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Tafinlar TM

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: dabrafenib

Brand name

(ARTG)

: TAFINLAR dabrafenib (as mesilate) 50 mg capsule bottle

Download the Consumer Medicine Information Leaflet

Download consumer medicine information leaflet (pdf) from the Therapeutic Goods Administration (TGA) website

What this medicine is used for

(ARTG)

Unresectable or metastatic melanoma,TAFINLAR in combination with trametinib is indicated for the treatment of patients with BRAFV600 mutation positive unresectable Stage III or metastatic (Stage IV) melanoma.,TAFINLAR as monotherapy is indicated for the treatment of patients with BRAF V600 mutation positive unresectable Stage III or metastatic (Stage IV) melanoma.,Adjuvant treatment of melanoma,TAFINLAR in combination with trametinib, is indicated for the adjuvant treatment of patients with a BRAF V600 mutation and involvement of the lymph node(s), following complete resection.,Anaplastic thyroid cancer (ATC),TAFINLAR in combination with trametinib is indicated for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with a BRAF V600 mutation and with no satisfactory locoregional treatment options.,Non-small cell lung cancer (NSCLC),TAFINLAR in combination with trametinib is indicated for the treatment of patients with advanced non-small cell lung cancer (NSCLC) with a BRAF V600 mutation.,Low-grade glioma,TAFINLAR in combination with trametinib is indicated for the treatment of paediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy (see section 5.1 Clinical studies).,High-grade glioma,TAFINLAR in combination with trametinib is indicated for the treatment of paediatric patients 1 year of age and older with high-grade glioma (HGG) with a BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options (see section 5.1 Clinical studies).

How to use this medicine

(ARTG)

This medicine contains one component only.

Component :

  • Capsule
  • Oral
  • Opaque size 2 dark red capsules imprinted with the identifying codes "GS TEW" and "50 mg"

Storage conditions

(ARTG)

  • Store below 30 degrees Celsius
  • Shelf lifetime is 36 Months.

Do I need a prescription ?

(ARTG)

These medicine packs are available from a pharmacist and requires a prescription. It is Schedule 4 : Prescription Only Medicine.

  • 120 pack
  • 28 pack

Is this medicine subsidised ?

(PBS)

This medicine was verified as being available on the PBS (Pharmaceutical Benefits Scheme) on December, 1 2024. To learn more about this subsidy, visit the Pharmaceutical Benefits Scheme (PBS) website.

Pregnant or planning a pregnancy ?

(AHT)

For the active ingredient dabrafenib

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.

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