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Therapy Management Strategies
Therapy Management Strategies for Specific Adverse ReactionsHyperlipidemia

Therapy management guidance for hyperlipidemia

  • The median time to onset was 15 days for both hypercholesterolemia and hypertriglyceridemia
  • Hyperlipidemia was generally managed with lipid-lowering agents and dose interruptions, and in more severe (Grade ≥3) cases, dose modification1
    • 83% of patients required initiation of lipid-lowering medications
    • Median time to start of lipid-lowering therapy: 17 days
    • Pitavastatin, pravastatin, or rosuvastatin are recommended statins based on their drug interaction potential1,2
      • If high-intensity statin therapy is needed, rosuvastatin is recommended based on its low involvement with CYP450 enzymes that are able to interact with LORBRENA2​​​​​​​
  • Monitor serum cholesterol and triglycerides before initiating LORBRENA, 1 and 2 months after initiating LORBRENA, and periodically thereafter
  • Incidence of dose interruption due to hyperlipidemia in the LORBRENA clinical trials:
    • 3.4% due to hypercholesterolemia and 7% due to hypertriglyceridemia in the LORBRENA first-line trial
    • 3.4% due to hypercholesterolemia and 6% due to hypertriglyceridemia in the Phase 1/2 trial 
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Laboratory abnormality1 Dosage modifications1
Mild OR moderate   Cholesterol ULN-400 mg/dL
OR
Triglycerides 150-500 mg/dL
  • Introduce or modify lipid-lowering therapy (LLT)
​​​​​​​
  • Continue at the same LORBRENA dose
Severe Cholesterol >400-500 mg/dL
OR
Triglycerides >500-1000 mg/dL
  • Introduce LLT or increase dosage of ongoing LLT, or change to a new LLT

  • Continue at the same LORBRENA dose without interruption
Life-threatening


 Cholesterol >500 mg/dL
OR
Triglycerides >1000 mg/dL
  • Introduce LLT or increase dosage of ongoing LLT, or change to a new LLT

  • Withhold LORBRENA dose until hyperlipidemia is moderate or mild before rechallenging at same dose while maximizing LLT

  • If severe hyperlipidemia recurs despite maximal LLT, reduce LORBRENA by 1 dose level (by 25 mg)
ULN=upper limit of normal.
Central nervous system (CNS) effects

A broad spectrum of CNS effects can occur in patients receiving LORBRENA

  • These include seizures, psychotic effects and changes in cognitive function, mood (including suicidal ideation), speech, mental status, and sleep
  • Patients should be assessed for mood and cognition before initiating LORBRENA and should be monitored by the entire healthcare team and their caregiver(s) during treatment2
  • Patients without a primary caregiver should receive frequent calls and be referred to resources such as therapists or social workers2
  • Concomitant medications should be considered as a potential contributing factor2​​​​​​​
  • In pooled clinical trial data, CNS effects led to permanent discontinuation in 2.1% of patients, temporary discontinuation in 10% of patients, and dose reduction in 8% of patients

Dosage modification guidance for CNS effects

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Adverse reaction grade Dosage modifications 
Grade 1 
  • Continue at the same dose or withhold dose until recovery to baseline

  • Resume LORBRENA at the same dose or at a reduced dose
Grade 2 OR Grade 3 
  • Withhold dose until Grade 0 or 1

  • Resume LORBRENA at a reduced dose
Grade 4 
  • Permanently discontinue LORBRENA
The data in the Warnings and Precautions section of the Prescribing Information reflect exposure to LORBRENA in 476 patients who received 100 mg LORBRENA once daily in Study B7461001 (n=327) and in Study B7461006 (n=149).
Cognitive effects
  • The most commonly reported cognitive effects were memory impairment, cognitive disorder, and amnesia1​​​​​​​
  • Patients and their caregivers should be instructed to report any changes in cognitive function to the patient’s healthcare professional1
  • The possibility of cognitive-related adverse reactions should be discussed with patients and caregivers prior to initiating LORBRENA treatment, along with advice on how to minimize the impact on daily activities (eg, setting reminders)1
  • ​​​​​​​​​​​​​Cognitive effects were generally Grades 1-2 and reversible after dose modification1
  • In the LORBRENA first-line trial, cognitive effects led to permanent discontinuation in 1.3% of patients and dose interruptions in 4.0% of patients​​​​​​​​​​​​​​
  • In the Phase 1/2 trial, cognitive effects led to permanent discontinuation in 0.7% of patients, dose interruptions in 4.4% of patients, and dose reductions in 4.1% of patients

