Alectinib
An oral ALK tyrosine kinase inhibitor for adult patients with ALK‑positive non‑small cell lung cancer.
Source:
EMA
Active Ingredients:
Indications
Representation
No sex-specific representation data
Efficacy
No sex-specific efficacy data
Posology
No sex-specific posology data
Potential Side Effects
No sex-specific potential side effect data
Sex- and gender-specific information
Men
Women
Disease prevalence by sex
62.8%
37.2%
Clinical study participation by sex
48%
52%
Representation Gap
No sex-specific data
-14.8%
+14.8%
Sex-specific efficacy/accuracy
No sex-specific data
Efficacy outcomes appear similar in men and women; subgroup analyses in related trials found objective response rates consistent across genders, with no clinically meaningful sex-based differences reported.
Sex-specific posology
No sex-specific data
Recommended dose is 600 mg alectinib (four 150 mg capsules) orally twice daily with food (total 1200 mg/day); for adjuvant use, continue until disease recurrence, unacceptable toxicity, or for 2 years, with dose reductions in 150 mg twice‑daily steps based on tolerability and permanent discontinuation if 300 mg twice daily is not tolerated.
Sex-specific differences in possible side effects
No sex-specific data
No sex-specific data were reported in the evaluated sources.
Pregnancy / lactation
N / A
There are no or limited data on use in pregnancy; based on mechanism of action and animal data, the drug may cause fetal harm and has shown reproductive toxicity and aneugenic potential. Women of childbearing potential should use highly effective contraception during treatment and for at least 5 weeks after the last dose, and men with female partners of childbearing potential should use highly effective contraception during treatment and for 3 months after the last dose. Breast‑feeding is not recommended during treatment because excretion in human milk is unknown and a risk to the infant cannot be excluded.
Sex-specific non-clinical findings
Non-clinical studies showed no adverse effects on male or female reproductive organs, but the drug is aneugenic and caused embryo‑foetal toxicity in animals, supporting sex‑specific contraception recommendations (longer post‑treatment contraception for men than for women).
Disease prevalence by sex
Men
62.8%
Women
37.2%
Clinical study participation by sex
Men
48%
Women
52%
Representation Gap
No sex-specific data
Men
-14.8%
Women
+14.8%
Sex-specific efficacy/accuracy
No sex-specific data
Efficacy outcomes appear similar in men and women; subgroup analyses in related trials found objective response rates consistent across genders, with no clinically meaningful sex-based differences reported.
Sex-specific posology
No sex-specific data
Recommended dose is 600 mg alectinib (four 150 mg capsules) orally twice daily with food (total 1200 mg/day); for adjuvant use, continue until disease recurrence, unacceptable toxicity, or for 2 years, with dose reductions in 150 mg twice‑daily steps based on tolerability and permanent discontinuation if 300 mg twice daily is not tolerated.
Sex-specific differences in possible side effects
No sex-specific data
No sex-specific data were reported in the evaluated sources.
Pregnancy / lactation
Men
N / A
Women
There are no or limited data on use in pregnancy; based on mechanism of action and animal data, the drug may cause fetal harm and has shown reproductive toxicity and aneugenic potential. Women of childbearing potential should use highly effective contraception during treatment and for at least 5 weeks after the last dose, and men with female partners of childbearing potential should use highly effective contraception during treatment and for 3 months after the last dose. Breast‑feeding is not recommended during treatment because excretion in human milk is unknown and a risk to the infant cannot be excluded.
Sex-specific non-clinical findings
Non-clinical studies showed no adverse effects on male or female reproductive organs, but the drug is aneugenic and caused embryo‑foetal toxicity in animals, supporting sex‑specific contraception recommendations (longer post‑treatment contraception for men than for women).
