Dose and Administration

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Dose and  Administration
Resected ALK+ NSCLC
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Alecensa 

Dose and administration

DOSING SCHEDULE IN
ALK+ RESECTED AND ADVANCED NSCLC

Oral medication; swallowed whole

In patients with underlying severe hepatic impairment (Child-Pugh C) the recommended dose is 450 mg orally twice daily with food¹
If a planned dose of ALECENSA is missed, patients may make up that dose unless the next dose is due within 6 hours¹
Patients should not take two doses at the same time to make up for a missed dose¹
If vomiting occurs after taking a dose of ALECENSA, patients should take the next dose at the scheduled time¹

DURATION OF TREATMENT

ALK+ RESECTED NSCLC¹

Treat with ALECENSA until

disease recurrence, unacceptable

toxicity or for 2 years

DURATION OF TREATMENT

ALK+ ADVANCED NSCLC¹

Treat with ALECENSA until

disease progression or  

unacceptable toxicity

Please refer to the SmPC for more details on monitoring and ALECENSA dose modifications

Explore the ALINA data

ALECENSA: Additional dosing considerations¹

Management of AEs may require dose reduction, temporary interruption, or discontinuation of treatment with ALECENSA
Reduce ALECENSA in steps of 150 mg twice daily based on tolerability
Permanently discontinue ALECENSA if patients are unable to tolerate the 300 mg twice daily dose

Dose reduction schedule	Dose level
Starting dose	ALECENSA 600 mg taken orally daily
First dose reduction	ALECENSA 450 mg taken orally daily
Second dose reduction	ALECENSA 300 mg taken orally daily

Dose modifications for specific adverse drug reactions¹

CRITERIA	ALECENSA DOSE MODIFICATION
ILD/pneumonitis of any severity grade	Immediately interrupt and permanently discontinue ALECENSA if no other potential causes of ILD/pneumonitis have been identified
ALT or AST elevation of >5 times ULN with total bilirubin ≤2 times ULN	Temporarily withhold until recovery to baseline or ≤3 times ULN, then resume at reduced dose (see table above)
ALT or AST elevation of >3 times ULN with total bilirubin elevation >2 times ULN in the absence of cholestasis or haemolysis	Permanently discontinue ALECENSA
Bradycardia† Grade 2 or 3 (symptomatic, may be severe and medically significant, medical intervention indicated)	Temporarily withhold ALECENSA until recovery to Grade ≤1 (asymptomatic) bradycardia or to a heart rate of ≥60 bpm. Evaluate concomitant medicinal products known to cause bradycardia, as well as anti-hypertensive medicinal products. If a contributing concomitant medicinal product is identified and discontinued, or its dose is adjusted, resume ALECENSA at previous dose upon recovery to Grade ≤1 (asymptomatic) bradycardia or to a heart rate ≥60 bpm. If no contributing concomitant medicinal product is identified, or if contributing concomitant medicinal products are not discontinued or dose modified, resume ALECENSA at reduced dose (see table above) upon recovery to Grade ≤1 (asymptomatic) bradycardia or to a heart rate of ≥60 bpm
Bradycardia† Grade 4 (life-threatening consequences, urgent intervention indicated)	Permanently discontinue ALECENSA if no contributing concomitant medicinal product is identified. If a contributing concomitant medicinal product is identified and discontinued, or its dose is adjusted, resume ALECENSA at reduced dose (see table above) upon recovery to Grade ≤1 (asymptomatic) bradycardia or to a heart rate of ≥60 bpm, with frequent monitoring as clinically indicated. Permanently discontinue ALECENSA in case of recurrence
CPK elevation >5 times the ULN	Temporarily withhold ALECENSA until recovery to baseline or to ≤2.5 times the ULN, then resume ALECENSA at same dose
CPK elevation >10 times the ULN or second occurrence of CPK elevation of >5 times  the ULN	Temporarily withhold ALECENSA until recovery to baseline or to ≤2.5 times the ULN, then resume ALECENSA at reduced dose (see table above)
Haemolytic anaemia with haemoglobin of <10 g/dL (Grade ≥2)	Temporarily withhold ALECENSA until resolution. Upon resolution, resume ALECENSA at reduced dose (see table above)