Dosage modification guidance for cognitive effects

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Adverse reaction grade Dosage modifications 
Grade 1 
  • Continue at the same dose or withhold dose until recovery to baseline

  • Resume LORBRENA at the same dose or at a reduced dose
Grade 2 OR Grade 3 
  • Withhold dose until Grade 0 or 1

  • Resume LORBRENA at a reduced dose
Grade 4 
  • Permanently discontinue LORBRENA​​​​​​​​​​​​​​
Mood effects
  • The most commonly reported mood effects were irritability, anxiety, depression, and affect lability1
  • Effects on mood should be discussed with patients prior to treatment initiation, particularly in those with preexisting psychiatric conditions1
  • Patients and their caregivers should be instructed to report any changes in mood to the patient’s healthcare professional1
  • Mood effects were generally Grades 1-2, temporary, and reversible after dose modification1​​​​​​​
  • In the LORBRENA first-line trial, mood effects led to dose interruptions in 4.0% of patients
  • In the Phase 1/2 trial, mood effects led to permanent discontinuation in 0.7% of patients, dose interruptions in 3.1% of patients, and dose reductions in 3.1% of patients

Dosage modification guidance for mood effects

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Adverse reaction grade Dosage modifications 
Grade 1 
  • Continue at the same dose or withhold dose until recovery to baseline

  • Resume LORBRENA at the same dose or at a reduced dose
Grade 2 OR Grade 3 
  • Withhold dose until Grade 0 or 1

  • Resume LORBRENA at a reduced dose
Grade 4 
  • Permanently discontinue LORBRENA
Speech effects
  • Speech effects have been reported by patients as a perception of slowed speech or difficulty in word finding1
  • Patients and their caregivers should be instructed to report any changes in speech to the patient's healthcare professional1

Dosage modification guidance for speech effects

  • Speech effects were generally mild in severity and reversible upon dose modification or discontinuation, if needed1
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Adverse reaction grade Dosage modifications 
Grade 1 
  • Continue at the same dose or withhold dose until recovery to baseline

  • Resume LORBRENA at the same dose or at a reduced dose
Grade 2 OR Grade 3 
  • Withhold dose until Grade 0 or 1

  • Resume LORBRENA at a reduced dose
Grade 4 
  • Permanently discontinue LORBRENA
Hypertension
  • Hypertension occurred in 13% of patients who received LORBRENA 100 mg once daily in pooled data from the 2 trials (N=476), including Grade 3 or 4 in 6% of patients​​​​​​​​​​​​​
  • 2.3% of patients temporarily discontinued LORBRENA for hypertension​​​​

​​​​Management strategies for hypertension

  • Control blood pressure prior to initiation of LORBRENA
  • Monitor blood pressure after 2 weeks and at least monthly thereafter during treatment with LORBRENA
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Adverse reaction grade Dosage modifications 
Grade 3  SBP ≥160 mmHg or DBP 
≥100 mmHg; medical intervention indicated; more than one antihypertensive drug, or more intensive therapy than previously used indicated
  • Withhold LORBRENA until hypertension has recovered to Grade ≤1 (SBP <140 mmHg and DBP <90 mmHg)

  • Resume LORBRENA at the same dose

  • If Grade 3 hypertension recurs, withhold LORBRENA until recovery to Grade ≤1, and resume at a reduced dose

