Alectinib

Alectinib was developed by Chugai Pharmaceutical Co., Ltd，produced by Lucius is a capsule with a specification of 150mg*56 capsules.

Alectinib expiration date of 24 months. It should be taken within the expiration date and avoided if the drug expires.

Alectinib is a targeted therapy for ALK positive non-small cell lung cancer with clear indications and dosage. During use, attention should be paid to the possible side effects and follow the doctor's guidance for reasonable use.

1. Main components

Alectinib

2. Adapt to the population

ALK positive non-small cell lung cancer patients.

3.Medication for special populations

3.1Pregnant

Based on findings from animal studies and its mechanism of action, Alectinib can cause fetal harm when administered to a pregnant woman . There are no available data on Alectinib use in pregnant women.Advise pregnant women of the potential risk to a fetus.

3.2Lactation

There are no data on the presence of alectinib or its metabolites in human milk, the effects of alectinib on the breastfed child, or its effects on milk production. Because of the potential for serious adverse reactions in breastfed children from alectinib, advise a lactating woman not to breastfeed during treatment with Alectinib and for 1 week after the last dose.

3.3Females and Males of Reproductive Potential

Females

Advise females of reproductive potential to use effective contraception during treatment with Alectinib and for 5 weeks after the last dose.

Males

Based on genotoxicity findings, advise males with female partners of reproductive potential to use effective contraception during treatment with Alectinib and for 3 months following the last dose.

3.4Pediatric Use

The safety and effectiveness of Alectinib in pediatric patients have not been established.

3.5Geriatric Use

Exploratory analysis suggests a higher incidence of serious adverse events (38% vs 25%), more frequent adverse events leading to treatment discontinuations (18% vs 6%) and dose modifications (48% vs 35%) in patients 65 years or older as compared to those younger than 65 years.

3.6Renal Impairment

No dose adjustment is recommended for patients with mild or moderate renal impairment. The safety of Alectinib in patients with severe renal impairment (creatinine clearance less than 30 mL/min) or end-stage renal disease has not been studied.

3.7Hepatic Impairment

No dose adjustment is recommended for patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment. Increased exposure of alectinib occurred in patients with severe hepatic impairment (Child-PughC). The recommended dose of Alectinib in patients with severe hepatic impairment (Child-Pugh C) is 450 mg orally twice daily.

4.Drug overdose

No experience with overdose is available. There is no specific antidote for overdose with Alectinib. Alectinib and its major active metabolite M4 are > 99% bound to plasma proteins; therefore, hemodialysis is likely to be ineffective in the treatment of overdose.

5. Drug storage

Do not store above 30°C (86°F). Store in the original container to protect from light and moisture.

6.Pharmacokinetics

Alectinib reached maximal concentrations at 4 hours following administration of Alectinib 600 mg twice daily under fed conditions in patients with ALK-positive NSCLC. 

The absolute bioavailability of alectinib was 37% (90% CI: 34%, 40%) under fed conditions.

from FDA,2024.04