nt with MAYZENT is considered in patients:
With some preexisting heart and cerebrovascular conditions [see Warnings and Precautions (5.3)]
With a prolonged QTc interval before dosing or during the 6-hour observation, or at additional risk for QT
prolongation, or on concurrent therapy with QT prolonging drugs with a known risk of torsades de pointes [seeWarnings and Precautions (5.3) and Drug Interactions (7.2)]
Receiving concurrent therapy with drugs that slow heart rate or AV conduction [see Drug Interactions (7.2, 7.3)]
2.5 Reinitiation of MAYZENT After Treatment Interruption
After the initial titration is complete, if MAYZENT treatment is interrupted for 4 or more consecutive daily doses,reinitiate treatment with Day 1 of the titration regimen [see Dosage and Administration (2.2, 2.3)]; also complete firstdosemonitoring in patients for whom it is recommended [see Dosage and Administration (2.4)].
3 DOSAGE FORMS AND STRENGTHS0.25 mg tablet: Pale red, unscored, round biconvex film-coated tablet with beveled edges, debossed with on one side &‘T’ on other side.
2 mg tablet: Pale yellow, unscored, round biconvex film-coated tablet with beveled edges, debossed with on one side& ‘II’ on other side.
4 CONTRAINDICATIONS
MAYZENT is contraindicated in patients who have:
A CYP2C9*3/*3 genotype [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.5)]
In the last 6 months experienced myocardial infarction, unstable angina, stroke, TIA, decompensated heart failurerequiring hospitalization, or Class III or IV heart failure Presence of Mobitz type II second-degree, third-degree AV block, or sick sinus syndrome, unless patient has afunctioning pacemaker [see Warnings andPrecautions (5.3)]
5 WARNINGS AND PRECAUTIONS
5.1 Infections
Risk of Infections
MAYZENT causes a dose-dependent reduction in peripheral lymphocyte count to 20%-30% of baseline values because ofreversible sequestration of lymphocytes in lymphoid tissues. MAYZENT may therefore increase the risk of infections,some serious in nature [see Clinical Pharmacology (12.2)]. Life-threatening and rare fatal infections have occurred inassociation with MAYZENT.
In Study 1 [see Clinical Studies (14)], the overall rate of infections was comparable between the MAYZENT-treated
patients and those on placebo (49.0% vs. 49.1% respectively). However, herpes zoster, herpes infection, bronchitis,
sinusitis, upper respiratory infection, and fungal skin infection were more common in MAYZENT-treated patients. In
Study 1, serious infections occurred at a rate of 2.9% in MAYZENT-treated patients compared to 2.5% of patients
receiving placebo.
Before initiating treatment with MAYZENT, results from a recent complete blood count (i.e., within 6 months or after
discontinuation of prior therapy) should be reviewed.
Initiation of treatment with MAYZENT should be delayed in patients with severe active infection until resolution.
Because residual pharmacodynamic effects, such as lowering effects on peripheral lymphocyte count, may persist for upto 3-4 weeks after discontinuation of MAYZENT, vigilance for infection should be continued throughout this period [seeWarnings and Precautions (5.11)].
Effective diagnostic and therapeutic strategies should be employed in patients with symptoms of infection while ontherapy. Suspensi |
