【Drug Name】

Name: Lorlatinib Tablets

Product Name: LORLADX

【Specification】

25mg/100mg

【Indications】

• that is caused by an abnormal anaplastic lymphoma kinase (ALK) gene and, 

• that has spread to other parts of your body and, 

• who have taken the medicine alectinib or ceritinib or who have taken both the medicine crizotinib and at least 1 other medicine to treat NSCLC that is caused by the ALK gene, and 

• their NSCLC is no longer responding to these treatments. 

It is not known if LORLADX is safe and effective in children. 

【Recommended Dosage】

• Take LORLADX exactly as your healthcare provider tells you to take it. Do not change your dose or stop taking LORLADX unless your healthcare provider tells you to. 

• Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with LORLADX if you develop side effects. 

• Swallow LORLADX tablets whole. Do not chew, crush, or split LORLADX tablets. Do not take LORLADX tablets if they are broken, cracked, or not intact. 

• Take LORLADX at approximately the same time each day. 

• You may take LORLADX with or without food. 

• If you miss a dose, take it as soon as you remember. However, if it is close to the time of your next dose (within 4 hours), just take your next dose at your regular time. 

• If you vomit after taking a dose of LORLADX, do not take an extra dose. Take your next dose at your regular time. 

【Side Effects】

• Liver problems due to interactions with other medicines. It is important to know what medicines should not be taken with LORLADX. 

• Problems with brain (central nervous system [CNS]) function. Many patients experienced problems with brain function including problems with thinking (such as forgetfulness or confusion), mood (such as depression), speech, seeing or hearing things that are not real (hallucinations), and seizures during treatment with LORLADX. In some patients, these problems are severe and your healthcare provider may need to have you stop taking LORLADX. 

• Increases in the cholesterol and triglycerides (lipid) levels in your blood. Most patients will have an increase in the lipid levels in your blood during treatment with LORLADX. 

o If you have increases in the lipid levels in your blood during treatment with LORLADX, your healthcare provider may need to start you on a medicine to lower the levels. If you are already taking a medicine to lower the lipid levels in your blood, your healthcare provider may need to increase your dose of that medicine. 

o Your healthcare provider should do blood tests to check the lipid levels in your blood before starting treatment, 1 to 2 months after starting treatment, and during treatment with LORLADX. 

• Heart problems. LORLADX may cause very slow or abnormal heartbeats. Your healthcare provider should check your heart rhythm (electrocardiogram [EKG]) before starting and during treatment with LORLADX. Tell your healthcare provider right away if you feel dizzy or faint or have abnormal heartbeats. In some patients, these problems are severe and your healthcare provider may need to have you stop taking LORLADX or have a pacemaker placed. 

• Lung problems. LORLADX may cause severe or life-threatening swelling (inflammation) of the lungs during treatment that can lead to death. Symptoms may be similar to those from lung cancer. Tell your healthcare provider right away if you have any new or worsening symptoms of lung problems, including trouble breathing, shortness of breath, cough, or fever. 

【Storage】

• Store LORLADX at room temperature between 68°F to 77°F (20°C to 25°C). 

Keep LORLADX and all medicines out of the reach of children.