Alecensa (Alectinib)
ALK tyrosine kinase inhibitor for ALK-positive non-small cell lung cancer
Alecensa (alectinib) is a targeted cancer medicine used to treat adults with ALK-positive non-small cell lung cancer (NSCLC). It works by blocking the ALK tyrosine kinase enzyme that drives cancer cell growth. Alecensa can be used as adjuvant therapy after surgery, as first-line treatment for advanced disease, or after prior treatment with crizotinib. It is taken orally as capsules twice daily with food.
Quick Facts
Key Takeaways
- Alecensa is a targeted therapy specifically designed for ALK-positive non-small cell lung cancer, offering significant improvement in progression-free survival compared to older ALK inhibitors.
- The standard dose is 600 mg (four capsules) taken twice daily with food, for a total daily dose of 1,200 mg. Capsules must be swallowed whole.
- Regular blood tests are essential to monitor liver function and muscle enzyme levels, particularly during the first three months of treatment.
- Alecensa crosses the blood-brain barrier effectively, making it particularly beneficial for patients with brain metastases from ALK-positive lung cancer.
- Sun sensitivity is a notable side effect — patients must use SPF 50+ sunscreen and avoid prolonged sun exposure during treatment and for 7 days after stopping.
What Is Alecensa and What Is It Used For?
Alecensa (alectinib) is a targeted anticancer medicine that treats ALK-positive non-small cell lung cancer by blocking the abnormal ALK tyrosine kinase enzyme that promotes tumor growth. It is approved for adjuvant treatment after surgery, first-line advanced treatment, and after crizotinib failure.
Alecensa belongs to a class of medicines known as ALK tyrosine kinase inhibitors. It contains the active substance alectinib hydrochloride, which specifically targets cancer cells that have a defect in the gene encoding the anaplastic lymphoma kinase (ALK) enzyme. Approximately 3–5% of all non-small cell lung cancer (NSCLC) cases harbor this ALK rearrangement, making them susceptible to targeted ALK inhibition.
Non-small cell lung cancer is the most common type of lung cancer, accounting for approximately 80–85% of all lung cancer cases worldwide. When lung cancer cells carry the ALK gene rearrangement, the resulting abnormal ALK protein continuously signals cells to divide and grow, driving tumor progression. Alecensa works by binding to and blocking this abnormal ALK protein, thereby slowing or stopping cancer cell proliferation.
Alecensa may be prescribed in three distinct clinical scenarios. First, it can be used as adjuvant therapy after the surgical removal of early-stage ALK-positive NSCLC, with the aim of reducing the risk of cancer recurrence. Second, it is approved as a first-line treatment for patients with advanced (metastatic) ALK-positive NSCLC who have not received prior ALK-directed therapy. Third, it may be given to patients whose cancer has progressed despite treatment with crizotinib, an earlier-generation ALK inhibitor.
One of the distinguishing features of Alecensa is its ability to effectively cross the blood-brain barrier. This property is particularly important because ALK-positive lung cancer has a high propensity to metastasize to the brain. Clinical trials have demonstrated that Alecensa provides superior central nervous system (CNS) activity compared to crizotinib, offering better control of existing brain metastases and reducing the risk of new ones developing.
How Does Alecensa Work?
Alecensa blocks the activity of the ALK tyrosine kinase enzyme. In ALK-positive NSCLC, a chromosomal rearrangement creates an abnormal fusion protein (most commonly EML4-ALK) that is constitutively active, meaning it continuously sends growth signals to cancer cells. By inhibiting this enzyme, Alecensa interrupts the downstream signaling pathways — including RAS/RAF/MEK/ERK and PI3K/AKT — that cancer cells rely on for proliferation and survival.
Alecensa is a highly selective inhibitor, meaning it targets ALK with great precision while having relatively limited effects on other kinases. It also demonstrates activity against several ALK resistance mutations that can develop during treatment with first-generation ALK inhibitors such as crizotinib, which is one reason why it remains effective in crizotinib-pretreated patients.
What Should You Know Before Taking Alecensa?
