Cardiac Evaluation

Obtain a cardiac evaluation in patients with certain preexisting conditions [see Dosage and Administration (2.4) and Warnings and Precautions (5.1)].

Prior to starting treatment, determine whether patients are taking drugs that could slow heart rate or atrioventricular (AV) conduction [see Dosage and Administration (2.4), Drug Interactions (7.5)].

Complete Blood Count (CBC)

Review results of a recent CBC [see Warnings and Precautions (5.2), Drug Interactions (7.6)].

Serum transaminases (ALT and AST) and Total Bilirubin Levels

Prior to starting treatment with TASCENSO ODT (i.e., within 6 months), review serum transaminases (ALT and AST) and total bilirubin levels [see Warnings and Precautions (5.5)].

Prior Medications

If patients are taking antineoplastic, immunosuppressive, or immune-modulating therapies, or if there is a history of prior use of these drugs, consider possible unintended additive immunosuppressive effects prior to initiating treatment with TASCENSO ODT [see Warnings and Precautions (5.2), Drug Interactions (7.4)].

Vaccinations

Prior to initiating TASCENSO ODT, test patients for antibodies to varicella zoster virus (VZV). VZV vaccination of antibody- negative patients is recommended prior to commencing treatment with TASCENSO ODT [see Warnings and Precautions (5.2)]. It is recommended that pediatric patients if possible, complete all other immunizations in accordance with current immunization guidelines prior to initiating TASCENSO ODT.

First 6-Hour Monitoring

Administer the first dose of TASCENSO ODT in a setting in which resources to appropriately manage symptomatic bradycardia are available. Monitor all patients for 6 hours after the first dose for signs and symptoms of bradycardia with hourly pulse and blood pressure measurement.

Additional Monitoring after 6-Hour Monitoring

Continue monitoring until the abnormality resolves if any of the following is present (even in the absence of symptoms) after 6 hours:

• ​The heart rate 6 hours postdose is less than 45 bpm in adults, less than 55 bpm in pediatric patients 12 years of age and older, or less than 60 bpm in pediatric patients 10 or 11 years of age
• The heart rate 6 hours postdose is at the lowest value postdose suggesting that the maximum pharmacodynamic effect on the heart may not have occurred
• The ECG 6 hours postdose shows new onset second degree or higher AV block.

If postdose symptomatic bradycardia occurs, initiate appropriate management, begin continuous ECG monitoring, and continue monitoring until the symptoms have resolved if no pharmacological treatment is required. If pharmacological treatment is required, continue monitoring overnight and repeat 6-hour monitoring after the second dose.

Overnight Monitoring

Continuous overnight ECG monitoring in a medical facility should be instituted:

• in patients that require pharmacologic intervention for symptomatic bradycardia. In these patients, the first-dose monitoring strategy should be repeated after the second dose of TASCENSO ODT
• in patients with some preexisting heart and cerebrovascular conditions [see Warnings and Precautions (5.1)]
• in patients with a prolonged QTc interval before dosing or during 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 [see Warnings and Precautions (5.1), Drug Interactions (7.1)]
• in patients receiving concurrent therapy with drugs that slow heart rate or AV conduction [see Drug Interactions (7.5)].