Alectinib (alectinib)
Alectinib is a second-generation, highly selective alk and ret tyrosine kinase inhibitor from Roche (Genentech in the US; originated by Chugai Pharmaceutical), marketed originally as Alecensa. This monograph covers approved indications, mechanism, dosing, side effects and the manufacturer landscape.
Overview
Alectinib is a second-generation, highly selective ALK and RET tyrosine kinase inhibitor, originated by Chugai Pharmaceutical and marketed by Roche (Genentech in the US) as Alecensa (安圣莎). It is approved for adults with ALK-positive metastatic non-small cell lung cancer, and as adjuvant treatment for adults after resection of ALK-positive NSCLC where tumours are at least 4 cm or node-positive. The usual dose is 600 mg - four 150 mg capsules - twice daily with food. Its main advantage over first-generation crizotinib is central nervous system penetration: alectinib is not pumped out of the brain, so it controls brain metastases, a common and disabling complication of ALK-positive disease. Its characteristic toxicities are hepatotoxicity, constipation, fatigue, myalgia, oedema, raised creatine phosphokinase, bradycardia and interstitial lung disease, and liver enzymes are checked every two weeks for the first three months. 07 per capsule). 62 lakh per 56-capsule box. Roche/Chugai originator patents remain in force in the major regulated markets.
How it works
Alectinib is an oral capsule that blocks the ALK and RET proteins that drive a subset of lung cancers. Because it is not pumped out of the brain, it works well against cancer that has spread to the central nervous system.
Alectinib is a tyrosine kinase inhibitor of ALK and RET; it inhibits ALK phosphorylation and ALK-mediated activation of the downstream STAT3 and AKT signalling proteins and decreases viability of cell lines harbouring ALK fusions, amplifications or activating mutations. Its major active metabolite M4 shows similar in vitro potency and activity.
Approved indications
- Adjuvant treatment in adult patients following tumor resection of ALK-positive non-small cell lung cancer (NSCLC) (tumors >= 4 cm or node positive) as detected by an FDA-approved test
- Treatment of adult patients with ALK-positive metastatic NSCLC as detected by an FDA-approved test
Dosage & administration
600 mg (four 150 mg capsules) orally twice daily with food. Adjuvant treatment of resected ALK-positive NSCLC: continue for a total of 2 years or until disease recurrence or unacceptable toxicity. Metastatic ALK-positive NSCLC: continue until disease progression or unacceptable toxicity. Swallow capsules whole; do not open or dissolve the contents. If a dose is missed or vomiting occurs after a dose, take the next dose at the scheduled time.
Dose adjustment
Severe hepatic impairment (Child-Pugh C): 450 mg orally twice daily. Dose reduction schedule: starting dose 600 mg twice daily, first reduction 450 mg twice daily, second reduction 300 mg twice daily; discontinue if 300 mg twice daily is not tolerated. Permanently discontinue for any grade treatment-related ILD/pneumonitis, for AST/ALT >3x ULN with total bilirubin >2x ULN without cholestasis or hemolysis, and for Grade 4 renal impairment. Withhold for Grade 3 renal impairment, severe CPK elevation, symptomatic bradycardia and suspected hemolytic anemia. No dose adjustment is required with CYP3A inducers or inhibitors based on combined alectinib plus M4 exposure.
Side effects
Constipation · Fatigue · Myalgia and musculoskeletal pain · Edema / swelling of hands, feet, ankles, face and eyelids · Rash · Cough · Bradycardia · Elevated creatine phosphokinase (CPK) · Hemolytic anemia · Anemia · Photosensitivity / sunburn · Nausea
- Hepatotoxicity (elevated ALT/AST/bilirubin; drug-induced liver injury reported)
- Interstitial lung disease / pneumonitis
- Renal impairment including fatal cases
Monitoring
- Liver function tests (ALT, AST, total bilirubin) every 2 weeks during the first 3 months of treatment, then once monthly and as clinically indicated
- Heart rate and blood pressure regularly (bradycardia occurred in 11% of patients; 20% had post-dose heart rates below 50 bpm)
- Creatine phosphokinase every 2 weeks during the first month of treatment and in any patient reporting unexplained muscle pain, tenderness or weakness
- Renal function including serum creatinine (Grade 3 renal impairment occurred in 1. 7% of patients, 0. 4% fatal)
- Prompt investigation of new or worsening respiratory symptoms for ILD/pneumonitis
- Complete blood count for suspected hemolytic anemia
Generic and biosimilar landscape
No publicly available bioequivalence study against Alecensa was found for the Bangladeshi or Indian brands; Everest's Alecnib is a nationally approved branded generic under Bangladesh's LDC patent exemption rather than an FDA/EMA-approved generic. No Indian-manufactured generic alectinib was confirmed in this search; Indian market listings found were the Roche originator product. Roche/Chugai originator patents remain in force in the major regulated markets.
