Erleada 240 mg film-coated tablets

  Section 4 has been updated to include lichenoid eruption.

• Section 4.8

• addition of Lichenoid eruption as new ADR with unknown frequency
• “decreased appetite (11%)” was added to the list of the most common adverse reactions reported under the “Summary of the safety profile” 

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.

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.

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.

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.