ZYKADIA (ceritinib)

There are 1 contraindications. Absolute contraindication.

Contraindication List
Lactation

There are 15 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Bradycardia
Child-pugh class C hepatic impairment
Congenital long QT syndrome
Disease of liver
Hyperglycemia
Hypocalcemia
Hypokalemia
Hypomagnesemia
Interstitial lung disease
Pancreatitis
Pregnancy
Prolonged QT interval
Severe diarrhea
Severe nausea
Severe vomiting

There are 1 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Chronic heart failure

There are 11 severe adverse reactions.

More Frequent	Less Frequent
Abnormal hepatic function tests Increased alanine transaminase Increased aspartate transaminase	Bradycardia Dehydration Interstitial pneumonitis Prolonged QT interval Renal failure

Rare/Very Rare
Drug-induced hepatitis Gastrointestinal perforation Pancreatitis

There are 32 less severe adverse reactions.

More Frequent	Less Frequent
Acute abdominal pain Anorexia Constipation Diarrhea Fatigue Hyperglycemia Nausea Vomiting Weight loss	Accommodation disorder Blurred vision Dysesthesia Dyspepsia Dysphagia Dyspnea Gait abnormality Gastroesophageal reflux disease Hyperbilirubinemia Hypoesthesia Hypotonia Muscle weakness Neuralgia Paresthesia Peripheral motor neuropathy Peripheral neuropathy Peripheral sensory neuropathy Photopsia Polyneuropathy Reduced visual acuity Skin photosensitivity Skin rash Visual changes

Rare/Very Rare
None.

Ceritinib may cause fetal harm if administered to pregnant women based on its mechanism of action and animal findings. (See Fetal/Neonatal Morbidity and Mortality under Cautions.) If ceritinib is used during pregnancy or if the patient becomes pregnant while receiving the drug, the patient should be apprised of the potential fetal hazard.

It is not known whether ceritinib or its metabolites are distributed into human milk or if the drug has any effect on milk production or the nursing infant. Because of the potential for serious adverse reactions to ceritinib in nursing infants, women should be advised not to breast-feed while receiving the drug and for 2 weeks after the drug is discontinued.

Contraindicated
Absolute contraindication. (Human data usually available to support recommendations.) This drug should not be given to breast feeding mothers.

Drug Name	Excretion Potential	Effect on Infant	Notes
Ceritinib	Unknown. It is unknown whether the drug is excreted in human breast milk.	It is not known whether this drug has an adverse effect on the nursing infant. (No data or inconclusive human data)	Insuff human data; avoid bf during and for 2 weeks after treatment

In clinical trials evaluating ceritinib 750 mg once daily in patients with ALK-positive non-small cell lung cancer (NSCLC), 18% of patients were >=65 years of age and 5% were >=75 years of age. No substantial differences in safety or efficacy of ceritinib were observed between geriatric patients and younger adults. In pharmacokinetic population analyses, age did not have a clinically important effect on the systemic exposure of ceritinib in adults.