Xcopri Dosage

General Dosing Recommendations

Monotherapy and Adjunctive Therapy

XCOPRI is administered orally once daily with or without food. The recommended dosage and titration, which should not be exceeded because of the potential for serious adverse reactions [see Warnings and Precautions (5.2)], is included in Table 1.

Dosage Modifications in Patients with Hepatic Impairment

For patients with mild to moderate (Child-Pugh Class A to B) hepatic impairment, the maximum recommended dosage is 200 mg once daily [see Use in Specific Populations (8.7)]. XCOPRI is not recommended for use in patients with severe (Child-Pugh Class C) hepatic impairment [see Clinical Pharmacology (12.3)].

​2.3 Administration Instructions

​XCOPRI can be taken whole or the tablets can be crushed. The crushed tablet can be mixed with water and either administered by mouth as an oral suspension or administered via a nasogastric tube, as described below [see Clinical Pharmacology (12.3)].

Administration of Crushed Tablets by Mouth as Oral Suspension

1. ​Crush the appropriate number of tablet(s) for the prescribed dose.
2. ​In a cup, combine the crushed tablet(s) and 25 mL of water.
3. ​Swirl to suspend the crushed tablet(s).
4. ​Drink the suspension immediately. Do not store the tablet-water mixture for later use.
5. ​To ensure no tablet residue is left in the container, rinse the container with 25 mL of water and drink.
6. ​Visually confirm that no particles are left in the container. If particles remain, repeat step 5.

Administration of Crushed Tablets via Nasogastric (NG) Tube

1. ​Crush the appropriate number of tablet(s) for the prescribed dose.
2. ​In an appropriate container, combine the crushed tablet(s) and 25 mL of water.
3. ​Swirl to suspend the crushed tablet(s).
4. ​Ensuring no particles are left in the container, instill the suspension with a syringe into the NG tube.
5. ​Refill the catheter-tip syringe again with 10 mL of water, swirl gently, and administer.
6. ​Visually confirm that no particles are left in the syringe. If particles remain, repeat step 5.

​2.4 Discontinuation of XCOPRI

​If XCOPRI is discontinued, the dosage should be gradually reduced over a period of at least 2 weeks, unless safety concerns require abrupt withdrawal [see Warnings and Precautions (5.1, 5.5)].