Key points
- Alectinib (Alecensa) is a targeted capsule that works only in lung cancer with an ALK gene change, so a genetic test of the tumour is needed first [1].
- It is used both after surgery and when the cancer has spread [1].
- 600 mg twice a day with food; swallow the capsules whole [1].
- After surgery, alectinib prevented the cancer from coming back better than chemotherapy did [1, 2].
- The most common side effects: changes in liver tests, constipation, tiredness, muscle pain, swelling and skin rash; avoid long periods in the sun [1].
What is this drug and how does it work?
For physicians
Alectinib (brand name Alecensa) is an oral targeted tyrosine kinase inhibitor that targets ALK and RET [1]. In a small proportion of lung cancers, an ALK (anaplastic lymphoma kinase) gene rearrangement keeps the ALK protein permanently active and drives cancer cell growth. Alectinib inhibits ALK phosphorylation and downstream signalling (STAT3 and AKT) and reduced the viability of cells with ALK alterations in the laboratory [1].
Its main active metabolite (M4) has similar potency [1]. Alectinib and M4 were active in vitro against several mutant forms of ALK, including some mutations seen in patients progressing on crizotinib, and showed antitumour activity in animal models with intracranial tumours [1]. Alectinib is not chemotherapy.
Which cancers is it used for?
According to the FDA label, alectinib is approved only for adults with ALK-positive non-small cell lung cancer in whom ALK positivity has been shown with an FDA-approved test (on tumour tissue; in metastatic disease, tissue or plasma) [1]. If no ALK rearrangement is found in plasma, tumour tissue should be tested if possible [1]. So not every patient with lung cancer is a candidate for this drug. The European Medicines Agency (EMA) has also approved alectinib as adjuvant treatment after complete resection in high-risk patients, as first-line treatment of advanced disease, and for advanced disease previously treated with crizotinib; the exact indications vary between countries [3].
Your doctor may prescribe this drug for:
- ALK-positive non-small cell lung cancer after surgery [1, 2]
- ALK-positive non-small cell lung cancer that has spread, without previous treatment [1, 4]
- ALK-positive non-small cell lung cancer that has spread, after crizotinib [1, 5, 6]
Whether it suits you depends on the type and stage of your cancer and your test results. Details of each use are in the section for doctors.
For physicians
| Cancer | Conditions of use | Key evidence |
|---|---|---|
| ALK-positive non-small cell lung cancer after surgery | Adjuvant treatment after resection, for tumours of 4 cm or larger or with nodal involvement; 2 years in total [1] | ALINA trial [2]; hazard ratio for recurrence or death 0.24 compared with platinum-based chemotherapy, both in stage II to IIIA and in the whole population [1] |
| Metastatic ALK-positive non-small cell lung cancer, no previous treatment | Monotherapy until disease progression or unacceptable toxicity [1] | ALEX trial [4]; median progression-free survival 25.7 vs 10.4 months compared with crizotinib (hazard ratio 0.53) [1] |
| Metastatic ALK-positive non-small cell lung cancer, after crizotinib | Within the label's metastatic indication [1] | Single-arm trials NP28761 [5] and NP28673 [6]; objective response by independent review committee 38% and 44% [1] |
Decide with the treating physician whether this drug is appropriate.
How it is taken and dosing
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Alectinib comes as 150 mg oral capsules and is taken twice a day with food [1]. Swallow the capsules whole; do not open them or dissolve them in liquid [1]. Taking it with food matters because food changes how much is absorbed; in one study a high-fat, high-calorie meal increased exposure 3.1-fold [1].
Duration: after surgery, the drug is taken for 2 years in total (or until the cancer comes back or side effects cannot be tolerated); in metastatic disease it continues until the disease progresses or side effects cannot be tolerated [1].
Missed dose or vomiting: if you miss a dose or vomit after taking it, do not take an extra dose; take the next one at the usual time [1].
Tests and follow-up:
- Before starting, ALK positivity must be confirmed with an approved test [1].
- Liver tests (ALT, AST and bilirubin) every 2 weeks for the first 3 months, then monthly [1].
- The muscle enzyme CPK every 2 weeks in the first month and whenever unexplained muscle pain, tenderness or weakness occurs [1].
- Regular checks of heart rate and blood pressure [1].
- Blood triglycerides before starting and periodically [1].
- A pregnancy test before starting in women who could become pregnant [1].
- Dose reduction levels: 600 → 450 → 300 mg twice daily; if 300 mg twice daily is not tolerated, discontinue permanently [1].
- Liver: ALT/AST above 5 times the upper limit with bilirubin ≤2 times: hold until baseline or ≤3 times, then resume at a lower dose. Bilirubin above 3 times: hold until baseline or ≤1.5 times, then a lower dose. ALT/AST above 3 times with bilirubin above 2 times (without cholestasis or haemolysis): discontinue permanently [1].
