DARUNAVIR = DRV

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    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, 300 mg, 400 mg and 600 mg tablets

    Dosage

    Patients with no previous use of protease inhibitors

    • 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)

     

    Patients with previous use of protease inhibitors

    • 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

    • The duration of treatment depends on the efficacy and tolerance of darunavir and ritonavir.

    Contra-indications, adverse effects, precautions

    • Do not administer in children under 3 years; in case of severe hepatic impairment, history of allergy to sulfonamides or in combination with rifampicin.
    • Administer with caution and monitor use in patients with haemophilia (increased bleeding) or in patients with mild or 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 oral contraceptives: use a non-hormonal contraception or injectable medroxyprogesterone or an oral contraceptive containing 50 micrograms of ethinylestradiol per tablet.
    • Pregnancy: no contra-indication

    Remarks

    • Take with meals together with ritonavir.

    Storage

     
    - Below 25 °C