Darunavir
PREZISTA
Pronunciation: da-ROON-a-veer (pre-ZIS-ta)
What it isHIV protease inhibitor; treatment-experienced and first-line HIV.
Why this oneHighest resistance barrier of the protease inhibitors, so it holds up against resistant virus.
What limits itRequires ritonavir or cobicistat boosting, bringing CYP3A4 interactions. Rash; it is a sulfonamide.
Darunavir prescription history
Animated chart of estimated U.S. prescriptions per year, HIV antiretrovirals (1987–2026). Darunavir enters in 2006 (estimated).
FDA-approved for
- HIV infection (2006)
Principal riskBoosting brings CYP3A4 interactions; it is a sulfonamide
Sulfonamide
Sulfonamide-derived drug (non-antibacterial) — label warns
The exception in the non-antibacterial class: its sulfonamide is a 4-aminobenzenesulfonamide — the sulfanilamide fragment, N4 aromatic amine included. The label says to use it with caution in known sulfonamide allergy3; Khan lists it with fosamprenavir among drugs to use with caution, noting that many such patients tolerate it.
Open the sulfonamide hypersensitivity presentation → · sources [n] are on its References slide.
Classes and tags
Clinical profile
Legacy pregnancy categoryUnknown / historical label unavailable
Defining liabilityAgent-specific renal, hepatic, hematologic, metabolic and drug-interaction toxicity.
FDA label
Read the full label on DailyMed ↗
NO BOXED WARNINGS
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| HIV-1 infection (with ritonavir + other ARVs) — treatment-naïve, or experienced with no darunavir RAMs | Adults | 800 mg + ritonavir 100 mg QD with food | 800 mg + ritonavir 100 mg QD | 800 mg QD |
| HIV-1 infection — treatment-experienced with ≥1 darunavir RAM (or no genotype) | Adults | 600 mg + ritonavir 100 mg BID with food | 600 mg + ritonavir 100 mg BID | 600 mg BID |
| HIV-1 infection during pregnancy | Pregnant adults | 600 mg + ritonavir 100 mg BID with food | 600 mg + ritonavir 100 mg BID | 600 mg BID |
| HIV-1 infection — treatment-naïve or no darunavir RAMs | Peds 3–<18 y, ≥10 kg | 10–<15 kg: 35 mg/kg + ritonavir 7 mg/kg QD (suspension); 15–<30 kg: 600 mg + RTV 100 mg QD; 30–<40 kg: 675 mg + RTV 100 mg QD; ≥40 kg: 800 mg + RTV 100 mg QD | weight-band dose QD with food | Adult dose (800 mg QD) |
| HIV-1 infection — treatment-experienced with ≥1 darunavir RAM | Peds 3–<18 y, ≥10 kg | 10–<15 kg: 20 mg/kg + ritonavir 3 mg/kg BID (suspension); 15–<30 kg: 375 mg + RTV 48 mg BID; 30–<40 kg: 450 mg + RTV 60 mg BID; ≥40 kg: 600 mg + RTV 100 mg BID | weight-band dose BID with food | Adult dose (600 mg BID) |
Renal No adjustment specified; PK not significantly affected in moderate impairment (CrCl 30–60); no data in severe/ESRD; unlikely removed by dialysis.
Hepatic Mild–moderate: no adjustment; severe: not recommended (no data).
Pregnancy: 800 mg + RTV 100 mg QD only for patients already stable and suppressed (HIV-1 RNA <50) pre-pregnancy. Not recommended <3 y (juvenile rat toxicity). See ritonavir label for its contraindications/ARs.
Instructions
- Must be co-administered with ritonavir and with food.
- Oral suspension (100 mg/mL) for patients unable to swallow tablets; shake well; give an 8 mL dose as two 4 mL administrations with the dosing syringe.
- Genotypic/phenotypic testing recommended in treatment-experienced patients; check liver tests before and during therapy.
Available strengths
- tab 75, 150, 300, 400, 600, 800 mg
- susp 100 mg/mL
Contraindications
- CYP3A-dependent narrow-therapeutic-index drugs: alfuzosin; colchicine (renal/hepatic impairment); lurasidone, pimozide; dronedarone, ivabradine, ranolazine; ergot derivatives; lomitapide, lovastatin, simvastatin; naloxegol; sildenafil for PAH; oral midazolam, triazolam
- Rifampin or St. John's wort (reduced darunavir efficacy)
- Elbasvir/grazoprevir
- Ritonavir contraindications also apply
Cautions
- Must co-administer with ritonavir and food
- Hepatotoxicity (drug-induced hepatitis; monitor LFTs)
- Severe skin reactions (SJS/TEN, DRESS, AGEP)
- Sulfonamide allergy
- Serious drug interactions (CYP3A)
- Diabetes mellitus/hyperglycemia
- Fat redistribution
- Immune reconstitution syndrome
- Increased bleeding in hemophilia
- Not recommended in children <3 years
Adverse reactions
- Diarrhea
- Nausea
- Rash
- Headache
- Abdominal pain
- Vomiting
Pregnancy Limited APR data show no significant increase in major birth defects vs background; exposures lower in pregnancy, so 600 mg + ritonavir 100 mg BID is recommended.
Lactation Do not breastfeed (HIV transmission, resistance, infant ARs); darunavir present in rat milk, no human data.
Cost
| Strength | #/mo | generic $ | CostPlus | |
|---|---|---|---|---|
| 75 mg | tab | 30 qd | not offered | |
| 150 mg | tab | 30 qd | not offered | |
| 300 mg | tab | 30 qd | not offered | |
| 400 mg | tab | 30 qd | not offered | |
| 600 mg | tab | 30 qd | $34.89/mo | offered |
| 800 mg | tab | 30 qd | $71.46/mo | not offered |
| 100 mg/mL | susp | per unit | not offered |
Generic entry2026
Open Darunavir in the interactive console ↗
Self-check
- Which boosters are required with darunavir?
Ritonavir or cobicistat. - How does darunavir’s resistance barrier compare within protease inhibitors?
Highest.