Do not take Alecensa if you are allergic to alectinib or any of its ingredients. Before starting treatment, inform your doctor about any liver problems, gastrointestinal conditions, pregnancy or breastfeeding plans, and all other medications you take. Regular monitoring of liver and muscle enzymes is required.
Contraindications
You must not take Alecensa if you are allergic (hypersensitive) to alectinib or any of the other ingredients in the capsules. The inactive ingredients include lactose monohydrate, hydroxypropyl cellulose, sodium lauryl sulfate, magnesium stearate, and carmellose calcium, among others. If you are unsure about any ingredient sensitivities, consult your doctor or pharmacist before starting treatment.
Warnings and Precautions
Before taking Alecensa, you should tell your doctor if you have ever had any of the following conditions, as they may affect whether this medicine is suitable for you or require additional monitoring:
- Gastrointestinal problems such as holes (perforation) in the stomach or intestinal wall, or diverticulitis (inflammation of small pouches in the intestinal wall), or if you have cancer that has spread within the abdomen (abdominal metastases). Alecensa may increase the risk of gastrointestinal perforation.
- Hereditary lactose intolerance, congenital lactase deficiency, or glucose-galactose malabsorption, since Alecensa capsules contain lactose.
Severe stomach or abdominal pain, fever, chills, nausea, vomiting, or a rigid or distended abdomen, as these may be symptoms of a hole in the intestinal wall (gastrointestinal perforation), which is a medical emergency.
Alecensa can cause several serious side effects that require careful monitoring and prompt medical attention:
- Liver damage (hepatotoxicity): Your doctor will perform blood tests before starting treatment and every two weeks during the first three months, then periodically thereafter. Contact your doctor immediately if you develop yellowing of the skin or eyes, dark urine, itching, decreased appetite, nausea, vomiting, fatigue, or easy bruising.
- Slow heart rate (bradycardia): Alecensa may cause a reduction in heart rate. Report any episodes of dizziness, fainting, or feeling lightheaded.
- Lung inflammation (pneumonitis): This is a potentially life-threatening complication. Inform your doctor immediately if you develop new or worsening breathing difficulties, shortness of breath, cough (with or without mucus), or fever.
- Severe muscle problems (myalgia): Blood tests for muscle enzyme levels (CPK) will be performed at least every two weeks during the first month. Report unexplained muscle pain, tenderness, or weakness.
- Abnormal breakdown of red blood cells (hemolytic anemia): Seek medical attention if you feel unusually tired, weak, or short of breath.
You should avoid prolonged sun exposure while taking Alecensa and for 7 days after stopping treatment. Use sunscreen and lip balm with SPF 50 or higher to prevent sunburn. Wear protective clothing and a hat when outdoors.
Pregnancy and Breastfeeding
Alecensa can cause harm to an unborn child and must not be taken during pregnancy. Women of childbearing potential must use highly effective contraception during treatment and for at least 5 weeks after the last dose. If you become pregnant while taking Alecensa or within 5 weeks of your last dose, inform your doctor immediately.
Male patients whose female partners can become pregnant must use highly effective contraception during treatment and for at least 3 months after the last dose. Oral contraceptives may be less effective when taken with Alecensa, so additional or alternative contraceptive methods should be discussed with your doctor.
Breastfeeding is not recommended during treatment with Alecensa, as it is unknown whether alectinib passes into breast milk and could therefore potentially harm the nursing infant.
Driving and Operating Machinery
Exercise particular caution when driving vehicles or operating machinery during Alecensa treatment. You may experience visual disturbances, slow heart rate, or low blood pressure, which could cause fainting or dizziness. If you experience any of these symptoms, do not drive or use machines until the symptoms have resolved.
Children and Adolescents
Alecensa has not been studied in children or adolescents. This medicine should not be given to patients under 18 years of age.
Important Information About Excipients
Alecensa capsules contain lactose. If you have been told by your doctor that you have an intolerance to certain sugars, speak to your doctor before taking this medicine. The capsules also contain approximately 48 mg of sodium per recommended daily dose (1,200 mg), which corresponds to 2.4% of the WHO recommended maximum daily sodium intake for adults.
How Does Alecensa Interact with Other Drugs?
