Instructions for use of brigatinib/brigatinib

1. Drug name

Common name: Brigatinib,Brigatinib

Trade name:Alunbrig, Amberry

Alias: brigatinib, brigitabine, brigatinib, brigitabine, cancer nengbi

2. Treatment indications

This product is mainly used to treat adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) confirmed by testing certified by the U.S. Food and Drug Administration (FDA).

3. Medication Instructions

1) Prerequisites for medication: Doctors need to determine whether to use brigatinib treatment based on the positive test results of ALK in tumor samples.

2) Recommended dosage:

Initial 7 days: once a day, 90mg each time.

Follow-up treatment: Increase to once a day, each time 180mg, continue to take the medication until the disease progresses or the side effects of the drug are unacceptable.

Brigatinib can be taken with food or alone. The tablets must be swallowed whole and not chewed or crushed.

If you miss a dose or vomit after taking the medicine, there is no need to take the next dose as originally planned.

3) Dosage adjustment:

Your doctor may adjust the dose when adverse reactions occur. Once the dose is lowered, it should not be increased.

Initial dose If the 90 mg dose is not tolerated, it can be reduced to 60 mg once a day. If the dose is not tolerated, the drug should be discontinued; if the 180 mg dose is not tolerated, it can be reduced to 120 mg, 90 mg, and 60 mg in sequence.

If the medication is interrupted for more than 14 days, treatment should be restarted at a dose of 90 mg for 7 days and then increased to the previously tolerated dose.

4) Interactions with other drugs:

Avoid concurrent use with strong or moderate CYP3A inhibitors; reduce brigatinib dose if necessary.

Avoid concurrent use with moderate CYP3A inducers; increase brigatinib dose if necessary.

5) Medication for special patients: For patients with severe liver and renal impairment, the dose of brigatinib needs to be reduced by approximately 40%.

4. Possible side effects

Common adverse reactions include hyperglycemia, hyperinsulinemia, anemia, nausea, leukopenia, diarrhea, fatigue, cough, headache, hypophosphatemia, rash, etc. There may also be signs of difficulty breathing, high blood pressure, and abnormal function of organs such as the liver and pancreas.

5. Drug storage

Brigatinib is an oral tablet and is recommended to be stored at 20°C to 25°C, with fluctuations between 15°C and 30°C allowed.

6. Precautions for use by special groups of people

1) Female patients: It is prohibited for pregnant women as it may cause harm to the fetus. Effective contraceptive measures should be taken during treatment and for at least 4 months after discontinuation of treatment. Breast-feeding women should not breast-feed during the medication and within 1 week after stopping the medication.

2)Male patients: In view of the possible impact on male fertility, it is recommended to take contraceptive measures during treatment and for at least3 months after stopping the drug.

7. Principle of drug action

Brigatinib is a tyrosine kinase inhibitor (TKI) that can inhibit the activity of multiple kinases at clinical trial concentrations, especially has a significant inhibitory effect on ALK. It can effectively control the proliferation of ALK-positive non-small cell lung cancer cells and is effective against a variety of ALK-resistant mutants. In addition, brigatinib can also reduce intracranial tumor burden and prolong survival.