Lorlatinib Lorbrexen 100mg

Drug Name: Lorlatinib

Drug Alias: Lorlatinib

English Name: Lorlatinib

Indications: Advanced Non-Small Cell Lung Cancer (NSCLC)

Dosage Form/Specification: 30 tablets per box; each tablet contains 100 mg of active ingredient.

[Introduction to Everest Lorbrexen (Lorlatinib)]

Lorlatinib is a third-generation ALK inhibitor. Serving as a subsequent treatment for patients who have developed resistance to Crizotinib, it is capable of inhibiting nine specific mutations associated with Crizotinib resistance. It is particularly suitable for the treatment of patients with advanced Non-Small Cell Lung Cancer (NSCLC) who have developed resistance to other ALK inhibitors.

[Indications for Lorlatinib]

This product is a targeted therapy indicated for the treatment of patients with ALK-positive Non-Small Cell Lung Cancer (NSCLC).

For ALK-positive NSCLC patients undergoing first-line treatment, the overall response rate for this product is as high as 90%, with an intracranial response rate reaching 75%.

For ALK-positive patients who have previously received Crizotinib, the overall response rate is 69%, with an intracranial response rate reaching 68%.

For ALK-positive patients who have previously received treatment with ALK inhibitors other than Crizotinib, the overall response rate is 33%, with an intracranial response rate reaching 42%.

For ALK-positive patients who have previously received treatment with 2 to 3 different ALK inhibitors, the overall response rate is 39%, with an intracranial response rate reaching 48%.

Clinical results demonstrate that this product exhibits clinically significant activity in treating both pulmonary tumors and brain metastases in patients with advanced ALK-positive and ROS1-positive NSCLC.

[Specifications for Everest Lorbrexen (Lorlatinib)]

This product is supplied in tablet form, with a specification of 30 tablets per box; each tablet contains 100 mg of the active ingredient.

[Usage and Administration of Everest Lorbrexen (Lorlatinib)]

This product is an oral medication. The recommended dosage is 100 mg (1 tablet) taken once daily. It may be taken either before or after meals. [Everest Lorbrexen (Lorlatinib) Precautions]

**Problems with Brain (Central Nervous System) Function.** Many patients have experienced problems with brain function while being treated with Lorlatinib. These include problems with thinking (such as forgetfulness or confusion), mood (such as depression), speech, seeing or hearing things that are not real (hallucinations), and seizures. In some patients, these problems are severe enough that your healthcare provider may require you to stop taking Lorlatinib.

**Increased Levels of Cholesterol and Triglycerides (Lipids) in the Blood.** During treatment with Lorlatinib, lipid levels in the blood increase in most patients.

If your blood lipid levels increase during treatment with Lorlatinib, your healthcare provider may need to start you on medication to lower these levels.

If you are already taking medication to lower your blood lipid levels, your healthcare provider may need to increase the dosage of your medication.

Your healthcare provider should perform blood tests to check your blood lipid levels before starting treatment, 1 to 2 months after starting treatment, and periodically throughout your treatment with Lorlatinib.

**Heart Problems.** Lorlatinib may cause a very slow or abnormal heartbeat. Your healthcare provider should check your heart rhythm (ECG) before you start treatment with LORBRENA and during treatment. Tell your healthcare provider immediately if you feel dizzy, weak, or notice an abnormal heartbeat. In some patients, these problems are severe enough that your healthcare provider may require you to stop taking Lorlatinib or have a pacemaker implanted.

**Lung Problems.** During treatment, Lorlatinib may cause severe or life-threatening swelling (inflammation) of the lungs, which can lead to death. Symptoms may resemble those of lung cancer.

Tell your healthcare provider immediately if you develop any new or worsening symptoms of lung problems, including difficulty breathing, shortness of breath, coughing, or fever. [Everest Lorbrexen (Lorlatinib) Adverse Reactions]

The most common side effects of Lorlatinib include: swelling of the arms, legs, hands, and feet (edema); numbness and tingling sensations in the joints, arms, or legs (peripheral neuropathy); difficulty thinking or confusion; difficulty breathing; fatigue; weight gain; joint pain; mood changes; feelings of sadness or anxiety; diarrhea; among others.

Lorlatinib may cause a decrease in male fertility. For men, this may affect your ability to father children. If you have concerns regarding fertility, please consult your healthcare provider.

[Product Specifications]

Product Name: Lorlatinib 100mg * 30 Tablets (Everest Lorlatinib / Lorbrexen 100mg)

Common Name: Lorlatinib

Active Ingredient: Lorlatinib

Dosage Form: Tablets

Specification: 100mg * 30 tablets per box

Manufacturer: Everest Pharmaceuticals (Bangladesh)

Indications: This product is a targeted therapy indicated for the treatment of patients with ALK-positive non-small cell lung cancer (NSCLC).

For ALK-positive NSCLC patients undergoing first-line treatment, this product demonstrates an overall response rate of up to 90%, with an intracranial response rate of up to 75%.

For ALK-positive patients who have previously received Crizotinib, this product demonstrates an overall response rate of 69%, with an intracranial response rate of 68%.

For ALK-positive patients who have previously received treatment with ALK inhibitors other than Crizotinib, this product demonstrates an overall response rate of 33%, with an intracranial response rate of 42%.

For ALK-positive patients who have previously received treatment with 2 to 3 different ALK inhibitors, this product demonstrates an overall response rate of 39%, with an intracranial response rate of 48%.

Clinical results indicate that this product demonstrates clinically significant activity in the treatment of pulmonary tumors and brain metastases in patients with advanced ALK-positive and ROS1-positive NSCLC.

Dosage and Administration: This product is an oral medication; the recommended dosage is 100mg (1 tablet) taken once daily. It may be taken either before or after meals.