Enzalutamide (Bdenza) 40 mg, 112 capsules

What is Enzalutamide / Bdenza

ENZALUTAMIDE is a second-generation androgen receptor antagonist. This means it blocks the action of androgens (such as testosterone) at the receptor level.

It interferes with several steps in the hormone-signaling pathway: androgen binding to the receptor, transport of the activated receptor into the nucleus, its interaction with DNA, and the transcription of genes that stimulate cancer cell growth.

Indications

Bdenza / enzalutamide is indicated for:

Metastatic castration-resistant prostate cancer (mCRPC) – when the cancer continues to grow despite declining testosterone levels. It is also used for non-metastatic castration-resistant prostate cancer.

It can be used in combination with testosterone-lowering therapy (androgen deficiency therapy, ADT) in metastatic prostate cancer that remains sensitive to androgen reduction.

Dosage

Standard dose: 160 mg once daily. This can be four 40 mg capsules or two 80 mg tablets, if the drug is available in these forms.

It can be taken with or without food, but it is important to maintain a consistent dosing schedule.

If severe side effects occur, a dose reduction or temporary discontinuation may be necessary until the condition improves.

Pharmacokinetics and Interactions

Metabolism: Liver, primarily via CYP2C8 and CYP3A4. Inhibition/induction effect: Enzalutamide is a potent inducer of some enzymes, which may interfere with other medications.

Interaction considerations:

Strong CYP2C8 inhibitors may increase enzalutamide blood concentrations, which may require a dose reduction.

Strong CYP3A4 inducers may reduce efficacy (by decreasing drug concentrations).

Excretion: Renal and hepatic metabolites. The half-life is long (several days).

Side effects

Like any potent drug, enzalutamide has a number of potential side effects. Here are the main ones:

Common

Fatigue, weakness, asthenia

Hot flashes

Headache, dizziness, decreased concentration, possible cognitive impairment

Digestive disorders: diarrhea, decreased appetite, nausea

Increased blood pressure, edema (e.g., peripheral)

Musculoskeletal complaints: back pain, joint pain, muscle pain

Less common/serious

Very rare: seizures

Central nervous system reactions are possible: confusion, vision changes, possibly even hallucinations

Possibility of bone fractures, falls

Effects on the liver: increased liver transaminases, usually mild and reversible.

Gynecomastia (breast enlargement in men), breast tenderness.

Contraindications and precautions

Do not use in women, especially pregnant women.

Do not use in children or adolescents.

Use caution if you have liver or kidney disease.

If you have seizures or a predisposition to them, the risk is higher.

Monitor your blood pressure and heart health, especially if you have cardiovascular disease.

Important information

Take regularly, without missing doses, and exactly as directed by your doctor.

Do not chew or open capsules.

Regularly perform tests: liver function tests, blood counts (e.g., white blood cell count), and monitor for possible side effects.

Avoid concomitant use with other medications that can significantly affect CYP enzymes without consulting a doctor.