Prezcobix (Darunavir and Cobicistat) – HIV | HongKong DengYue Medicine

Darunavir and Cobicistat Application Scope

For the treatment of HIV-1 infection in adults and adolescents (≥40 kg), in combination with other antiretroviral agents. Not for use as monotherapy.

Darunavir and Cobicistat Characteristics

• Ingredients:Darunavir 800 mg, Cobicistat 150 mg (per tablet)

• Properties:​Fixed-dose combination of a protease inhibitor (darunavir) and a pharmacokinetic enhancer (cobicistat). Used as part of antiretroviral therapy (ART) for the treatment of HIV-1 infection.

• Packaging Specification:​Each box contains 30 film-coated tablets, each tablet contains darunavir 800 mg and cobicistat 150 mg.

• Storage:​Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

• Expiry Date:Refer to the packaging for specific expiration date.

• Executive Standard: ​Manufactured according to current Good Manufacturing Practice (cGMP) standards.

• Approval Number:Vary by country. Example (U.S. FDA): NDA 205395

• Date of Revision:[Insert applicable date – e.g., August 2025]

• Manufacturer:Janssen Therapeutics, Division of Janssen Products, LP

Guidelines for the Use of Prezcobix

• Dosage and Administration:

  • Recommended Dose: One tablet (darunavir 800 mg/cobicistat 150 mg) once daily.

  • Administration: Administer orally with food to improve absorption.

  • Missed Dose: If a dose is missed by less than 12 hours, take it with food as soon as possible. If more than 12 hours, skip the dose and take the next dose at the regular time. Do not double the dose.

• Adverse Reactions:

  • Common Adverse Reactions (≥5% and >3% higher than placebo):

    • • Diarrhea

      • Nausea

      • Rash

      • Headache

      • Abdominal pain

  • Serious Adverse Reactions:

    • • Severe skin reactions (e.g., Stevens-Johnson syndrome)

      • Hepatotoxicity

      • Immune reconstitution syndrome

• Contraindications:

  • Known hypersensitivity to darunavir, cobicistat, or any component of the formulation

  • Concurrent use with drugs highly dependent on CYP3A for clearance, for which elevated plasma concentrations are associated with serious adverse events

• Precautions:

  Hepatic Impairment:
  Use with caution in patients with underlying liver disease.

  Drug Interactions:
  Potential for multiple drug-drug interactions; review concomitant medications carefully.

  Pregnancy and Lactation:
  Limited human data. Use only if clearly needed. Cobicistat may reduce the effectiveness of hormonal contraceptives.

Darunavir and Cobicistat Interactions

• Darunavir and cobicistat may interact with drugs metabolized by CYP3A. Avoid coadministration with drugs that are highly dependent on CYP3A for clearance or have narrow therapeutic windows.

 

Note:

• If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
•  This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.