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HIVManagement.org |
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HIVManagement.org |
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darunavir |
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Detailed Prescribing Information |
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Darunavir =
Prezista |
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| Dosing Forms | 300 mg tablets |
| Dosing |
Two
300 mg tablets twice a day
plus one 100 mg ritonavir gel capsule
twice a day, both
with food The drug is always administered with ritonavir. |
| Hepatic impairment: Darunavir has not been studied in this regard. Administration in patients with hepatitis B or C did not affect pharmacokinetics. | |
| Renal impairment: Moderate renal failure does not alter pharmacokinetics. The drug has not been studied in severe renal failure or end-stage renal disease. | |
| Food dependence | Darunavir should be taken with food. |
| Adverse Effects |
Diarrhea, nausea & vomiting,
headache, rash (7% and included all severities including Stevens-Johnson) Elevated liver enzymes/hepatitis Also perioral paresthesia, hepatitis, fat redistribution, hyperlipidemia, Type 2 diabetes are possible. |
| Contraindications |
Rifampin Antihistamines: terfenadine, astemizole Ergot derivatives: dihydroergotamine, ergonovine, ergotamine, methylergonovine GI molitlity agent: cisapride Neuroleptic: pimozide Sedative/hypnotics: midazolam, triazolam |
| Interactions |
Statins, certain antiarrhythmics, ergot
derivatives, antihistamines, neuroleptics, sedatives - similar to other
protease inhibitors (inhibitors of CY3PA) Protease inhibitors: lopinavir/ritonavir levels may be decreased significantly. NNRTIs: no dose adjustment is required for darunavir/ritonavir when used with other NNRTIs |
| Suggested laboratory evaluations | Liver profile and glucose monthly x 3 months, then every 3-4 months; lipid profile every 3-4 months |
| Warnings |
Darunavir contains a sulfonamide component.
Use cautiously in persons with sulfonamide allergy. Hemophilia: Increased bleeding has been noted in persons treated with protease inhibitors. |
| Usage Suggestions | The drug has been studied only as salvage therapy and appears active in the setting of multiple protease inhibitor mutations. At the time of approval, darunavir is indicated by the FDA only for treatment-experienced adults for whom virologic suppression is not possible with other antiretrovirals. |
| Full Prescribing Information |
http://www.prezista.com Patient information sheet HERE. |
| Supporting Literature |
| 48 Week Data from Power 1 and Power 2 Studies |
| Links to Antiretroviral Sections (click on anything) |
| Nucleoside & Nucleotide Reverse Transcriptase Inhibitors (NRTI) |
| AZT | ddC | ddI | d4T | 3TC | ABC | FTC | TDF | Combivir | Trizivir | Epzicom | Truvada | Atripla |
| Nonnucleoside Reverse Transcriptase Inhibitors (NNRTI) |
| efavirenz | nevirapine | delavirdine |
| Protease Inhibitors (PI) | Boosted Protease Inhibitors |
| saquinavir | indinavir | ritonavir | nelfinavir | amprenavir | lopinavir + ritonavir | atazanavir | fosamprenavir | tipranavir | darunavir |
| Fusion Inhibitors |
| enfuvirtide |
Updated 4.9.2007