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TAFINLAR + MEKINIST is the first and only targeted treatment regimen for low- and high-grade paediatric glioma with BRAF V600E mutations

 

As of July 2025.

 

BRAF V600E+ mutation is common in paediatric glioma and typically has a poor prognosis

 

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Flexible, weight-based dosing with paediatric-friendly formulations

 

TAFINLAR + MEKINIST is an oral regimen with weight-based dosing for paediatric patients (aged ≥1 year) with low- and high-grade glioma from 8 kg.1,2 TAFINLAR is available in capsules or dispersible tablet forms, and MEKINIST is available as tablets or powder for oral solution.1,2

 

Capsule and tablet formulation (patients weighing ≥26 kg)1,2

 

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Oral suspension and solution formulation (patients weighing ≥8 kg)1,2

 

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Dosing for capsules and tablets administration (patients weighing ≥26 kg)

 

Recommended weight-based dosing and dose reductions for TAFINLAR capsule administration1

 

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BID, twice daily
Permanently discontinue if unable to tolerate maximum of three dose reductions or a TAFINLAR 50 mg capsule orally twice daily1

 

 

Recommended weight-based dosing and dose reductions for MEKINIST tablet administration2

 

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QD, once daily
Permanently discontinue if unable to tolerate a maximum of two dose reductions2

 

Dosing for oral suspension and oral solution administration (patients weighing ≥8 kg)

 

Recommended weight-based dosing and dose reductions for TAFINLAR dispersible tablets1

 

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BID, twice daily
Permanently discontinue if unable to tolerate a maximum of 3 dose reductions or a TAFINLAR 10 mg dispersible tablet orally twice daily1

 

Recommended weight-based dosing and dose reductions for MEKINIST powder for oral solution2

 

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QD, once daily
Permanently discontinue if unable to tolerate a maximum of two dose reductions2

TAFINLAR and MEKINIST PBS Information: Authority Required. Please refer to PBS Schedule for full authority information for products.

▼ These medicinal products are subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at www.tga.gov.au/reporting-problems.

For Australian healthcare professionals only. Please review Product Information before prescribing. For TAFINLAR Product Information, please click here. For MEKINIST Product Information, please click here. Alternatively, contact med info on 1800 671 203 to access the full Product Information.

 

Footnotes and References

Abbreviations: AE, adverse event; CI, confidence interval; HR, hazard ratio; ORR, objective response rate; OS, overall survival; PBS, Pharmaceutical Benefits Scheme; PFS, progression-free survival.

References: 1. TAFINLAR (dabrafenib) Australian approved product information. 2. MEKINIST (trametinib) Australian approved
product information. 3. Bouffet E, et al. N Engl J Med. 2023;389:1108–1120. 4. Hargrave DR, et al. J Clin Oncol. 2023;41(28):5174–
5183. 5. Lassaletta A, et al. J Clin Oncol. 2017;35(25):2934–2941.


®Registered trademark of Novartis AG. ©2025 NOVARTIS PHARMACEUTICALS AUSTRALIA PTY LIMITED, ABN 18 004 244 160.
Sydney NSW. Ph (02) 9805 3555. For medical enquiries please contact 1800 671 203 or [email protected].
AU-28363. July 2025.

Adverse events should be reported.

Adverse events and product complaints should also be reported to Novartis.

For Medical Enquiries, Information Services, Adverse Events and Product Complaints please contact: 1800 671 203 or [email protected]

Colleagues are available from 9:00 to 17:00 from Monday to Friday.