Erleada

Treatment with apalutamide should be initiated and supervised by specialist physicians experienced in the medical treatment of prostate cancer. Posology 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.

8). 2). 3 Renal impairment No dose adjustment is necessary for patients with mild to moderate renal impairment. 2). 2 Posology and method of administration. Hepatic impairment No dose adjustment is necessary for patients with baseline mild or moderate hepatic impairment (Child-Pugh Class A and B, respectively).

2). Paediatric population There is no relevant use of apalutamide in the paediatric population. Method of administration Oral use. The tablets should be swallowed whole to ensure that the full intended dose is taken. The tablets should not be crushed or split.

The tablets can be taken with or without food. Taking Erleada with non-fizzy beverage or soft food For patients who cannot swallow tablets 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, drinkable yogurt, or additional water as follows: 1.

Place the entire prescribed dose of Erleada in a cup. Do not crush or split the tablets. 2. Add about 20 mL (4 teaspoons) of non-fizzy water to make sure that the tablets are completely in water. 3. Wait 2 minutes until the tablets are 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, drinkable yogurt, or additional water and stir the mixture. 5. Swallow the mixture immediately.

Summary of the safety profile The most common adverse reactions are fatigue (26%), skin rash (26% of any grade and 6% Grade 3 or 4), hypertension (22%), hot flush (18%), arthralgia (17%), diarrhoea (16%), fall (13%), and weight decreased (13%).

Other important adverse reactions include fractures (11%), decreased appetite (11%) and hypothyroidism (8%). Tabulated list of adverse reactions Adverse reactions observed during clinical studies and/or in post-marketing experience are listed below by frequency category.

Frequency categories are defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000); very rare (< 1/10 000) and not known (frequency cannot be estimated from the available data).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 4 f See “Skin rash” under “Description of selected adverse reactions” g Includes rib fracture, lumbar vertebral fracture, spinal compression fracture, spinal fracture, foot fracture, hip fracture, humerus fracture, thoracic vertebral fracture, upper limb fracture, fractured sacrum, hand fracture, pubis fracture, acetabulum fracture, ankle fracture, compression fracture, costal cartilage fracture, facial bones fracture, lower limb fracture, osteoporotic fracture, wrist fracture, avulsion fracture, fibula fracture, fractured coccyx, pelvic fracture, radius fracture, sternal fracture, stress fracture, traumatic fracture, cervical vertebral fracture, femoral neck fracture, tibia fracture.

See below. Description of selected adverse reactions Skin rash Skin rash associated with apalutamide was most commonly described as macular or maculo-papular. Skin rash included rash, rash maculo-papular, rash generalised, urticaria, rash pruritic, rash macular, conjunctivitis, erythema multiforme, rash papular, skin exfoliation, genital rash, rash erythematous, stomatitis, drug eruption, mouth ulceration, rash pustular, blister, papule, pemphigoid, skin erosion, 10 dermatitis, and rash vesicular.

Seizure Erleada is not recommended in patients with a history of seizures or other predisposing factors including, but not limited to, underlying brain injury, recent stroke (within one year), primary brain tumours or brain metastases.

If a seizure develops during treatment with Erleada, treatment should be discontinued permanently. The risk of seizure may be increased in patients receiving concomitant medicinal products that lower the seizure threshold. 2% of patients treated with placebo.

These studies excluded patients with a history of seizure or predisposing factors for seizure. There is no clinical experience in re-administering Erleada to patients who experienced a seizure. 8). Patients should be evaluated for fracture and fall risk before starting Erleada and should continue to be monitored and managed according to established treatment guidelines and use of bone-targeted agents should be considered.

8). The majority of patients had cardiac/cerebrovascular ischaemic disease risk factors. Patients should be monitored for signs and symptoms of ischaemic heart disease and ischaemic cerebrovascular disorders. Management of risk factors, such as hypertension, diabetes, or dyslipidaemia should be optimised as per standard of care.

5). A review of concomitant medicinal products should therefore be conducted when apalutamide treatment is initiated. 5) should generally be avoided if their therapeutic effect is of large importance to the patient, and if dose adjustments cannot easily be performed based on monitoring of efficacy or plasma concentrations.

Co-administration of apalutamide with warfarin and coumarin-like anticoagulants should be avoided. 5). , pulmonary embolism, cerebrovascular accident including transient ischaemic attacks), or clinically significant ventricular arrhythmias were excluded from the clinical studies.

Therefore, the safety of apalutamide in these patients has not been established. 8). Patients should be treated, if appropriate, after initiating Erleada for these conditions according to established treatment guidelines. 5), physicians should assess the benefit-risk ratio including the potential for Torsade de pointes prior to initiating Erleada.

1. 6).