General information
General Efficacy
Not reported
General Posology
Not reported
Further Dose Adjustments
Not reported
Possible Side Effects
Across pivotal clinical trials (n=533), the most common adverse drug reactions (≥20%) were constipation, myalgia, oedema, anaemia, rash, increased bilirubin, increased ALT and increased AST. Very common (≥1/10) adverse reactions included anaemia, bradycardia, diarrhoea, vomiting, constipation, nausea, increased AST, increased ALT, increased bilirubin, increased alkaline phosphatase, rash, myalgia, increased blood creatine phosphokinase, oedema and weight increased. Clinically important serious reactions included interstitial lung disease (ILD)/pneumonitis (1.3% overall, with 0.4% Grade 3 and 0.9% treatment discontinuation), drug-induced liver injury and Grade ≥3 elevations of transaminases and bilirubin (leading to dose modifications and withdrawals in a small proportion of patients), severe myalgia and creatine phosphokinase (CPK) elevations (Grade ≥3 CPK elevations in 5.5% with dose modifications but no withdrawals), haemolytic anaemia (3.1%, Grade 1–2, no discontinuations), and uncommon acute kidney injury including one Grade 5 event. Gastrointestinal events such as constipation, nausea, diarrhoea and vomiting were very common but mostly Grade 1–2 and did not lead to treatment withdrawal. No cases of bradycardia, myalgia, or CPK elevation led to permanent discontinuation.
Contraindications
Not reported
Clinical Trial Type and Population
Not reported
Representation
No sex-specific representation data
Efficacy
No sex-specific efficacy data
Posology
No sex-specific posology data
Potential Side Effects
No sex-specific potential side effect data
Sex- and gender-specific information
Men
Women
Disease prevalence by sex
62.8%
37.2%
Clinical study participation by sex
45%
55%
Representation Gap
No sex-specific data
-17.8%
+17.8%
Sex-specific efficacy/accuracy
No sex-specific data
Efficacy outcomes appear similar in men and women; subgroup analyses in related trials found objective response rates consistent across genders, with no clinically meaningful sex-based differences reported.
Sex-specific posology
No sex-specific data
Recommended dose is 600 mg alectinib (four 150 mg capsules) orally twice daily with food (total 1200 mg/day); for advanced NSCLC, treatment should be continued until disease progression or unacceptable toxicity, with dose reductions in 150 mg twice‑daily steps based on tolerability and discontinuation if 300 mg twice daily is not tolerated.
Sex-specific differences in possible side effects
No sex-specific data
No sex-specific data were reported in the evaluated sources.
Pregnancy / lactation
N / A
There are no or limited data on use in pregnancy; based on mechanism of action and animal data, the drug may cause fetal harm and has shown reproductive toxicity and aneugenic potential. Women of childbearing potential should use highly effective contraception during treatment and for at least 5 weeks after the last dose, and men with female partners of childbearing potential should use highly effective contraception during treatment and for 3 months after the last dose. Breast‑feeding is not recommended during treatment because excretion in human milk is unknown and a risk to the infant cannot be excluded.
Sex-specific non-clinical findings
Non-clinical studies showed no adverse effects on male or female reproductive organs, but the drug is aneugenic and caused embryo‑foetal toxicity in animals, supporting sex‑specific contraception recommendations (longer post‑treatment contraception for men than for women).
Disease prevalence by sex
Men
62.8%
Women
37.2%
Clinical study participation by sex
Men
45%
Women
55%
Representation Gap
No sex-specific data
Men
-17.8%
Women
+17.8%
Sex-specific efficacy/accuracy
No sex-specific data
Efficacy outcomes appear similar in men and women; subgroup analyses in related trials found objective response rates consistent across genders, with no clinically meaningful sex-based differences reported.
Sex-specific posology
No sex-specific data
Recommended dose is 600 mg alectinib (four 150 mg capsules) orally twice daily with food (total 1200 mg/day); for advanced NSCLC, treatment should be continued until disease progression or unacceptable toxicity, with dose reductions in 150 mg twice‑daily steps based on tolerability and discontinuation if 300 mg twice daily is not tolerated.
