Darunavir

داروناویر

⚠ Unverified

🦠 Antiinfectives For Systemic UseProtease inhibitor (boosted with ritonavir)

Market / country: 🇺🇸 USA

Prezista (US)

🧮 Dose calculator

HIV-1 infection (treatment) · Regimen source: FDA Prezista · 2.3

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🛡️ Safety & information

Contraindications

  • ⛔ Drugs highly dependent on CYP3A with narrow therapeutic index (alfuzosin, ranolazine, dronedarone, colchicine in renal/hepatic impairment, lurasidone, pimozide, oral midazolam, triazolam, sildenafil for PAH, simvastatin, lovastatin, ergots…) and strong inducers (rifampin, St John’s wort). FDA Prezista · 4

Warnings

  • • Hepatotoxicity; severe skin reactions; contains a sulfonamide moiety (caution in sulfa allergy). FDA Prezista · 5

Formulations

👥 Special populations

  • 🤰 PregnancyUse with caution

    Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Prezista · 8.1

    “Risk Summary Prospective pregnancy data from the APR are not sufficient to adequately assess the risk of birth defects or miscarriage.”
  • 🤱 BreastfeedingUse with caution

    Label: use with caution while breastfeeding; see the label text. FDA Prezista · 8.2

    “Risk Summary The Centers for Disease Control and Prevention recommend that HIV-infected mothers not breastfeed their infants to avoid risking postnatal transmission of HIV.”
  • 👶 ChildrenUse with caution

    The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Prezista · 8.4

    “PREZISTA/ritonavir is not recommended in pediatric patients below 3 years of age because of toxicity and mortality observed in juvenile rats dosed with darunavir (from 20 mg/kg to 1000 mg/kg) up to days 23 to 26 of age [see Warnings and Precautions (5.10) , Use in Specific Populations (8.1) and Clinical Pharmacology …”
  • 👴 Older adultsUse with caution

    Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Prezista · 8.5

    “In general, caution should be exercised in the administration and monitoring of PREZISTA in elderly patients, reflecting the greater frequency of decreased hepatic function, and of concomitant disease or other drug therapy [see Clinical Pharmacology (12.3) ] .”
  • ⚥ Females & males of reproductive potentialUse with caution

    Label has advice on pregnancy testing, contraception or fertility for females and males. FDA Prezista · 8.3

    “Contraception Use of PREZISTA may reduce the efficacy of combined hormonal contraceptives and the progestin only pill.”

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