- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Oral formulations of alectinib.
Anaplastic lymphoma kinase (ALK)+ve advanced non-small cell lung cancer
First-line treatment of adult patients with anaplastic lymphoma kinase (ALK)- positive advanced non-small cell lung cancer (NSCLC).
Anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib.
Whilst the doses stated below are those recommended by the manufacturer, local cancer network protocols for the relevant indication should be consulted.
The recommended dose is 600mg (four 150mg capsules) taken twice daily (total daily dose of 1200mg).
Patients with Hepatic Impairment
Severe hepatic impairment
The recommended starting dose is 450mg (three 150mg capsules) taken twice daily with food (total daily dose of 900mg).
Additional Dosage Information
A missed dose may be taken if it is more than 6 hours before next scheduled dose. Patients may not take two doses at the same time to make up for missed dose. If vomiting occurs after a dose, the next dose should be taken at the scheduled time.
Starting dose: 600mg twice daily
First dose reduction: 450mg twice daily
Second dose reduction: 300mg twice daily
Liver enzymes and bilirubin
ALT or AST elevation of 5 times the upper limit of normal (ULN) or greater (grade 3),with total bilirubin equal to or less then 2 times ULN: Interrupt treatment until recovery to baseline or 3 times ULN, then resume at reduced dose.
ALT or AST elevation of 3 times ULN or greater (grade 2), with total bilirubin more then 2 times ULN in absence of cholestasis or haemolysis: Discontinue treatment.
Bradycardia Grade 2 or 3: Interrupt treatment until recovery to grade 1 (or to a heart rate equal to or below 60 bpm), then resume at reduced dose.
Bradycardia Grade 2 or 3 with contributing concomitant medicinal product: Interrupt treatment until recovery to grade 1 (or to a heart rate equal to or below 60 bpm). If concomitant product is discontinued or adjusted restart alectinib at previous dose, otherwise reduce dose of alcetinib following recovery to grade 1 (or to a heart rate equal to or below 60 bpm).
Bradycardia Grade 4: Permanently discontinue.
Bradycardia Grade 4 with contributing concomitant medicinal product: Interrupt treatment until recovery to grade 1. If concomitant product is discontinued or adjusted restart alectinib at reduced dose. Upon recurrence, permanently discontinue.
Creatine phosphokinase (CPK) elevations
CPK elevation greater than 5 times ULN: Interrupt treatment until recovery to baseline or equal to or less than 2.5 times ULN, then resume at previous dose.
Recurrence of CPK elevation greater than 5 times ULN: Interrupt treatment until recovery to baseline or equal to or less than 2.5 times ULN, then resume at reduced dose.
CPK elevation greater than 10 times ULN: Interrupt treatment until recovery to baseline or equal to or less than 2.5 times ULN, then resume at reduced dose.
Children under 18 years
Precautions and Warnings
Creatine phosphokinase (CPK) above 5 times the upper limit of normal
Elevated serum transaminases - greater than 5 times upper limit of normal
Predisposition to gastrointestinal perforation
Glucose-galactose malabsorption syndrome
Serum bilirubin above 2 times upper limit of normal
Severe hepatic impairment - Child-Pugh score greater than or equal to 10
Reduce dose in patients with severe hepatic impairment
Advise ability to drive/operate machinery may be affected by side effects
Confirm ALK-positive status prior to treatment
Treatment to be initiated and supervised by a specialist
Consult local policy on the safe use of oral anti-cancer drugs
Staff: Not to be handled by pregnant staff
Advise patient to report signs of gastrointestinal perforation immediately
Monitor hepatic function prior to treatment
Monitor CPK every 2 weeks for first month then as clinically indicated
Monitor for signs and symptoms of interstitial lung disease
Monitor for signs and symptoms of pneumonitis
Monitor heart rate and blood pressure regularly
Monitor hepatic function every 2 weeks for first 3 months then periodically
Reduce dose if bradycardia develops
Advise patients to report muscle pain/tenderness/weakness
Discontinue treatment if interstitial lung disease develops
Discontinue if AST or ALT level > 3x ULN and bilirubin > 2x ULN
Discontinue if severe bradycardia occurs
Discontinue if treatment related pneumonitis is diagnosed
Discontinue treatment if gastrointestinal perforation occurs
Suspend if AST/ALT >5 x ULN and bilirubin less than or equal to 2 x ULN
Withhold treatment if CPK > 5 x upper limit of normal
Advise patient not to take St John's wort concurrently
Advise patient Seville (sour) orange products may increase plasma level
Advise patient to avoid grapefruit products
Female: Contraception required during and for 3 months after treatment
Advise patient to minimise sun exposure during and 7 days after treatment
Advise to use SPF50+ UVA/UVB sunscreen & lip balm during & for 7 days after
Pregnancy and Lactation
Alectinib is contraindicated during pregnancy.
The use of alectinib during pregnancy is contraindicated by the manufacturer. At the time of writing, human data is limited but animal studies have shown reproductive toxicity. The potential risks in human pregnancy are unknown.
Alectinib is contraindicated during breastfeeding.
Use of alectinib when breastfeeding is contraindicated by the manufacturer. The presence of alectinib in human breast milk is unknown but due to its high plasma protein binding, limited transfer is expected but may accumulate in the infant due to its long half-life. Effects on exposed infants are unknown.
Acute kidney injury
Creatine phosphokinase increased
Increase in alkaline phosphatase
Increase in serum ALT/AST
Interstitial lung disease
Reduced visual acuity
Serum bilirubin increased
Serum creatinine increased
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: November 2019
Summary of Product Characteristics: Alecensa 150 mg hard capsules. Roche Products Ltd. Revised May 2018.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 13 November 2019.
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Alectinib Last revised: 13 December 2018.
Last accessed: 13 November 2019.
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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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