View by Tumor Type
Lung Cancer
Home › All Therapies › Alecensa

Alecensa

alectinib
ALK TKI (2nd Generation) FDA Approved 2015 Genentech/Roche
Route
Oral
Half-Life
33 hrs
FDA Approved
2015
Manufacturer
Genentech/Roche
Navigation -->
1. Indications and Usage

ALK-Positive NSCLC: Adult patients with ALK-positive metastatic NSCLC as detected by an FDA-approved test.
Adjuvant ALK-Positive NSCLC: Adjuvant treatment following tumor resection in adult patients with ALK-positive NSCLC as detected by an FDA-approved test.

2. Dosage and Administration

Metastatic: 600 mg orally twice daily with food
Adjuvant: 600 mg orally twice daily with food for 2 years
Dose reductions: First: 450 mg twice daily; Second: 300 mg twice daily. Discontinue if unable to tolerate 300 mg twice daily.

3. Dosage Forms and Strengths

Capsules: 150 mg

4. Contraindications

None listed in the prescribing information.

5. Warnings and Precautions
  • Hepatotoxicity: Drug-induced liver injury with fatal outcome reported. Monitor LFTs every 2 weeks during first 3 months, then monthly.
  • ILD/Pneumonitis: Reported in 1.5% of patients. Permanently discontinue for any grade ILD/pneumonitis.
  • Myalgia and CPK Elevation: Rhabdomyolysis reported. Monitor CPK every 2 weeks during first month and as clinically indicated.
  • Bradycardia: Monitor heart rate and blood pressure regularly.
  • Severe Photosensitivity: Advise patients to avoid prolonged sun exposure.
  • Embryo-Fetal Toxicity: Can cause fetal harm.
6. Adverse Reactions
Most Common Adverse Reactions

Fatigue (41%), Constipation (34%), Edema (30%), Myalgia (29%), Anemia (20%), Nausea (18%), Rash (18%), AST Increased (16%), Diarrhea (16%), Vomiting (12%)

Fatigue
41%
Constipation
34%
Edema
30%
Myalgia
29%
Anemia
20%
Nausea
18%
Rash
18%
AST Increased
16%
Diarrhea
16%
Vomiting
12%

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

7. Drug Interactions

No clinically significant interactions identified. Alectinib is primarily metabolized by CYP3A4 but no dose adjustments needed with CYP3A inhibitors or inducers based on clinical data.

8. Use in Specific Populations
Pregnancy

Consult the full prescribing information for pregnancy-related considerations.

Lactation

Refer to prescribing information for lactation guidance.

Pediatric Use

Pediatric safety and efficacy information is detailed in the full label.

Hepatic/Renal Impairment

Dose modifications for organ impairment are specified in the complete prescribing information.

12. Clinical Pharmacology
Mechanism of Action

Alectinib is a second-generation ALK inhibitor that targets ALK and RET receptor tyrosine kinases. It inhibits ALK phosphorylation and ALK-mediated activation of downstream signaling pathways including STAT3, AKT, and ERK1/2. Alectinib is active against multiple ALK resistance mutations, including the L1196M gatekeeper mutation. It demonstrates CNS penetration and activity against brain metastases.

Pharmacokinetics

Tmax: 4 hours (fed). Bioavailability: 37% with food. Vd: 4016 L. Protein binding: >99%. Metabolized by CYP3A4 to active metabolite M4 (similar potency). Half-life: 33 hours (alectinib), 31 hours (M4). Steady state in 7 days. Elimination: feces 98%, urine <0.5%.

14. Clinical Studies

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

Pivotal Clinical Trials
Additional Resources
📋 All Alectinib Trials on ClinicalTrials.gov ↗ 📚 PubMed: Alectinib Clinical Trials ↗
FDA-Approved Tumor Types

Alecensa has FDA-approved indications across the following cancer types covered on CancerDrugEvidence:

Non-Small Cell Lung Cancer
External Resources
📋 DailyMed Label ↗ 🏛️ FDA Drugs@FDA ↗ 🔬 ClinicalTrials.gov ↗ 📚 PubMed Pivotal Trials ↗
Important Notice: This page is intended as a navigational reference to the FDA-approved prescribing information for Alecensa. It does not replace the full prescribing information. Healthcare professionals should consult the complete package insert available at DailyMed before making prescribing decisions. Patient-specific factors should always guide clinical decision-making.

Frequently Asked Questions

What is Alecensa (alectinib) approved for?

Alecensa (alectinib) is an FDA-approved oncology agent. Refer to the full prescribing information for complete indication details.

How is Alecensa (alectinib) administered?

Refer to the full prescribing information for dosing schedules, administration instructions, and dose modifications.

How does Alecensa (alectinib) work?

Alectinib is a second-generation ALK inhibitor that targets ALK and RET receptor tyrosine kinases. It inhibits ALK phosphorylation and ALK-mediated activation of downstream signaling pathways including STAT3, AKT, and ERK1/2. Alectinib is active against multiple ALK resistance mutations, including the L1196M gatekeeper mutation. It demonstrates CNS penetration and activity against brain metastases

What are the most common side effects?

Fatigue (41%), Constipation (34%), Edema (30%), Myalgia (29%), Anemia (20%), Nausea (18%), Rash (18%), AST Increased (16%), Diarrhea (16%), Vomiting (12%) Fatigue 41% Constipation 34% Edema 30% Myalgia 29% Anemia 20% Nausea 18% Rash 18% AST Increased 16% Diarrhea 16% Vomiting 12%

← All Therapies Full Prescribing Information ↗