Who makes it
| Manufacturer | Country | Brand | Strength | Notes |
|---|---|---|---|---|
| Everest Pharmaceuticals Ltd. | Bangladesh | Alecnib | 150 mg capsule | Labelled as monotherapy for first-line ALK-positive advanced NSCLC and for ALK-positive advanced NSCLC previously treated with crizotinib; pack sizes 1 x 56 and 1 x 16; the only no |
Availability in Southeast Asia
| Country | Status | Notes |
|---|---|---|
| Singapore | Approved | Alecensa approved by the Health Sciences Authority (HSA) of Singapore for ALK-positive NSCLC; MIMS Singapore publishes dosing including the 450 mg twice daily severe hepatic impairment dose referencing HSA |
| Vietnam | Approved | Alecensa approved by the Vietnam Ministry of Health for the treatment of ALK-positive NSCLC following review of clinical evidence |
| Thailand | Approved | Thailand is listed among the countries where Alecensa received approval as an initial (first-line) treatment for ALK-positive metastatic NSCLC, per Roche's media release |
| Philippines | Approved | Alectinib has a Philippine product information monograph listed on MIMS Philippines; alectinib is reported to outperform crizotinib in Asian patients with treatment-naive advanced ALK-positive NSCLC (ALESIA trial) |
| Malaysia | Not confirmed | No NPRA approval record or public source for alectinib was located in this search round |
| Indonesia | Not confirmed | No BPOM approval record or public source for alectinib was located in this search round |
| Laos | Local generic manufacturing | Lucius Pharmaceuticals (Lao) LTD manufactures oncology products including ALK-targeted therapies from its Vientiane campus; no published Lao alectinib the data was found |
| Bangladesh (regional supply hub) | Available | One domestic generic (Everest's Alecnib) the datad at roughly a quarter of the Roche originator the data per capsule; Everest also lists alectinib among its oncology export products |
Frequently asked questions
Alecnib vs Alecensa: are they the same medicine?
Alectinib (Second-generation, highly selective ALK and RET tyrosine kinase inhibitor, originally Alecensa (安圣莎) by Roche (Genentech in the US; originated by Chugai Pharmaceutical)) Alectinib is an oral capsule that blocks the ALK and RET proteins that drive a subset of lung cancers. Because it is not pumped out of the brain, it works well against cancer that has spread to the central nervous system. 600 mg (four 150 mg capsules) orally twice daily with food. Adjuvant treatment of resected ALK-positive NSCLC: continue for a total of 2 years or until disease recurrence or unacceptable toxicity. Metastatic ALK-positive NSCLC: continue until disease progression or unacceptable toxicity. Swallow capsules whole; do not open or dissolve the contents. If a dose is missed or vomiting occurs after a do
What is the dose of alectinib for ALK-positive lung cancer?
Standard dosing for alectinib: 600 mg (four 150 mg capsules) orally twice daily with food. Adjuvant treatment of resected ALK-positive NSCLC: continue for a total of 2 years or until disease recurrence or unacceptable toxicity. Metastatic ALK-positive NSCLC: continue until disease progression or unacceptable toxicity. Swallow capsules whole; do not open or dissolve the contents. If a dose is missed or vomiting occurs after a dose, take the next dose at the scheduled time. Dose adjustments: Severe hepatic impairment (Child-Pugh C): 450 mg orally twice daily. Dose reduction schedule: starting dose 600 mg twice daily, first reduction 450 mg twice daily, second reduction 300 mg twice daily; discontinue if 300 mg twice daily is not tolerated. Permanently discontinue for any grade treatment-related ILD/pneumonitis, for AST/ALT >3x ULN with total bilirubin >2x ULN without cholestasis or hemolysis, and for Grade 4 renal impairment. Withhold for Grade 3 renal impairment, severe CPK elevation, symptomatic bradycardia and suspected hemolytic anemia. No dose adjustment is required with CYP3A inducers or inhibitors based on combined alectinib plus M4 exposure.
How long do patients take alectinib after surgery?
Alectinib (Second-generation, highly selective ALK and RET tyrosine kinase inhibitor, originally Alecensa (安圣莎) by Roche (Genentech in the US; originated by Chugai Pharmaceutical)) Alectinib is an oral capsule that blocks the ALK and RET proteins that drive a subset of lung cancers. Because it is not pumped out of the brain, it works well against cancer that has spread to the central nervous system. 600 mg (four 150 mg capsules) orally twice daily with food. Adjuvant treatment of resected ALK-positive NSCLC: continue for a total of 2 years or until disease recurrence or unacceptable toxicity. Metastatic ALK-positive NSCLC: continue until disease progression or unacceptable toxicity. Swallow capsules whole; do not open or dissolve the contents. If a dose is missed or vomiting occurs after a do
Does alectinib cause liver problems or bradycardia?
