Therapy management for specific adverse reactions

There are specific recommendations for dose modifications related to particular adverse reactions. Click on an adverse reaction below to see the recommendations.

Hyperlipidaemia1
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Severity1 Guidance1
MILD
Cholesterol ULN-300 mg/dL OR
Triglycerides 150-300 mg/dL
OR
MODERATE
Cholesterol 301-400 mg/dL OR
Triglycerides 301-500 mg/dL
  • Introduce or modify lipid-lowering therapya
  • Continue LORVIQUA at the same dose
SEVERE
Cholesterol 401-500 mg/dL OR
Triglycerides 501-1000 mg/dL
  • Introduce lipid-lowering therapya
  • If currently on lipid-lowering therapy, increase the dose of lipid-lowering therapy or change to a new lipid-lowering therapya
  • Continue LORVIQUA at the same dose without interruption
LIFE-THREATENING
Cholesterol >500 mg/dL OR
Triglycerides >1000 mg/dL
  • Introduce lipid-lowering therapy, increase the dose of lipid-lowering therapy, or change to a new lipid-lowering therapya
  • Withhold LORVIQUA until recovery of hypercholesterolaemia and/or hypertriglyceridaemia to moderate or mild severity grade 
  • Rechallenge at same LORVIQUA dose while maximising lipid-lowering therapya
  • If severe hypercholesterolaemia and/or hypertriglyceridaemia recur despite maximal lipid-lowering therapy,a reduce LORVIQUA by 1 dose levelb
a Lipid-lowering therapy may include HMG-CoA reductase inhibitor, nicotinic acid, fibric acid derivatives, or ethyl esters of omega-3 fatty acids.b The recommended dose of LORVIQUA is 100 mg taken orally, once daily. The first dose reduction level is 75 mg once daily.1
CNS effects1
  • CNS effects were primarily cognitive effects, mood effects, speech effects, and psychotic effects, and were generally mild, transient, and typically reversible upon dose delay and/or dose reduction1
  • Patients and their caregivers should be advised to notify their healthcare team if they experience or observe new or worsening CNS effects2
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Severity1 Guidance1
Grade 2: Moderate
OR
Grade 3:
Severe
  • Withhold dose until toxicity is ≤Grade 1 
  • Then resume LORVIQUA at 1 reduced dose levela
Grade 4: Life-threatening/urgent intervention indicated
  • Permanently discontinue LORVIQUA
a The recommended dose of LORVIQUA is 100 mg taken orally, once daily. The first dose reduction level is 75 mg once daily.1
Lipase/amylase increase1Patients should be monitored for lipase and amylase elevations1:
  • Prior to the start of treatment
  • Regularly thereafter as clinically indicated
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Severity1 Guidance1
Grade 3: Severe
OR
Grade 4:
Life-threatening/urgent intervention indicated
  • Withhold LORVIQUA until lipase or amylase returns to baseline 
  • Then resume LORVIQUA at 1 reduced dose levela
aThe recommended dose of LORVIQUA is 100 mg taken orally, once daily. The first dose reduction level is 75 mg once daily.1
ILD/pneumonitis1Any patient who presents with worsening of respiratory symptoms indicative of ILD/pneumonitis (eg, dyspnoea, cough, and fever) should be promptly evaluated.1
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Severity1 Guidance1
Grade 1: Mild
OR
Grade 2:
Moderate
  • Withhold LORVIQUA until symptoms have returned to baseline, and consider initiating corticosteroids
  • Then resume LORVIQUA at 1 reduced dose levela
  • Permanently discontinue LORVIQUA if ILD/pneumonitis recurs or fails to recover after 6 weeks of withholding LORVIQUA and treating with steroids
Grade 3: Severe
OR
Grade 4:
Life-threatening/urgent intervention indicated
  • Permanently discontinue LORVIQUA
aThe recommended dose of LORVIQUA is 100 mg taken orally, once daily. The first dose reduction level is 75 mg once daily.1
First-degree AV block1
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Severity1 Guidance1
First-degree AV block: Asymptomatic
  • Continue LORVIQUA at the same dose without interruption 
  • Consider effects of concomitant medicinal products 
  • Assess and correct electrolyte imbalance that may prolong PR interval
  • Monitor ECG/symptoms potentially related to AV block closely
First-degree AV block: Symptomatic
  • Withhold LORVIQUA 
  • Consider effects of concomitant medicinal products 
  • 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 levela
aThe recommended dose of LORVIQUA is 100 mg taken orally, once daily. The first dose reduction level is 75 mg once daily.1
Second-degree AV block1
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Severity1 Guidance1
Second-degree AV block: Asymptomatic
  • Withhold LORVIQUA 
  • Consider effects of concomitant medicinal products 
  • Assess and correct electrolyte imbalance that may prolong PR interval 
  • Monitor ECG/symptoms potentially related to AV block closely
  • If subsequent ECG does not show second-degree AV block, resume LORVIQUA at 1 reduced dose levela
Second-degree AV block: Symptomatic
  • Withhold LORVIQUA 
  • Consider effects of concomitant medicinal products 
  • 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 patient reverts to asymptomatic first-degree AV block, resume LORVIQUA at 1 reduced dose levela
aThe recommended dose of LORVIQUA is 100 mg taken orally, once daily. The first dose reduction level is 75 mg once daily.1
Complete AV block1
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Severity1 Guidance1
Complete AV block
  • Withhold LORVIQUA 
  • Consider effects of concomitant medicinal products 
  • 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 
  • If pacemaker is placed, resume LORVIQUA at full dose
  • If no pacemaker is placed, resume LORVIQUA at 1 reduced dose levela only when symptoms resolve and PR interval is less than 200 msec
aThe recommended dose of LORVIQUA is 100 mg taken orally, once daily. The first dose reduction level is 75 mg once daily.1
Hypertension1

