Prescribing information For Healthcare Professionals Only

ERLEADA®

60 mg film-coated tablets

PRESCRIBING INFORMATION

Active Ingredient(s):

Apalutamide

Please refer to Summary of Product Characteristics (SmPC) before prescribing.

Indications(S): 

Treatment of adult men with non-metastatic castration-resistant prostate cancer (NM-CRPC), at high risk of developing metastatic disease.

Dosage & Administration:

Adults: 240 mg (four 60 mg tablets) single daily dose, swallowed whole with or without food. Continue medical castration with gonadotropin releasing hormone analogue (GnRHa) throughout in patients not surgically castrated.
Elderly: No dose adjustment.
Renal impairment: Mild to moderate - no dose adjustment. Severe - not studied; caution advised. If treating, monitor patients for side effects, reduce dose if required.
Hepatic impairment: Baseline mild or moderate (Child Pugh Class A and B) - no dose adjustment. Severe - not recommended. 

Contraindications:

Hypersensitivity to active substance or any excipient. Women who are or may become pregnant. 

Special warnings & Precautions:

Seizure: History of seizures or other predisposing factors - not recommended. Discontinue permanently if seizure develops during treatment. Risk of seizure may be increased in patients receiving concomitant medicinal products that lower the seizure threshold.
Falls and fractures: Reported; evaluate patients for risk before starting Erleada; continue monitoring and manage fractures, consider use of bone-targeted agents.
Concomitant use with other medicinal products: Potent enzyme inducer; may lead to loss of efficacy of concomitant medication. Review concomitant medication and refer to SmPC for further guidance. Avoid co-administration with warfarin and coumarin-like anticoagulants. If co-administered with an anticoagulant metabolised by CYP2C9 (e.g. warfarin or acenocoumarol), conduct additional International Normalised Ratio (INR) monitoring.
Recent cardiovascular disease: Monitor patients with clinically significant cardiovascular disease for risk factors (e.g. hypercholesterolaemia, hypertriglyceridaemia, other cardio-metabolic disorders) as safety in patients with clinically significant cardiovascular disease in the past 6 months has not been established.
Androgen deprivation therapy may prolong QT interval: Assess benefit-risk including potential for Torsade de pointes prior to initiating Erleada in patients with a history or risk factors for QT prolongation and those receiving concomitant medicinal products that might prolong QT interval.
Effects on ability to drive and use machines: Seizures reported; potential risk for driving or operating machines. 

Side Effects:

Refer to SmPC for other side effects.
Very common: Skin rash, fracture, arthralgia, fatigue, weight decreased, fall.
Common: Hypothyroidism, hypercholesterolaemia, hypertriglyceridaemia, pruritus.
Other side effects: Seizure, QT prolongation.

FERTILITY, PREGNANCY and LACTATION:

Use appropriate barrier contraception during sex with female partners of reproductive potential and for 3 months after last dose of Erleada. May cause harm to foetus (contraindicated in pregnancy). Do not use during breast-feeding. 

INTERACTIONS:

Refer to SmPC for full details of interactions.
CYP2C8 and CYP3A4 inhibitors: CYP2C8 and CYP3A4 involved in elimination of apalutamide and formation of active metabolite. No initial dose adjustment necessary with strong inhibitors of CYP2C8 (e.g., gemfibrozil, clopidogrel) or strong inhibitors of CYP3A4 (e.g., ketoconazole, ritonavir, clarithromycin), but consider reduction of Erleada dose based on tolerability.
Drug metabolising enzymes: Erleada is strong inducer of CYP3A4 and CYP2C19, and weak inducer of CYP2C9. Concomitant use with medicinal products primarily metabolised by CYP3A4 (e.g., darunavir, felodipine, midazolam, simvastatin), CYP2C19 (e.g., diazepam, omeprazole), or CYP2C9 (e.g., warfarin, phenytoin) can result in lower exposure to these medicinal products. Substitution for these medicinal products is recommended or evaluation for loss of efficacy if no substitution. If given with warfarin, monitor INR. Concomitant administration with medicinal products that are substrates of UDP glucuronosyl transferase (UGT) (e.g., levothyroxine, valproic acid) can result in lower exposure to these medicinal products; evaluate for loss of efficacy and adjust dose of substrate if required.
Drug transporters: Apalutamide is weak inducer of P-glycoprotein (P-gp), breast cancer resistance protein (BCRP), and organic anion transporting polypeptide 1B1 (OATP1B1). Concomitant use with medicinal products that are substrates of P-gp (e.g., colchicine, dabigatran etexilate, digoxin), BCRP or OATP1B1 (e.g., lapatinib, methotrexate, rosuvastatin, repaglinide) can result in lower exposure of these medicinal products; evaluate for for loss of efficacy and adjust dose of substrate if required.
Medicinal products which prolong QT interval: Carefully evaluate use of Erleada and also with medicinal products that induce Torsade de pointes such as class IA (e.g. quinidine, disopyramide) or class III (e.g., amiodarone, sotalol, dofetilide, ibutilide), antiarrhythmics, methadone, moxifloxacin, antipsychotics (e.g. haloperidol), etc.

LEGAL CATEGORY: POM 

 

PRESENTATIONS, PACK SIZES, MARKETING AUTHORISATION NUMBER(S) & BASIC NHS COSTS

PRESENTATIONS PACK SIZES MARKETING AUTHORISATION NUMBER(S) BASIC NHS COSTS
Blister pack  112 EU/1/18/1342/001 £2735

MARKETING AUTHORISATION HOLDER: JANSSEN-CILAG INTERNATIONAL NV, Turnhoutseweg 30, B-2340 Beerse, Belgium.

FURTHER INFORMATION IS AVAILABLE FROM: Janssen-Cilag Limited, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG UK.

Prescribing information last revised: January 2019

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