List of Chinese instructions for Assimini

1. Common name:Asciminib

Product name:Scemblix

Other names: Assimini (transliteration)

2. Who can take Asiminib? Indications?

Asciminib (Asciminib) is indicated for the treatment of the following adult patients:

1. Newly diagnosed Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+CML) is in the chronic phase (CP);

2. Ph+CML has been treated in CP before;

3. Ph+CML in CP with T315I mutation;

3. What are the side effects of Aceminid?

In clinical studies of Asiminib, common adverse reactions include musculoskeletal pain, rash, fatigue, upper respiratory tract infection, headache, abdominal pain and diarrhea; it may also cause serious adverse reactions, including bone marrow suppression, pancreatic toxicity, hypertension, hypersensitivity reactions and cardiovascular toxicity.

Common laboratory abnormalities include decreased lymphocyte count, decreased white blood cell count, decreased platelet count, decreased neutrophil count, decreased corrected blood calcium level, increased lipase, increased cholesterol, increased uric acid, increased alanine aminotransferase (ALT), increased alkaline phosphatase (ALP), decreased hemoglobin, increased triglycerides, increased creatine kinase, increased amylase, and increased aspartate aminotransferase (AST).

4. How should you take Asiminib?

1. Recommended dosage

(1) Newly diagnosed or previously treated Ph+CML-CP patients: The recommended dose of aximinib is 80 mg orally once daily at approximately the same time, or 40 mg orally twice daily, approximately 12 hours apart, without food. Avoid eating at least 2 hours before and 1 hour after taking. Treatment with aximinib was continued as long as clinical benefit was observed or unacceptable toxicity occurred.

(2) T315I mutation Ph+CML-CP patients: The recommended dose of aximinib is 200 mg orally twice a day, about 12 hours apart, without food, and avoid eating at least 2 hours before and at least 1 hour after taking it.

5. How to store Acemini?

Aximini tablets are available20mg, 40mg and 100mg, can be stored at 20°C to 25°C (68°F to 77°F); tolerances are allowed between 15°C and 30°C (59°F and 86°F), can be aliquoted and stored in original containers to protect them from moisture.

6. How does Assimini work?

Aximinib is an ABL/BCR-ABL1 tyrosine kinase inhibitor. Aceminib inhibits the ABL1 kinase activity of the BCR:ABL1 fusion protein by binding to the myristoyl pocket of ABL. In studies conducted in vitro or in animal models of CML, aceminib showed activity against wild-type BCR:ABL1 and several mutant forms of the kinase, including the T315I mutation.

7. What will happen if you overdose on Aceminid?

There are no data regarding overdose with aceminib. Effects associated with overdose may be consistent with the adverse effect profile of aceminib and therefore may include significant hematologic abnormalities and/or gastrointestinal effects.

8. Who can’t use Acemini?

Based on the results and mechanism of action of animal studies, administration of aceminid to pregnant women can cause embryonic-fetal damage; women of reproductive potential should use effective contraception during treatment and within 1 week after the last dose; do not breastfeed during treatment with the drug and within 1 week after the last dose.