Alecensa can interact with numerous medications including heart medicines, blood thinners, cancer drugs, antifungals, antibiotics, HIV treatments, anti-epileptics, and oral contraceptives. Always tell your doctor about all medicines you take, including over-the-counter products and herbal supplements.
Drug interactions with Alecensa can be significant and may either increase the risk of side effects or reduce the effectiveness of your treatments. It is essential that you inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or might take, including prescription medicines, over-the-counter drugs, and herbal remedies.
Major Interactions
The following medications have clinically significant interactions with Alecensa and require careful management by your healthcare team:
| Medication | Therapeutic Use | Interaction Effect |
|---|---|---|
| Digoxin | Heart conditions | Alecensa may increase digoxin blood levels, raising the risk of cardiac toxicity |
| Dabigatran etexilate | Blood clot prevention | Increased dabigatran levels, raising the risk of bleeding |
| Methotrexate | Arthritis, cancer, psoriasis | Increased methotrexate exposure, raising the risk of toxicity |
| Ketoconazole, Itraconazole | Fungal infections | Strong CYP3A inhibitors may increase alectinib blood levels |
| Ritonavir, Saquinavir | HIV/AIDS treatment | Strong CYP3A inhibitors may increase alectinib levels |
| Rifampicin, Rifabutin | Tuberculosis | Strong CYP3A inducers may significantly reduce alectinib effectiveness |
| Phenytoin, Carbamazepine, Phenobarbital | Epilepsy / seizures | Strong CYP3A inducers may reduce alectinib blood levels |
| St. John’s Wort | Herbal remedy for depression | CYP3A inducer that may reduce alectinib effectiveness |
Other Notable Interactions
Several other medications may also interact with Alecensa. Your doctor should be aware if you are taking any of the following:
| Medication | Therapeutic Use | Interaction Effect |
|---|---|---|
| Nilotinib | Certain cancers | Altered blood levels of either drug |
| Lapatinib | Certain breast cancers | Altered blood levels of either drug |
| Mitoxantrone | Cancer, multiple sclerosis | Increased mitoxantrone exposure |
| Everolimus, Sirolimus | Cancer, organ transplant rejection | Increased immunosuppressant levels |
| Topotecan | Certain cancers | Increased topotecan exposure |
| Oral contraceptives | Birth control | Reduced contraceptive effectiveness |
Inform your doctor if you consume grapefruit juice or eat grapefruit or Seville oranges during treatment with Alecensa, as these foods can alter the amount of alectinib in your body by inhibiting CYP3A enzymes in the gut wall.
What Is the Correct Dosage of Alecensa?
The recommended dose of Alecensa is 600 mg (four 150 mg capsules) taken twice daily with food, for a total daily dose of 1,200 mg. Capsules must be swallowed whole and always taken with food for proper absorption. For patients with severe liver impairment, the starting dose is reduced to 450 mg twice daily.
Always take Alecensa exactly as your doctor or pharmacist has instructed. If you are unsure about any aspect of your dosing regimen, consult your healthcare team for clarification. Do not adjust your dose independently.
Adults
Standard Adult Dosage
The recommended dose is 600 mg (4 capsules) taken twice daily, giving a total daily dose of 1,200 mg (8 capsules). The capsules must be swallowed whole — do not open or dissolve them. Alecensa must be taken with food, as this significantly improves drug absorption.
Patients with Severe Liver Impairment
If you have severe liver problems before starting treatment, the recommended starting dose is 450 mg (3 capsules) taken twice daily, giving a total daily dose of 900 mg (6 capsules).
Your doctor may need to reduce your dose, temporarily interrupt treatment, or stop it entirely depending on how well you tolerate the medicine. Dose adjustments are typically made in response to side effects such as liver enzyme elevations, muscle toxicity, or other adverse reactions.
Children
Alecensa is not approved for use in children and adolescents under 18 years of age. There are no clinical data supporting its use in this population.
Elderly
No dose adjustment is required for elderly patients based on age alone. However, elderly patients may be more susceptible to certain side effects and should be monitored accordingly by their healthcare team.
