Erleada 240 mg film-coated tablets

*
Pharmacy Only: Prescription
  • Company:

    Janssen Sciences Ireland
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
  • Active Ingredient(s):

    *Additional information is available within the SPC or upon request to the company

Updated on 22 August 2024

File name

240mg Clean-Erleada-SmPC-II-37.pdf

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 5.1

The following text has been added:

Prostate Specific Antigen (PSA) reduction

Apalutamide 240 mg daily in combination with ADT in patients with mHSPC (in TITAN study) reduced PSA to undetectable levels (<0.2 ng/mL) at any time in 68% of patients compared to 32% of patients taking ADT alone. Median time to undetectable PSA for patients receiving apalutamide in combination with ADT was 1.9 months. Apalutamide in combination with ADT led to a ≥ 50% PSA reduction from baseline at any time in 90% of patients compared to 55% of patients taking ADT alone.

Apalutamide 240 mg daily in combination with ADT in patients with nmCRPC (in SPARTAN study) reduced PSA to undetectable levels (<0.2 ng/mL) at any time in 38% of patients compared to no patients (0%) taking ADT alone. Median time to undetectable PSA for patients receiving apalutamide in combination with ADT was 2.8 months. Apalutamide in combination with ADT led to a ≥ 50% PSA reduction from baseline at any time in 90% of patients compared to 2.2% of patients taking ADT alone.


Updated on 01 August 2024

File name

IRE NI_EN_PIL_Erleada 240mg FCTs.pdf

Reasons for updating

  • Change to other sources of information section

Free text change information supplied by the pharmaceutical company

Section 6 has been updated to include the following text, as well as the QR code 

To get the most up-to-date package leaflet, scan the QR code here or on the carton. The same information is also available on the following URL: https://epi.jnj.

Updated on 22 May 2024

File name

240mg PIL-Erleada-20240425-EUPI-II-036-clean.pdf

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Section 3 has been updated as follows:

If you cannot swallow the tablet whole

• If you cannot swallow this medicine whole, you can:

  • Mix with one of the following non fizzy beverages or soft foods; orange juice, green tea, applesauce, or drinkable yogurt, or additional water as follows:
  • Place the whole tablet in a cup. Do not crush or split the tablet.
  • Add about 10 mL (2 teaspoons) of non fizzy water to make sure that the tablet is completely in water.
  • Wait 2 minutes until the tablet is broken up and spread out, then stir the mixture.
  • Add in 30 mL (6 teaspoons or 2 tablespoons) of one of the following non fizzy beverages or soft foods: orange juice, green tea, applesauce, or drinkable yogurt, or additional water and stir the mixture.
  • Swallow the mixture immediately.
  • Rinse the cup with enough water to make sure the whole dose is taken and drink it immediately.
  • Do not save the medicine/food mixture for later use.
  • Feeding tube: This medicine may also be given through certain feeding tubes. Ask your healthcare provider for specific instructions on how to properly take the tablet through a feeding tube.


Updated on 22 May 2024

File name

240mg SMPC-Erleada-20240425-EUPI-II-036-Clean.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.2 has been updated as follows:

Taking Erleada with non‑fizzy beverage or soft food

For patients who cannot swallow the tablet whole, Erleada can be dispersed in non‑fizzy water and then mixed with one of the following non‑fizzy beverages or soft foods; orange juice, green tea, applesauce, or drinkable yogurt, or additional water as follows:

1.          Place the whole Erleada 240 mg tablet in a cup. Do not crush or split the tablet.

2.          Add about 10 mL (2 teaspoons) of non‑fizzy water to make sure that the tablet is completely in water.

3.          Wait 2 minutes until the tablet is broken up and spread out, then stir the mixture.

4.          Add in 30 mL (6 teaspoons or 2 tablespoons) of one of the following non‑fizzy beverages or soft foods; orange juice, green tea, applesauce, or drinkable yogurt, or additional water and stir the mixture.

5.          Swallow the mixture immediately.

6.          Rinse the cup with enough water to make sure the whole dose is taken and drink it immediately.

7.          Do not save the medicinal product/food mixture for later use.

 

Administration by nasogastric feeding tube

Erleada 240 mg tablet can also be administered through a nasogastric feeding tube (NG tube) 8 French or greater as follows:

1.          Place one the whole Erleada 240 mg tablet in the barrel of a syringe (use at least a 20 mL syringe) and draw up 10 mL of non‑carbonated fizzy water into the syringe.

2.          Wait 10 minutes and then shake vigorously to disperse the contents completely.

3.          Administer immediately through the NG feeding tube.

4.          Refill the syringe with non‑carbonated fizzy water and administer. Repeat until no tablet residue is left in the syringe or feeding tube.

 

Updated on 15 December 2023

File name

IE NI 240mg PIL-EUPI-PSUSA-10745-202302-Clean-approved.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect

Updated on 15 December 2023

File name

IE NI 240mg SMPC Localised EUPI-PSUSA-10745-202302-Clean-approved.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 14 November 2023

File name

SPC-Erleada 240 mg film-coated tablets-IENI.pdf

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 14 November 2023

File name

PIL-Erleada 240 mg film-coated tablets IENI.pdf

Reasons for updating

  • New PIL for new product