Tybost

TYBOST- cobicistat tablet, film coated
Gilead Sciences, Inc.

1 INDICATIONS AND USAGE

1.1 Indications

Adult Patients:

TYBOST is a CYP3A inhibitor indicated to increase systemic exposure of atazanavir or darunavir (once daily dosing regimen) in combination with other antiretroviral agents in the treatment of HIV-1 infection in adults [see Dosage and Administration (2.1)].

Pediatric Patients:

TYBOST is a CYP3A inhibitor indicated to increase systemic exposure of atazanavir or darunavir (once daily dosing regimen) in combination with other antiretroviral agents in the treatment of HIV-1 infection in pediatric patients [see Dosage and Administration (2.2)]:

  • weighing at least 35 kg coadministered with atazanavir or
  • weighing at least 40 kg coadministered with darunavir.

1.2 Limitations of Use

  • TYBOST is not interchangeable with ritonavir to increase systemic exposure of darunavir 600 mg twice daily, fosamprenavir, saquinavir, or tipranavir due to lack of exposure data. The use of TYBOST is not recommended with darunavir 600 mg twice daily, fosamprenavir, saquinavir, or tipranavir [see Warnings and Precautions (5.4)].
  • Complex or unknown mechanisms of drug interactions preclude extrapolation of ritonavir drug interactions to certain TYBOST interactions. TYBOST and ritonavir when administered with either atazanavir or darunavir may result in different drug interactions when used with concomitant medications [see Warnings and Precautions (5.3), Drug Interactions (7), and Clinical Pharmacology (12.3)].

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage in Adults

Administer TYBOST in conjunction with atazanavir or darunavir and other antiretroviral agents in the treatment of adults with HIV-1 infection. The recommended dosages of TYBOST and atazanavir or darunavir given with food are presented in Table 1. TYBOST must be coadministered at the same time as atazanavir or darunavir [see Drug Interactions (7)]. Consult the prescribing information for atazanavir or darunavir.

Table 1 Recommended Dosing Regimens in Treatment-Naïve or Treatment-Experienced Adults
TYBOST Dosage Coadministered Agent Dosage Patient Populations
150 mg orally once daily atazanavir 300 mg orally once daily Treatment-naïve or treatment-experienced
darunavir 800 mg orally once daily Treatment-naïve or treatment-experienced with no darunavir resistance-associated substitutions

2.2 Recommended Dosage in Pediatric Patients

Administer TYBOST in conjunction with atazanavir or darunavir and other antiretroviral agents in the treatment of pediatric patients with HIV-1 infection. The recommended dosages of TYBOST and atazanavir or darunavir given with food are based on weight and presented in Table 2. TYBOST must be coadministered at the same time as atazanavir or darunavir [see Drug Interactions (7)]. Consult the prescribing information for atazanavir or darunavir.

Table 2 Recommended Dosing Regimens in Treatment-Naïve or Treatment-Experienced Pediatric Patients
TYBOST Dosage Coadministered Agent Dosage Patient Populations and Weight
150 mg orally once daily atazanavir 300 mg orally once daily Treatment-naïve or treatment-experienced weighing at least 35 kg
darunavir 800 mg orally once daily Treatment-naïve or treatment-experienced with no darunavir resistance-associated substitutions weighing at least 40 kg

2.3 Testing Prior to Initiation of TYBOST

Prior to or when initiating TYBOST and during treatment with TYBOST, on a clinically appropriate schedule, assess estimated creatinine clearance because TYBOST decreases estimated creatinine clearance due to inhibition of tubular secretion of creatinine without affecting actual renal glomerular function [see Warnings and Precautions (5.1)]. When coadministering TYBOST with TDF, assess estimated creatinine clearance, urine glucose, and urine protein at baseline. In patients with chronic kidney disease, also assess serum phosphorus [see Warnings and Precautions (5.2)].

2.4 Renal Impairment

TYBOST coadministered with TDF is not recommended in patients who have an estimated creatinine clearance below 70 mL/min because dose adjustment of TDF is required below 50 mL/min and such dose adjustments have not been established for coadministration with TYBOST [see Warnings and Precautions (5.2) and Adverse Reactions (6.1)].

2.5 Not Recommended During Pregnancy

TYBOST coadministered with darunavir is not recommended for use 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)].

TYBOST coadministered with atazanavir is not recommended for use during pregnancy because of substantially lower exposures of cobicistat during the second and third trimesters [see Use in Specific Populations (8.1) and Clinical Pharmacology (12.3)].

TYBOST coadministered with darunavir or atazanavir should not be initiated in pregnant individuals. An alternative regimen is recommended for individuals who become pregnant during therapy with TYBOST coadministered with darunavir or atazanavir.

3 DOSAGE FORMS AND STRENGTHS

Orange, round, biconvex, film-coated tablets debossed with “GSI” on one side and plain faced on the other side providing 150 mg of cobicistat.

4 CONTRAINDICATIONS

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 [see Drug Interactions (7.3) and Clinical Pharmacology (12.3)].

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

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