TM Owner Novartis
Zykadia 150mg Capsule
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Indications & Clinical Uses
- Zykadia 150mg contains ceritinib, an oral kinase inhibitor that blocks anaplastic lymphoma kinase (ALK).
- In the US it is approved for adults with metastatic non-small cell lung cancer (NSCLC) whose tumours are ALK-positive, as detected by an approved test.
- It is prescribed by a cancer specialist.
- The recommended dose is 450 mg (three 150 mg units) once daily with food; this differs from older fasted, higher-dose regimens.
- Zykadia is supplied as both 150 mg hard capsules and 150 mg film-coated tablets, which are bioequivalent, and the food-based dosing applies to both.
- Zykadia is marketed by Novartis.
Side Effects
- The most common side effects, affecting at least 25% of patients at the recommended dose with food, are diarrhoea, nausea, abdominal pain, vomiting and tiredness.
- Stomach and bowel toxicity occurs in about 79% of patients.
- Serious effects include liver injury (raised liver enzymes), interstitial lung disease or pneumonitis (about 2.4%), a slow heart rate, QT prolongation on the heart tracing, high blood sugar (grade 3 to 4 in about 13%) and pancreatitis.
- Tell your care team about new cough or breathlessness, yellow skin or eyes, dark urine, dizziness, fainting, fast or irregular heartbeat, severe stomach pain, or excessive thirst.
- There is no boxed warning on the US label.
Precautions & Warnings
- Liver tests are done once a month and more often if enzymes rise.
- Your heart rate and ECG (QT interval), blood sugar and lipase may also be monitored.
- There are no contraindications listed in the US label.
- Zykadia can harm an unborn baby: females should use effective contraception during treatment and for 6 months after the last dose, and males should use condoms during treatment and for 3 months afterwards.
- Do not breastfeed during treatment and for 2 weeks after the last dose.
- Take it with food at the same time each day, as directed.
Avoid Interactions
- Increase the effect or toxicity: avoid strong CYP3A inhibitors, which raise ceritinib levels (if unavoidable, the dose is reduced); do not eat grapefruit or drink grapefruit juice.
- Avoid medicines that prolong the QT interval or slow the heart rate where possible, such as beta-blockers.
- Zykadia can raise levels of sensitive CYP3A substrates and problematic CYP2C9 substrates, so avoid these combinations.
- Reduce the effect: avoid strong CYP3A inducers, which lower ceritinib levels.
- Tell your prescriber about all prescription and over-the-counter medicines, herbal products and supplements, and check with your pharmacist before starting any new product, because some change ceritinib levels.
References
Frequently Asked Questions
Zykadia (ceritinib) treats adults with metastatic non-small cell lung cancer whose tumours are ALK-positive, confirmed by an approved test. It is a once-daily oral medicine prescribed by a cancer specialist and taken until the disease progresses or side effects become unacceptable.
Zykadia (ceritinib) is taken by mouth as 450 mg, three 150 mg tablets or capsules, once daily with food. Taking it with food is the current dosing and is different from older fasted, higher-dose instructions. Take it at about the same time each day.
Zykadia (ceritinib) commonly causes diarrhoea, nausea, abdominal pain, vomiting and tiredness. Serious effects include liver problems, lung inflammation, slow heart rate, QT prolongation, high blood sugar and pancreatitis. Report new cough, breathlessness, yellow skin, fainting, palpitations or severe stomach pain promptly.
Avoid grapefruit and grapefruit juice, and avoid strong CYP3A inhibitors or inducers with Zykadia (ceritinib). Also avoid medicines that prolong the QT interval or slow the heart rate, such as beta-blockers, where possible. Tell your prescriber about every medicine and supplement you use.
On Zykadia (ceritinib), liver tests are done once a month and more often if enzymes rise. Your heart rate, ECG for QT prolongation, blood sugar and lipase may also be checked. These checks catch the liver, heart rhythm, blood sugar and pancreas problems the label warns about.
No. Zykadia (ceritinib) can harm an unborn baby. Females should use effective contraception during treatment and for 6 months after the last dose; males should use condoms during treatment and for 3 months after. Do not breastfeed during treatment and for 2 weeks after the last dose.
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