- Approval Id
- 04d8c8ea67cef882
- Drug Name
- ERLEADA FILM-COATED TABLET 60MG
- Product Name
- ERLEADA FILM-COATED TABLET 60MG
- Approval Number
- SIN15698P
- Approval Date
- 2019-05-27
- Registrant
- JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD
- Licence Holder
- JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- TABLET, FILM COATED
- Dosage
- <p><strong>Dosage and Administration</strong><br>
<strong>Dosage</strong><br>
The recommended dose of ERLEADA® is 240 mg (four 60 mg tablets) administered orally once daily.</p>
<p>Medical castration with gonadotropin releasing hormone analogue (GnRHa) should be continued during treatment in patients not surgically castrated.</p>
<p><strong>Administration</strong><br>
ERLEADA® should be administered orally once daily, with or without food. Swallow the tablet(s) whole.</p>
<p><strong>Alternative Method of Administration</strong><br>
<strong>Disperse tablet(s) in water and administer with non-fizzy beverage or soft food</strong><br>
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:</p>
<ol>
<li><p>Place the entire prescribed dose of ERLEADA® tablet(s) in a cup. Do not crush or split the tablet(s).</p></li>
<li><p>Add about 4 teaspoons (20 mL) of non-fizzy water to make sure that the tablets are completely in water.</p></li>
<li><p>Wait 2 minutes until the tablet(s) are broken up and spread out, then stir the mixture.</p></li>
<li><p>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.</p></li>
<li><p>Swallow the mixture immediately.</p></li>
<li><p>Rinse the cup with enough water to make sure the whole dose is taken and drink it immediately.</p></li>
</ol>
<p>Do not save the medicine/food mixture for later use (see <em>PHARMACOLOGICAL PROPERTIES – Pharmacokinetic Properties</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><strong>Administer tablet(s) through a feeding tube</strong><br>
ERLEADA® tablet(s), four 60 mg tablets, can be administered through a nasogastric feeding tube (NG tube) 8 French or greater as follows:</p>
<ol>
<li><p>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.</p></li>
<li><p>Wait 10 minutes and then shake vigorously to disperse contents completely</p></li>
<li><p>Administer immediately through the NG feeding tube.</p></li>
<li><p>Refill the syringe with non-fizzy water and administer. Repeat until no tablet residue is left in the syringe or feeding tube.</p></li>
</ol>
<p><strong>Dose modification</strong><br>
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.</p>
<p><strong>Missed dose(s)</strong><br>
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.</p>
<p><strong>Special populations</strong><br>
<strong><em>Pediatrics (17 years of age and younger)</em></strong><br>
The safety and effectiveness of ERLEADA® in children have not been evaluated.<br>
There is no relevant use of ERLEADA® in pediatric patients aged 17 years and younger.</p>
<p><strong><em>Elderly (65 years of age and older)</em></strong><br>
No dose adjustment is necessary for elderly patients (see <em>Clinical studies and Pharmacokinetic Properties</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><strong><em>Renal impairment</em></strong><br>
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/1.73m<sup>2</sup>) (see <em>Pharmacokinetic Properties</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><strong><em>Hepatic impairment</em></strong><br>
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 <em>Pharmacokinetic Properties</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>Indications</strong><br>
ERLEADA® is indicated for the treatment of patients with</p>
<ul>
<li>metastatic castration-sensitive prostate cancer (mCSPC)</li>
<li>non-metastatic, castration-resistant prostate cancer (nm-CRPC) who are at high risk of developing metastatic disease (see <em>Clinical studies</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</li>
</ul>
- Contraindications
- <p><strong>Contraindications</strong><br>
ERLEADA® is contraindicated in women who are or may become pregnant (see <em>Pregnancy, Breast-feeding and Fertility</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
- Atc Code
- pending
- Atc Item Name
- xpending
- Pharma Manufacturer Name
- JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE. LTD.
- Company Detail Path
- /organization/johnson-and-johnson-international-singapore-pte-ltd
