Ceritinib
Ceritinib is a targeted cancer medicine used to treat metastatic non-small cell lung cancer (NSCLC) in adults whose tumors have a specific genetic change called ALK positivity.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Ceritinib: Patient Information Guide
A plain-language walkthrough of Ceritinib — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Ceritinib is a targeted cancer therapy approved for use in adults with a specific type of advanced lung cancer.
- Zykadia (ceritinib) tablets are indicated for the treatment of adults with metastatic non-small cell lung cancer (NSCLC) whose tumors are positive for the ALK (anaplastic lymphoma kinase) gene abnormality, as detected by an FDA-approved test. This applies to both previously untreated patients and those who have received prior therapy.
⚙️How it works▾
Ceritinib is a kinase inhibitor — a drug that blocks specific proteins that tell cancer cells to grow and divide. Its main target is ALK (anaplastic lymphoma kinase), a protein that is abnormally active in certain lung cancers due to a genetic rearrangement. By blocking ALK, ceritinib cuts off a key signal that drives tumor growth. It also inhibits related proteins including IGF-1R, InsR, and ROS1, though ALK is by far its most potent target.
Importantly, ceritinib has shown activity in tumors that have developed resistance to an earlier ALK inhibitor called crizotinib, making it an option even when that prior therapy has stopped working.
💊How it's taken▾
Zykadia tablets are taken orally once daily with food. Taking it with food is important — studies showed it reduces stomach-related side effects compared to taking it on an empty stomach. Treatment continues until the cancer progresses or side effects become unacceptable.
- If you miss a dose, take it as soon as you remember — unless your next scheduled dose is within 12 hours, in which case skip it.
- If you vomit after taking a dose, do not take a replacement dose — just continue with your next scheduled dose.
- Your doctor may adjust or temporarily stop your dose if side effects occur; always follow their specific instructions.
🤒Side effects — in detail▾
The most common side effects of Zykadia include:
- Diarrhea
- Nausea
- Vomiting
- Abdominal (stomach) pain
- Fatigue (tiredness or weakness)
- Decreased appetite
- Weight loss
- Increased liver enzyme levels (seen on blood tests)
Taking Zykadia with food reduces the frequency and severity of stomach-related side effects. More serious reactions — including liver damage, lung inflammation, dangerous heart rhythm changes, very high blood sugar, slow heart rate, and pancreatitis — can occur and require prompt medical attention. Report any new or worsening symptoms to your doctor right away.
⚠️Warnings & precautions▾
- Liver toxicity (hepatotoxicity): Significant liver enzyme elevations occurred in many patients. Liver labs are monitored monthly. Severe cases may require dose reduction or stopping the drug permanently.
- Lung inflammation (ILD/pneumonitis): Occurred in ~2.4% of patients; some cases were fatal. Ceritinib must be permanently stopped if treatment-related ILD/pneumonitis is confirmed.
- Heart rhythm changes (QT prolongation): Ceritinib can alter the heart's electrical activity in a way that may cause dangerous rhythms. Regular ECG monitoring is needed, especially if you take other QT-prolonging medications.
- High blood sugar (hyperglycemia): Severe cases occurred in 13% of patients. Blood sugar is monitored before and during treatment.
- Slow heart rate (bradycardia): Monitor heart rate regularly. Avoid combining with other medicines that slow the heart when possible.
- Pancreatitis: Pancreatic enzyme elevations and pancreatitis (including one fatality) have occurred. Levels are checked before and during treatment.
- Fetal harm (embryo-fetal toxicity): Ceritinib caused skeletal defects in animal studies at doses below the human dose. Pregnancy must be avoided during treatment and for 6 months after the last dose in women; men should use condoms for 3 months after the last dose.
🔀What it interacts with▾
Ceritinib interacts with several medications and foods that affect how it is processed by the body or that share similar risks:
- Strong CYP3A inhibitors (e.g., ketoconazole, certain antifungals) — raise ceritinib blood levels, increasing side effect risk; avoid if possible, or a dose reduction is required.
- Strong CYP3A inducers (e.g., rifampin) — greatly lower ceritinib blood levels, potentially making it less effective; avoid if possible.
- Sensitive CYP3A substrates (e.g., midazolam) — ceritinib raises their levels; avoid combining, or reduce the dose of the other drug.
- Warfarin (blood thinner) — ceritinib boosts warfarin's anticoagulant effect, raising bleeding risk; more frequent INR checks are needed.
- CYP2C9 substrates — ceritinib can raise levels of drugs processed by this enzyme; avoid those where even small increases could cause serious harm.
- Grapefruit / grapefruit juice — inhibits the same enzyme that processes ceritinib, raising its blood levels; avoid during treatment.
- QT-prolonging medications — combining raises the risk of dangerous heart rhythms; avoid when possible.