  • If adequate hypertension control cannot be achieved with optimal medical management, permanently discontinue LORBRENA
Grade 4  Life-threatening consequences, urgent intervention indicated
  • Withhold LORBRENA until recovery to Grade ≤1 

  • Resume at a reduced dose or permanently discontinue LORBRENA
​​​​​​​
  • If Grade 4 hypertension recurs, permanently discontinue LORBRENA
​​​​​​DBP=diastolic blood pressure; SBP=systolic blood pressure.Hyperglycemia
  • Hyperglycemia occurred in 9% of patients who received LORBRENA 100 mg once daily in pooled data from the 2 trials (N=476), including Grade 3 or 4 in 3.2% of patients 
  • 0.8% of patients temporarily discontinued LORBRENA for hyperglycemia

Dosage modification guidance for hyperglycemia

  • ​​​​​​​Assess fasting serum glucose prior to initiation of LORBRENA and monitor periodically thereafter
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Adverse reaction grade Dosage modifications 
Grade 3 (>250 mg/dL) despite optimal anti-hyperglycemic therapy OR Grade 4
  • Withhold LORBRENA until hyperglycemia is adequately controlled

  • Resume LORBRENA at the next lower dosage

  • If adequate hyperglycemic control cannot be achieved with optimal medical management, permanently discontinue LORBRENA
Weight gain
  • An increase in appetite has been reported by some patients, suggesting that body weight increase may potentially be associated with increased caloric intake and a heightened desire to eat; however, causality has not been determined1
  • Patients should be advised of likely weight gain of some degree1

Therapy management guidance for weight gain
  • Dose modifications may help manage more severe cases of weight gain1
  • Counseling on food intake, dietary advice from a nutritionist, and exercise may be effective weight-management strategies for some patients1​​​
  • ​​​​Lifestyle modifications are preferred over LORBRENA dose reductions2​​​​​​​
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Adverse reaction grade
 Dosage modifications
Grade 1 OR Grade 2 
 Continue LORBRENA at same dose or at a reduced dose 
Grade 3 OR Grade 4 
  • Withhold LORBRENA until symptoms resolve to Grade ≤2 or baseline

  • Resume LORBRENA at a reduced dose
Edema

Therapy management guidance for edema

  • Prior to LORBRENA dose modification, consider the following to manage low-grade edema in LORBRENA-treated patients1:
    • Compression stockings
    • Leg elevation
    • Lifestyle modifications (increased exercise and limiting dietary salt)
    • Diuretics (usually furosemide)
  • If edema persists or worsens, follow general dose-modification guidance for LORBRENA until1: 
    • Edema resolves to Grade ≤2 (if not a safety risk)
    • Edema resolves to baseline; rechallenge at a reduced dose
  • In the LORBRENA first-line trial, edema led to dose interruptions in 5% of patients and dose reductions in 5% of patients
  • Edema was the most common cause of dose interruptions (7%) and reductions (6%) in the Phase 1/2 trial
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Adverse reaction grade Dosage modifications 
Grade 1 OR Grade 2 

 Continue LORBRENA at same dose or a reduced dose 
Grade 3 OR Grade 4 
  • Withhold LORBRENA until symptoms resolve to Grade ≤2 or baseline

  • Resume LORBRENA at a reduced dose​​​​​​​
​​​​​​​Peripheral neuropathy

Therapy management guidance for peripheral neuropathy

  • Most reports of peripheral neuropathy were mild (Grades 1-2) and generally reversible following standard medical therapy or dose modification1
  • Treatment with vitamin B1 and vitamin B6 and medications for pain associated with peripheral neuropathy may provide symptom relief for some patients1
  • For carpal tunnel syndrome, the use of a night splint may provide improvement1
  • In the LORBRENA first-line trial, peripheral neuropathy led to dose reduction in 3.4% of patients
  • In the Phase 1/2 trial, peripheral neuropathy led to dose interruptions in 5% of patients and dose reductions in 4.7% of patients
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Adverse reaction grade Dosage modifications 
Grade 1 OR Grade 2 

