PREZCOBIX - Tablet Splitting, Crushing, or Chewing

Summary

• PREZCOBIX is available in two different dosage forms¹:
  • 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
• Johnson & Johnson has no internal stability data regarding dissolving crushed 800 mg/150 mg or 675 mg/150 mg tablets into water, juice, or other liquids, or mixing with food (i.e., applesauce).
• In addition, no studies have been conducted to determine if adsorption of drug to plastic material may occur when crushed tablets are administered via NG or PEG tubes.
• For children 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.¹
• PREZCOBIX PED 600 mg/90 mg film-coated tablets for oral suspension are available for pediatric patients aged 3 years and older and weighing at least 15 kg to less than 25 kg. PREZCOBIX PED must be dispersed in drinking water and taken immediately. The patient should not crush, chew, or swallow the PREZCOBIX PED tablet for oral suspension.¹
• In a study conducted in Italy, when PREZCOBIX 800 mg/150 mg was crushed and suspended in either a commercially available base vehicle (Syrspend^®) or a 1% w/v carboxymethylcellulose (CMC) aqueous suspension, both darunavir (DRV) and cobicistat (COBI) remained within ±20% of the initial value for 7 days when stored at 4°C and at room temperature (~25°C).²

Clinical data

Zanon et al (2020)² evaluated the chemical stability of PREZCOBIX suspended in either Syrspend^® or a 1% w/v CMC aqueous suspension.

• In this study, 2 tablets of PREZCOBIX were crushed in a mortar to obtain a fine and homogenous powder.
• The powder was mixed with 20 mL of the suspension vehicle (Syrspend^® or a 1% w/v CMC solution in pH 4.2 citrate buffer) to obtain a suspension containing 20 mg/mL of DRV and 3.75 mg/mL of COBI.
• Aliquots of the suspensions (1.5 mL each) were stored at 4°C and room temperature (~25°C) for 1 week.
• On days 0, 3, and 7, samples were analyzed using high pressure liquid chromatography (HPLC).
• Data on the chemical stability of DRV and COBI are presented in Table. Chemical Stability of DRV and COBI in Syrspend^®-based Extemporaneous Suspension and Table. Chemical Stability of DRV and COBI in CMC-based Extemporaneous Suspension.

LITERATURE SEARCH

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, DERWENT^® (and/or other resources, including internal/external databases) was conducted on 15 April 2026.