Brigatinib/Brigatinib official instructions for use

Brigatinib/Brigatinib (Brigatinib) is an oral targeted anti-cancer drug and a second-generation ALK (anaplastic lymphoma kinase) tyrosine kinase inhibitor (TKI). The drug was first developed by Ariad Pharmaceuticals and is now owned by Takeda. Brigatinib is approved by the FDA, EMA and China NMPA for the treatment of patients with specific types of advanced non-small cell lung cancer (NSCLC). It is especially suitable for patients who have discovered ALK gene rearrangement mutations and have failed first-line treatment (such as crizotinib).

1. Description of indications

Brigatinib is suitable for patients with ALK-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC).

Applicable to patients whose disease has progressed after treatment with at least one ALK inhibitor, such as those who have failed crizotinib treatment.

According to the recommendations of domestic and foreign guidelines, it can also be used as the initial first-line treatment option for ALK mutation-positive lung cancer

Currently it is not applicable to lung cancer types with EGFR, ROS1 and other target mutations. It is limited to ALK-positive patients.

2. Recommended usage and dosage (adults)

Initial dose: It is recommended to take 90 mg orally once a day for the first 7 days of treatment.

Maintenance dose: Starting from the 8th day, if the patient has no obvious adverse reactions, the dose will be increased to 180 mg per day, once a day.

How to take the medicine: Try to take it orally at the same time every day. It can be taken with a meal or on an empty stomach. Do not chew, break or grind the tablets.

Dose adjustment: If intolerable adverse reactions occur (such as pulmonary toxicity, hypertension, abnormal liver function, etc.), the dose can be reduced to 90 mg according to symptoms, and if necessary, the dose can be further reduced to 60 mg, or the drug can be temporarily discontinued.

Handling of missed doses: If you forget to take the medicine and the time interval is insufficient12 hours should be skipped and the dose should not be doubled.

3. Important safety monitoring tips

Interstitial lung disease/Pneumonia: Brigatinib may cause severe pulmonary adverse reactions in the early stages of treatment (especially in the first 7 days), manifesting as shortness of breath, cough or fever. Once this occurs, the drug must be discontinued immediately and medical treatment required.

Hypertension: Blood pressure needs to be monitored regularly during treatment. Some patients may develop drug-related hypertension, and antihypertensive treatment can be provided if necessary.

Abnormal liver function: It is recommended to regularly detect liver enzyme indicators such as ALT, AST, and bilirubin, especially in the initial stage of treatment and dose adjustment stage.

Elevated creatine phosphokinase (CPK): Some patients may experience elevated muscle enzymes, and attention should be paid to muscle pain, weakness and other symptoms.

Visual abnormalities and electrocardiogramQT interval prolongation: Visual changes and electrocardiogram need to be monitored during medication to prevent serious arrhythmia or visual impairment.

4. Overview of common adverse reactions

The most commonly reported side effects include nausea, diarrhea, loss of appetite, fatigue, cough, headache, rash, etc. Relatively serious adverse events include: pneumonia-like manifestations, hypertension, liver function damage, CPK elevation, pancreatic enzyme elevation, etc. Adverse reactions usually improve after dose adjustment or symptomatic treatment, but should be closely observed.

Reference materials:https://www.alunbrig.com/