Apalutamide 60 mg tablet (Prostaxen)

What is Apalutamide?

Apalutamide 60 mg tablet (Prostaxen) is an FDA-approved androgen receptor inhibitor that was initially approved in 2018 for patients with non-metastatic castration-resistant prostate cancer, and on September 17, 2019, for patients with metastatic castration-sensitive prostate cancer (mCSPC).

The brand name of this endrogen receptor inhibitor is ERLEADA, discovered and marketed by Janssen Biotech, Inc. 

On the other hand, Prostaxen is a Bangladeshi-manufactured generic Apalutamide marketed by Everest Pharmaceuticals Ltd.

How does Apalutamide work?

• This is an orally active androgen receptor inhibitor that binds directly to ligand-binding of the ligand-binding domain of the AR.
• It works by impeding AR-mediated transcription, preventing AR nuclear translocation, inhibiting DNA binding, and lacking androgen receptor agonist activity.
• It helps in reducing tumor cell proliferation and in increasing apoptosis, leading to potent antitumor activity.

Why is Apalutamide 60 mg used (Indications)?

It is used to treat male adult patients with 

• Non-metastatic castration-resistant prostate cancer(nmCRPC) that has not spread to other parts of the body. Cancer grows in this stage because of low testosterone
• Metastatic castration sensitive prostate cancer(mCSPC) that has spread to other parts of the body 

Apalutamide Dose

Take 240 mg of Apalutamide tablets (4 tablets, each 60 mg) every day by mouth, with or without food, until disease progression or unacceptable toxicity occurs. Doctors may reduce the dose depending on the patient’s health condition or discontinue.

How to take Apalutamide?.

• Administered the drug by mouth with or without food as suggested by the healthcare professionals.
• To get the full potential of the medication, patients must follow their prescription made by their doctor after their diagnosis.
• Do not chew or crush the tablet; swallow the whole tablet with water.
• If you are unable to swallow the full Prostaxen tablet, mix it with a sufficient amount of water, then drink it.
• Rinse the water pot after drinking the suspension, and then drink the rinsed water.

Apalutamide Tablet’s Side Effects

Patients who have taken Prostaxen 60 mg experienced these common effects in most cases

• Hypercholesterolemia, nonfasting (76%)
• Anemia (70%)
• Hyperglycemia (70%)
• Hypertriglyceridemia, nonfasting (67%)
• Leukopenia (47%)
• Lymphopenia (41%)
• Fatigue (39%)
• Hyperkalemia (32%)
• Hypertension (25%)
• Rash (24%)

Based on animal studies, this medication may decrease reproductive capability in male patients.

Apalutaimde Adverse Reactions

Seizure

Seizure occurred in patients who have been treated with this medication, and it is advised to stop the treatment permanently if a seizure occurs. It is not known if anti-epileptic medication can prevent seizure during the treatment. 

Advise patients of the risk of developing seizure to be aware during the treatment of sudden loss of consciousness could harm themselves or others.

Falls and Fractures

A fracture occurred in patients receiving the Prostaxen 60 mg tablet. Evaluate patients for fracture risk. Monitor and manage patients at risk of fracturing with established treatment guidelines.

According to the information from the FDA approval label, among patients with non-metastatic castration-resistant prostate cancer, the rate of fracture was 12%.

And patients with metastatic castration-resistant prostate cancer who received this medication, the fracture rate was 9%. 

Ischaemic heart disease 

Some patients could suffer from some heart problems, like heart attacks, particularly if they have a previous history. 

Any heart symptoms should be screened by your physician and controlled according to the routine of primary care for hypertensive, diabetic, and hyperlipidemic patients.

Concomitant use with other medicinal products

This medicine can affect how other drugs work by speeding up their breakdown in the body, making them less effective. If you are taking medicines that depend on specific enzymes or transporters, your doctor may need to adjust your treatment. 

Extra care is needed if you use blood thinners like warfarin or similar drugs. Regular blood tests (INR) and dose monitoring are recommended to ensure safety.

What are the drug interactions of Apalutamide?

Effect of Other Drugs on Prostaxen

Elimination of the drug alongside its active metabolite is assisted by CYP2C8. A strong CYP2C8 inhibitor such as gemfibrozil brought the peak concentration (Cmax) 21% lower, while overall exposure (AUC) was 68% greater. 

Active constituents (drug plus active metabolite) of Cmax also AUC, both Cmax decreased by 21% and AUC increased by 45%. When administered with strong CYP2C8 inhibitors, no initial dose adjustment is required, but dose reduction may be necessary depending on patient tolerance. 

It is expected that mild or moderate CYP2C8 inhibitors will have minimal impact on the drug’s levels.

Medicinal products that inhibit CYP3A4

CYP3A4 strong inhibitors, such as ketoconazole or ritonavir, do not change overall exposure but may lower peak levels. 

No dose change is usually needed, though your doctor may make adjustments if side effects develop. Moderate and mild inhibitors do not have much to do little about the active.

Effect of Prostaxen on other drugs

Other medications metabolized by your body may have underlying effects as well. It may decrease the effects of drugs metabolized by CYP3A4, CYP2C19, CYP2C9, and UGT enzymes. 

If these medications are used in combination, your physician may re-evaluate your medication plan or increase surveillance to check for a decrease in effects.

Apalutamide 60 mg tablet price in Bangladesh

The cost of Apalutamide in Bangladesh depends on the manufacturer, dosage strength, and pharmacy source. It is generally considered a high-cost oncology medicine and is available through selected hospital pharmacies or authorized suppliers. The price may vary slightly between local and imported brands.

Regional Price Comparison

In regions such as the Middle East and Southeast Asia, including countries like Singapore, India, and China, Apalutamide is usually priced at a comparable or slightly higher level than in Bangladesh. Factors such as import duties, brand availability, and healthcare policies often influence the overall treatment cost.

Common Questions Asked by People about Apalutamide

Disclaimer: Information above is not for use as a medical advice alternative; always consult your doctor before taking any prescription medicines.