Alectinib (Second-generation, highly selective ALK and RET tyrosine kinase inhibitor, originally Alecensa (安圣莎) by Roche (Genentech in the US; originated by Chugai Pharmaceutical)) Alectinib is an oral capsule that blocks the ALK and RET proteins that drive a subset of lung cancers. Because it is not pumped out of the brain, it works well against cancer that has spread to the central nervous system. 600 mg (four 150 mg capsules) orally twice daily with food. Adjuvant treatment of resected ALK-positive NSCLC: continue for a total of 2 years or until disease recurrence or unacceptable toxicity. Metastatic ALK-positive NSCLC: continue until disease progression or unacceptable toxicity. Swallow capsules whole; do not open or dissolve the contents. If a dose is missed or vomiting occurs after a do
Why is alectinib better than crizotinib for brain metastases?
Alectinib (Second-generation, highly selective ALK and RET tyrosine kinase inhibitor, originally Alecensa (安圣莎) by Roche (Genentech in the US; originated by Chugai Pharmaceutical)) Alectinib is an oral capsule that blocks the ALK and RET proteins that drive a subset of lung cancers. Because it is not pumped out of the brain, it works well against cancer that has spread to the central nervous system. 600 mg (four 150 mg capsules) orally twice daily with food. Adjuvant treatment of resected ALK-positive NSCLC: continue for a total of 2 years or until disease recurrence or unacceptable toxicity. Metastatic ALK-positive NSCLC: continue until disease progression or unacceptable toxicity. Swallow capsules whole; do not open or dissolve the contents. If a dose is missed or vomiting occurs after a do
Is generic alectinib available in the Philippines or Vietnam?
No publicly available bioequivalence study against Alecensa was found for the Bangladeshi or Indian brands; Everest's Alecnib is a nationally approved branded generic under Bangladesh's LDC patent exemption rather than an FDA/EMA-approved generic. No Indian-manufactured generic alectinib was confirmed in this search; Indian market listings found were the Roche originator product. Roche/Chugai originator patents remain in force in the major regulated markets. Manufacturers supplying alectinib generic versions include Everest Pharmaceuticals Ltd. . Brands registered in Bangladesh include Alecensa, Alecnib.
What is the half-life of alectinib and how should it be stored?
Storage: Do not store above 30 C (86 F); store capsules in the original container, keep dry and away from light Keep the product in its original packaging and check the expiry date printed on the pack.
Can alectinib capsules be opened or taken without food?
Alectinib (Second-generation, highly selective ALK and RET tyrosine kinase inhibitor, originally Alecensa (安圣莎) by Roche (Genentech in the US; originated by Chugai Pharmaceutical)) Alectinib is an oral capsule that blocks the ALK and RET proteins that drive a subset of lung cancers. Because it is not pumped out of the brain, it works well against cancer that has spread to the central nervous system. 600 mg (four 150 mg capsules) orally twice daily with food. Adjuvant treatment of resected ALK-positive NSCLC: continue for a total of 2 years or until disease recurrence or unacceptable toxicity. Metastatic ALK-positive NSCLC: continue until disease progression or unacceptable toxicity. Swallow capsules whole; do not open or dissolve the contents. If a dose is missed or vomiting occurs after a do
Sources
- https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208434s015lbl.pdf
- https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=42c49deb-713b-427a-9670-08af08adcffb&audience=consumer
- https://www.medicines.org.uk/emc/product/2438/smpc
- https://ec.europa.eu/health/documents/community-register/2017/20170216136901/anx_136901_en.pdf
- https://medex.com.bd/generics/1501/alectinib/brand-names
- https://medex.com.bd/brands/34677/alecnib-150-mg-capsule
- https://medex.com.bd/companies/127/everest-pharmaceuticals-ltd/brands
- https://drugx.com.bd/generic/34/Alectinib/brand-name
- https://www.indiamart.com/proddetail/alecensa-alectinib-150-mg-capsules-2859305014255.html
- https://www.mims.com/singapore/drug/info/alectinib?mtype=generic
- https://www.mims.com/philippines/drug/info/alectinib?mtype=generic
- https://www.roche.com/media/releases/med-cor-2018-08-20
- https://everyone.org/alecensa-alectinib
- https://emergencydrug.com/shop/alecnib-alectinib-150-mg
- https://www.911globalmeds.com/buy-alectinib-alecensa-online
- https://www.alecensa.com/hcp.html
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