Registered Kenya · PPB

BDENZA

ENZALUTAMIDE CAPSULES 40MG

H2021/CTD5995/1872ER 40MG NEW/INNOVATOR antineoplastic and immunomodulating agents INN generic

What it does

Enzalutamide is a medication used primarily to treat advanced prostate cancer.

Commonly used for: advanced prostate cancer, metastatic prostate cancer

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Answers come only from this medicine's registration record, BNF monograph and interaction data - not medical advice.

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Registration & product details

Registration no.
H2021/CTD5995/1872ER
Registration date
2021-04-19 00:00:00
Expiry date
-
Status
Registered
Active ingredient
ENZALUTAMIDE CAPSULES 40MG
Dosage form
40MG
Strength
-
Pack size
CAPSULES
Therapeutic class
NEW/INNOVATOR
ATC class (WHO)
L02BB - Anti-androgens
RxNorm RxCUI
1307298
Manufacturer / MAH
Ripple Pharmaceuticals
Country of origin
FOREIGN
Manufacturer location
Swaminarayan Road/ Laxcon Court Mezzanine, Nairobi, Kenya

Source: Pharmacy and Poisons Board · fetched 2026-01-28 19:35:33 · updated 2026-08-03 02:22:25

Drug Interactions

22
Check interactions

Moderate (9)

Amlodipine - decreases exposure

Enzalutamide is predicted to decrease the exposure to calcium channel blockers (amlodipine, felodipine, lacidipine, lercanidipine, nicardipine, nifedipine, nimodipine). Monitor and adjust dose.

Moderate Study

Calcium Channel Blockers - decreases exposure

Enzalutamide is predicted to decrease the exposure to calcium channel blockers (amlodipine, felodipine, lacidipine, lercanidipine, nicardipine, nifedipine, nimodipine). Monitor and adjust dose.

Moderate Study

Coumarins - decreases exposure

Enzalutamide potentially decreases the exposure to coumarins. Avoid or adjust dose and monitor INR.

Moderate Study

Felodipine - decreases exposure

Enzalutamide is predicted to decrease the exposure to calcium channel blockers (amlodipine, felodipine, lacidipine, lercanidipine, nicardipine, nifedipine, nimodipine). Monitor and adjust dose.

Moderate Study

Lacidipine - decreases exposure

Enzalutamide is predicted to decrease the exposure to calcium channel blockers (amlodipine, felodipine, lacidipine, lercanidipine, nicardipine, nifedipine, nimodipine). Monitor and adjust dose.

Moderate Study

Lercanidipine - decreases exposure

Enzalutamide is predicted to decrease the exposure to calcium channel blockers (amlodipine, felodipine, lacidipine, lercanidipine, nicardipine, nifedipine, nimodipine). Monitor and adjust dose.

Moderate Study

Nicardipine - decreases exposure

Enzalutamide is predicted to decrease the exposure to calcium channel blockers (amlodipine, felodipine, lacidipine, lercanidipine, nicardipine, nifedipine, nimodipine). Monitor and adjust dose.

Moderate Study

Nifedipine - decreases exposure

Enzalutamide is predicted to decrease the exposure to calcium channel blockers (amlodipine, felodipine, lacidipine, lercanidipine, nicardipine, nifedipine, nimodipine). Monitor and adjust dose.

Moderate Study

Nimodipine - decreases exposure

Enzalutamide is predicted to decrease the exposure to calcium channel blockers (amlodipine, felodipine, lacidipine, lercanidipine, nicardipine, nifedipine, nimodipine). Monitor and adjust dose.

Moderate Study

Unknown (13)

Antiepileptics - decreases exposure

Enzalutamide is predicted to slightly decrease the exposure to antiepileptics (brivaracetam).

Unknown Theoretical

Antipsychotics, Second Generation - decreases exposure

Enzalutamide is predicted to decrease the exposure to antipsychotics, second generation (clozapine).

Unknown Theoretical

Atorvastatin - decreases exposure

Enzalutamide is predicted to decrease the exposure to statins (atorvastatin, simvastatin).

Unknown Study

Avatrombopag - decreases exposure

Enzalutamide is predicted to decrease the exposure to avatrombopag. Adjust avatrombopag dose with moderate CYP2C9 inducers in chronic immune thrombocytopenia, p. 1141.

Unknown Study

Brivaracetam - decreases exposure

Enzalutamide is predicted to slightly decrease the exposure to antiepileptics (brivaracetam).

