Erleada 60 mg apalutamide film‑coated Tablets 120 TAB

Erleada 60 mg Apalutamide Film-Coated Tablets – 120 Tablets

Erleada 60 mg (Apalutamide) is a prescription medication used to treat specific types of prostate cancer in adult men.

It belongs to a class of medicines called androgen receptor inhibitors, which block the effects of male hormones, particularly testosterone, on prostate cancer cells.

Erleada is used to treat non-metastatic castration-resistant prostate cancer (nmCRPC) and metastatic castration-sensitive prostate cancer (mCSPC), according to approved indications and specialist assessment.

By blocking androgen receptor signaling, Erleada helps slow cancer progression and improve treatment outcomes in appropriately selected patients.

Erleada is generally used with ongoing androgen deprivation therapy unless the patient has undergone bilateral orchiectomy.

Pack Contents: 120 film-coated tablets, each containing 60 mg of apalutamide.

Active Ingredient & Strength

Apalutamide

Apalutamide is an androgen receptor inhibitor that blocks hormone-driven signaling in prostate cancer cells.

Therapeutic Benefits:

• Inhibit androgen receptor activity.
• Reduce hormone-driven cancer growth signaling.
• Help delay disease progression.
• Reduce the risk of disease spread in selected patients.
• Improve clinical outcomes in approved prostate cancer populations.
• Support specialist-directed hormonal cancer therapy.

Strength: 60 mg per film-coated tablet.

Therapeutic Indications

1. Non-Metastatic Castration-Resistant Prostate Cancer (nmCRPC)

Erleada is used in patients whose prostate cancer progresses despite castrate testosterone levels, without detectable distant metastases on conventional imaging.

Treatment helps delay the development of metastases and improve clinical outcomes in appropriately selected patients.

2. Metastatic Castration-Sensitive Prostate Cancer (mCSPC)

Erleada is also used in patients with metastatic prostate cancer that remains sensitive to testosterone-lowering treatment.

It helps block androgen receptor signaling and delay disease progression when combined with androgen deprivation therapy.

How It Works

Some prostate cancer cells rely on androgen hormones to support their growth.

Apalutamide binds to androgen receptors and inhibits their activation, reducing signaling that promotes cancer cell growth.

This mechanism helps slow disease progression in eligible prostate cancer patients.

Erleada is an androgen receptor-targeted hormonal therapy, not traditional cytotoxic chemotherapy.

Dosage & Administration

Usual Adult Dose: 240 mg once daily, equivalent to four 60 mg tablets.

• Take once daily.
• May be taken with or without food.
• Swallow tablets whole with water.
• Do not crush, split or chew the tablets.
• Approved alternative administration methods may be available for swallowing difficulties; follow the product leaflet.
• Take at approximately the same time each day.
• Do not change the dose without medical advice.
• Continue androgen deprivation therapy as prescribed.

Missed Dose

Take a missed dose as soon as remembered on the same day.

Do not take extra tablets the following day to make up for a missed dose.

Monitoring Requirements

Monitoring may include:

• PSA Levels: To assess treatment response.
• Testosterone Levels: To evaluate androgen deprivation therapy.
• Thyroid Function: Due to hypothyroidism risk.
• Bone Health: Because of fracture risk.
• Blood Pressure: To monitor hypertension.
• Cardiovascular Health: Particularly in patients with risk factors.
• Imaging Studies: To assess disease progression.
• Medication Review: To identify drug interactions.

Possible Side Effects

• Fatigue.
• Skin rash.
• Hypertension.
• Hot flushes.
• Joint pain.
• Decreased appetite.
• Weight loss.
• Diarrhea.
• Falls.
• Fractures.
• Hypothyroidism.

Serious Adverse Effects

• Ischemic cardiovascular or cerebrovascular events.
• Seizures.
• Falls and fractures.
• Severe cutaneous adverse reactions.
• Interstitial lung disease or pneumonitis.

Seek urgent medical attention for chest pain, sudden weakness, seizures, severe blistering rash or new or worsening shortness of breath.

Warnings & Precautions

• Prescription-only medicine.
• Use under oncology specialist supervision.
• Intended for approved prostate cancer indications.
• May cause fetal harm.
• Men with partners who can become pregnant should use effective contraception during treatment and for 3 months after the final dose.
• Do not donate sperm during treatment and for 3 months after the last dose.
• May impair male fertility.
• May increase the risk of falls and fractures.
• May cause hypertension.
• Use caution in patients with seizure risk.
• May increase cardiovascular and cerebrovascular risks.
• May cause hypothyroidism.
• Can interact with multiple medications through effects on drug-metabolizing enzymes.
• Inform the healthcare team about all medications and supplements.
• Do not discontinue or adjust treatment independently.

Drug Interactions

Apalutamide may reduce the effectiveness of certain medications through its effects on drug-metabolizing enzymes and transporters.

Examples requiring medical review include:

• Warfarin and certain anticoagulants.
• Some cardiovascular medicines.
• Certain antiseizure medicines.
• Some anti-infective medications.
• Drugs metabolized by CYP3A4, CYP2C9 or CYP2C19.

Dose adjustments or additional monitoring may be necessary.

Storage

• Store according to the approved packaging instructions, generally at 20°C–25°C.
• Keep in the original packaging to protect from moisture.
• Do not discard the desiccant if included.
• Protect from excessive heat and humidity.
• Keep out of reach of children.

Frequently Asked Questions

What is Erleada 60 mg used for?

It treats non-metastatic castration-resistant prostate cancer and metastatic castration-sensitive prostate cancer.

What is the active ingredient in Erleada?

Apalutamide.

Is Erleada chemotherapy?

No. It is an androgen receptor-targeted hormonal therapy.

What is the usual Erleada dose?

240 mg once daily, equivalent to four 60 mg tablets, unless otherwise prescribed.

Can Erleada be taken with food?

Yes. It may be taken with or without food.

Does Erleada lower testosterone?

It primarily blocks androgen receptor signaling and is generally combined with testosterone-lowering treatment.

Can Erleada cure prostate cancer?

A cure cannot be guaranteed. It helps control disease progression and improve outcomes in eligible patients.

Can Erleada cause skin rash?

Yes. Skin rash is a recognized adverse effect.

Does Erleada affect thyroid function?

It may cause hypothyroidism, requiring monitoring.

Can Erleada increase blood pressure?

Yes. Hypertension may occur during treatment.

Can Erleada be stopped when PSA improves?

Do not stop or adjust treatment without oncology specialist instructions.

How many tablets are included?

120 film-coated tablets containing 60 mg each.

How long does a 120-tablet pack last?

At the usual dose of four tablets daily, one pack lasts 30 days.

Product Details

• Brand Name: Erleada
• Active Ingredient: Apalutamide
• Strength: 60 mg per Tablet
• Pack Size: 120 Tablets
• Dosage Form: Film-Coated Tablets
• Drug Class: Androgen Receptor Inhibitor
• Indications: Non-Metastatic Castration-Resistant Prostate Cancer and Metastatic Castration-Sensitive Prostate Cancer
• Usual Dose: 240 mg Once Daily
• Tablets per Usual Dose: 4 Tablets
• Pack Duration at Usual Dose: 30 Days
• Route of Administration: Oral
• Manufacturer: Janssen, a Johnson & Johnson Company
• Storage: Room Temperature According to Packaging Instructions
• Prescription Status: Prescription Only
• Category: Oncology – Prostate Cancer Treatment