Enzamide 40 mg (Enzalutamide) Tablets

Introduction

Enzamide 40 mg (Enzalutamide) is a highly potent, targeted oncology medication classified as a second-generation androgen receptor inhibitor. Manufactured by Everest Pharmaceuticals Ltd. and supplied globally by Onco Solution, Enzamide represents a standard-of-care therapy for advanced prostate cancer. It is specifically designed to treat prostate malignancies that continue to progress despite surgical or medical castrations. By completely blocking the cellular pathways that allow testosterone to fuel tumor growth, Enzamide significantly delays disease progression and improves overall survival rates in advanced oncological settings.

Indications

Enzamide 40 mg (Enzalutamide) is indicated for the treatment of patients with:

• Castration-Resistant Prostate Cancer (CRPC): Treatment of adult men with metastatic or non-metastatic castration-resistant prostate cancer.
• Metastatic Castration-Sensitive Prostate Cancer (mCSPC): Treatment of adult men with metastatic hormone-sensitive prostate cancer.
• Note: Patients receiving Enzamide should also continue concurrent medical castration with a gonadotropin-releasing hormone (GnRH) analog if they have not undergone a bilateral orchiectomy.

Pharmacology

Enzalutamide, the active ingredient in Enzamide, is an oral androgen receptor (AR) inhibitor that acts on multiple steps of the AR signaling pathway.

• Mechanism of Action: Prostatic carcinoma lines are highly dependent on androgens (like testosterone) to proliferate. Enzalutamide competitively inhibits androgen binding to androgen receptors.
• Intracellular Blockade: Beyond competitive receptor binding, Enzamide prevents the nuclear translocation of the activated receptor complex and inhibits its subsequent binding to DNA. This triple-action pathway blockade halts AR-mediated gene transcription, leading to decreased prostate cancer cell proliferation and inducing tumor cell apoptosis.

Dosage & Administration

Oral Administration for Adults:

• Standard Recommended Dose: 160 mg (four 40 mg tablets) taken orally once daily.
• Administration Guide: Tablets can be taken with or without food. They should be taken at approximately the same time each day.
• Method: Swallow the 40 mg tablets whole with water. Do not chew, crush, split, or dissolve the tablets, as they are formulated to release the drug systematically.
• Missed Dose: If a dose is missed, the patient should take it as soon as remembered. If it is almost time for the next day’s dose, skip the missed dose and resume the normal daily schedule. Do not take a double dose.

Drug Interactions

• Strong CYP2C8 Inhibitors: Concomitant use (e.g., Gemfibrozil) increases enzalutamide plasma levels. If co-administration is unavoidable, reduce the Enzamide dose to 80 mg once daily.
• Strong CYP3A4 Inducers: Avoid co-administration (e.g., Rifampin, Phenytoin) as they can decrease enzalutamide exposure and lower clinical efficacy.
• CYP3A4, CYP2C9, and CYP2C19 Substrates: Enzalutamide is a strong inducer of CYP3A4 and a moderate inducer of CYP2C9 and CYP2C19. It may significantly lower the blood concentrations of drugs metabolized by these enzymes (e.g., oral anticoagulants, certain statins).

Contraindications

• Pregnancy: Enzamide is strictly contraindicated in women who are or may become pregnant. It can cause severe fetal harm or pregnancy loss.
• Hypersensitivity: Known severe hypersensitivity or systemic allergic reaction to Enzalutamide or any of the structural excipients in the tablet.

Side Effects

Patients receiving Enzamide 40 mg may experience:

• Systemic: Severe fatigue, hot flashes, asthenia (weakness), and peripheral edema (swelling of the hands or feet).
• Musculoskeletal: Back pain, arthralgia (joint pain), muscle weakness, and an increased risk of bone fractures.
• Vascular: Hypertension (high blood pressure) and an increased risk of ischemic heart disease.
• Gastrointestinal: Nausea, decreased appetite, diarrhea, and altered taste sensation.
• Neurological: Dizziness, headaches, and a rare but serious risk of seizures.

Pregnancy & Reproductive Safety

• Pregnancy & Lactation: Enzamide is not indicated for use in females. It carries a high risk of embryo-fetal toxicity.
• Contraceptive Measures: Male patients with female partners of reproductive potential must use effective contraception during treatment and for 3 months after the final dose. Males must also use a condom when engaging in sexual activity with a pregnant woman.

Precautions & Warnings

• Seizure Risks: Seizures have occurred in patients receiving enzalutamide. Use with extreme caution in patients with a history of epilepsy, stroke, or pre-disposing brain lesions. Permanently discontinue Enzamide if a seizure develops.
• Ischemic Heart Disease: Monitor closely for signs and symptoms of cardiovascular events. Optimize management of cardiovascular risk factors like hypertension and hyperlipidemia during treatment.
• Falls and Fractures: Enzamide increases the risk of falls and bone fractures. Evaluate patients for fracture risks and implement standard bone-protective therapies where clinically appropriate.
• Posterior Reversible Encephalopathy Syndrome (PRES): Discontinue Enzamide immediately if a patient develops PRES (symptoms include seizures, headache, lethargy, or visual loss).

Use in Special Populations

• Hepatic/Renal Impairment: No dose adjustment is required for patients with mild-to-moderate liver or kidney impairment. Use with caution in patients with severe hepatic or end-stage renal disease.
• Pediatric Use: The safety and clinical efficacy of Enzalutamide have not been established in children.

Overdose Effects

An acute overdose of Enzamide may precipitate severe, life-threatening seizures and exaggerated systemic side effects like extreme fatigue. Treatment consists of immediate medical stabilization, discontinuing the medication, and executing supportive symptomatic care.

Storage

• Condition: Store at controlled room temperature (15°C to 30°C).
• Protection: Keep the medication sealed inside its original moisture-resistant blister pack. Protect from humidity, direct heat, and sunlight. Keep safely out of reach of children.

Supplier Information

Onco Solution is an established premier global oncology medicine supplier dedicated to bridging gaps in advanced global cancer care. We ensure the secure, authentic, and compliant international distribution of cutting-edge targeted treatments like Enzamide 40 mg. For professional medical quotes, verification documentation, or wholesale export inquiries, visit www.oncosolution.com.

Manufacturer Information

Enzamide 40 mg is manufactured under strict international cGMP quality controls by Everest Pharmaceuticals Ltd., a leading high-tech pharmaceutical generic manufacturer in Bangladesh recognized globally for its high-quality, specialized oncology product lines.