Erleada 60 mg Film coated tablet
PDF Leaflet Revision Date: 07 March 2023
Clinical Summary
Quick overview from the medicine insert
Indication
Treatment of metastatic castration-sensitive and non-metastatic castration-resistant prostate cancer in adult males.
Dosage (summary)
240 mg (four 60 mg tablets) orally once daily.
Special Populations
- Elderly
- Renal impairment
- Hepatic impairment
Pregnancy & Breastfeeding
Contraindicated in pregnancy; not recommended during breastfeeding.
Key Drug Interactions
- CYP2C8 inhibitors
- CYP3A4 inhibitors
- CYP3A4 inducers
Contraindications
- Hypersensitivity to apalutamide
- Pregnancy
- History of seizures
Common side effects
- Fatigue
- Skin rash
- Weight loss
- Arthralgia
- Hypertension
- Hot flush
- Diarrhoea
- Falls
Counselling Points
- Take with or without food
- Monitor for seizures
- Use contraception during treatment
- Do not breastfeed
- Inform about potential for falls
Serious warnings
- Seizures
- Falls and fractures
- Ischaemic heart disease
- Hypothyroidism
- Severe cutaneous adverse reactions
Important Disclaimer
The Erleada 60 mg Film coated tablet professional information leaflet below is the property of Janssen Pharmaceutica (Pty) Ltd and is provided on Medinsert exactly as issued, with no.. alterations or editorial changes. We make every effort to keep content current by updating documents as soon as new versions become available. Medinsert serves as a trusted access point for healthcare professionals, but does not replace official sources or clinical judgement. For more details, please read our full disclaimer. read more>>
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