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darunavir (Prezista, DRV/r)

Tradenames: Prezista Indications: 1) HIV patients resistant to other protease inhibitors 2) also FDA-approved for treatment-naive patients [4] 3) MUST be taken with ritonavir or atazanavir - atazanvir/darunavir acceptable for use during pregnancy [6] Contraindications: - pregnancy category: C [4] Dosage: 1) 200 mg PO BID together with ritonavir 100 mg PO BID 2) 800 mg daily plus 100 mg ritonavir daily for treatment naive patients [4] Tablets: 300, 400, 600 mg [2,4] Monitor: - serum AST, serum ALT (& serum alkaline phosphatase, Canada) at basline, every 2 weeks for the 1st month of therapy, then monthly [5] Adverse effects: 1) diarrhea 2) nausea 3) headache 4) skin rash (7%) 5) hepatotoxicity [3] 6) cumulative use of ritonavir-boosted darunavir is associated with an increasing cardiovascular risk [7] Drug interactions: - ritonavir increases plasma darunavir levels - hepatotoxicity observed in combination with ritonavir [3] Laboratory: - darunavir in serum/plasma Notes: Cost 2008 $13.70/400 mg tablet

Interactions

drug interactions drug adverse effects of antiretroviral protease inhibitors

Related

ritonavir (Norvir, RTV)

General

antiretroviral protease inhibitor

References

  1. Prescriber's Letter 13(8): 2006 Recent Changes in HIV Drug Therapy FDA Approves New HIV Treatment for Patients Who Do Not Respond to Existing Drugs Detail-Document#: 220808 (subscription needed) http://www.prescribersletter.com
  2. FDA, HIV/AIDS List Serve Archive Feb 25, 2008 http://www.fda.gov/oashi/aids/listserve/listserve2008.html
  3. FDA MedWatch http://www.fda.gov/medwatch/safety/2008/safety08.htm#Prezista - Prezista (darunavir) tablets [prescribing information]. Raritan, NJ: Tibotec, Inc; 2008 http://tinyurl.com/yuuva9
  4. Prezista (darunavir) tablets [prescribing information]. Raritan, NJ: Tibotec, Inc.; 2008 http://www.prezista.com/prezista/documents/us_package_insert.pdf
  5. Prescriber's Letter 17(7): 2010 Recommended Lab Monitoring for Common Medications Liver Function Test Scheduling Detail-Document#: 260704 (subscription needed) http://www.prescribersletter.com
  6. Zuger A Use of Antiretroviral Drugs in Pregnancy. Physician's First Watch, April 22, 2014 David G. Fairchild, MD, MPH, Editor-in-Chief Massachusetts Medical Society http://www.jwatch.org - Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. Recommendations for use of antiretroviral drugs in pregnant HIV-1-infected women for maternal health and interventions to reduce perinatal HIV transmission in the United States. 2014. AIDSinfo. Clinical Guidelines Portal. March 28, 2014. http://aidsinfo.nih.gov/Guidelines/HTML/3/perinatal-guidelines/0 (corresponding NGC guideline withdrawn March 2016)
  7. Boggs W. Increased Risk of Cardiovascular Disease With Darunavir. Medscape - May 21, 2018. https://www.medscape.com/viewarticle/896983

Component-of

cobicistat/darunavir cobicistat/darunavir/emtricitabine/tenofovir