Sex-specific differences in possible side effects
No sex-specific data
No sex-specific data were reported in the evaluated sources.
Pregnancy / lactation
Men
N / A
Women
There are no or limited data on use in pregnancy; based on mechanism of action and animal data, the drug may cause fetal harm and has shown reproductive toxicity and aneugenic potential. Women of childbearing potential should use highly effective contraception during treatment and for at least 5 weeks after the last dose, and men with female partners of childbearing potential should use highly effective contraception during treatment and for 3 months after the last dose. Breast‑feeding is not recommended during treatment because excretion in human milk is unknown and a risk to the infant cannot be excluded.
Sex-specific non-clinical findings
Non-clinical studies showed no adverse effects on male or female reproductive organs, but the drug is aneugenic and caused embryo‑foetal toxicity in animals, supporting sex‑specific contraception recommendations (longer post‑treatment contraception for men than for women).
General information
General Efficacy
Not reported
General Posology
Not reported
Further Dose Adjustments
Not reported
Possible Side Effects
Across pivotal clinical trials (n=533), the most common adverse drug reactions (≥20%) were constipation, myalgia, oedema, anaemia, rash, increased bilirubin, increased ALT and increased AST. Very common (≥1/10) adverse reactions included anaemia, bradycardia, diarrhoea, vomiting, constipation, nausea, increased AST, increased ALT, increased bilirubin, increased alkaline phosphatase, rash, myalgia, increased blood creatine phosphokinase, oedema and weight increased. Clinically important serious reactions included interstitial lung disease (ILD)/pneumonitis (1.3% overall, with 0.4% Grade 3 and 0.9% treatment discontinuation), drug-induced liver injury and Grade ≥3 elevations of transaminases and bilirubin (leading to dose modifications and withdrawals in a small proportion of patients), severe myalgia and creatine phosphokinase (CPK) elevations (Grade ≥3 CPK elevations in 5.5% with dose modifications but no withdrawals), haemolytic anaemia (3.1%, Grade 1–2, no discontinuations), and uncommon acute kidney injury including one Grade 5 event. Gastrointestinal events such as constipation, nausea, diarrhoea and vomiting were very common but mostly Grade 1–2 and did not lead to treatment withdrawal. No cases of bradycardia, myalgia, or CPK elevation led to permanent discontinuation.
Contraindications
Not reported
Clinical Trial Type and Population
Not reported
Representation
No sex-specific representation data
Efficacy
No sex-specific efficacy data
Posology
No sex-specific posology data
Potential Side Effects
No sex-specific potential side effect data
Sex- and gender-specific information
Men
Women
Disease prevalence by sex
62.8%
37.2%
Clinical study participation by sex
44-45%
55-56%
Representation Gap
No sex-specific data
-18.8% to -17.8%
+17.8% to +18.8%
Sex-specific efficacy/accuracy
No sex-specific data
Efficacy outcomes appear similar in men and women; subgroup analyses in the crizotinib-pre-treated Phase II studies found objective response rates consistent across genders, with no clinically meaningful sex-based differences reported.
Sex-specific posology
No sex-specific data
Recommended dose is 600 mg alectinib (four 150 mg capsules) orally twice daily with food (total 1200 mg/day); for advanced NSCLC previously treated with crizotinib, continue until disease progression or unacceptable toxicity, with dose reductions in 150 mg twice‑daily steps based on tolerability and discontinuation if 300 mg twice daily is not tolerated.
Sex-specific differences in possible side effects
No sex-specific data
No sex-specific data were reported in the evaluated sources.
Pregnancy / lactation
N / A
There are no or limited data on use in pregnancy; based on mechanism of action and animal data, the drug may cause fetal harm and has shown reproductive toxicity and aneugenic potential. Women of childbearing potential should use highly effective contraception during treatment and for at least 5 weeks after the last dose, and men with female partners of childbearing potential should use highly effective contraception during treatment and for 3 months after the last dose. Breast‑feeding is not recommended during treatment because excretion in human milk is unknown and a risk to the infant cannot be excluded.
