LORVIQUA® (lorlatinib) as monotherapy is indicated for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) or for patients with ALK-positive metastatic NSCLC whose disease has progressed after alectinib or ceritinib as the first ALK tyrosine kinase inhibitor (TKI) therapy, or crizotinib and at least one other ALK TKI1
Hyperlipidemia CNS effects Interstitial lung disease/pneumonitis Lipase/amylase increase
PR interval prolongation/AV block Hypertension Hyperglycaemia Other adverse drug reactions

Therapy Management

LORVIQUA® Dose Modifications: PR interval prolongation/AV block

Dosage modification guidance for AV block1​​​​​​​
  • Monitor electrocardiogram (ECG) prior to initiating LORVIQUA® and monthly thereafter, particularly in patients with predisposing conditions to the occurrence of clinically significant cardiac events
  • Dose modifications may be required for those patients who develop AV block

Adverse reaction grade1

Dosage modifications1

First-degree AV block: Asymptomatic

Continue LORVIQUA® at the same dose without interruption. Consider effects of concomitant medicinal products, and assess and correct electrolyte imbalance that may prolong PR interval. Monitor ECG/symptoms potentially related to heart block closely.

First-degree AV block: Symptomatic

Withhold LORVIQUA®. Consider effects of concomitant medicinal products, and assess and correct electrolyte imbalance that may prolong PR interval. Monitor ECG/symptoms potentially related to AV block closely. If symptoms resolve, resume LORVIQUA® at 1 reduced dose level.

Second-degree AV block: Asymptomatic

Withhold LORVIQUA®. Consider effects of concomitant medicinal products, and assess and correct electrolyte imbalance that may prolong PR interval. Monitor ECG/symptoms potentially related to heart block closely. If subsequent ECG does not show second-degree AV block, resume LORVIQUA® at 1 reduced dose level.

Second-degree AV block: Symptomatic

Withhold LORVIQUA®. Consider effects of concomitant medicinal products, and assess and correct electrolyte imbalance that may prolong PR interval. Refer for cardiac observation and monitoring. Consider pacemaker placement if symptomatic AV block persists. If symptoms and the second-degree AV block resolve or if patients revert to asymptomatic first-degree AV block, resume LORVIQUA® at 1 reduced dose level.

Complete AV block

Withhold LORVIQUA®. Consider effects of concomitant medicinal products, and assess and correct electrolyte imbalance that may prolong PR interval. Refer for cardiac observation and monitoring. Pacemaker placement may be indicated for severe symptoms associated with AV block. If AV block does not resolve, placement of a permanent pacemaker may be considered.
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If pacemaker placed, resume LORVIQUA® at full dose. If no pacemaker placed, resume LORVIQUA® at 1 reduced dose level only when symptoms resolve and PR interval is less than 200 msec.

      AV, atrioventricular; ECG, electrocardiogram
      Please refer to the LORVIQUA®(lorlatinib) Prescribing Information or medical information for dose recommendations for different grades of adverse reactions.
      ​​​​​​​Reference
      1.Pfizer. LORVIQUA® (lorlatinib) Prescribing Information, Available from: http://labeling.pfizer.com/ShowLabeling.aspx?id=12540 Accessed 6 January, 2022.
      The use of lorlatinib has been associated with increases in serum cholesterol and triglycerides. Serum cholesterol and triglycerides should be monitored before the initiation of lorlatinib; 2, 4, and 8 weeks after initiating lorlatinib, and periodically thereafter. Initiation, or increase in the dose, of lipid-lowering agents is required.
      Central nervous system (CNS) effects have been observed in patients receiving lorlatinib including seizures, psychotic effects, changes in cognitive function, mood (including suicidal ideation), mental status, sleep, and speech. Dose modification or discontinuation may be required for those patients who develop CNS effects.
      PR interval prolongation and atrioventricular (AV) block events have been reported in patients receiving lorlatinib. Monitor electrocardiogram (ECG) prior to initiating lorlatinib and monthly thereafter, particularly in patients with predisposing conditions to the occurrence of clinically significant cardiac events. Dose modification may be required for those patients who develop AV block.
      Elevations of lipase and/or amylase have occurred in patients receiving lorlatinib. Median time of occurrence of increase in serum lipase and amylase is 70 days (range: 7 days to 696 days) and 41 days (range: 7 days to 489 days), respectively. Risk of pancreatitis should be considered in patients receiving lorlatinib due to concomitant hypertriglyceridemia and/or a potential intrinsic mechanism. Patients should be monitored for lipase and amylase elevations prior to the start of lorlatinib treatment and regularly thereafter as clinically indicated.
      Severe or life threatening pulmonary adverse drug reactions consistent with ILD/pneumonitis have occurred with lorlatinib. Any patient who presents with worsening of respiratory symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough and fever) should be promptly evaluated for ILD/pneumonitis. Lorlatinib should be withheld and/or permanently discontinued based on severity.
      Hypertension has been reported in patients receiving lorlatinib. Blood pressure should be controlled prior to the initiation of lorlatinib. Blood pressure should be monitored after 2 weeks and at least monthly thereafter during treatment with lorlatinib. Lorlatinib should be withheld and resumed at a reduced dose or permanently discontinued based on severity.
      Hyperglycemia has occurred in patients receiving lorlatinib. Fasting serum glucose should be assessed prior to the initiation of lorlatinib and monitored periodically thereafter. Lorlatinib should be withheld and resumed at a reduced dose or permanently discontinued based on severity.
      Concomitant use of any strong CYP3A inducer is contraindicated. Any strong CYP3A inducers have to be discontinued for at least 3 plasma half-lives of the strong CYP3A inducer before lorlatinib treatment is started. No clinically meaningful changes in liver function tests were seen in healthy subjects after receiving a combination of lorlatinib with the moderate CYP3A inducer modafinil.
      Women of childbearing potential should be advised to avoid getting pregnant while receiving lorlatinib. Male fertility may be compromised during treatment with lorlatinib. Men should seek advice on effective fertility preservation before treatment.

      ​​​​​​​LORVIQUA® Efficacy

      ​​​​​​​LORVIQUA
      ® Safety Profile
      LORVIQUA® Dosing and Therapy
      ​​​​​​​Management
      Click here for LORVIQUA® Prescribing Information

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