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Label Changes for:

Tybost (cobicistat)

June 2016

Changes have been made to the CONTRAINDICATIONS, WARNINGS and PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)  

June 2016

CONTRAINDICATIONS

Table 2 Drugs that are Contraindicated with Concomitant use with Tybost and Atazanaivr or Darunavir

Three drug classes added; please refer to label:

  • Antianginal (ranolazine)
  • Anti-gout (colcichine)
  • Antipsychotics (lurasidone and pimozide)

WARNINGS AND PRECAUTIONS

Antiretrovirals that are Not Recommended in Combination with TYBOST (addition to subheading)

DRUG INTERACTIONS

Table 6 Established and Other Potentially Significant Drug Interactions: Alteration in Dose or Regimen May Be Recommended Based on Drug Interaction Studies or Predicted Interaction

New Drug Class added; please refer to label:

  • Antipsychotic Drug class (perphenazine, risperidone, thioridazine, and quetiapine)

PATIENT COUNSELING INFORMATION

has been reformatted – refer to label.

PATIENT INFORMATION

Do not take TYBOST combined with atazanavir or darunavir if you also take any of the following medicines:

  • alfuzosin hydrochloride (UROXATRAL®)
  • carbamazepine (CARBATROL®, EPITOL®, EQUETRO®, TEGRETOL®)
  • cisapride (PROPULSID®, PROPULSID® QUICKSOLV)
  • colchicine (COLCRYS , MITIGARE™), if you have liver or kidney problems
  • dronedarone hydrochloride (MULTAQ®)
  • ergot-containing medicines:
    • dihydroergotamine mesylate (D.H.E. 45®, MIGRANAL®)
    • ergotamine tartrate (CAFERGOT®, MIGERGOT®, ERGOSTAT®, MEDIHALER ERGOTAMINE®, WIGRAINE®, WIGRETTES®)
    • methylergonovine maleate (ERGOTRATE®, METHERGINE®)
  • lovastatin (ADVICOR®, ALTOPREV®, MEVACOR®)
  • lurasidone (LATUDA®)
  • midazolam (VERSED®), when taken by mouth
  • phenobarbital (LUMINAL®)
  • phenytoin (DILANTIN®, PHENYTEX®)
  • pimozide (ORAP®)
  • ranolazine (RANEXA®)
  • rifampin (RIFADIN®, RIFAMATE®, RIFATER®, RIMACTANE®)
  • sildenafil (REVATIO®), when used for treating the lung problem pulmonary arterial hypertension (PAH)
  • simvastatin (SIMCOR®, VYTORIN®, ZOCOR®)
  • St. John’s wort (Hypericum perforatum) or a product that contains St. John’s wort
  • triazolam (HALCION®)

 

November 2015

CONTRAINDICATIONS

Table 2 Drugs that are Contraindicated with Concomitant use with Tybost and Atazanavir or Darunavir
  • Anticonvulsants (carbamazepine, phenobarbital, phenytoin): Potential for decreased atazanavir or darunavir plasma concentrations, which may result in loss of therapeutic effect and development of resistance.

 

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