Bring the potential of ROZLYTREK® to life

ROZLYTREK

offers convenient

once-daily,

oral dosing1

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ROZLYTREK offers convenient once-daily, oral dosing1

  • The recommended dose for adults is 600 mg orally once-daily
  • ROZLYTREK can be taken with or without food

ROZLYTREK dosing

Dosing

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  • Adults: Recommended dose is 600 mg orally once-daily
  • Children 12 years and over: Recommended dose is 300 mg/m2 orally once-daily for those who can swallow whole capsules
  • Available in 100 mg and 200 mg hard capsules
  • Can be taken with or without food
    • No significant effect of food on bioavailability was observed

Paediatric dosing1

ROZLYTREK paediatric dosing table according to body surface area

ROZLYTREK dosing modifications

 

Temporary interruption, dose reduction or discontinuation of treatment with ROZLYTREK may help manage adverse reactions1

 

Dose Reduction Schedule of ROZLYTREK for Paediatric Patients BSA of 1.11 m2 to 1.50 m2

Starting Dose

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400 mg once-daily

First Reduction

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300 mg once-daily

Second Reduction

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200 mg, for 5 days each week (Monday, Wednesday, Friday, Saturday, Sunday)

  • ROZLYTREK should be permanently discontinued if patients are unable to tolerate the lowest reduced rate

Dose Reduction Schedule of ROZLYTREK for Adult Patients and Paediatric Patients BSA ≥ 1.51 m2

Starting Dose

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600 mg once-daily

First Reduction

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400 mg once-daily

Second Reduction

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200 mg once-daily

  • ROZLYTREK should be permanently discontinued if patients are unable to tolerate a dose of 200 mg once-daily
Dose reduction table for ROZLYTREK adverse events: congestive heart failure, cognitive disorders

ROZLYTREK SmPC

Download the ROZLYTREK Summary of Product Characteristics

To read the full product information:

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for details on how to report adverse reactions.

Footnotes

ALT, alanine aminotransferase; AR, adverse reaction; AST, aspartate aminotransferase; BSA, body surface area; ms, millisecond; QT, time from the start of the Q wave to the end of the T wave; QTc, the corrected QT interval; SmPC, summary of product characteristics; ULN, upper limit of normal.

 

References

  1. ROZLYTREK Summary of Product Characteristics, 2020.