Enfuvirtide

CLINICAL USE


Treatment of HIV-1 in combination with other antiretroviral agents

DOSE IN NORMAL RENAL FUNCTION

90 mg twice daily

PHARMACOKINETICS

  • Molecular weight &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp :4491.9
  • %Protein binding &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp :92
  • %Excreted unchanged in urine &nbsp &nbsp : No data

  • Volume of distribution (L/kg) &nbsp &nbsp &nbsp :4.4–6.6 litres

  • half-life – normal/ESRD (hrs)&nbsp &nbsp &nbsp :3.2–4.4/Probably unchanged

    DOSE IN RENAL IMPAIRMENT

    GFR (mL/MIN)

    35–50 Dose as in normal renal function10–35 Dose as in normal renal function1
  • <10 &nbsp &nbsp &nbsp &nbsp &nbsp : Dose as in normal renal function1

    DOSE IN PATIENTS UNDERGOING RENAL REPLACEMENT THERAPIES

  • CAPD &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp:Unlikely to be dialysed. Dose as in GFR <10 mL/min

  • HD &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp :13% dialysed.1 Dose as in GFR <10 mL/min
  • HDF/high flux &nbsp :Unlikely to be dialysed. Dose as in GFR <10 mL/min
  • CAV/VVHD &nbsp &nbsp &nbsp:Unlikely to be dialysed. Dose as in GFR=10–35 mL/min

    IMPORTANT DRUG INTERACTIONS

    Potentially hazardous interactions with other drugs
  • None known

    ADMINISTRATION

    Reconstition

    1.1 mL water for injection

    Route

    SC

    Rate of Administration

    –

    Comments

    Do not shake vial or turn it upside down as this causes foamingThe powder may take up to 45 minutes to dissolveUse within 24 hours if kept in refrigerator. Allow to reach room temperature before injecting

    OTHER INFORMATION

    Renal calculi have been reported with enfuvirtide therapyC max and AUC are increased in CKD 5 patients
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