Apalutamide: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: May 29, 2026🚩 Report this page

Apalutamide

Anti-Androgens

Sold as Erleada

GB MHRAEU EMACA Health Canada

Drug class: Anti-Androgens
Availability: See label
Routes: Oral
Markets covered: 3
Products on record: 10

Overview

Apalutamide is an active pharmaceutical ingredient in the Anti-Androgens group (L02BB). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
GB United Kingdom	MHRA	7	May 29, 2026
EU European Union	EMA	1	April 22, 2026
CA Canada	Health Canada	2	April 15, 2026

GBUnited Kingdom· MHRA

7 products

Uses

GBOfficial regulatory label· revised May 29, 2026[1]

1). 1).

How to take

GBOfficial regulatory label· revised May 29, 2026

EUEuropean Union· EMA

1 product

Uses

EUOfficial regulatory label· revised April 22, 2026[2]

1). 1).

How to take

EUOfficial regulatory label· revised April 22, 2026

CACanada· Health Canada

2 products

2 products on record with this regulator. Detailed label text (uses, dosage, side effects) is being ingested — the original document is linked under Sources [3].

Brands in Canada (1)

ERLEADAJANSSEN INC

Drug interactions

Known interactions involving Apalutamide. Select one for details. This list is informational and not a complete interaction checker.

Abemaciclib Abiraterone Acalabrutinib Alpelisib Amiodarone Amisulpride Amlodipine Anagrelide Apixaban Apremilast Arsenic Trioxide Artemether Avapritinib Axitinib Bedaquiline Benzhydrocodone Bepridil Bictegravir Boceprevir Bortezomib Bosutinib Brigatinib Bupropion Buspirone Butorphanol Cabozantinib Capmatinib Ceritinib Cisapride Citalopram Clozapine Cobicistat Cobimetinib Copanlisib Crizotinib Daclatasvir Darolutamide Dasatinib Deflazacort Delavirdine Disopyramide Dofetilide Dolasetron Dolutegravir Doravirine Dronedarone Droperidol Duvelisib Eliglustat Elvitegravir Encorafenib Entrectinib Eravacycline Erdafitinib Escitalopram Etravirine Everolimus Fedratinib Felodipine Fentanyl Fingolimod Flibanserin Fostamatinib Fostemsavir Gatifloxacin Gilteritinib Glasdegib Grazoprevir Grepafloxacin Guanfacine Halofantrine Haloperidol Hydrocodone Ibrutinib Ibutilide Idelalisib Iloperidone Imatinib Iohexol Iopamidol Irinotecan Isavuconazonium Isradipine Istradefylline Ivabradine Ivacaftor Ivosidenib Ixazomib Larotrectinib Lefamulin Levamlodipine Lonafarnib Lorlatinib Lumateperone Lurasidone Lurbinectedin Macitentan Maraviroc Mesoridazine Methadone Midostaurin Mifepristone Moxifloxacin Naldemedine Naloxegol Neratinib Netupitant Nicardipine Nifedipine Nilotinib Nimodipine Nisoldipine Olaparib Oliceridine Osilodrostat Osimertinib Oxycodone Ozanimod Palbociclib Panobinostat Papaverine Pasireotide Pemigatinib Pexidartinib Pimozide Pitolisant Pralsetinib Praziquantel Pretomanid Procainamide Quetiapine Quinidine Ranolazine Ribociclib Rilpivirine Rimegepant Ripretinib Ritonavir Rivaroxaban Rolapitant Saquinavir Selpercatinib Selumetinib Simeprevir Siponimod Sirolimus Sofosbuvir Sonidegib Sotalol Sparfloxacin Stiripentol Sunitinib Suvorexant Tacrolimus Tasimelteon Tazemetostat Telithromycin Temsirolimus Thioridazine Ticagrelor Tofacitinib Tolvaptan Toremifene Trabectedin Tramadol Tucatinib Ubrogepant Upadacitinib Valbenazine Vandetanib Vemurafenib Venetoclax Vorapaxar Voxelotor Zanubrutinib Ziprasidone Acetaminophen Adenosine Afatinib Albendazole Albuterol Alfentanil Alfuzosin Aliskiren Alosetron Alprazolam Alvimopan Ambrisentan Amifampridine Amitriptyline Amoxapine Amprenavir Anisindione Apomorphine Arformoterol Aripiprazole Artesunate Asenapine Astemizole Atazanavir Atomoxetine Atorvastatin Avanafil Avatrombopag Azithromycin Belinostat Betrixaban Bisacodyl Bosentan Brentuximab Vedotin Brexpiprazole Buprenorphine Cabazitaxel Cannabidiol Capromab Pendetide Cariprazine Carisoprodol Caspofungin Castor Oil Celecoxib Cerivastatin Chloroquine Chlorpromazine Chlorpropamide Cilostazol Ciprofloxacin Clarithromycin Clindamycin Clobazam Clofazimine Clomipramine Clonazepam Clorazepate Codeine Colchicine Cyclophosphamide Dabrafenib Dapagliflozin Dapsone Darifenacin