Missed Dose
If you forget to take a dose of Alecensa, the action you should take depends on how long it is until your next scheduled dose:
- If there are more than 6 hours until your next dose: take the missed dose as soon as you remember.
- If there are fewer than 6 hours until your next dose: skip the missed dose and take your next dose at the usual time.
- Never take a double dose to make up for a missed one.
Overdose
If you take more Alecensa than prescribed, contact your doctor or go to a hospital emergency department immediately. Take the medicine packaging with you so that the medical team can identify what you have taken. There is no specific antidote for alectinib overdose, and treatment is supportive.
Do not take an extra dose. Simply take your next dose at the usual scheduled time. Vomiting may reduce drug absorption for that individual dose, but doubling up is not recommended as it could increase the risk of side effects.
Stopping Treatment
Do not stop taking Alecensa without first discussing it with your doctor. It is important to continue taking your medicine as prescribed for as long as your doctor recommends. Stopping treatment prematurely could allow the cancer to progress.
What Are the Side Effects of Alecensa?
Like all medicines, Alecensa can cause side effects, though not everyone experiences them. The most common side effects include elevated liver enzymes, elevated muscle enzymes, anemia, nausea, vomiting, constipation, diarrhea, skin rash, edema, and weight gain. Some side effects such as hepatotoxicity, pneumonitis, and severe myalgia require immediate medical attention.
It is important to be aware of potential side effects so you can recognize them early and report them to your healthcare team promptly. Some side effects are serious and require urgent medical evaluation, while others are manageable with appropriate supportive care.
- Signs of lung inflammation (pneumonitis): new or worsening breathing difficulties, shortness of breath, cough with or without mucus, or fever
- Signs of liver damage: yellowing of skin or eyes, dark urine, itching, decreased appetite, nausea, vomiting, fatigue, or easy bruising/bleeding
- Signs of muscle damage: unexplained muscle pain, tenderness, or weakness that does not resolve
- Signs of slow heart rate: fainting, dizziness, or lightheadedness
- Signs of hemolytic anemia: unusual tiredness, weakness, or shortness of breath
Very Common
Affects more than 1 in 10 people
- Elevated liver enzymes (ALT, AST, bilirubin)
- Elevated creatine phosphokinase (CPK) — marker of muscle damage
- Elevated alkaline phosphatase
- Anemia (low red blood cell count) — may cause tiredness, weakness, shortness of breath
- Nausea
- Vomiting
- Constipation
- Diarrhea
- Skin rash
- Edema (swelling due to fluid retention)
- Weight gain
Common
Affects up to 1 in 10 people
- Elevated blood creatinine (kidney function marker)
- Stomatitis (inflammation of the mouth lining)
- Photosensitivity (increased sensitivity to sunlight)
- Dysgeusia (altered sense of taste)
- Visual disturbances — blurred vision, visual loss, black spots or white patches in the visual field, double vision
- Hyperuricemia (elevated uric acid levels in blood)
Uncommon
Affects up to 1 in 100 people
- Acute kidney injury (rapid loss of kidney function)
Serious (Any Frequency)
Requires immediate medical attention
- Hepatotoxicity (severe liver damage)
- Pneumonitis (interstitial lung disease)
- Bradycardia (dangerously slow heart rate)
- Severe myalgia / rhabdomyolysis
- Hemolytic anemia
- Gastrointestinal perforation
If you experience any side effects not listed here, or if any side effects become severe or troublesome, inform your doctor, pharmacist, or nurse. You can also report suspected side effects to your national medicines regulatory authority to help continuously monitor the safety profile of this medicine.
How Should You Store Alecensa?
Store Alecensa in its original packaging to protect from moisture. Keep out of the sight and reach of children. Do not use after the expiry date printed on the carton. Return unused capsules to your pharmacy for safe disposal.
Proper storage of Alecensa is important to ensure the medicine remains effective throughout its shelf life. Follow these guidelines:
- Keep out of the sight and reach of children at all times.
- Do not use the capsules after the expiry date stated on the carton and either the blister pack or bottle after “EXP.” The expiry date refers to the last day of the stated month.
- If supplied in blister packs: store in the original packaging to protect from moisture.
