TRECONDI®
‑ Improving perspectives of AML and MDS patients

TRECONDI® INDICATION

TRECONDI®, in combination with fludarabine, is indicated as part of conditioning treatment prior to allogeneic haematopoietic stem cell transplantation (alloHSCT) in adult patients with malignant and non-malignant diseases, and in paediatric patients older than one month with malignant diseases.

TRECONDI® PRESCRIBING INFORMATION

Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk.

Adverse events should also be reported to medac drug safety at: drugsafety@medac.de

NICE Recommended TRECONDI® PRODUCT CHARACTERISTICS1

Tresulfan conditioning treatment for allogeneic haematopoietic stem cell transplantation (alloHSCT)

  • Powder for solution for infusion
  • Active ingredient is treosulfan
  • Shelf life of 5 years for unopened vials
  • Unopened vials have no special storage conditions
  • After reconstitution with 0.45% sodium chloride solution, chemical and physical stability has been demonstrated for 3 days at 25°C3
  • Do not store reconstituted solutions in a refrigerator (2°C to 8°C) as this might cause precipitation
  • 2 hour infusion time

Instructions INSTRUCTIONS FOR USE

Instructions for reconstitution of TRECONDI®1

1. TRECONDI® is reconstituted in its original glass container. Reconstituted TRECONDI® solutions can be combined into larger vials, PVC bags or PE bags.

2. Warm the solvent, sodium chloride 4.5mg/mL (0.45%) solution, to 25°C – 30°C (not higher), for example by using a water bath.

3. Remove the TRECONDI® powder carefully from the inner surface of the vial by shaking. That action is very important as powder attached to the surface causes clumping. If so, the vial must be vigorously shaken so that the clumping dissolves.

4. Reconstitute each vial of TRECONDI® containing 1g treosulfan in 20mL of pre-warmed (maximum 30°C) sodium chloride 4.5mg/mL (0.45%) solution by shaking. Reconstitute each vial of TRECONDI® containing 5g treosulfan in 100mL of pre-warmed (maximum 30°C) sodium chloride 4.5mg/mL (0.45%) solution by shaking.

ADDITIONAL INFORMATION FOR RECONSTITUTION

  • For the preparation of a 0.45% sodium chloride solution equivalent volumes of 0.9% sodium chloride solution (9mg/ml) and water for injection can be mixed.1
  • Alternatively commercially available products may also be used.
  • The reconstituted solution contains 50mg treosulfan per mL and appears as a clear colourless solution. Solutions showing any sign of precipitation should not be used.1
  • If sterile filtration during cytostatic preparation is necessary: polytetrafluoroethylene filters are compatible with TRECONDI®.3

TRECONDI® has mutagenic and carcinogenic potential. Remnants of the medicinal product as well as all materials that have been used for reconstitution and administration must be destroyed according to standard procedures applicable to antineoplastic agents, with due regard to current laws related to the disposal of hazardous waste.1

References
1. Trecondi® Summary of Product Characteristics (SmPC)
2. www.nice.org.uk/guidance/ta640
3. Data on File

ORDERING TRECONDI®

TRECONDI® is available from Alloga
Tel: +44 (0)1773 441 702

Alloga product codes:
1g – USP6843
5g – USP6845

CONTACT US

TRECONDI® National Account Manager

Jane McNeil
Mobile: 07795 614282
Email: jane.mcneil@medacpharma.co.uk


Medicines Information

For enquiries about Trecondi®, please contact the Medicines Information Department at medac Pharma LLP.

Tel: +44 (0)1786 458086
Email: info@medacpharma.co.uk

Our normal enquiry service is available from 9am to 5pm Monday to Friday. However, we do offer an emergency service outside these hours for urgent enquiries.

medacpharma