Sex-specific non-clinical findings
Non-clinical studies showed no adverse effects on male or female reproductive organs, but the drug is aneugenic and caused embryo‑foetal toxicity in animals, supporting sex‑specific contraception recommendations (longer post‑treatment contraception for men than for women).
Disease prevalence by sex
Men
62.8%
Women
37.2%
Clinical study participation by sex
Men
44-45%
Women
55-56%
Representation Gap
No sex-specific data
Men
-18.8% to -17.8%
Women
+17.8% to +18.8%
Sex-specific efficacy/accuracy
No sex-specific data
Efficacy outcomes appear similar in men and women; subgroup analyses in the crizotinib-pre-treated Phase II studies found objective response rates consistent across genders, with no clinically meaningful sex-based differences reported.
Sex-specific posology
No sex-specific data
Recommended dose is 600 mg alectinib (four 150 mg capsules) orally twice daily with food (total 1200 mg/day); for advanced NSCLC previously treated with crizotinib, continue until disease progression or unacceptable toxicity, with dose reductions in 150 mg twice‑daily steps based on tolerability and discontinuation if 300 mg twice daily is not tolerated.
Sex-specific differences in possible side effects
No sex-specific data
No sex-specific data were reported in the evaluated sources.
Pregnancy / lactation
Men
N / A
Women
There are no or limited data on use in pregnancy; based on mechanism of action and animal data, the drug may cause fetal harm and has shown reproductive toxicity and aneugenic potential. Women of childbearing potential should use highly effective contraception during treatment and for at least 5 weeks after the last dose, and men with female partners of childbearing potential should use highly effective contraception during treatment and for 3 months after the last dose. Breast‑feeding is not recommended during treatment because excretion in human milk is unknown and a risk to the infant cannot be excluded.
Sex-specific non-clinical findings
Non-clinical studies showed no adverse effects on male or female reproductive organs, but the drug is aneugenic and caused embryo‑foetal toxicity in animals, supporting sex‑specific contraception recommendations (longer post‑treatment contraception for men than for women).
General information
General Efficacy
Not reported
General Posology
Not reported
Further Dose Adjustments
Not reported
Possible Side Effects
Across pivotal clinical trials (n=533), the most common adverse drug reactions (≥20%) were constipation, myalgia, oedema, anaemia, rash, increased bilirubin, increased ALT and increased AST. Very common (≥1/10) adverse reactions included anaemia, bradycardia, diarrhoea, vomiting, constipation, nausea, increased AST, increased ALT, increased bilirubin, increased alkaline phosphatase, rash, myalgia, increased blood creatine phosphokinase, oedema and weight increased. Clinically important serious reactions included interstitial lung disease (ILD)/pneumonitis (1.3% overall, with 0.4% Grade 3 and 0.9% treatment discontinuation), drug-induced liver injury and Grade ≥3 elevations of transaminases and bilirubin (leading to dose modifications and withdrawals in a small proportion of patients), severe myalgia and creatine phosphokinase (CPK) elevations (Grade ≥3 CPK elevations in 5.5% with dose modifications but no withdrawals), haemolytic anaemia (3.1%, Grade 1–2, no discontinuations), and uncommon acute kidney injury including one Grade 5 event. Gastrointestinal events such as constipation, nausea, diarrhoea and vomiting were very common but mostly Grade 1–2 and did not lead to treatment withdrawal. No cases of bradycardia, myalgia, or CPK elevation led to permanent discontinuation.
Contraindications
Not reported
Clinical Trial Type and Population
Not reported
EQUAL CARE® Evaluations
EQUAL CARE® Evaluation
Medication
Source
Source:
EMA
Source URL:
Prevalence Source: