Monitoring and dosing1
Adverse event reporting information can be found at the bottom of this page.
Click HERE for prescribing information.
Monitoring
Monitoring for all patients
Monitor platelet counts and triglycerides as recommended during treatment to determine if dosage modifications are needed, as shown in the table below
Patient body weight should be monitored to assess dose adjustment
Additional monitoring for certain patient profiles only
In patients with underlying cardiac disease or in patients who are taking concomitant medications that cause QT prolongation, obtain ECGs prior to initiating treatment with Duvyzat®, during concomitant use and as clinically indicated
Dose modifications due to adverse events
* If the adverse reaction(s) persist after the first dosage modification, proceed to the second dosage modification.
Discontinuations:
- If after the second dosage modification, the adverse reaction(s) persist, Duvyzat® should be discontinued
- QTc interval prolongation: Withhold Duvyzat® if the QTc interval is > 500 ms or the change from baseline is > 60 ms
- If the platelet count is < 150 x 109/L OR moderate or severe diarrhoea OR fasting triglycerides > 3.42 mmol/L persist after the second dosage modification, Duvyzat® should be discontinued
Precautions for use
- This medicinal product contains 400 mg sorbitol in each mL which is equivalent to 40 mg/kg. The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account
- This medicinal product contains 4.4 mg sodium benzoate in each mL which is equivalent to 0.44 mg/kg
- Duvyzat® can cause QTc interval prolongation. Caution is advised when prescribing Duvyzat® with medicinal products known to prolong the QTc interval with known or possible risk for torsades de pointes
Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in the Google Play or Apple App Store.
Adverse events should also be reported to ITF Pharma Ltd Medical Information on: 0800 098 4040 or UK.Medical.Information@italfarmacogroup.com
Product Quality Complaints should also be reported to ITF Pharma Ltd Medical Information on: 0800 098 4040 or UK.Medical.Information@italfarmacogroup.com
References
- Duvyzat Summary of Product Characteristics, MHRA, https://www.medicines.org.uk/emc/product/100605/smpc
