Cobicistat

What it is used for

PREZCOBIX is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in treatment-naïve and treatment-experienced adults and pediatric patients weighing at least 40 kg with no darunavir resistance-associated substitutions (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, L89V).

PREZCOBIX is a two-drug combination of darunavir, a human immunodeficiency virus (HIV-1) protease inhibitor, and cobicistat, a CYP3A inhibitor, and is indicated for the treatment of HIV-1 infection in treatment-naïve and treatment-experienced adults and pediatric patients weighing at least 40 kg with no darunavir resistance-associated substitutions (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, L89V).

Side effects, and when to stop

The following adverse reaction is described in greater detail in another section of the labeling:

• New Onset or Worsening Renal Impairment When Used with Tenofovir Disoproxil Fumarate.

Who should not take it

The concomitant use of TYBOST with atazanavir or darunavir and the following drugs is contraindicated due to the potential for serious and/or life-threatening events or loss of therapeutic effect.

• Alpha 1-adrenoreceptor antagonist: alfuzosin
• Antianginal: ranolazine
• Antiarrhythmic: dronedarone
• Anticonvulsants: carbamazepine, phenobarbital, phenytoin
• Anti-gout: colchicine
• Antimycobacterial: rifampin
• Antineoplastics: irinotecan These contraindications apply only to TYBOST coadministered with atazanavir
• Antipsychotics: lurasidone, pimozide
• Ergot Derivatives: dihydroergotamine, ergotamine, methylergonovine
• Herbal Products: St. John's wort ( Hypericum perforatum )
• Hormonal Contraceptives: drospirenone/ ethinyl estradiol
• Lipid-modifying Agents: lomitapide, lovastatin, simvastatin
• Non-nucleoside Reverse Transcriptase Inhibitor: nevirapine
• Phosphodiesterase-5 (PDE-5) Inhibitor: sildenafil when administered as Revatio ® for the treatment of pulmonary arterial hypertension
• Protease Inhibitor: indinavir
• Sedative/hypnotics triazolam, orally administered midazolam

Storing it

• TYBOST tablets, 150 mg, are orange, round, biconvex, film-coated, and debossed with “GSI” on one side and plain faced on the other side. (NDC 61958-1401-1).
• TYBOST tablets, 90 mg, are white, round, biconvex, film-coated, and debossed with “TYB” on one side and “ 90 ” on the other side. (NDC 61958-1402-1).

Store at 25 °C (77 °F); excursions permitted to 15°C –30 °C (59–86 °F) (see USP Controlled Room Temperature).

• Keep container tightly closed.
• Dispense only in original container.
• Do not use if seal over bottle opening is broken or missing.