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What is Erleada (apalutamide)?

Erleada (apalutamide) is indicated for the treatment of patients with non-metastatic prostate cancer who no longer respond to medical or surgical hormone treatment that lowers testosterone1,2,3,4. This type of cancer is known as non-metastatic castration-resistant prostate cancer (NM-CRPC)1,2,3,4. Erleada (apalutamide) is the first approved medicine for this disease5.

How does Erleada (apalutamide) work?

Erleada (apalutamide) is an androgen receptor (AR) inhibitor, which works by blocking the effect of androgens on the tumour1,2,3.

Androgens are hormones that regulate the development of the male sex characteristicsand are needed for the correct functioning of the prostate4. These hormones, of which testosterone is the most prevalent, work by attaching to androgen receptors (AR) located on both healthy and some cancerous cells6; when androgen binds to its receptor, the receptor sends signals to the cell to grow and divide7. In prostate cancer, this results in the growth of the tumour7.

Erleada (apalutamide), as an AR inhibitor, interferes with this mechanism and helps prevent cancer cells from growing4.

Where has Erleada (apalutamide) been approved?

Erleada (apalutamide) was approved for non-metastatic castration-resistant prostate cancer by:

  • Food and Drug Administration (FDA), USA, on February, 20181
  • Health Canada, Canada, on July, 20182
  • Therapeutic Goods Administration (TGA), Australia, on July 20183, under the name Erlyand.

In November 2018, the European Medicines Agency recommended the granting of a marketing authorisation for Erleada (apalutamide)8. This means that it will be made available in some European countries in the first months of 2019.

Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.

How is Erleada (apalutamide) taken?

The recommended dosage is1,2,3:

  • 240 mg (4 60 mg-tablets) taken orally once daily.

Reduction in dose may be required based on symptoms and experienced side effects1,2,3.

Complete information about Erleada (apalutamide) dosage and administration can be found in the official prescribing information listed in our resources section1,2,3.

Note: Please consult with your treating doctor for personalised dosing.

Are there any side effects or adverse reactions of Erleada (apalutamide)?

Serious adverse reactions

The serious adverse reactions listed in the prescribing information include1,2,3:

  • falls and fractures
  • seizures.

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