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Zykadia

ceritinib
ALK TKI FDA Approved 2014 Novartis
Route
Oral
Half-Life
41 hrs
FDA Approved
2014
Manufacturer
Novartis
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1. Indications and Usage

NSCLC: ALK-positive metastatic NSCLC.

2. Dosage and Administration

450 mg orally once daily with food.

3. Dosage Forms and Strengths

Capsules: 150 mg

4. Contraindications

None listed.

5. Warnings and Precautions
  • Hepatotoxicity: Grade 3-4 ALT 27%. Monitor biweekly ×9 weeks.
  • ILD/Pneumonitis: Discontinue if confirmed.
  • QTc Prolongation: Monitor ECGs.
  • Pancreatitis: Monitor lipase/amylase.
  • Hyperglycemia: Monitor glucose.
  • Embryo-Fetal Toxicity: Can cause fetal harm.
6. Adverse Reactions
Most Common Adverse Reactions

Diarrhea (72%), Nausea (69%), Vomiting (56%), ALT Elevation (45%), Fatigue (36%), Abdominal Pain (35%), Decreased Appetite (34%), AST Elevation (31%)

Diarrhea
72%
Nausea
69%
Vomiting
56%
ALT Elevation
45%
Fatigue
36%
Abdominal Pain
35%
Decreased Appetite
34%
AST Elevation
31%

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

7. Drug Interactions

Strong CYP3A Inhibitors: Avoid.
Strong CYP3A Inducers: Avoid.
CYP3A/CYP2C9 Substrates: May alter exposure.

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

ALK tyrosine kinase inhibitor also active against IGF-1R, InsR, and ROS1. Inhibits ALK phosphorylation and downstream signaling.

Pharmacokinetics

Tmax: 4-6h. Bioavailability: increased with food. Protein binding: 97%. t½: 41h. Feces 68%.

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 Zykadia Trials on ClinicalTrials.gov ↗ 📚 PubMed: Zykadia Clinical Trials ↗
FDA-Approved Tumor Types

Zykadia 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 Zykadia. 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 Zykadia (ceritinib) approved for?

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

How is Zykadia (ceritinib) administered?

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

How does Zykadia (ceritinib) work?

ALK tyrosine kinase inhibitor also active against IGF-1R, InsR, and ROS1. Inhibits ALK phosphorylation and downstream signaling.

What are the most common side effects?

Diarrhea (72%), Nausea (69%), Vomiting (56%), ALT Elevation (45%), Fatigue (36%), Abdominal Pain (35%), Decreased Appetite (34%), AST Elevation (31%) Diarrhea 72% Nausea 69% Vomiting 56% ALT Elevation 45% Fatigue 36% Abdominal Pain 35% Decreased Appetite 34% AST Elevation 31%

← All Therapies Full Prescribing Information ↗