- Bradycardia-causing medications (e.g., beta-blockers, digoxin, clonidine, non-dihydropyridine calcium channel blockers) — increases risk of dangerously slow heart rate; avoid when possible.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Pregnancy: Ceritinib can cause serious harm to an unborn baby. Women must use effective contraception during treatment and for 6 months after the last dose. A pregnancy test is required before starting therapy.
- Breastfeeding: Do not breastfeed during treatment with Zykadia or for 2 weeks after stopping — risk of harm to the nursing infant.
- Males with reproductive potential: Use condoms during treatment and for 3 months after the last dose if your partner could become pregnant.
- Severe liver impairment (Child-Pugh C): A dose reduction is required; the drug's exposure is significantly increased in this group.
- Mild to moderate liver impairment: No dose adjustment needed, but your doctor will monitor you.
- Severe kidney impairment: Patients with severe kidney impairment were not included in clinical trials; discuss with your doctor.
- Heart conditions: Patients with congenital long QT syndrome, congestive heart failure, or electrolyte abnormalities need closer ECG monitoring — or may need to avoid ceritinib.
- Children: Safety and effectiveness in pediatric patients have not been established.
- Older adults (65+): Included in clinical studies without notable differences in safety or effectiveness, but routine monitoring still applies.
📡Pharmacodynamics — effects in the body▾
Ceritinib causes concentration-dependent prolongation of the QTc interval — a measure of the heart's electrical recharge time. In clinical studies, about 6% of patients had a meaningful increase in QTc from their baseline, and approximately 1.3% had QTc values above 500 milliseconds, a threshold associated with increased arrhythmia risk. Additionally, about 1.1% of patients developed sinus bradycardia (a heart rate below 50 beats per minute) during treatment, requiring heart rate and blood pressure monitoring throughout therapy.
🔬Pharmacokinetics — how your body processes it▾
After an oral dose of Zykadia, peak blood levels are reached in about 4 to 6 hours. The drug has a half-life of approximately 41 hours, meaning it stays in the body for a prolonged period and reaches steady-state (stable blood levels) within about 15 days of daily dosing. Ceritinib is broken down primarily by a liver enzyme called CYP3A, and about 92% of the drug is eliminated through the feces. Food increases absorption — both high-fat and low-fat meals raise blood levels compared to fasting — which is why the tablet formulation is taken with food. Severe liver impairment significantly increases drug exposure and requires a dose reduction.
📦How to store it▾
Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) .
📄 Written from Ceritinib’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
Supplements & herbs that interact with Ceritinib
67 supplements and herbal products have documented interactions with Ceritinib in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 10
- Moderate · 48
- Minor · 9
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Ceritinib — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is Zykadia and why has my doctor prescribed it for me? ▾
Do I need to take Zykadia with food, and does it matter what I eat? ▾
What side effects are most likely, and which ones should I call my doctor about right away? ▾
Are there any medicines or supplements I should avoid while taking this? ▾
Can I get pregnant or father a child while on Zykadia? ▾
What happens if I miss a dose or vomit after taking it? ▾
Is Ceritinib available over the counter? ▾
When was Ceritinib first available? ▾
Who makes Ceritinib? ▾
💬 Answers drafted from Ceritinib’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Ceritinib comes
Ceritinib is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Tablet
How this form is used
- Zykadia tablets are used to treat adults with metastatic non-small cell lung cancer (NSCLC) whose tumors test positive for the ALK gene abnormality, as confirmed by an FDA-approved test
- Zykadia tablets are taken by mouth once daily with food
- If a dose is missed, take it as soon as possible unless the next dose is due within 12 hours — in that case, skip the missed dose
- If vomiting occurs after taking Zykadia, do not take an extra dose; continue with the next scheduled dose
- Swallow Zykadia tablets as directed by your prescriber; do not eat grapefruit or drink grapefruit juice during treatment
📊 Ceritinib across the U.S. market
How Ceritinib appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (1) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
🔍 Compare Ceritinib products
A representative set of FDA-listed product records for Ceritinib — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Tablet | ||||
| 150 mg | Oral | Novartis Pharmaceuticals Corporation × 3 listings | NDA | View NDC → |
| 150 mg | — | Novartis Pharma Produktions GmbH | DRUG FOR FURTHER PROCESSING | View NDC → |
| 💊Bulk drug substance | ||||
| 1 kg/kg | — | MSN Laboratories Private Limited | BULK INGREDIENT | View NDC → |
Showing 5 of 5 products — FDA National Drug Code Directory. See every product, package size and price: browse all 5 Ceritinib NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Ceritinib — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Ceritinib in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Ceritinib went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 1535457 2 dose forms · 2 strengths
-
Dose form (SCDF) Oral Capsule RxCUI 1535461No current FDA listingClinical drug / strength (SCD) 150 MGRxCUI 1535462 -
Dose form (SCDF) Oral Tablet RxCUI 2121058In current FDA listingsClinical drug / strength (SCD) 150 MGRxCUI 2121059
Look up RxCUI 1535457 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Ceritinib is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Ceritinib belongs to the Kinase Inhibitor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Novartis Pharmaceuticals Corporation is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.