Chinese instructions for acalatinib/acalabrutinib

1. Common name: Acalabrutinib capsule, Acalabrutinib

Product name:Calquence, Kangkeqi

Other names: acalabrutinib,ACP-196, acalabrutinib

2. Who can take acotinib? Indications?

Acalabrutinib/Acalabrutinib is suitable for the treatment of the following conditions:

1. Mantle cell lymphoma (MCL): This product is suitable for adult patients with mantle cell lymphoma who have received at least one treatment in the past.

2. Chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL): This product is suitable for the treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.

3. What are the side effects of acotinib?

The most common side effects of acotinib are anemia, neutropenia, upper respiratory tract infection, thrombocytopenia, headache, diarrhea and musculoskeletal pain; ventricular arrhythmia (heart disease), drug-induced liver injury (hepatobiliary disease), etc. have also occurred after the drug was launched on the market.

4. How should you take acotinib?

1. Drug management: Acotinib is provided in the form of oral capsules or tablets. It is recommended that patients swallow the capsules whole with water and do not open, break or chew the capsules. Acotinib can be taken with or without food. If you miss a dose of acotinib by more than 3 hours, the dose should be skipped and the next dose should be taken at its regularly scheduled time. Additional doses of acotinib should not be taken to make up for missed doses.

2. Dose: ForIn patients with MCL, CLL, or SLL, the recommended dose of acotinib is 100 mg orally every 12 hours until disease progression or unacceptable toxicity. When coadministered with obinutuzumab, the recommended dose of acotinib in patients with previously untreated CLL/SLL is 100 mg orally every 12 hours until disease progression or unacceptable toxicity. Start acotinib on cycle 1 (28 days per cycle). Obinutuzumab was started in cycle 2 for a total of 6 cycles. When dosing on the same day, administer acotinib before obinutuzumab.

5. How to store acotinib?

Acotinib is stored at 20°C-25°C (68°F-77°F); excursions allowed to 15°C-30°C (59°F-86°F).

6. How does acotinib work?

Acotinib is a small moleculeBTK inhibitor. Acotinib and its active metabolite ACP-5862 form covalent bonds with the cysteine u200bu200bresidues in the active site of BTK, resulting in the inhibition of BTK enzyme activity. BTK is a signaling molecule of the B cell antigen receptor (BCR) and cytokine receptor pathways. In B cells, BTK signaling leads to the activation of pathways required for B cell proliferation, trafficking, chemotaxis, and adhesion. In nonclinical studies, acotinib inhibited BTK-mediated activation of the downstream signaling proteins CD86 and CD69 and inhibited malignant B cell proliferation and tumor growth in mouse xenograft models.

7. What will happen if you overdose on acotinib?

Data on the toxicity of acotinib are not readily available.

8. Who cannot use acotinib?

Avoid the use of acotinib in patients with severe hepatic impairment.