Showing 240 of 508. Type above to find a specific drug.

Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.

Sources & citations

[1]MHRA (UK) · PLGB002420750 · revised May 29, 2026
[2]European Medicines Agency · EMEA/H/C/004452 · revised April 22, 2026
[3]Health Canada (DPD) · 02478374 · revised April 15, 2026

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Treatment with apalutamide should be initiated and supervised by an appropriate prescriber experienced in the treatment of prostate cancer. Posology The recommended dose is 240 mg (one 240 mg tablet) 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). 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 tablet should be swallowed whole to ensure that the full intended dose is taken. The tablet should not be crushed or split.
The tablet can be taken with or without food. Taking Erleada with non-fizzy beverage or soft food For patients who cannot swallow the tablet 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 whole Erleada 240 mg tablet in a cup. Do not crush or split the tablet. 2. Add about 10 mL (2 teaspoons) of non-fizzy water to make sure that the tablet is completely in water. 3. Wait 2 minutes until the tablet is 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.
6. Rinse the cup with enough water to make sure the whole dose is taken and drink it immediately. 7. Do not save the medicinal product/food mixture for later use. Administration by nasogastric feeding tube Erleada 240 mg tablet can also be administered through a nasogastric feeding tube (NG tube) 8 French or greater as follows: 1.
Place the whole Erleada 240 mg tablet in the barrel of a syringe (use at least a 20 mL syringe) and draw up 10 mL of non-fizzy water into the syringe. 2. Wait 10 minutes and then shake vigorously to disperse the 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.

Side effects & warnings

GBOfficial regulatory label· Adverse reactions· revised May 29, 2026[1]

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, dermatitis, and rash vesicular.
Adverse reactions of skin rash were reported for 26% of patients treated with apalutamide. Grade 3 skin rashes (defined as covering > 30% body surface area [BSA]) were reported with apalutamide treatment in 6% of patients. The median days to onset of skin rash was 83 days.
Seventy-eight percent of patients had resolution of rash with a median of 78 days to resolution. Medicinal products utilised included topical corticosteroids, oral anti-histamines, and 19% of patients received systemic corticosteroids.
2). Skin rash recurred in 59% of patients who had dose interruption. Skin rash led to apalutamide treatment discontinuation in 7% of patients who experienced skin rash. 5% of patients treated with placebo. Half of the patients experienced a fall within 7 days before the fracture event in both treatment groups.
4). Ischaemic heart disease and ischaemic cerebrovascular disorders In a randomised study (SPARTAN) of patients with nmCRPC, ischaemic heart disease occurred in 4% of patients treated with apalutamide and 3% of patients treated with placebo.
In a randomised study (TITAN) in patients with mHSPC, ischaemic heart disease occurred in 4% of patients treated with apalutamide and 2% of patients treated with placebo. 4). In the SPARTAN study, with a median […]

GBOfficial regulatory label· Warnings and precautions· revised May 29, 2026[1]

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.

This is not medical advice. Consult a qualified healthcare professional.

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.
6. Rinse the cup with enough water to make sure the whole dose is taken and drink it immediately. 7. Do not save the medicinal product/food mixture for later use. Administration by nasogastric feeding tube Erleada can also be administered through a nasogastric feeding tube (NG tube) 8 French or greater as follows: 1.
Place the entire prescribed dose of Erleada in the barrel of a 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 the 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.