HIGHLIGHTS OF PRESCRIBING INFORMATION

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

INDICATIONS AND USAGE

LuciTena is a sodium hydrogen exchanger 3 (NHE3) inhibitor indicated to reduce serum phosphorus inadults with chronic kidney disease (CKD) on dialysis as add-on therapy in patients who have an inadequateresponse to phosphate binders or who are intolerant of any dose of phosphate binder therapy.

DOSAGE AND ADMINISTRATION

• Recommended dosage: 30 mg orally twice daily before the morning and evening meals.

• Manage serum phosphorus levels and tolerability with dosage adjustments.

• Take just prior to the first and last meals of the day.

• Instruct patients not to take right before a hemodialysis session, and instead take right before the next meal following dialysis. 

DOSAGE FORMS AND STRENGTHS

Tablets: 30 mg×14 tablets

CONTRAINDICATIONS

Pediatric patients under 6 years of age.

Patients with known or suspected mechanical gastrointestinal obstruction.

WARNINGS AND PRECAUTIONS

Patients may experience severe diarrhea. 

ADVERSE REACTIONS

Most common adverse reaction in the combined clinical trials was diarrhea, reported by 43-53% of

patients. 

DRUG INTERACTIONS

• OATP2B1 Substrates: Potential for reduced exposure of the concomitant drug (e.g., enalapril). Monitor for signs related to loss of efficacy and adjust the dosage of the concomitantly administered drug as needed.

• Sodium Polystyrene Sulfonate (SPS): Separate administration by at least three hours. 

Storage

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