HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use LuciLeter safely and effectively. See full prescribing information for LuciLeter.

INDICATIONS AND USAGE

LuciLeter is a CMV DNA terminase complex inhibitor indicated for:

• Prophylaxis of cytomegalovirus (CMV) infection and disease in adult and pediatric patients 6 months of age and older and weighing at least 6 kg who are CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT).

• Prophylaxis of CMV disease in adult and pediatric patients 12 years of age and older and weighing at least 40 kg who are kidney transplant recipients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-]).

DOSAGE AND ADMINISTRATION

• Adult and Pediatric Patients 12 Years of Age and Older and Weighing at least 30 kg Who Are HSCT Recipients or Adult and Pediatric Patients 12 Years of Age and Older and Weighing at least 40 kg Who Are Kidney Transplant Recipients:

o HSCT: 480 mg administered once daily orally or as an intravenous (IV) infusion over 1 hour through 100 days post-HSCT. In patients at risk for late CMV infection and disease, LuciLeter may be continued through 200 days post-HSCT.

o Kidney Transplant: 480 mg administered once daily orally or as an IV infusion over 1 hour through 200 days post-transplant.

• Pediatric Patients 6 Months to Less than 12 Years of Age or 12 Years of Age and Older and Weighing Less than 30 kg Who Are HSCT Recipients:

    o HSCT: Dosing based on weight administered once daily orally or as an IV infusion over 1 hour through 100 days post-HSCT. In patients at risk for late CMV infection and disease, LuciLeter may be continued through 200 days post-HSCT.

• Following the completion of LuciLeter prophylaxis, monitoring for CMV reactivation in HSCT recipients is recommended.

• Dosage Adjustment: If LuciLeter is co-administered with cyclosporine, the dosage of LuciLeter should be decreased to 240 mg once daily in adult and pediatric patients 12 years of age and older.  If LuciLeter is co-administered with cyclosporine in pediatric patients less than 12 years of age, dose adjustment may be required.

DOSAGE FORMS AND STRENGTHS

Tablets: 240 mg×30 tablets

CONTRAINDICATIONS

LuciLeter is contraindicated with:

 • Pimozide.

 • Ergot Alkaloids.

 • Pitavastatin and simvastatin when co-administered with cyclosporine.

WARNINGS AND PRECAUTIONS

• Risk of Adverse Reactions or Reduced Therapeutic Effect Due to Drug Interactions: The concomitant use of LuciLeter with certain drugs may result in potentially significant drug interactions, some of which may lead to adverse reactions (LuciLeter or concomitant drugs) or reduced therapeutic effect of LuciLeter or the concomitant drug. Consult the full prescribing information for contraindications and dosage recommendations for concomitant drugs.

• Risks Associated with Hydroxypropyl Betadex Excipient in Intravenous Formulation: Intravenous formulation of LuciLeter contains the excipient hydroxypropyl betadex. LuciLeter injection should be used only in patients unable to take oral therapy. If possible, intravenous administration should not exceed 4 weeks. In patients with renal impairment, accumulation of hydroxypropyl betadex may occur. Animal studies have shown the potential for hydroxypropyl betadex to cause ototoxicity.

ADVERSE REACTIONS

• Adult HSCT Patients: Most common adverse events (occurring in at least 10% of subjects in the LuciLeter group and at a frequency at least 2% greater than placebo) are nausea, diarrhea, vomiting, peripheral edema, cough, headache, fatigue, and abdominal pain.

• Adult Kidney Transplant Patients: Most common adverse event (occurring in at least 10% of subjects in the LuciLeter group and at a frequency greater than valganciclovir) is diarrhea.

• Pediatric Patients: Adverse events in pediatric patients are similar to adults.

DRUG INTERACTIONS

• Dosage Adjustment: If LuciLeter is co-administered with cyclosporine, the dosage of LuciLeter should be decreased to 240 mg once daily in adult and pediatric patients 12 years of age and older. (2.4) If LuciLeter is co-administered with cyclosporine in pediatric patients less than 12 years of age, dose adjustment may be required.

• Co-administration of LuciLeter may alter the plasma concentrations of other drugs and other drugs may alter the plasma concentrations of LuciLeter. Consult the full prescribing information prior to and during treatment for potential drug interactions.

USE IN SPECIFIC POPULATIONS

• Renal Impairment: Closely monitor serum creatinine levels in patients with CLcr less than 50 mL/min using LuciLeter injection.

• Hepatic Impairment: LuciLeter is not recommended for patients with severe (Child-Pugh C) hepatic impairment.

Storage

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Protect from moisture.