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Vidaza

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Vidaza

Vidaza

INDICATIONS

Myelodysplastic Syndromes (MDS)

VIDAZA® is indicated for treatment of patients with the following French-American-British (FAB) myelodysplastic syndrome subtypes: refractory anemia (RA) or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL).

DOSAGE AND ADMINISTRATION

First Treatment Cycle

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. Patients should be premedicated for nausea and vomiting.

Complete blood counts, liver chemistries and serum creatinine should be obtained prior to first dose.

Subsequent Treatment Cycles

Cycles should be repeated 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.

Patients should be monitored for hematologic response and renal toxicities [see WARNINGS AND PRECAUTIONS], and dosage delay or reduction as described below may be necessary.

Dosage Adjustment Based On Hematology Laboratory Values

  • For patients with baseline (start of treatment) WBC ≥ 3.0 x109/L, ANC ≥ 1.5 x109/L, and platelets ≥ 75.0 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) Platelets (x109/L)
< 0.5 < 25.0 50%
0.5 –1.5 25.0-50.0 67%
> 1.5 > 50.0 100%

  • For patients whose baseline counts are WBC < 3.0 x109/L, ANC < 1.5 x109/L, or platelets < 75.0 x109/L, dose adjustments should be based 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 the dose of the current treatment should be continued.

WBC or Platelet Nadir % decrease in counts from baseline Bone Marrow Biopsy Cellularity at Time of Nadir (%)
30-60 15-30 < 15
% Dose in the Next Course
50 - 75 100 50 33
> 75 75 50 33

If a nadir as defined in the table above has occurred, the next course of treatment should be given 28 days after the start of the preceding course, provided that both the WBC and the platelet counts are > 25% above the nadir and rising. If a > 25% increase above the nadir is not seen by day 28, counts should be reassessed every 7 days. If a 25% increase is not seen by day 42, then the patient should be treated with 50% of the scheduled dose.

Dosage Adjustment Based On Serum Electrolytes And Renal Toxicity

If unexplained reductions in serum bicarbonate levels to < 20 mEq/L occur, the dosage should be reduced by 50% on the next course. Similarly, if unexplained elevations of BUN or serum creatinine occur, the next cycle should be delayed until values return to normal or baseline and the dose should be reduced by 50% on the next treatment course [see WARNINGS AND PRECAUTIONS].

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, care should be taken in dose selection, and it may be useful to monitor renal function [see WARNINGS AND PRECAUTIONS and Use in Specific Populations].

Preparation Of VIDAZA

VIDAZA is a cytotoxic drug and, as with other potentially toxic compounds, caution should be exercised when handling and preparing VIDAZA suspensions [see HOW SUPPLIED/Storage and Handling].

If reconstituted VIDAZA comes into contact with the skin, immediately and thoroughly wash with soap and water. If it comes into contact with mucous membranes, flush thoroughly with water.

The VIDAZA vial is single-use and does not contain any preservatives. Unused portions of each vial should be discarded properly [see HOW SUPPLIED/Storage and Handling]. Do not save any unused portions for later administration.

Instructions For Subcutaneous Administration

VIDAZA should be reconstituted aseptically with 4 mL sterile water for injection. The diluent should be injected slowly into the vial. Vigorously shake or roll the vial until a uniform suspension is achieved. The suspension will be cloudy. The resulting suspension will contain azacitidine 25 mg/mL. Do not filter the suspension after reconstitution. Doing so could remove the active substance.

Preparation for Immediate Subcutaneous Administration: Doses greater than 4 mL should be divided equally into 2 syringes. 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. Doses greater than 4 mL should be divided equally into 2 syringes. The product must be refrigerated immediately. When VIDAZA is reconstituted using water for injection that has not been refrigerated, the reconstituted product may be held under refrigerated conditions (2°C - 8°C, 36°F - 46°F) for up to 8 hours. When VIDAZA is reconstituted using refrigerated (2°C - 8°C, 36°F - 46°F) water for injection, the reconstituted product may be stored under refrigerated conditions (2°C - 8°C, 36°F - 46°F) for up to 22 hours. 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. Doses greater than 4 mL should be divided equally into 2 syringes and injected into 2 separate sites. 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.

Suspension Stability: VIDAZA reconstituted with non-refrigerated water for injection for subcutaneous administration may be stored for up to 1 hour at 25°C (77°F) or for up to 8 hours between 2°C and 8°C (36°F and 46°F); when reconstituted with refrigerated (2°C - 8°C, 36°F - 46°F) water for injection, it may be stored for 22 hours between 2°C and 8°C (36°F and 46°F).

Instructions For Intravenous Administration

Reconstitute the appropriate number of VIDAZA vials to achieve the desired dose. Reconstitute each vial with 10 mL sterile water for injection. 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. Parenteral drug product should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

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 or Lactated Ringer's Injection.

Intravenous Solution Incompatibility

VIDAZA is incompatible with 5% Dextrose 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 for intravenous administration may be stored at 25°C (77°F), but administration must be completed within 1 hour of reconstitution.

HOW SUPPLIED

Dosage Forms And Strengths

VIDAZA (azacitidine for injection) is supplied as lyophilized powder in 100 mg single-use vials.

Storage And Handling

VIDAZA (azacitidine for injection) is supplied as a lyophilized powder in 100 mg single-use vials packaged in cartons of 1 vial (NDC 59572-102-01).

Storage

Store unreconstituted vials at 25° C (77° F); excursions permitted to 15°-30° C (59°-86° F) (See USP Controlled Room Temperature).

Handling and Disposal

Procedures for proper handling and disposal of anticancer drugs should be applied. Several guidelines on this subject have been published.1-4 There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.

REFERENCES

1. Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings. NIOSH Alert 2004-165.

2. OSHA Technical Manual, TED 1-0.15A, Section VI: Chapter 2. Controlling Occupational Exposure to Hazardous Drugs. OSHA, 1999. http://www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html

3. American Society of Health-System Pharmacists. ASHP guidelines on handling hazardous drugs. Am J Health-Syst Pharm. (2006) 63:1172-1193.

4. Polovich, M., White, J. M., & Kelleher, L.O. (eds.) 2005. Chemotherapy and biotherapy guidelines and recommendations for practice (2nd. ed.) Pittsburgh, PA: Oncology Nursing Society.

Manufactured for: Celgene Corporation Summit, NJ 07901. Manufactured by: Baxter Oncology GmbH 33790 Halle/Westfalen Germany Or BSP Pharmaceuticals S.r.l. 04013 Latina Scalo (Lt) Italy. 01/14

Last reviewed on RxList: 1/23/2014
This monograph has been modified to include the generic and brand name in many instances.

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