Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340, Beerse, Belgium
Erleada is indicated:
Treatment with apalutamide should be initiated and supervised by specialist physicians experienced in the medical treatment of prostate cancer.
The recommended dose is 240 mg (four 60 mg tablets) as an oral single daily dose.
Medical castration with gonadotropin releasing hormone analogue (GnRHa) should be continued during treatment in patients not surgically castrated.
If a dose is missed, it should be taken as soon as possible on the same day with a return to the normal schedule the following day. Extra tablets should not be taken to make up the missed dose.
If a ≥ Grade 3 toxicity or an intolerable adverse reaction is experienced by the patient, dosing should be held rather than permanently discontinuing treatment until symptoms improve to ≤ Grade 1 or original grade, then should be resumed at the same dose or a reduced dose (180 mg or 120 mg), if warranted. For the most common adverse reactions, see section 4.8.
No dose adjustment is necessary for elderly patients (see sections 5.1 and 5.2).
No dose adjustment is necessary for patients with mild to moderate renal impairment.
Caution is required in patients with severe renal impairment as apalutamide has not been studied in this patient population (see section 5.2). If treatment is started, patients should be monitored for the adverse reactions listed in section 4.8 and dose reduce as per section 4.2 Posology and method of administration.
No dose adjustment is necessary for patients with baseline mild or moderate hepatic impairment (Child-Pugh Class A and B, respectively).
Erleada is not recommended in patients with severe hepatic impairment as there are no data in this patient population and apalutamide is primarily hepatically eliminated (see section 5.2).
There is no relevant use of apalutamide in the paediatric population.
Oral use.
The tablets should be swallowed whole and can be taken with or without food.
There is no known specific antidote for apalutamide overdose. In the event of an overdose, Erleada should be stopped and general supportive measures should be undertaken until clinical toxicity has been diminished or resolved. Adverse reactions in the event of an overdose has not yet been observed, it is expected that such reactions would resemble the adverse reactions listed in section 4.8.
Shelf life: 2 years.
Store in the original package in order to protect from moisture. This medicinal product does not require any special temperature storage conditions.
White opaque high-density polyethylene (HDPE) bottle with a polypropylene (PP) child-resistant closure. Each bottle contains 120 film-coated tablets and a total of 6 g of silica gel desiccant.
PVC-PCTFE foil blister with an aluminum push-through foil sealed inside a wallet pack.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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