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.

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.

No sex- or gender-based dose adjustments are required; population pharmacokinetic analyses showed that gender had no clinically meaningful effect on systemic exposure, so dosing recommendations are the same for men and women.

No sex-specific differences in adverse reactions were identified in the available sources.

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.

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.

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).