Apalutamide: Uses, Interactions and Safety
Uses
Apalutamide is an androgen receptor inhibitor for selected prostate cancers. Current EU information includes high-risk non-metastatic castration-resistant and metastatic hormone-sensitive disease. The Turkish manufacturer document reviewed, dated March 2021, describes the non-metastatic setting. Its age and narrower scope should be recognised when checking local treatment eligibility.
Administration
Apalutamide is taken orally, with or without food, under specialist supervision. Follow the instructions for the exact tablet strength. Some presentations have specific alternative administration instructions for swallowing difficulties; these should not be improvised. Ongoing medical or surgical androgen deprivation is part of the indicated treatment setting.
Safety
Important warnings include seizures, falls and fractures, ischaemic heart or cerebrovascular events, severe skin reactions, and interstitial lung disease. Seek urgent assessment for a seizure, stroke symptoms, chest pain, a blistering or widespread rash, or new breathing difficulty. Thyroid function and cardiovascular risk may also need review. A history of seizures calls for careful specialist assessment rather than being silently added to the formal contraindication list.
Interactions
Apalutamide strongly induces CYP3A4 and CYP2C19 and weakly induces CYP2C9 according to the EMA product information. It also induces P-gp, BCRP and OATP1B1. Warfarin, some cholesterol medicines, digoxin, levothyroxine and other anticancer drugs may lose effect. Gemfibrozil and strong CYP3A inhibitors warrant a tolerability review. Do not assume the interaction pattern is the same for every androgen receptor inhibitor.
Pregnancy and breastfeeding
Apalutamide is contraindicated in women who are or could become pregnant and should not be used while breastfeeding. Men with partners who can become pregnant need the recommended barrier and effective contraception measures during treatment and for three months afterwards.
Adverse effects
Fatigue, rash, hypertension, hot flushes, joint pain, diarrhoea, falls and weight loss are common. Hypothyroidism and fractures also matter. Report symptoms early and keep planned monitoring appointments.
Sources
Additional verified references
The linked Turkish profile contains the medicine record and its documented interaction list.