Rozlytrek TM
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You should seek medical advice in relation to medicines and use only as directed by a healthcare professional. Always read the label. If symptoms persist see your healthcare professional.
Active ingredients: entrectinib
Brand name
(ARTG)
: ROZLYTREK entrectinib 200 mg hard capsule bottleConsumer Medicine Information (CMI)
Read the CMI leaflet for facts you need to know before, during and after taking your medicine.
Listen to the audio transcription of the CMI leaflet.
For more information about CMIs and how to read them, please visit How to read Consumer Medicine Information (CMI).
What this medicine is used for
(ARTG)
Non-small cell lung cancer (NSCLC),Rozlytrek is indicated for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) whose tumours are ROS1-positive.Solid tumours,Rozlytrek is indicated for the treatment of adult and paediatric patients 12 years of age and older with solid tumours that:, have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation,, are metastatic or where surgical resection is likely to result in severe morbidity, and, have either progressed following treatment or have no satisfactory alternative therapy.,This indication was approved via the provisional approval pathway, based on objective response rate and duration of response in single-arm trials. Full registration for this indication depends on verification and description of clinical benefit in confirmatory trials.
How to use this medicine
(ARTG)
This medicine contains one component only.
Component :
- Capsule, hard
- Oral
- Size 0 hard capsules with orange body and cap with 'ENT 200' imprinted in blue on the body.
Storage conditions
(ARTG)
- Store below 30 degrees Celsius
- Keep Container Tightly Closed/Airtight
- Protect from Moisture
- Store in Original Container
- Shelf lifetime is 48 Months.
Do I need a prescription ?
(ARTG)
These medicine packs are available from a pharmacist and requires a prescription. It is
- 90 pack
Is this medicine subsidised ?
(PBS)
This medicine was verified as being available on the PBS (Pharmaceutical Benefits Scheme) on May, 1 2025. To learn more about this subsidy, visit the Pharmaceutical Benefits Scheme (PBS) website.
Pregnant or planning a pregnancy ?
(AHT)
For the active ingredient entrectinib
You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.
Reporting side effects
This medicine is under additional monitoring as it is new or being used in a different way. You can help identify new safety information by reporting any side effects you may get.
- You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems.
- For more information on the Black Triangle Scheme and how to report side effects, see www.tga.gov.au/black-triangle-scheme
