DARUNAVIR = DRV oral

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    Last updated: November 2022

     

    Prescription under medical supervision

     

    Therapeutic action

    • Antiretroviral, HIV protease inhibitor

    Indications

    • HIV infection, in combination with ritonavir (booster) and other antiretrovirals

    Forms and strengths

    • 75 mg, 150 mg, 400 mg and 600 mg tablets
    • 400 mg darunavir/50 mg ritonavir tablet

    Dosage

    Patients with no previous use of protease inhibitors

    • Single formulations
      • Child 14 to < 35 kg: 600 mg once daily (+ 100 mg ritonavir once daily)
      • Child ≥ 35 kg and adult: 800 mg once daily (+ 100 mg ritonavir once daily) 
    • Fixed-dose combination
      • Child ≥ 40 kg and ≥ 12 years and adult: two 400/50 mg tablets once daily

     

    Patients with previous use of protease inhibitors

    • Single formulations
      • Child 14 to < 25 kg: 375 mg 2 times daily (+ 50 mg ritonavir 2 times daily)
      • Child 25 to < 35 kg: 400 mg 2 times daily (+ 100 mg ritonavir 2 times daily)  
      • Child ≥ 35 kg and adult: 600 mg 2 times daily (+ 100 mg ritonavir 2 times daily)

    Duration

    • Depending on the efficacy and tolerance of darunavir and ritonavir.

    Contra-indications, adverse effects, precautions

    • Do not administer to children under 3 years; and to patients with severe hepatic impairment or allergy to sulfonamides (risk of cross-sensitivity). 
    • Do not combine with rifampicin (decreased plasma concentrations of darunavir). Replace rifampicin with rifabutin.
    • Administer with caution and monitor use in patients with haemophilia (increased bleeding) or mild to moderate hepatic impairment.
    • May cause:
      • gastrointestinal disturbances, headache, insomnia, fatigue, dizziness, peripheral neuropathy, renal disorders, myocardial infarction, hypertension, tachycardia, hyperglycaemia, hyperlipidaemia, lipodystrophy;
      • skin rash sometimes severe, hepatic disorders; in this event, stop treatment immediately.
    • Darunavir in combination with ritonavir reduces the efficacy of implants and oral contraceptives: use injectable medroxyprogesterone or an intrauterine device.
    • Pregnancy: no contra-indication; use 2 times daily dosing due to decreased plasma concentrations of darunavir during pregnancy.

    Remarks

    • Take with meals together with ritonavir.

    Storage

     
    –  Below 25 °C 
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