PREZCOBIX

2 DOSAGE AND ADMINISTRATION Recommended dosage: Adults and pediatric patients weighing at least 40 kg: One 800 mg/150 mg tablet taken once daily with food. ( 2.1 , 2.2 ) Pediatric patients weighing at least 25 kg to less than 40 kg: One 675 mg/150 mg tablet taken once daily with food. ( 2.1 , 2.2 ) Pediatric patients 3 years of age and older weighing at least 15 kg to less than 25 kg: One 600 mg/90 mg tablet for oral suspension taken once daily with food. PREZCOBIX PED must be dispersed in drinking water and taken immediately with food. ( 2.2 , 2.3 ) Testing Prior to Initiation: HIV genotypic testing is recommended for antiretroviral treatment experienced patients. Assess estimated creatinine clearance in all patients prior to starting PREZCOBIX or PREZCOBIX PED. When used with tenofovir disoproxil fumarate (TDF): Assess urine glucose and urine protein at baseline and monitor creatinine clearance, urine glucose, and urine protein. Monitor serum phosphorus in patients with or at risk for renal impairment. ( 2.5 ) 2.1 Overview of Different Dosage Forms Two different dosage forms are available: PREZCOBIX Tablets: 800 mg/150 mg film-coated tablets for adults and pediatric patients weighing at least 40 kg. 675 mg/150 mg film-coated tablets for pediatric patients weighing at least 25 kg to less than 40 kg. PREZCOBIX PED Tablets for Oral Suspension: 600 mg/90 mg film-coated tablet for oral suspension for pediatric patients aged 3 years and older weighing at least 15 kg to less than 25 kg [see Dosage and Administration (2.2 , 2.3) ] . 2.2 Recommended Dosage in Adults and Pediatrics 3 Years of Age and Older Weighing at Least 15 kg The recommended dosages for adults and pediatric patients weighing at least 15 kg are shown in Table 1. The pediatric dose is based on weight. PREZCOBIX and PREZCOBIX PED are taken orally with food once daily in conjunction with other antiretroviral agents. Table 1: Recommended Dosages of PREZCOBIX and PREZCOBIX PED in Adults and Pediatric Patients Weighing at Least 15 kg, who are Treatment-Naïve or Treatment-Experienced Without DRV RAMs DRV-resistance-associated mutations (RAMs): V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V, L89V. Patient Population Total Daily Dose Adults and pediatric patients weighing at least 40 kg One PREZCOBIX 800 mg darunavir/150 mg cobicistat tablet Pediatric Patients weighing at least 25 kg to less than 40 kg One PREZCOBIX 675 mg darunavir/150 mg cobicistat tablet Pediatric Patients aged 3 years and older weighing at least 15 kg to less than 25 kg One PREZCOBIX PED 600 mg darunavir/90 mg cobicistat tablet for oral suspension Before prescribing PREZCOBIX 675 mg/150 mg tablets, children should be assessed for the ability to swallow tablets. For patients unable to swallow the 675 mg/150 mg tablet whole, the scored tablet may be split by hand into two pieces. Each piece should be consumed immediately after splitting to ensure the entire dose is administered. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 2.3 Preparation and Administration Instructions for PREZCOBIX PED Advise patients or caregivers of patients taking PREZCOBIX PED to refer to the Instructions for Use to properly prepare and take the medication. PREZCOBIX PED must be dispersed in drinking water and taken immediately as described below. If not taken immediately, then the oral suspension should be discarded, and a new dose of medicine should be prepared. The patient should not crush, chew or swallow the PREZCOBIX PED tablet for oral suspension. The following instructions should be followed: Place the tablet for oral suspension in a cup, add 30 mL (2 tablespoons) of non-carbonated room temperature drinking water. Stir well with a spoon until the tablet is completely dispersed. The prepared medicine will appear reddish purple. Take all the prepared medicine immediately or to aid in administration, the prepared medicine can be further diluted with 10 mL (2 teaspoons) of water, orange juice, or 1 teaspoon of applesauce or yogurt. Mix and take the entire mixture immediately. Add another 5 mL (1 teaspoon) of non-carbonated drinking water to the cup, swirl and drink completely. This step may be repeated as needed to ensure the entire dose is consumed. 2.4 Testing Prior to Initiation of PREZCOBIX or PREZCOBIX PED HIV Genotypic Testing HIV genotypic testing is recommended for antiretroviral treatment-experienced patients. However, when HIV genotypic testing is not feasible, PREZCOBIX or PREZCOBIX PED can be used in protease inhibitor-naïve patients, but is not recommended in protease inhibitor-experienced patients. Creatinine Clearance Prior to starting PREZCOBIX or PREZCOBIX PED, assess estimated creatinine clearance because cobicistat decreases estimated creatinine clearance due to inhibition of tubular secretion of creatinine without affecting actual renal glomerular function [see Warnings and Precautions (5.3) ] . When co-administering PREZCOBIX or PREZCOBIX PED with tenofovir disoproxil fumarate (tenofovir DF) assess estimated creatinine clearance, urine glucose, and urine protein at baseline [see Warnings and Precautions (5.4) ] . 2.5 Not Recommended in Severe Renal Impairment PREZCOBIX or PREZCOBIX PED co-administered with tenofovir DF is not recommended in patients who have an estimated creatinine clearance below 70 mL per minute [see Warnings and Precautions (5.4) and Adverse Reactions (6) ] . 2.6 Not Recommended in Severe Hepatic Impairment PREZCOBIX or PREZCOBIX PED is not recommended for use in patients with severe hepatic impairment [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3) ] . 2.7 Not Recommended During Pregnancy PREZCOBIX or PREZCOBIX PED is not recommended during pregnancy because of substantially lower exposures of darunavir and cobicistat during the second and third trimesters [see Use in Specific Populations (8.1) and Clinical Pharmacology (12.3) ] . PREZCOBIX or PREZCOBIX PED should not be initiated in pregnant individuals. An alternative regimen is recommended for those who become pregnant during therapy with PREZCOBIX or PREZCOBIX PED.

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1 INDICATIONS AND USAGE PREZCOBIX and PREZCOBIX PED are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) in treatment-naïve and treatment-experienced adults and pediatric patients 3 years of age and older weighing at least 15 kg with no darunavir resistance-associated substitutions (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, L89V) [see Use in Specific Populations (8.4) and Clinical Studies (14) ] .