Lorbriqua Tablet

Lorlatinib ® is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. Lorlatinib is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

• Risk of Serious Hepatotoxicity with Concomitant Use of Strong CYP3A Inducers: Discontinue strong CYP3A inducers for 3 plasma half-lives of the strong CYP3A inducer prior to initiating Lorlatinib. - Central Nervous System (CNS) Effects: CNS effects include seizures, psychotic effects and changes in cognitive function, mood (including suicidal ideation), speech, mental status, and sleep. Withhold and resume Lorlatinib at same or reduced dose or permanently discontinue Lorlatinib based on severity. - Hyperlipidemia: Initiate or increase the dose of lipid-lowering agents. Withhold and resume Lorlatinib at same or reduced dose based on severity. - Atrioventricular Block: Withhold and resume Lorlatinib at same or reduced dose based on severity. - Interstitial Lung Disease/Pneumonitis: Immediately withhold Lorlatinib in patients with suspected ILD/pneumonitis. Permanently discontinue Lorlatinib for treatment-related ILD/pneumonitis of any severity. - Hypertension: Monitor blood pressure after 2 weeks and then at least monthly during treatment. For severe hypertension, withhold Lorlatinib, then dose reduce or permanently discontinue. - Hyperglycemia: Assess fasting serum glucose prior to starting Lorlatinib and regularly during treatment. If not adequately controlled with optimal medical management, withhold Lorlatinib, then consider dose reduction or permanently discontinue, based on severity. - Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus. Advise males and females of reproductive potential to use an effective non-hormonal method of contraception. Risk of Serious Hepatotoxicity with Concomitant Use of Strong CYP3A Inducers Severe hepatotoxicity occurred in 10 of 12 healthy subjects receiving a single dose of Lorlatinib with multiple daily doses of rifampin, a strong CYP3A inducer. Grade 4 alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevations occurred in 50% of subjects, Grade 3 ALT or AST elevations occurred in 33% and Grade 2 ALT or AST elevations occurred in 8%. ALT or AST elevations occurred within 3 days and returned to within normal limits after a median of 15 days (7 to 34 days); the median time to recovery was 18 days in subjects with Grade 3 or 4 ALT or AST elevations and 7 days in subjects with Grade 2 ALT or AST elevations. Lorlatinib is contraindicated in patients taking strong CYP3A inducers. Discontinue strong CYP3A inducers for 3 plasma half-lives of the strong CYP3A inducer prior to initiating Lorlatinib. Central Nervous System Effects A broad spectrum of central nervous system (CNS) effects can occur in patients receiving Lorlatinib. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

The following adverse reactions are described elsewhere in the labeling: - Risk of Serious Hepatotoxicity with Concomitant Use of Strong CYP3A Inducers - Central Nervous System Effects - Hyperlipidemia - Atrioventricular Block - Interstitial Lung Disease/Pneumonitis - Hypertension - Hyperglycemia Most common (incidence ≥20%) adverse reactions and Grade 3–4 laboratory abnormalities are edema, peripheral neuropathy, weight gain, cognitive effects, fatigue, dyspnea, arthralgia, diarrhea, mood effects, hypercholesterolemia, hypertriglyceridemia, and cough. www.pfizer.com or FDA Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The pooled safety population described in the Warnings and Precautions section reflects exposure to Lorlatinib in 476 patients who received 100 mg Lorlatinib once daily in Study B7461001 (N=327) and Study B7461006 (N=149). Among 476 patients who received Lorlatinib, 75% were exposed for 6 months or longer and 61% were exposed for greater than 1 year. In this pooled safety population, the most frequent adverse reactions in ≥ 20% of 476 patients who received Lorlatinib were edema (56%), peripheral neuropathy (44%), weight gain (31%), cognitive effects (28%), fatigue (27%), dyspnea (27%), arthralgia (24%), diarrhea (23%), mood effects (21%), and cough (21%). The most frequent Grade 3–4 laboratory abnormalities in ≥ 20% of 476 patients who received Lorlatinib were hypercholesterolemia (21%) and hypertriglyceridemia (21%). Previously Untreated ALK-Positive Metastatic NSCLC (CROWN Study) The safety of Lorlatinib was evaluated in 149 patients with ALK-positive NSCLC in a randomized, open-label, active-controlled trial for the treatment of patients with ALK-positive, locally advanced or metastatic, NSCLC who had not received previous systemic treatment for advanced disease. The median duration of exposure to Lorlatinib was 16.7 months (4 days to 34.3 months) and 76% received Lorlatinib for at least 12 months. Serious adverse reactions occurred in 34% of patients treated with Lorlatinib; the most frequently reported serious adverse reactions were pneumonia (4.7%), dyspnea (2.7%), respiratory failure (2.7%), cognitive effects (2.0%), and pyrexia (2.0%). Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.