Acemini detailed instructions

1. Indications and Usage

Asciminib (scemblix/asciminib) is a kinase inhibitor used to treat the following adult patients:

Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML) is in the chronic phase (CP) and has been treated with two or more tyrosine kinase inhibitors (TKIs).

T315Imutant chronic myelogenous leukemiaPh+chronic myelogenous leukemia.

2. Dosage and usage

Recommended doses in Ph+CML CP:80mg orally once daily or 40mg orally twice daily.

T315ImutatedCPPh+ CMLRecommended dose:200 mg orally twice daily.

Avoid eating at least2 hours before and at least 1 hours after taking Asiminil .

Swallow tablets whole Do not break, crush, or chew tablets.

Three. Dosage form and strength

Film-coated tablets: 20mg and 40mg.

Four. Contraindications

No.

Five. Warnings and Precautions

1.Myelosuppression:Severe thrombocytopenic and neutropenic events may occur. Monitor complete blood counts periodically during treatment and manage by interrupting treatment or reducing dosage.

2.Pancreatic toxicity:Monitor serum lipase and amylase. Interrupt and then reduce dose or discontinue aceminib based on severity. Evaluate for pancreatitis when elevated lipase is associated with abdominal symptoms.

3.Hypertension:Monitor blood pressure and manage hypertension as clinically indicated. If hypertension is not controlled with medication, interrupt, reduce dose, or discontinue aceminib.

4.Hypersensitivity:May cause allergic reactions. Monitor patients for signs and symptoms and initiate appropriate treatment as clinically indicated.

5.Cardiovascular Toxicity:Cardiovascular toxicity may occur. Monitor patients with a history of cardiovascular risk factors for cardiovascular signs and symptoms. Initiate appropriate treatment as clinically indicated.

6.Embryo-Fetal Toxicity:Can cause harm to the fetus. Inform women of reproductive potential of potential risks to the fetus and use effective contraceptive measures.

6. Adverse reactions

The most common adverse reactions (≥ 20%) were upper respiratory tract infection, musculoskeletal pain, headache, fatigue, nausea, rash, and diarrhea.

The most common laboratory abnormalities (≥ 20%) were decreased platelet count, increased triglycerides, decreased neutrophil count, decreased hemoglobin, increased creatine kinase, increased alanine aminotransferase (ALT), increased lipase, increased amylase, increased aspartate aminotransferase (AST), increased uric acid, and decreased lymphocyte count.

7. Drug interactions

StrongCYP3A4Inhibitors:Closely monitor for adverse reactions during coadministration of 200 mg acemini twice daily.

Itraconazole oral solution containing hydroxypropyl-β-cyclodextrin; avoid concurrent use of aceminib at all recommended doses.

Certain Substrates of CYP3A4:Closely monitor for adverse reactions during coadministration of aceminib at a total daily dose of 80 mg. Avoid taking 200mg ofacemini twice daily.

Substrates of CYP2C9:Avoid concurrent use of aceminib at all recommended doses.

80Total daily dose:If unavoidable, reduce CYP2C9 substrate dose if necessary.

200mg twice daily:If unavoidable, consider alternative therapy that is not a CYP2C9 substrate.

CertainP-gpsubstrates:Clearly monitor for adverse reactions when coadministeringaceminib at all recommended doses.

Substrates for OATP1BorBCRP:Avoid concurrent use with rosuvastatin and atorvastatin at all recommended doses. Closely monitor for adverse reactions with other OATP1B or BCRP substrates during concurrent use of acemini at all recommended doses.

8. Use among specific groups of people

Breastfeeding:Breastfeeding is not recommended.

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