What Vidaza contains
- The active substance is azacitidine. 1 vial contains 100 mg azacitidine. After reconstitution with 4 ml of water for injections, the reconstituted suspension contains 25 mg/ml azacitidine .
- The other ingredient is mannitol (E421).
What Vidaza looks like and contents of the pack
Vidaza is a white powder for suspension for injection and is supplied in a glass vial containing 100 mg of azacitidine.
Marketing Authorisation Holder
Celgene Europe Ltd
Riverside House
Riverside Walk
Windsor
SL4 1NA
United Kingdom
Manufacturer
Baxter Oncology GmbH
Kantstrasse 2
33790 Halle/Westfalen
Germany
OR
Catalent UK Packaging Limited
Sedge CloseGreat Oakley
Headway
Corby
Northamptonshire
NN18 8HS
United Kingdom
This leaflet was last approved in
The following information is intended for medical or healthcare professionals only:
Recommendations for safe handling
Vidaza is a cytotoxic medicinal product and, as with other potentially toxic compounds, caution should be exercised when handling and preparing azacitidine suspensions. Procedures for proper handling and disposal of anticancer medicinal products should be applied.
If reconstituted azacitidine 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.
Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned below ?Reconstitution Procedure?.
Reconstitution procedure
1. The following supplies should be assembled:
- Vial(s) of azacitidine; vial(s) of water for injections; nonsterile surgical gloves;
- Alcohol wipes; 5 ml injection syringe(s) with needle(s).
2. 4 ml of water for injections should be drawn into the syringe, making sure to purge any air trapped within the syringe.
3. The needle of the syringe containing the 4 ml of water for injections should be inserted through the rubber top of the azacitidine vial followed by injection of the water for injections into the vial.
4. Following removal of the syringe and needle, the vial should be vigorously shaken until a uniform cloudy suspension is achieved. After reconstitution each ml of suspension will contain 25 mg of azacitidine (100 mg/4 ml). The reconstituted product is a homogeneous, cloudy suspension, free of agglomerates. The product should be discarded if it contains large particlesor agglomerates.
5. The rubber top should be cleaned and a new syringe with needle inserted. The vial should then be turned upside down, making sure the needle tip is below the level of the liquid. The plunger should then be pulled back to withdraw the amount of medicinal product required for the proper dose, making sure to purge any air trapped within the syringe. The syringe with needle should then be removed from the vial and the needle disposed of.
6. A fresh subcutaneous needle (recommended 25-gauge) should then be firmly attached to the syringe. The needle should not be purged prior to injection, in order to reduce the incidence of local injection site reactions.
7. If needed (doses over 100 mg) all the above steps for preparation of the suspension should be repeated. For doses greater than 100 mg (4 ml), the dose should be equally divided into 2 syringes (e.g, dose 150 mg = 6 ml, 2 syringes with 3 ml in each syringe).
8. The contents of the dosing syringe must be re-suspended immediately prior to administration. The temperature of the suspension at the time of injection should be approximately 20ºC-25ºC. To re-suspend, vigorously roll the syringe between the palms until a uniform, cloudy suspension is achieved. The product should be discarded if it contains large particles or agglomerates.
The Vidaza suspension should be prepared immediately before use and the reconstituted suspension should be administered within 45 minutes. If elapsed time is greater than 45 minutes, the reconstituted suspension should be discarded appropriately and a new dose prepared. Alternatively, if the product needs to be reconstituted in advance of the administration, it must be placed in a refrigerator (2°C to 8°C) immediately after reconstitution, and kept in the refrigerator for a maximum of 8 hours. If the elapsed time in the refrigerator is greater than 8 hours, the suspension should be discarded appropriately and a new dose prepared. The syringe filled with reconstituted suspension should be allowed up to 30 minutes prior to administration to reach a temperature of approximately 20ºC-25ºC. If the elapsed time is longer than 30 minutes, the suspension should be discarded appropriately and a new dose prepared.
Calculation of an individual dose
The total dose, according to the body surface area (BSA) can be calculated as follows:
Total dose mg Dose mgm2 x BSA m2
The following table is provided only as an example of how to calculate individual azacitidine doses based on an average BSA value of 1.8 m 2.
Total dose based on Number of vials Dose mgm2 of recommended BSA value of 1.8 m2required starting dose Total volume of reconstituted suspension required 75 mgm2 100 135 mg 2 vials 5.4 ml 37.5 mgm 50 267.5 mg 1 vial 2.7 ml 25 mgm2 33 45 mg 1 vial 1.8 ml
Method of administration angle using a Reconstituted Vidaza should be injected subcutaneously insert the needle at a 45-90o25-gauge needle into the upper arm, thigh or abdomen.
Doses greater than 4 ml should be injected into two separate sites.
Injection sites should be rotated. New injections should be given at least 2.5 cm from the previous site and never into areas where the site is tender, bruised, red, or hardened.
Any unused product or waste material should be disposed of in accordance with local requirements.