CRITERIA AND ALECENSA DOSE MODIFICATION

ILD/pneumonitis of any severity grade

Immediately interrupt and permanently discontinue ALECENSA if no other potential causes of ILD/pneumonitis have been identified

ALT or AST elevation of >5 times ULN with total bilirubin ≤2 times ULN

Temporarily withhold until recovery to baseline or ≤3 times ULN, then resume at reduced dose (see table above)

ALT or AST elevation of >3 times ULN with total bilirubin elevation >2 times ULN in the absence of cholestasis or haemolysis

Permanently discontinue ALECENSA

Bradycardia† Grade 2 or 3 (symptomatic, may be severe and medically significant, medical intervention indicated)

Temporarily withhold ALECENSA until recovery to Grade ≤1 (asymptomatic) bradycardia or to a heart rate of ≥60 bpm. Evaluate concomitant medicinal products known to cause bradycardia, as well as anti-hypertensive medicinal products. If a contributing concomitant medicinal product is identified and discontinued, or its dose is adjusted, resume ALECENSA at previous dose upon recovery to Grade ≤1 (asymptomatic) bradycardia or to a heart rate ≥60 bpm. If no contributing concomitant medicinal product is identified, or if contributing concomitant medicinal products are not discontinued or dose modified, resume ALECENSA at reduced dose (see table above) upon recovery to Grade ≤1 (asymptomatic) bradycardia or to a heart rate of ≥60 bpm

Bradycardia† Grade 4 (life-threatening consequences, urgent intervention indicated)

Permanently discontinue ALECENSA if no contributing concomitant medicinal product is identified. If a contributing concomitant medicinal product is identified and discontinued, or its dose is adjusted, resume ALECENSA at reduced dose (see table above) upon recovery to Grade ≤1 (asymptomatic) bradycardia or to a heart rate of ≥60 bpm, with frequent monitoring as clinically indicated. Permanently discontinue ALECENSA in case of recurrence

CPK elevation >5 times the ULN

Temporarily withhold ALECENSA until recovery to baseline or to ≤2.5 times the ULN, then resume ALECENSA at same dose

CPK elevation >10 times the ULN or second occurrence of CPK elevation of >5 times  the ULN

Temporarily withhold ALECENSA until recovery to baseline or to ≤2.5 times the ULN, then resume ALECENSA at reduced dose (see table above)

Haemolytic anaemia with haemoglobin of <10 g/dL (Grade ≥2)

Temporarily withhold ALECENSA until resolution. Upon resolution, resume ALECENSA at reduced dose (see table above)

Please refer to the SmPC for more details on  monitoring and ALECENSA dose modifications

Monitoring and special warnings¹

ILD/pneumonitis: Patients should be monitored for pulmonary symptoms indicative of pneumonitis. ALECENSA should be immediately interrupted in patients diagnosed with ILD/pneumonitis and should be permanently discontinued if no other potential causes of ILD/pneumonitis have been identified*

Hepatotoxicity: Liver function, including ALT, AST and total bilirubin should be monitored before starting ALECENSA and then at every 2 weeks during the first 3 months of treatment. Thereafter, monitoring should be performed periodically, since events may occur later than 3 months, with more frequent testing in patients who develop aminotransferase and bilirubin elevations. Based on the severity of the adverse drug reaction, ALECENSA should be withheld and resumed at a reduced dose, or permanently discontinued*

Severe myalgia and CPK elevation: Patients should be advised to report any unexplained muscle pain, tenderness, or weakness. CPK levels should be assessed every 2 weeks for the first month of treatment and as clinically indicated in patients reporting symptoms. Based on the severity of CPK elevations, ALECENSA should be withheld, then resumed or the dose reduced*

