Prescribing information

 

ADAKVEO® is the first and only once-monthly sickle cell disease (SCD) treatment for the prevention of VOCs1–3

ADAKVEO® 5 mg/kg is administered by intravenous (IV) infusion over 30 minutes at Weeks 0 and 2, then every 4 weeks1

ADAKVEO® provides VOC prevention with a once-monthly IV infusion1–3

 

A time line image showing: ADAKVEO® is the first and only once-monthly sickle cell disease (SCD) treatment for the prevention of VOCs, 3 calendar boxes with text: week 0, week 2, and week 6, red arrow point right, with text:initial does under week 0, loading dose under week 2, administer every 4 weeks under week 6 box.

 

Do not mix or co-administer with other drugs through the same IV line. Do not administer as IV push or bolus1

A healthcare professional should prepare the solution for infusion using aseptic techniques, using the following equation to determine the total dose and required volume of ADAKVEO® based on the patient’s body weight (kg)1

 

Table of two equations showing how to determine the total dose and required volume of ADAKVEO® based on the patient’s body weight (kg). Box a) showing total volume. Box b) number of Vials.

 

Banner with text: Please refer to full summary of product characteristics for additional dosage and administration instructions.

 

ADAKVEO® is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. Reporting suspected adverse reactions after authorisation of ADAKVEO® is important to understand the safety profile of the treatment for SCD patients.

Indication: ADAKVEO® (crizanlizumab) is indicated for the prevention of recurrent VOCs in patients with SCD who are aged 16 years and over. It can be given as an add-on therapy to hydroxyurea/hydroxycarbamide (HU/HC) or as monotherapy in patients for whom HU/HC is inappropriate or inadequate.1

ADAKVEO® has a conditional marketing authorisation and further evidence is awaited.

Abbreviations: HC, hydroxycarbamide; HU, hydroxyurea; IV, intravenous; SCD, sickle cell disease; VOC, vaso-occlusive crisis.

References

  1. ADAKVEO® Summary of Product Characteristics.  
  2. National Heart, Lung, and Blood Institute. SBIR Success Stories. NHLBI funding leads to promising drug candidate to prevent sickle cell pain. Available at: www.nhlbi.nih.gov/grants-and-training/fundin-opportunities-andcontacts/s... funding-leads-promisingdrug-candidate-preventsickle-cell-pain. Date accessed: March 2021.
  3. Ataga KI, et al. N Engl J Med. 2017;376(5):429–439. 
Rate this content: 
No votes yet
UK | June 2021 | 104672
×

Ask Speakers

×

Medical Information Request

 

ADAKVEO® has a conditional marketing authorisation and further evidence is awaited.

For more information, refer to the ADAKVEO® ▼ (crizanlizumab) prescribing information available here:  https://www.health.novartis.co.uk/sites/health.novartis.co.uk/files/adak...

Legal Category: POM.

Marketing Authorisation (MA) number, quantities and price: EU/1/20/1476/001  £1,038.00 per 10ml vial

 

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Novartis via [email protected] or online through the pharmacovigilance intake (PVI) tool at www.report.novartis.com
If you have a question about the product, please contact Medical Information on 01276 698370 or by email at [email protected]