Prostaxen is a targeted therapy containing Apalutamide, a selective androgen receptor (AR) inhibitor, indicated for the treatment of prostate cancer. It is specifically used in patients with non-metastatic or metastatic castration-resistant prostate cancer, in combination with androgen deprivation therapy (ADT) or following bilateral orchiectomy.

Apalutamide works by directly binding to the ligand-binding domain of the androgen receptor, preventing its nuclear translocation, DNA binding, and AR-mediated transcription. This inhibition reduces tumor cell proliferation and increases apoptosis, leading to potent antitumor activity. Prostaxen offers an effective oral treatment option that helps control disease progression in patients with advanced prostate cancer.

রেজিস্টার্ড চিকিৎসকের পরামর্শ অনুযায়ী ঔষধ সেবন করুন

Therapeutic Class

Cytotoxic chemotherapy / Androgen receptor inhibitor

Pharmacology

• Mechanism of Action: Apalutamide selectively inhibits androgen receptor signaling, preventing cancer cell growth and promoting apoptosis.

• Effect on Tumor Cells: Decreases proliferation, reduces tumor size, and enhances treatment efficacy when combined with ADT.

• Administration Route: Oral

Indications

Prostaxen is indicated for the treatment of:

• Patients with non-metastatic castration-resistant prostate cancer (nmCRPC)

• Patients with metastatic castration-sensitive prostate cancer (mCSPC) in combination with ADT

• Use alongside GnRH analog therapy or in patients who have undergone bilateral orchiectomy

Dosage and Administration

• Recommended Dose: 240 mg (four 60 mg tablets) orally once daily

• Swallow tablets whole; may be taken with or without food

• Continue concurrent androgen deprivation therapy unless patient has had bilateral orchiectomy

Note: Dose adjustments may be necessary for tolerability, and monitoring is required for adverse effects.

Drug Interactions

• CYP2C8 and CYP3A4 inhibitors: Can increase plasma exposure of Prostaxen; dose reduction may be considered if necessary.

• CYP2C8 and CYP3A4 inducers: No significant effect expected; no dose adjustment required.

• Enzyme induction: Prostaxen is a strong inducer of CYP3A4 and CYP2C19, weak inducer of CYP2C9, and may reduce exposure to drugs metabolized by these enzymes.

• Transporter interactions: May reduce plasma levels of P-gp, BCRP, and OATP1B1 substrates such as fexofenadine and rosuvastatin. Monitor and adjust co-administered drugs as needed.

Contraindications

• Known hypersensitivity to Apalutamide or any component of the formulation

• Women who are pregnant or may become pregnant

Side Effects

Common and clinically significant adverse reactions include:

• Fatigue, rash, and weight loss

• Falls and fractures

• Hypertension and cardiovascular events (ischemic heart disease)

• Seizures (rare)

• Hypothyroidism

• QT prolongation in at-risk patients

Patients should be monitored for fractures, cardiovascular events, and neurologic symptoms during treatment.

রেজিস্টার্ড চিকিৎসকের পরামর্শ অনুযায়ী ঔষধ সেবন করুন

Pregnancy and Lactation

• Contraindicated in pregnancy: Apalutamide may cause fetal harm

• Breastfeeding: Should be discontinued during treatment

• Contraception: Effective contraception required for males with female partners of reproductive potential during treatment and for 3 months after the last dose

Precautions & Warnings

• Avoid in patients with seizure history or predisposing factors

• Monitor for cardiovascular risk factors

• Use caution in patients at risk of QT prolongation

• Prostaxen may reduce the effectiveness of concomitant medications metabolized by CYP enzymes or transported via P-gp/BCRP/OATP1B1

Overdose

No specific antidote exists. In case of overdose, discontinue Prostaxen and provide supportive care until resolution of toxicity.

Storage Conditions

Store below 30°C, away from light and moisture. Keep out of reach of children.