Bradycardia: Heart rate and blood pressure should be monitored as clinically indicated. ALECENSA dose modification is not required in case of asymptomatic bradycardia. If patients experience symptomatic bradycardia or life-threatening events, concomitant medicinal products known to cause bradycardia, as well as anti-hypertensive medicinal products should be evaluated and treatment with ALECENSA adjusted*

Haemolytic anaemia: If haemoglobin concentration is below 10 g/dL and haemolytic anaemia is suspected, ALECENSA should be withheld, and appropriate laboratory testing should be initiated. If haemolytic anaemia is confirmed, ALECENSA should be resumed at a reduced dose upon resolution*

Gastrointestinal perforation: Discontinuation of ALECENSA in patients who develop gastrointestinal perforation should be considered. Patients should be informed of the signs and symptoms of gastrointestinal perforations and advised to consult rapidly in case of occurrence*

Photosensitivity: Patients should be advised to avoid prolonged sun exposure while taking ALECENSA, and for at least 7 days after discontinuation of treatment. Patients should be advised to use a broad-spectrum ultraviolet A/ultraviolet B sunscreen and lip balm (sun protection factor ≥50) to help protect against potential sunburn*

Sodium content: ALECENSA contains 48 mg sodium per daily dose (1200 mg), which is equivalent to 2.4% of the World Health Organization recommended maximum daily intake of 2 g sodium for an adult

Women of child-bearing potential: ALECENSA may cause foetal harm when administered to a pregnant woman. Female patients of child-bearing potential receiving ALECENSA must use highly effective contraceptive methods during and for at least 3 months following the last dose of ALECENSA. Please refer to the full SmPC for additional information on fertility, pregnancy and lactation*

Lactose intolerance: ALECENSA contains lactose. Patients with rare hereditary problems of galactose intolerance, a congenital lactase deficiency or glucose-galactose malabsorption should not take ALECENSA

Please refer to the SmPC for more details on  monitoring and ALECENSA dose modifications

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*Please refer to the SmPC for more details on dose modifications. †Heart rate <60 bpm.

AE: adverse event; ALK: anaplastic lymphoma kinase; ALT: alanine transaminase; AST: aspartate aminotransferase; bpm: beats per minute; CPK: creatinine phosphokinase; ILD: interstitial lung disease; NSCLC: non-small cell lung cancer; SmPC: Summary of Product Characteristics; ULN: upper limit of normal.

1. Roche. ALECENSA (alectinib) Summary of Product Characteristics. 2024. Available here (accessed July 2024).

M-XX-00017982; Date of preparation: July 2024
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FOR HEALTHCARE PROFESSIONALS

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DOSING SCHEDULE IN
ALK+ RESECTED AND ADVANCED NSCLC

DURATION OF TREATMENT

ALK+ RESECTED NSCLC¹

DURATION OF TREATMENT

ALK+ ADVANCED NSCLC¹

Explore the ALINA data

Discover

Explore

FOR HEALTHCARE PROFESSIONALS

Leaving website

DOSING SCHEDULE IN ALK+ RESECTED AND ADVANCED NSCLC

DURATION OF TREATMENT

ALK+ RESECTED NSCLC1

DURATION OF TREATMENT

ALK+ ADVANCED NSCLC1

Explore the ALINA data

Please refer to the SmPC for more details on monitoring and ALECENSA dose modifications

Monitoring and special warnings1

Please refer to the SmPC for more details on monitoring and ALECENSA dose modifications

Discover

Explore

DOSING SCHEDULE IN
ALK+ RESECTED AND ADVANCED NSCLC

ALK+ RESECTED NSCLC¹

ALK+ ADVANCED NSCLC¹

Please refer to the SmPC for more details on  monitoring and ALECENSA dose modifications

Monitoring and special warnings¹

Please refer to the SmPC for more details on  monitoring and ALECENSA dose modifications