PHOAPAL Drug name: PHOAPAL Generic name: Apalutamide tablets/Apalutamide

The following is the general instructions for apalutamide, which is for reference only. Please refer to the instructions in the drug package for specific use and follow the doctor's instructions.

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Drug Name

Generic Name: Apalutamide
Product Name: PHOAPAL

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Indications

Apalutamide is an androgen receptor inhibitor used for the following conditions:

1. Non-metastatic castration-resistant prostate cancer (nmCRPC) :
   • It is used for patients whose disease progresses despite androgen deprivation therapy (ADT).
2. Metastatic castration-sensitive prostate cancer (mCSPC) :
   • In combination with androgen deprivation therapy for patients with newly diagnosed metastatic prostate cancer.

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Mechanism of action

Apalutamide selectively blocks the androgen receptor (AR) signaling pathway, inhibiting the growth-promoting effect of androgens on prostate cancer cells, thereby delaying disease progression.

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Dosage

• Recommended dose : 240 mg (4 tablets, 60 mg each) orally once daily.
• Dosage : Can be taken with or without food. Tablets should be swallowed whole and should not be crushed, chewed or split.

Dosage adjustments :
If serious adverse reactions occur, your doctor may suspend treatment or adjust the dosage.

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Precautions

1. Side Effect Monitoring :
   • Common side effects : rash, hypertension, fatigue, joint pain, decreased appetite, weight loss, diarrhea, hypokalemia, abnormal thyroid function, etc.
   • Serious side effects : cardiovascular events (such as heart attack, stroke), fractures, epileptic seizures, etc.
2. Use in special populations :
   • Pregnant and lactating women : Contraindicated. Apalutamide may cause fetal harm, and female partners of childbearing age are advised to take effective contraceptive measures.
   • Children : Safety and effectiveness have not been established.
   • Elderly : Elderly patients are prone to fractures or fatigue and should use the drug with caution.
3. Other notes :
   • Thyroid function, cardiovascular health, and bone density should be monitored during treatment.
   • Advise patients to use bone-protective drugs (such as bisphosphonates or denosumab) to prevent bone loss.

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Drug interactions

• CYP3A4 and CYP2C8 substrates : Apalutamide can induce the activity of CYP3A4 and CYP2C8 metabolizing enzymes, which may reduce the efficacy of certain drugs (such as antiepileptic drugs, certain cholesterol-lowering drugs).
• Anticoagulants : Close monitoring is required when used concurrently with warfarin or other anticoagulants.
• CYP3A4 inhibitors : May affect the metabolism of apalutamide and should be used with caution.

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Contraindications

• Patients who are allergic to apalutamide or its excipients are contraindicated.
• Contraindicated during pregnancy and lactation.

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Storage conditions

• Store in a dry environment at 20°C to 25°C.
• Avoid high temperature, humidity and direct sunlight. Keep out of reach of children.

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Important Tips

• Apalutamide should be used under the guidance of a physician with experience in treating prostate cancer.
• If serious adverse reactions occur (such as seizures, cardiovascular events, or severe rash), stop taking the drug immediately and contact your doctor.
• Perform hematologic tests and imaging assessments regularly during treatment to monitor disease progression.

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Note : If you need more detailed information or special case medication plans, please consult your doctor or pharmacist. If you have any other questions, please feel free to let me know!