 Continue LORBRENA at same dose or a reduced dose 
Grade 3 OR Grade 4 
  • Withhold LORBRENA until symptoms resolve to Grade ≤2 or baseline

  • Resume LORBRENA at a reduced dose​​​​​​​
Increased lipase

Dosage modification guidance for increased lipase

  • In the Phase 1/2 trial, dose interruption was required in 3.7% of patients due to increased lipase
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Adverse reaction grade Dosage modifications 
Grade 1 OR Grade 2 

 Continue LORBRENA at same dose or a reduced dose 
Grade 3 OR Grade 4 
  • Withhold LORBRENA until symptoms resolve to Grade ≤2 or baseline

  • Resume LORBRENA at a reduced dose
Gastrointestinal (GI) effects
  • GI effects were generally mild in severity1
  • Dose modifications due to GI effects were rare1
​​​​​​​
Therapy management guidance for GI effects
  • Constipation and diarrhea may be managed with standard medical therapy1
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Adverse reaction grade Dosage modifications 
Grade 1 OR Grade 2 

 Continue LORBRENA at same dose or at a reduced dose 
Grade 3 OR Grade 4 
  • Withhold LORBRENA until symptoms resolve to Grade ≤2 or baseline

  • Resume LORBRENA at a reduced dose
Atrioventricular (AV) block and other ECG findings
  • In 476 patients who received LORBRENA at a dose of 100 mg orally once daily in pooled data from the 2 studies and who had a baseline electrocardiography (ECG):
    • 1.9% experienced AV block
    • 0.2%* experienced Grade 3 AV block and underwent pacemaker placement
  • Before starting LORBRENA, patients should be1:
    • Informed about potential risks of AV block
    • Advised to contact their healthcare professional immediately if they experience new chest pain or discomfort, heartbeat changes, palpitations, dizziness, lightheadedness, fainting, or changes in or new use of heart or blood pressure medication
  • Monitor ECG prior to initiating LORBRENA and periodically thereafter
  • For patients with preexisting PR prolongation, ECG monitoring should be conducted throughout treatment1

Dosage modification guidance for AV block

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Adverse reaction grade Dosage modifications 
Second-degree AV block 
  • Withhold LORBRENA until PR interval is <200 ms

  • Resume LORBRENA at a reduced dose
First occurrence of complete AV block
  • Withhold LORBRENA until
    • pacemaker placed OR
    • PR interval <200 ms 

  • If a pacemaker is placed, resume LORBRENA at the same dose

  • If no pacemaker is placed, resume LORBRENA at a reduced dose
Recurrent complete AV block 
  • Place pacemaker or permanently discontinue LORBRENA
*Patient had preexisting second-degree AV block.1
  ECG=electrocardiography.
Interstitial lung disease (ILD)/Pneumonitis
  • In pooled data from the 2 trials, 4 patients (0.8%) discontinued LORBRENA for ILD/pneumonitis
  • Promptly investigate for ILD/pneumonitis in any patient who presents with worsening of respiratory symptoms indicative of ILD/pneumonitis (eg, dyspnea, cough, and fever)
​​​​​​​
Dosage modification guidance for ILD/pneumonitis
  • Immediately withhold LORBRENA in patients with suspected ILD/pneumonitis
  • Permanently discontinue LORBRENA for treatment-related ILD/pneumonitis of any severity
The data in the Warnings and Precautions section of the Prescribing Information reflect exposure to LORBRENA in 476 patients who received 100 mg LORBRENA once daily in Study B7461001 (n=327) and in Study B7461006 (n=149).
Other adverse reactions

Dosage modification guidance for other adverse reactions

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Adverse reaction grade Dosage modifications 
Grade 1 OR Grade 2 

 Continue LORBRENA at same dose or at a reduced dose 
Grade 3 OR Grade 4 
  • Withhold LORBRENA until symptoms resolve to Grade ≤2 or baseline

  • Resume LORBRENA at a reduced dose​​​​​​​
DBP=diastolic blood pressure; SBP=systolic blood pressure.TitleManagement strategies include those found within the product labeling as well as additional considerations drawn from publications by Bauer et al and Reed et al (see references below).Grade based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
ECG=electrocardiography.ReferencesBauer TM, Felip E, Solomon BJ, et al. Oncologist. 2019;24(8):1103-1110.Reed M, Rosales ALS, Chioda MD, Parker L, Devgan G, Kettle J. Adv Ther. 2020;37(6):3019-3030.

