ERLEADA FILM-COATED TABLET 60MG [SIN15698P]

Product Info

ERLEADA FILM-COATED TABLET 60MG

[SIN15698P]

Indication

Indications
ERLEADA® is indicated for the treatment of patients with

• metastatic castration-sensitive prostate cancer (mCSPC)

• non-metastatic, castration-resistant prostate cancer (nm-CRPC) who are at high risk of developing metastatic disease (see Clinical studies – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Dosing

Dosage and Administration
Dosage
The recommended dose of ERLEADA® is 240 mg (four 60 mg tablets) administered orally once daily.

Medical castration with gonadotropin releasing hormone analogue (GnRHa) should be continued during treatment in patients not surgically castrated.

Administration
ERLEADA® should be administered orally once daily, with or without food. Swallow the tablet(s) whole.

Alternative Method of Administration
Disperse tablet(s) in water and administer with non-fizzy beverage or soft food
For patients who cannot swallow tablets whole, the recommended dose of ERLEADA® tablet(s), four 60 mg tablets, 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, drinkable yogurt, or additional water as follows:

1. Place the entire prescribed dose of ERLEADA® tablet(s) in a cup. Do not crush or split the tablet(s).

2. Add about 4 teaspoons (20 mL) of non-fizzy water to make sure that the tablets are completely in water.

3. Wait 2 minutes until the tablet(s) are broken up and spread out, then stir the mixture.

4. Add in 6 teaspoons or 2 tablespoons (30 mL) of one of the following non-fizzy beverages or soft foods; orange juice, green tea, applesauce, 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.

Do not save the medicine/food mixture for later use (see PHARMACOLOGICAL PROPERTIES – Pharmacokinetic Properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Administer tablet(s) through a feeding tube
ERLEADA® tablet(s), four 60 mg tablets, can be administered through a nasogastric feeding tube (NG tube) 8 French or greater as follows:

1. Place the entire prescribed dose of ERLEADA® tablet(s) in the barrel of the syringe (use at least a 50 mL syringe) and draw up 20 mL of non-fizzy water into the syringe.

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

3. Administer immediately through the NG feeding tube.

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

Dose modification
If a patient experiences a ≥ Grade 3 toxicity or an intolerable side effect, hold dosing until symptoms improve to ≤ Grade 1 or original grade, then resume at the same dose or a reduced dose (180 mg or 120 mg), if warranted.

Missed dose(s)
If the patient misses a dose, it should be taken as soon as possible on the same day with a return to the normal schedule on the following day. The patient should not take extra tablets to make up the missed dose.

Special populations
Pediatrics (17 years of age and younger)
The safety and effectiveness of ERLEADA® in children have not been evaluated.
There is no relevant use of ERLEADA® in pediatric patients aged 17 years and younger.

Elderly (65 years of age and older)
No dose adjustment is necessary for elderly patients (see Clinical studies and Pharmacokinetic Properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Renal impairment
No dosage adjustment is necessary for patients with mild to moderate renal impairment. No data are available in patients with severe renal impairment or end-stage renal disease (eGFR ≤ 29 mL/min/1.73m²) (see Pharmacokinetic Properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Hepatic impairment
No dosage adjustment is necessary for patients with baseline mild or moderate hepatic impairment. No data are available in patients with severe hepatic impairment (Child-Pugh Class C) (see Pharmacokinetic Properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Contraindications

Contraindications
ERLEADA® is contraindicated in women who are or may become pregnant (see Pregnancy, Breast-feeding and Fertility – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).