- Lung: treatment-related ILD/pneumonitis of any grade: discontinue permanently [1].
- Kidney: grade 3 renal impairment: hold until creatinine ≤1.5 times the upper limit, then a lower dose; grade 4: discontinue permanently [1].
- Bradycardia: asymptomatic: no dose change. Symptomatic: hold until resolved or heart rate ≥60 and review concomitant drugs (including antihypertensives); if the contributing drug is stopped or adjusted, resume at the same dose, otherwise at a lower dose. Life-threatening: without a contributing drug, discontinue permanently; with a contributing drug that is stopped, resume at a lower dose and discontinue on recurrence [1].
- CPK: above 5 times the upper limit: hold until baseline or ≤2.5 times, then the same dose. Above 10 times or a second rise above 5 times: hold, then a lower dose [1].
- Haemolytic anaemia: if suspected, hold; after recovery, a lower dose or permanent discontinuation [1].
- Triglycerides above 500 mg/dL (5.7 mmol/L): hold until ≤500 and monitor lipase, amylase and symptoms of pancreatitis; then the same dose with regular monitoring; on recurrence, consider a dose reduction [1].
- Hepatic and renal impairment: Child-Pugh C: 450 mg twice daily; Child-Pugh A and B: no adjustment. Mild and moderate renal impairment: no adjustment; CLcr below 30 mL/min has not been studied [1].
- Interactions: the FDA label recommends no dose adjustment for CYP3A inhibitors or inducers; posaconazole, rifampicin and esomeprazole had no clinically meaningful effect on exposure to alectinib and M4 [1].
For physicians
Standard dosing (FDA label)
Adjuvant alectinib
ALK-positive non-small cell lung cancer (FDA-approved test) after resection, tumour ≥4 cm or node-positiveCycle length: Continuous
ALK-positive non-small cell lung cancer (FDA-approved test) after resection, tumour ≥4 cm or node-positive
Before prescribing: Prescribing notes| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Alectinib | 600 mg (4 capsules of 150 mg) twice daily | Oral, with food | Every day, continuously |
Alectinib in metastatic disease
Metastatic ALK-positive non-small cell lung cancer (FDA-approved test)Cycle length: Continuous
Metastatic ALK-positive non-small cell lung cancer (FDA-approved test)
Before prescribing: Prescribing notes| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Alectinib | 600 mg twice daily | Oral, with food | Every day, continuously |
Doses follow the trial protocol, guideline or official drug label (source given in the notes of each regimen). Before prescribing, check blood counts, renal and hepatic function, drug interactions and the patient’s condition, and adjust the dose according to the drug label.
Side effects
The most common side effects:
- Changes in liver tests: in about 4 in 10 people, mostly in the first 3 months; they cause no symptoms and are found with regular blood tests [1].
- Constipation, tiredness and muscle pain [1].
- Swelling of the hands, feet, face or eyelids, and spots or rash on the skin [1].
- Sensitivity to sunlight: in about 1 in 10 people; avoid long periods in the sun and use sunscreen [1].
- Cough and weight gain [1].
For physicians
Among 533 patients who received alectinib monotherapy at 600 mg twice daily in NP28761, NP28673, ALEX and ALINA, the most common adverse reactions (20% or more) were [1]:
- Hepatotoxicity (raised enzymes or bilirubin): 41%
- Constipation: 39%
- Fatigue: 36%
- Myalgia: 31%
- Oedema (hands, feet, face or eyelids): 29%
- Rash: 23%
- Cough: 21%
The most common grade 3 or 4 laboratory abnormalities were increased CPK (6%), decreased haemoglobin (4.4%), increased ALT (4.2%), increased bilirubin (4.0%) and increased AST (3.4%) [1].
Photosensitivity: occurred in 9.9% of patients in NP28761 and NP28673, almost all mild (grade 1) [1]. Weight gain was reported in 9.9% of patients in ALEX and 13% in ALINA [1].
Serious side effects
These are less common but serious; tell your team early if you notice any sign of them:
- Liver damage: yellow skin or eyes, dark urine or pain on the right side of the abdomen [1].
- A slow heartbeat: dizziness, weakness or fainting [1].
- Kidney damage: passing less urine or swelling [1].
- Severe muscle pain or muscle weakness [1].
- Lung inflammation (rare): a new cough or shortness of breath [1].
- Anaemia from breakdown of red blood cells (severe tiredness, paleness, yellowing) and harm to an unborn baby [1].
