Livtencity Dosage/Direction for Use

Recommended dosage: The recommended dose of LIVTENCITY in adults and pediatric patients (12 years of age and older and weighing at least 35 kg) is 400 mg (two 200 mg tablets) twice daily resulting in a daily dose of 800 mg. Treatment duration may need to be individualised based on the clinical characteristics of each patient.
In the pivotal efficacy Study 303, 400 mg twice daily dose of LIVTENCITY was administered for 8 weeks (see Pharmacology: Pharmacodynamics: Clinical Trials under Actions).
Dose adjustment when co-administered with anti-convulsants: If LIVTENCITY is co-administered with carbamazepine, adjust the dosage of LIVTENCITY to 800-1,200 mg twice daily (see Interactions).
If LIVTENCITY is co-administered with phenytoin or phenobarbital, increase the dosage of LIVTENCITY to 1,200 mg twice daily (see Interactions).
Special patient populations: Elderly patients: No dose adjustment is required for patient over 65 years of age.
Paediatric patients: The recommended dosing regimen in pediatric patients 12 years of age and older and weighing at least 35 kg is the same as that in adults. Use of LIVTENCITY in this age group is based on the following: Evidence from controlled studies of LIVTENCITY in adults.
Population pharmacokinetic (PK) modeling and simulation demonstrating that age and body weight had no clinically meaningful effect on plasma exposures of LIVTENCITY.
LIVTENCITY exposure is expected to be similar between adults and children 12 years of age and older and weighing at least 35 kg.
The course of the disease is similar between adults and pediatric patients to allow extrapolation of data in adults to pediatric patients [see previous text and Pharmacology: Pharmacodynamics under Actions].
The safety and efficacy of LIVTENCITY have not been established in children younger than 12 years of age.
Renal impairment: No dose adjustment of LIVTENCITY is needed for patients with mild, moderate, or severe renal impairment. Administration of LIVTENCITY in patients with end stage renal disease (ESRD), including patients on dialysis, has not been studied (see Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: No dose adjustment of LIVTENCITY is needed for patients with mild (Child-Pugh Class A) or moderate hepatic impairment (Child-Pugh Class B). Administration of LIVTENCITY in patients with severe hepatic impairment (Child-Pugh Class C) has not been studied (see Pharmacology: Pharmacokinetics under Actions).
Method of administration: LIVTENCITY is intended for oral use only and can be taken with or without food. The immediate-release tablet can be taken as whole, dispersed, or crushed tablets by mouth, or as dispersed tablets through a polyvinyl chloride (PVC) or polyurethane nasogastric or orogastric tube (French size 10 or larger). The suspension may be prepared ahead of time and stored at room temperature for up to 8 hours.
Administration of dispersed or crushed tablets by mouth: 1. Place the appropriate number of tablets for the prescribed dose into a suitable container. If desired, the tablets may be crushed. Add the appropriate volume of drinking water (other liquids have not been tested) to make a suspension (see Table 7).
2. Swirl the container gently to keep the particles from settling and administer the suspension before it settles.
3. Rinse the container with 15 mL of drinking water and administer the rinsed water. (See Table 7.)

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4. Repeat Step 3. Visually confirm that no particles are left in the container. If particles remain, repeat Step 3.
Administration of dispersed tablets through a nasogastric (NG) or orogastric (OG) tube: 1. Remove the plunger out of a 50- or 60-mL syringe. Add two tablets into the syringe body and place the plunger back in the syringe.
2. Withdraw 30 mL of drinking water (other liquids have not been tested) into the syringe and hold the syringe with the tip pointing upward. Pull the plunger further to a higher volume position to have some air space in the syringe. Shake the syringe well (careful not to spill the contents) for about 30 to 45 seconds or until the tablets are completely dispersed.
3. Once the tablets are completely dispersed in the syringe, attach the syringe to the NG or OG tube and administer the dispersion before it settles.
4. Withdraw 15 mL of water using the same syringe and flush through the same NG or OG tube.
5. Repeat Step 4 and make sure no particles are left in the syringe by visual inspection. If particles remain, repeat Step 4.
For recommended doses of 800 mg and 1,200 mg (see Table 7), repeat Steps 1-5, two or three times accordingly. The same syringe, NG or OG tube can be used.