25% increase is not seen by day 42, reduce the scheduled dose by 50%.

Pediatric Patients with JMML

As hematological toxicity will be difficult to assess and to differentiate from the natural course of the underlying disorder, dose reductions are not recommended due to hematological toxicity within the first 3 cycles. However, if the patient has a neutrophil count of less than 0.5 x109/L at end of Cycle 3 or on Day 1 of Cycles 5 or 6, discontinue the treatment.

Dosage Adjustment Based on Serum Electrolytes and Renal Toxicity

If unexplained reductions in serum bicarbonate levels to less than 20 mEq/L occur, reduce the dosage by 50% for the next course. Similarly, if unexplained elevations of BUN or serum creatinine occur, delay the next cycle until values return to normal or baseline and reduce the dose by 50% for the next course [see Warnings and Precautions (5.4)].

Use in Geriatric Patients

Azacitidine and its metabolites are known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, select the dose carefully and monitor renal function [see Warnings and Precautions (5.4) and Use in Specific Populations (8.5)].

Preparation of VIDAZA

VIDAZA is a hazardous drug. Follow applicable special handling and disposal procedures. 1

The VIDAZA vial is single-dose and does not contain any preservatives. Discard unused portions of each vial properly [see How Supplied/Storage and Handling (16)]. Do not save any unused portions for later administration.

Instructions for Subcutaneous Administration

Reconstitute VIDAZA aseptically with 4 mL Sterile Water for Injection, USP to obtain a concentration of 25 mg/mL. Inject the diluent slowly into the vial. Vigorously shake or roll the vial until a uniform suspension is achieved. The suspension will be cloudy. Do not filter the suspension after reconstitution. Doing so could remove the active substance.

Preparation for Immediate Subcutaneous Administration: For doses requiring more than 1 vial, divide the dose equally between the syringes (e.g., dose 150 mg = 6 mL, 2 syringes with 3 mL in each syringe) and inject into two separate sites. Due to retention in the vial and needle, it may not be feasible to withdraw all of the suspension from the vial. The product may be held at room temperature for up to 1 hour, but must be administered within 1 hour after reconstitution.

Preparation for Delayed Subcutaneous Administration: The reconstituted product may be kept in the vial or drawn into a syringe. For doses requiring more than 1 vial, divide the dose equally between the syringes (e.g., dose 150 mg = 6 mL, 2 syringes with 3 mL in each syringe) and inject into two separate sites. Due to retention in the vial and needle, it may not be feasible to withdraw all of the suspension from the vial. The product must be refrigerated immediately. See Table 2 for suspension stability storage timelines based on the temperature of the diluent for delayed subcutaneous administration.

After removal from refrigerated conditions, the suspension may be allowed to equilibrate to room temperature for up to 30 minutes prior to administration.

Subcutaneous Administration

To provide a homogeneous suspension, the contents of the dosing syringe must be re-suspended immediately prior to administration. To re-suspend, vigorously roll the syringe between the palms until a uniform, cloudy suspension is achieved.

VIDAZA suspension is administered subcutaneously. Rotate sites for each injection (thigh, abdomen, or upper arm). New injections should be given at least one inch from an old site and never into areas where the site is tender, bruised, red, or hard.

Table 2 Suspension Stability: Storage timelines based on the temperature of the diluent for suspension stability storage:

Suspension Stability Storage timelines

Diluent

Storage

Temperature/Duration

Room temperature (25°C / 77°F)

Sterile Water for Injection, USP

Store at room

temperature at 25°C

(77°F) for up to 1 hour

or refrigerated at 2°C to

8°C (36°F to 46°F) for

up to 8 hours.

Cold (2°C to 8°C / 36°F to 46°F)

Sterile Water for Injection, USP

Store refrigerated at

2°C to 8°C

(36°F to 46°F) for up to

22 hours.

Instructions for Intravenous Administration

Parenteral drug product should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use the product if there is evidence of particulate matter or discoloration.

Adult Patients with MDS

Reconstitute the appropriate number of VIDAZA vials to achieve the desired dose. Reconstitute each vial with 10 mL Sterile Water for Injection, USP. Vigorously shake or roll the vial until all solids are dissolved. The resulting solution will contain azacitidine 10 mg/mL. The solution should be clear.

Withdraw the required amount of VIDAZA solution to deliver the desired dose and inject into a 50 -100 mL infusion bag of either 0.9% Sodium Chloride Injection, USP or Lactated Ringer’s Injection, USP.

Pediatric Patients with JMML

For pediatric patients with JMML, withdraw the required amount of VIDAZA solution to deliver the desired dose and inject into an infusion bag (volume up to 100 mL) of either 0.9% Sodium Chloride Injection, USP or Lactated Ringer’s Injection, USP to achieve a final VIDAZA concentration between 0.9 mg/mL and 4 mg/mL.

Intravenous Solution Incompatibility

VIDAZA is incompatible with 5% Dextrose Injection, USP solutions, Hespan, or solutions that contain bicarbonate. These solutions have the potential to increase the rate of degradation of VIDAZA and should therefore be avoided.

Intravenous Administration

VIDAZA solution is administered intravenously. Administer the total dose over a period of 10 - 40 minutes. The administration must be completed within 1 hour of reconstitution of the VIDAZA vial.

Solution Stability: VIDAZA reconstituted and diluted for intravenous administration may be stored at 25°C (77°F), but administration must be completed within 1 hour of reconstitution.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.