For physicians
The alectinib label has no boxed warning but includes these important warnings (frequencies in the pool of 533 patients unless stated otherwise) [1]:
- Hepatotoxicity: 41% (grade 3 or higher 8%); in ALINA 61% (grade 3 or higher 4.7%). Most enzyme rises occurred in the first 3 months, and three patients had drug-induced liver injury [1].
- Interstitial lung disease/pneumonitis: 1.3% (grade 3 in 0.4%) [1].
- Renal impairment: 12%, including grade 3 or higher in 1.7%, fatal in 0.4% [1].
- Bradycardia: 11%; in 20% of patients with serial ECGs, the post-dose heart rate was below 50 per minute [1].
- Severe myalgia and CPK elevation: myalgia 31% (grade 3 or higher 0.8%); CPK elevation in 56% (grade 3 or higher 6%) [1].
- Haemolytic anaemia: 3.1% in ALINA [1].
- Severe hypertriglyceridaemia leading to pancreatitis: in NP28761, raised triglycerides in 57% (grade 3 in 7%); severe cases with life-threatening acute pancreatitis have been reported after marketing [1].
- Embryo-fetal toxicity: based on animal studies and mechanism of action [1].
When should I call my doctor?
Tell your treatment team straight away if you have any of these symptoms [1]:
- Yellow skin or whites of the eyes, dark urine, itching, nausea or vomiting, pain on the right side of the abdomen, loss of appetite, or bruising and bleeding more easily than usual
- New or worsening shortness of breath, cough or fever
- A change in the amount or colour of your urine, or new or worsening swelling of the legs
- Dizziness, light-headedness or fainting
- Unexplained or persistent muscle pain, tenderness or weakness
- Yellowing, weakness or dizziness with shortness of breath (possible haemolytic anaemia)
- Upper abdominal pain with nausea, vomiting, bloating or fever (possible pancreatitis)
- Pregnancy or a possible pregnancy
In severe cases (such as severe shortness of breath or fainting), call your local emergency number.
Interactions, pregnancy and precautions
Other medicines: give your doctor a list of all your medicines, supplements and herbal products, and mention heart and blood pressure medicines in particular, because they may slow the heart further [1]. Fortunately, antifungal drugs, the tuberculosis drug rifampicin and stomach medicines such as omeprazole hardly change the level of alectinib [1].
Sun: during treatment and for at least 7 days after stopping, avoid long periods in the sun and use a broad-spectrum (UVA/UVB) sunscreen and lip balm with SPF 50 or higher [1].
Pregnancy and contraception: women who could become pregnant should use effective contraception during treatment and for 5 weeks after the last dose, and men whose partner could become pregnant during treatment and for 3 months after the last dose [1]. The effect on fertility has not been studied in animals [1].
Breastfeeding: do not breastfeed during treatment and for 1 week after the last dose [1].
Vaccines: the FDA label gives no specific advice about vaccines; talk to your treatment team before any vaccination.
Storage: at no more than 30 °C, in the original container, away from light and moisture [1].
Frequently asked questions
Is alectinib chemotherapy?
Why do I have to take alectinib with food?
The drug label recommends taking it with food because food increases how much is absorbed; a high-fat, high-calorie meal increased exposure 3.1-fold [1].
How long do I need to take this drug?
After surgery, treatment lasts 2 years in total unless the cancer comes back or side effects cannot be tolerated; in metastatic disease it continues until the disease progresses or side effects cannot be tolerated [1].
Does alectinib work on brain metastases?
What should I do if I forget a dose or vomit after taking it?
Do not take an extra dose; take the next dose at your usual time [1].
Scientific evidence
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Key studies
1 itemAlectinib in Resected ALK-Positive Non–Small-Cell Lung Cancer
Related cancer types
Treatment regimens (physicians)
References
6 referencesShow all references, 4 with a study cardClose the reference list
Numbers in the text, such as [1], refer to these sources. Sources with a “Study card” button are summarised in the site’s evidence library.
- 1ALECENSA (alectinib) capsules, for oral use: Prescribing Information
- 2
- 3Alecensa (alectinib): European public assessment report (EPAR)
- 4Alectinib versus Crizotinib in Untreated ALK-Positive Non–Small-Cell Lung Cancer
- 5Alectinib in ALK-positive, crizotinib-resistant, non-small-cell lung cancer: a single-group, multicentre, phase 2 trial
- 6Alectinib in Crizotinib-Refractory ALK-Rearranged Non–Small-Cell Lung Cancer: A Phase II Global Study
This page is based on reputable scientific sources and was last updated on 27 October 2026. The content of this website is for educational and informational purposes only and does not replace consultation, diagnosis or treatment by a specialist physician. Consult your treating physician about any treatment decision.
Printed from the website; the full and up-to-date version: https://drdabiri.com/en/drugs/alectinib/
