PHOACA Drug name: PHOACA Generic name: Acalabrutinib Capsules/Acalabrutinib

The following is the general instructions for Acalabrutinib, which is for reference only. For specific use, please refer to the instructions in the drug packaging and follow the doctor's instructions.

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Drug Name

Generic Name: Acalabrutinib
Product Name: PHOACA

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Indications

Acalabrutinib is a Bruton's tyrosine kinase (BTK) inhibitor used in the following conditions:

1. Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL):
   • Indicated for first-line or relapsed/refractory treatment of adult patients.
2. Mantle Cell Lymphoma (MCL) :
   • For use in adult patients who have received at least one prior therapy.

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Mechanism of action

Acalabrutinib is a selective BTK inhibitor that irreversibly binds to BTK and inhibits its activity, thereby blocking the B cell receptor signaling pathway and reducing B cell proliferation and survival.

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Dosage

• Recommended dose :
  • Take 100 mg twice a day, about 12 hours apart.
• Directions :
  • Can be taken with or without food.
  • Swallow the capsule whole; do not crush, chew, or open.

Dosage adjustments :

• If serious adverse reactions occur (such as blood toxicity, infection, abnormal heart rhythm, etc.), the doctor may suspend treatment or adjust the dosage.

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Precautions

1. Side Effect Monitoring :
   • Common side effects : headache, diarrhea, fatigue, musculoskeletal pain, infection, nausea, rash, etc.
   • Serious side effects :
     • Risk of bleeding (e.g. spontaneous bleeding or serious bleeding events).
     • Infections (including viral, bacterial, and fungal infections).
     • Abnormal heart rhythm (such as atrial fibrillation).
     • Second primary malignancy (commonly skin cancer).
2. Use in special populations :
   • Pregnant and lactating women : Do not use, may cause serious harm to the fetus or infant.
   • Children : Safety and effectiveness have not been established.
   • Elderly : Close monitoring is required based on the patient's condition, especially the risk of infection.
3. Other notes :
   • Avoid concurrent use of strong CYP3A inhibitors or inducers (such as ketoconazole, rifampin).
   • Discontinue use 7 days before invasive surgery to reduce the risk of bleeding.

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Drug interactions

• CYP3A4 inhibitors : May increase the plasma concentration of acalabrutinib and the dose should be adjusted.
• CYP3A4 inducers : May reduce the efficacy of acalabrutinib and it is recommended to avoid co-administration.
• Anticoagulants and antiplatelet drugs : The risk of bleeding may be increased when used concomitantly with acalabrutinib.

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Contraindications

• Patients who are allergic to acalabrutinib or its excipients are contraindicated.

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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

• The use of acalabrutinib should be carried out under the guidance of a physician with experience in treating hematological tumors.
• If serious adverse reactions occur (such as serious infection or persistent bleeding), stop taking the medicine immediately and contact your doctor.
• Monitor hematologic parameters and cardiac function regularly during treatment.

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Note : For more detailed information or special case medication regimens, please consult your doctor or pharmacist. If you need further explanation, please let me know!