Unknown Theoretical

Data from BNF 85 (British National Formulary). This is not a substitute for professional medical advice. Matched via: exact

Disclaimer: This information is sourced from Pharmacy and Poisons Board (Kenya). Always consult a qualified healthcare professional before using any medication.

About this medicine

Enzalutamide is a medication used primarily to treat advanced prostate cancer.

What it treats

  • advanced prostate cancer
  • metastatic prostate cancer

How it works

Enzalutamide works by blocking the effects of male hormones on cancer cells, helping to slow down the growth of cancer.

Who it's for

This medication is for adult men diagnosed with advanced prostate cancer that has spread beyond the prostate gland.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: Enzalutamide

BNF-referenced

Enzalutamide is a second-generation androgen receptor inhibitor used primarily in the treatment of prostate cancer. It acts by blocking the androgen receptor's activity, thereby inhibiting androgen signaling pathways that promote cancer cell proliferation. Enzalutamide is indicated for use in hormone-sensitive and hormone-relapsed metastatic prostate cancer, particularly in cases where other treatments have been ineffective or when chemotherapy is not yet indicated.

Indications

  • Metastatic hormone-relapsed prostate cancer
  • Castration-resistant prostate cancer
  • Hormone-sensitive prostate cancer

Dosage

Adults: The usual dose for adults is 160 mg taken orally once daily. In patients with moderate to severe hepatic impairment, the initial dose may need to be reduced to 300 mg twice daily.

Mechanism of action

Enzalutamide competitively inhibits androgen receptors (AR) with a binding affinity 5 to 8 times greater than first-generation antiandrogens like bicalutamide. It prevents androgen binding, inhibits AR nuclear translocation, and blocks interaction with chromosomal DNA, disrupting oncogene upregulation. This multi-faceted inhibition effectively reduces prostate cancer cell growth and induces apoptosis.

Pharmacodynamics

Enzalutamide exerts its effects by blocking AR activity, which is pivotal in the progression of prostate cancer. While it is effective in the initial stages of treatment, resistance can develop due to mutations in the AR. Clinical studies have shown that enzalutamide reduces serum prostate-specific antigen (PSA) levels significantly and decreases overall mortality risk in patients compared to placebo.

Pharmacokinetics

Enzalutamide is administered orally and has a high oral bioavailability. It is extensively metabolized in the liver, primarily through CYP2C8 and CYP3A4 pathways. The half-life of enzalutamide is approximately 5.8 days, allowing for once-daily dosing. It is important to monitor liver function, particularly in patients with hepatic impairment.

BNF 85 (British National Formulary) p.1057 PubChem / pathway

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: Enzalutamide

PubChem CID 15951529

Molecular formula: C21H16F4N4O2S

Mechanism of action

Enzalutamide is a competitive androgen receptor (AR) inhibitor that has a threefold inhibition on the androgen signaling pathway without significant AR agonist activity. It inhibits androgen binding to its receptor, androgen receptor nuclear translocation, and subsequent interaction with chromosomal DNA to upregulate oncogenes. Enzalutamide binds to the AR with 5 to 8-fold greater affinity than first-generation antiandrogens such as bicalutamide and only 2-3 fold reduced affinity than the natural ligand dihydrotestosterone. Molecular docking showed that enzalutamide binds to the ligand binding domain of the AR distinctive from that of bicalutamide.

Pharmacodynamics

Enzalutamide is a second-generation antiandrogen that blocks the activity of androgen and androgen receptor (AR) in prostate cancer. AR activity and prostate cancer progression are closely related due to the normal physiology of prostate cells, providing the rationale for androgen deprivation therapy (ADT). However, resistance will eventually arise after the commencement of ADT in 2-3 years due to the accumulation of mutations, including constitutively active mutation, AR overexpression, and changes in AR splicing variants. Enzalutamide was therefore designed to exploit these mutations. In vitro experiments in human prostate cancer cell line VCaP showed that enzalutamide can suppress cell growth and induce apoptosis while other antiandrogens like bicalutamide did not. Clinical trials on prostate cancer patients indicated that enzalutamide can lead to a decrease in serum PSA for at least 12 weeks, although this response can be short-lived and thus resulting in enzalutamide resistance. Patients receiving enzalutamide also had a 37% decreased in the risk of death compared to placebo.

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.

South Africa 1 product