ERLEADA FLIM-COATED TABLETS
Apalautamide
What it does
Apalutamide is a medication used to treat prostate cancer, particularly in cases that have not spread to other parts of the body.
Commonly used for: prostate cancer
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Source: Food and Drugs Authority · fetched 2026-04-18 08:37:39 · updated 2026-07-31 04:00:12
About this medicine
Apalutamide is a medication used to treat prostate cancer, particularly in cases that have not spread to other parts of the body.
What it treats
- prostate cancer
How it works
Apalutamide works by blocking the effects of male hormones that can help cancer cells grow.
Who it's for
This medicine is for adult men diagnosed with prostate cancer who have not yet developed metastasis.
AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.
Clinical monograph: apalautamide
Apalutamide is a non-steroidal androgen receptor inhibitor used primarily in the treatment of prostate cancer. It works by blocking the action of androgens, such as testosterone, which can promote the growth of prostate cancer cells. Apalutamide is particularly indicated for patients with non-metastatic castration-resistant prostate cancer (nmCRPC) and for those with metastatic hormone-sensitive prostate cancer (mHSPC). It can help delay disease progression and improve patient outcomes.
Indications
- Non-metastatic castration-resistant prostate cancer (nmCRPC)
- Metastatic hormone-sensitive prostate cancer (mHSPC)
Dosage
Adults: Refer to the specific product guidelines for dosing recommendations, which may vary based on the indication and patient characteristics.
Mechanism of action
Apalutamide inhibits the androgen receptor signaling pathway by binding to the androgen receptor, preventing its activation by androgens. This action leads to decreased proliferation of prostate cancer cells and induces apoptosis in cancerous tissues. Additionally, it may reduce the expression of genes regulated by androgens, further contributing to its anti-tumor effects.
Pharmacodynamics
The pharmacodynamics of apalutamide involve its ability to inhibit androgen receptor activity, leading to reduced cell proliferation and increased apoptosis in prostate cancer cells. This results in a decrease in serum prostate-specific antigen (PSA) levels, which is a biomarker for prostate cancer progression. The drug's effects are dose-dependent, with higher doses showing greater inhibition of tumor growth.
Pharmacokinetics
Apalutamide is well-absorbed following oral administration, with peak plasma concentrations occurring approximately 2 to 6 hours after dosing. It has a high protein binding capacity (approximately 95%) and is primarily metabolized by CYP2C19 and CYP3A4 isoenzymes. The elimination half-life is approximately 3 days, allowing for once-daily dosing. The drug is excreted mainly in feces and urine, with a small fraction excreted unchanged.
Contra-indications
- Hypersensitivity to apalutamide or any excipients
- Severe hepatic impairment (Child-Pugh Class C)
Adverse effects
- Fatigue
- Rash
- Nausea
- Diarrhea
- Hypertension
- Weight loss
- Falls
- Seizures
Interactions
- CYP2C19 inducers may decrease apalutamide levels
- CYP3A4 inducers may decrease apalutamide levels
- CYP2C19 inhibitors may increase apalutamide levels
- CYP3A4 inhibitors may increase apalutamide levels
Precautions
- Regular monitoring of blood pressure is recommended
- Caution in patients with a history of seizures
- Assess renal function prior to initiation
- Monitor for signs of severe skin reactions
Pregnancy
Apalutamide may cause fetal harm. Women of childbearing potential should be advised to avoid pregnancy during treatment.
Breast-feeding
It is not known whether apalutamide is excreted in human milk. Caution is advised.
Storage
Store at room temperature, between 20°C to 25°C (68°F to 77°F). Protect from moisture and light.
Formulations
- Tablets: 15 mg, 30 mg, 60 mg
AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.