- If supplied in bottles: store in the original packaging and keep the bottle tightly closed to protect from moisture.
- No special temperature storage conditions are required.
Do not dispose of medicines via wastewater or household waste. Return unused or expired capsules to your pharmacist for environmentally responsible disposal.
What Does Alecensa Contain?
Each Alecensa hard capsule contains alectinib hydrochloride equivalent to 150 mg of alectinib. The capsules also contain lactose monohydrate and sodium as excipients. The white capsules are printed with “ALE” on the cap and “150 mg” on the body in black ink.
Active Ingredient
Each hard capsule contains alectinib hydrochloride equivalent to 150 mg of alectinib.
Inactive Ingredients
The capsule contents include:
- Lactose monohydrate
- Hydroxypropyl cellulose
- Sodium lauryl sulfate
- Magnesium stearate
- Carmellose calcium
The capsule shell is made from hypromellose, carrageenan, potassium chloride, titanium dioxide (E171), maize starch, and carnauba wax. The printing ink contains red iron oxide (E172), yellow iron oxide (E172), indigo carmine aluminium lake (E132), carnauba wax, white shellac, and glycerol monooleate.
Appearance and Packaging
Alecensa hard capsules are white, with “ALE” printed in black ink on the cap and “150 mg” printed in black ink on the body. The capsules are available in two packaging formats:
- Blister packs: cartons containing 224 hard capsules (4 packs of 56)
- Plastic bottles: containing 240 hard capsules
Not all pack sizes may be marketed in all countries.
Manufacturer
Alecensa is manufactured by Roche Pharma AG, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany. The marketing authorization holder is Roche Registration GmbH at the same address.
Frequently Asked Questions About Alecensa
Medical References and Sources
This article is based on current medical research and international regulatory documents. All claims are supported by scientific evidence from peer-reviewed sources.
- European Medicines Agency (EMA). “Alecensa (alectinib) — Summary of Product Characteristics.” EMA EPAR — Alecensa Official European regulatory document including full prescribing information.
- Peters S, Camidge DR, Shaw AT, et al. (2017). “Alectinib versus Crizotinib in Untreated ALK-Positive Non–Small-Cell Lung Cancer.” New England Journal of Medicine. 377(9):829–838. doi:10.1056/NEJMoa1704795 ALEX trial: Phase III randomized trial demonstrating superior PFS with alectinib vs crizotinib. Evidence level: 1A.
- Mok T, Camidge DR, Gadgeel SM, et al. (2020). “Updated overall survival and final progression-free survival data for patients with treatment-naive advanced ALK-positive non-small-cell lung cancer in the ALEX study.” Annals of Oncology. 31(8):1056–1064. doi:10.1016/j.annonc.2020.04.478 Updated ALEX trial data with mature overall survival results.
- National Comprehensive Cancer Network (NCCN). “Clinical Practice Guidelines in Oncology: Non-Small Cell Lung Cancer.” Version 3.2025. NCCN Guidelines Comprehensive evidence-based guidelines for NSCLC management including ALK-positive disease.
- Planchard D, Popat S, Kerr K, et al. (2023). “Metastatic non-small cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up.” Annals of Oncology. European Society for Medical Oncology guidelines for metastatic NSCLC.
- U.S. Food and Drug Administration (FDA). “Alecensa (alectinib) — Prescribing Information.” FDA Label Official US prescribing information and safety data.
Evidence grading: This article uses the GRADE framework (Grading of Recommendations Assessment, Development and Evaluation) for evidence-based medicine. Clinical trial data from the ALEX and ALESIA studies provide Level 1A evidence, the highest quality based on randomized controlled trials.
iMedic Editorial Standards
Peer Review Process
All medical content is reviewed by at least two licensed specialist physicians before publication.
Fact-Checking
All medical claims are verified against peer-reviewed sources and international guidelines.
Update Frequency
Content is reviewed and updated at least every 12 months or when new research emerges.
Corrections Policy
Any errors are corrected immediately with transparent changelog. Read more
Medical Editorial Board: iMedic has an independent medical editorial board consisting of specialist physicians in oncology, clinical pharmacology, respiratory medicine, and internal medicine.