Before Initiation of Therapy :
CBC, ALT, AST, GGT, LD, bilirubin, TSH
HBsAg, anti-HBc, anti-HBs, hepatitis C. HIV, VZV serology
Verification of vaccination status and update if necessary
CYP2C9*3*3 genotype (Go Program)
Monitoring During Therapy :
CBC, ALT, AST, GGT, LD, bilirubin, TSH q.3monthsx4, then q.6months
- All patients should undergo an ophthalmological examination at month 3 or 4
MAYZENT should not be used in patients with a CYP2C9*3*3 genotype (see CONTRAINDICATIONS; WARNINGS AND PRECAUTIONS, Endocrine and Metabolism – Pharmacogenomics; and ACTION AND CLINICAL PHARMACOLOGY, Special Populations and Conditions).
Initiation of treatment with MAYZENT causes a transient decrease in heart rate and atrioventricular conduction delays. Prescribers should:
Obtain an electrocardiogram (ECG) for all patients to determine whether pre-existing conduction abnormalities are present (see WARNINGS AND PRECAUTIONS, Cardiovascular - Treatment Initiation Recommendations and Bradyarrhythmia and Atrioventricular Conduction Delays).
Determine whether patients are taking concomitant medications that reduce heart rate or atrioventricular conduction (see WARNINGS AND PRECAUTIONS, Cardiovascular - Bradyarrhythmia and Atrioventricular Conduction Delays; and DRUG INTERACTIONS).
For patients with sinus bradycardia (heart rate (HR) <55 bpm), first or second-degree [Mobitz type I] atrioventricular block (AV block), or a history of myocardial infarction or heart failure, prepare to administer the first dose of MAYZENT in a clinical setting where they can be monitored for signs and symptoms of bradycardia, with hourly pulse and blood pressure measurements for at least 6 hours, and where symptomatic bradycardia can be managed (see WARNINGS AND PRECAUTIONS, Cardiovascular - Treatment Initiation Recommendations).
For patients with certain other pre-existing cardiac conditions, seek an evaluation from a cardiologist prior to initiating treatment, to assess suitability of treatment and to determine the most appropriate strategy for monitoring cardiac effects (see WARNINGS AND PRECAUTIONS, Cardiovascular - Treatment Initiation Recommendations).
Patients with a history of diabetes mellitus, uveitis and underlying/co-existing retinal diseases are at increased risk of macular edema. It is recommended that patients with diabetes mellitus, uveitis or a history of retinal disorders undergo an ophthalmic evaluation prior to initiating MAYZENT therapy and during treatment (see WARNINGS AND PRECAUTIONS, Ophthalmologic; and ADVERSE REACTIONS, Macular edema).