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PP-LOR-USA-0507
INDICATION LORBRENA® (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.
Important Safety Information

Contraindications: LORBRENA is contraindicated in patients taking strong CYP3A inducers, due to the potential for serious hepatotoxicity.

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 LORBRENA with multiple daily doses of rifampin, a strong CYP3A inducer. Grade 4 ALT or AST elevations occurred in 50% of subjects, Grade 3 in 33% of subjects, and Grade 2 in 8% of subjects. ALT or AST elevations occurred within 3 days and returned to within normal limits after a median of 15 days (7 to 34 days); median time to recovery in subjects with Grade 3 or 4 or Grade 2 ALT or AST elevations was 18 days and 7 days, respectively. LORBRENA 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 LORBRENA.

Central Nervous System (CNS) Effects: A broad spectrum of CNS effects can occur; overall, CNS effects occurred in 52% of the 476 patients receiving LORBRENA. These included seizures (1.9%, sometimes in conjunction with other neurologic findings), psychotic effects (7%; 0.6% severe [Grade 3 or 4]), and changes in cognitive function (28%; 2.9% severe), mood (including suicidal ideation) (21%; 1.7% severe), speech (11%; 0.6% severe), mental status (1.3%; 1.1% severe), and sleep (12%). Median time to first onset of any CNS effect was 1.4 months (1 day to 3.4 years). Overall, 2.1% and 10% of patients required permanent or temporary discontinuation of LORBRENA, respectively, for a CNS effect; 8% required dose reduction. Withhold and resume at same or reduced dose or permanently discontinue based on severity.

Hyperlipidemia: Increases in serum cholesterol and triglycerides can occur. Grade 3 or 4 elevations in total cholesterol occurred in 18% and Grade 3 or 4 elevations in triglycerides occurred in 19% of the 476 patients who received LORBRENA. Median time to onset was 15 days for both hypercholesterolemia and hypertriglyceridemia. Approximately 4% and 7% of patients required temporary discontinuation and 1% and 3% of patients required dose reduction of LORBRENA for elevations in cholesterol and in triglycerides in Study B7461001 and Study B7461006, respectively. Eighty-three percent of patients required initiation of lipid-lowering medications, with a median time to onset of start of such medications of 17 days. Initiate or increase the dose of lipid-lowering agents in patients with hyperlipidemia. Monitor serum cholesterol and triglycerides before initiating LORBRENA, 1 and 2 months after initiating LORBRENA, and periodically thereafter. Withhold and resume at same dose for the first occurrence; resume at same or reduced dose of LORBRENA for recurrence based on severity.

Atrioventricular (AV) Block: PR interval prolongation and AV block can occur. In 476 patients who received LORBRENA at a dose of 100 mg orally once daily and who had a baseline electrocardiography (ECG), 1.9% experienced AV block and 0.2% experienced Grade 3 AV block and underwent pacemaker placement. Monitor ECG prior to initiating LORBRENA and periodically thereafter. Withhold and resume at reduced or same dose in patients who undergo pacemaker placement. Permanently discontinue for recurrence in patients without a pacemaker.