Blood pressure should be controlled prior to initiation of LORVIQUA and monitored after 2 weeks and at least monthly thereafter during treatment with LORVIQUA.1

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Severity1 Guidance1
Grade 3:
  • SBP ≥160 mmHg OR DBP ≥100 mmHg
  • Medical intervention indicated
  • >1 antihypertensive drug, or more intensive therapy than previously used, indicated
  • Withhold LORVIQUA until hypertension has recovered to ≤Grade 1 (SBP <140 mmHg and DBP <90 mmHg), then resume LORVIQUA at the same dose
  • If Grade 3 hypertension recurs, withhold LORVIQUA until recovery to ≤Grade 1 and resume at a reduced dosea
  • If adequate hypertension control cannot be achieved with optimal medical management, permanently discontinue LORVIQUA
Grade 4:
Life-threatening consequences, urgent intervention indicated
  • Withhold LORVIQUA until recovery to ≤Grade 1, and resume at a reduced dosea or permanently discontinue LORVIQUA
  • If Grade 4 hypertension recurs, permanently discontinue LORVIQUA
aThe recommended dose of LORVIQUA is 100 mg taken orally, once daily. The first dose reduction level is 75 mg once daily.1
Hyperglycaemia1

Fasting serum glucose should be assessed prior to initiation of LORVIQUA and monitored periodically thereafter.1

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Severity1 Guidance1
Grade 3
OR
Grade 4:
Persistent hyperglycaemia >250 mg/dL despite optimal antihyperglycaemic therapy
  • Withhold LORVIQUA until hyperglycaemia is adequately controlled, then resume LORVIQUA at the next lower dosagea
  • If adequate hyperglycaemic control cannot be achieved with optimal medical management, permanently discontinue LORVIQUA
aThe recommended dose of LORVIQUA is 100 mg taken orally, once daily. The first dose reduction level is 75 mg once daily.1
Other adverse reactions1,a

Fasting serum glucose should be assessed prior to initiation of LORVIQUA and monitored periodically thereafter.1

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Severity1 Guidance1
Grade 1: Mild
OR
Grade 2:
Moderate
  • Consider no dose modification, or reduce by 1 dose level,b as clinically indicated 
≥Grade 3: Severe
  • Withhold LORVIQUA until symptoms resolve to ≤Grade 2 or baseline
  • Then resume LORVIQUA at 1 reduced dose levelb
aOther adverse reactions may include oedema, peripheral neuropathy, gastrointestinal effects, or weight increase.2bThe recommended dose of LORVIQUA is 100 mg taken orally, once daily. The first dose reduction level is 75 mg once daily.1
AV=atrioventricular; CNS=central nervous system; DBP=diastolic blood pressure; ECG=electrocardiogram; ILD=interstitial lung disease; SBP=systolic blood pressure; ULN=upper limit of normal.References:

Pfizer. LORVIQUA (lorlatinib) Summary of Product Characteristics. 

Bauer TM, Felip E, Solomon BJ, et al. Clinical management of adverse events associated with lorlatinib. Oncologist. 2019;24(8):1103-1110.
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