Interstitial Lung Disease (ILD)/Pneumonitis: Severe or life-threatening pulmonary adverse reactions consistent with ILD/pneumonitis can occur. ILD/pneumonitis occurred in 1.9% of patients, including Grade 3 or 4 ILD/pneumonitis in 0.6% of patients. Four patients (0.8%) discontinued LORBRENA for ILD/pneumonitis. Promptly investigate for ILD/pneumonitis in any patient who presents with worsening of respiratory symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, and fever). Immediately withhold LORBRENA in patients with suspected ILD/pneumonitis. Permanently discontinue LORBRENA for treatment-related ILD/pneumonitis of any severity.

Hypertension: Hypertension can occur. Hypertension occurred in 13% of patients, including Grade 3 or 4 in 6% of patients. Median time to onset of hypertension was 6.4 months (1 day to 2.8 years), and 2.3% of patients temporarily discontinued LORBRENA for hypertension. Control blood pressure prior to initiating LORBRENA. Monitor blood pressure after 2 weeks and at least monthly thereafter. Withhold and resume at reduced dose or permanently discontinue based on severity.

Hyperglycemia: Hyperglycemia can occur. Hyperglycemia occurred in 9% of patients, including Grade 3 or 4 in 3.2% of patients. Median time to onset of hyperglycemia was 4.8 months (1 day to 2.9 years), and 0.8% of patients temporarily discontinued LORBRENA for hyperglycemia. Assess fasting serum glucose prior to initiating LORBRENA and monitor periodically thereafter. Withhold and resume at reduced dose or permanently discontinue based on severity.

Embryo-fetal Toxicity: LORBRENA can cause fetal harm. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use an effective non-hormonal method of contraception, since LORBRENA can render hormonal contraceptives ineffective, during treatment with LORBRENA and for at least 6 months after the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with LORBRENA and for 3 months after the final dose.

Adverse Reactions: In the pooled safety population of 476 patients who received 100 mg LORBRENA once daily, the most frequent (≥ 20%) adverse reactions 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 (≥ 20%) Grade 3-4 laboratory abnormalities in patients receiving LORBRENA were hypercholesterolemia (21%) and  hypertriglyceridemia (21%).

In previously untreated patients, serious adverse reactions occurred in 34% of the 149 patients treated with LORBRENA; 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%). Fatal adverse reactions occurred in 3.4% of patients and included pneumonia (0.7%), respiratory failure (0.7%), cardiac failure acute (0.7%), pulmonary embolism (0.7%), and sudden death (0.7%). In the Phase 1/2 study, serious adverse reactions occurred in 32% of the 295 patients; the most frequently reported serious adverse reactions were pneumonia (3.4%), dyspnea (2.7%), pyrexia (2%), mental status changes (1.4%), and respiratory failure (1.4%). Fatal adverse reactions occurred in 2.7% of patients and included pneumonia (0.7%), myocardial infarction (0.7%), acute pulmonary edema (0.3%), embolism (0.3%), peripheral artery occlusion (0.3%), and respiratory distress (0.3%).

Drug Interactions: LORBRENA is contraindicated in patients taking strong CYP3A inducers. Avoid concomitant use with moderate CYP3A inducers, strong CYP3A inhibitors, and fluconazole. If concomitant use of moderate CYP3A inducers cannot be avoided, increase the LORBRENA dose as recommended. If concomitant use with a strong CYP3A inhibitor or fluconazole cannot be avoided, reduce the LORBRENA dose as recommended. Avoid concomitant use of LORBRENA with CYP3A substrates and P-gp substrates, which may reduce the efficacy of these substrates.

Lactation: Because of the potential for serious adverse reactions in breastfed infants, instruct women not to breastfeed during treatment with LORBRENA and for 7 days after the final dose.

Hepatic Impairment: No dose adjustment is recommended for patients with mild hepatic impairment. The recommended dose of LORBRENA has not been established for patients with moderate or severe hepatic impairment.

Renal Impairment: Reduce the dose of LORBRENA for patients with severe renal impairment. No dose adjustment is recommended for patients with mild or moderate renal impairment.

Please see Full Prescribing Information.

Indication

LORBRENA® (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.

​​​​​​Please see Full Prescribing Information.