TM Owner Janssen
Prezista 800mg Tablet
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Indications & Clinical Uses
- Prezista 800 mg film-coated tablets (darunavir, Janssen) are an antiretroviral protease inhibitor used with low-dose ritonavir (or, in the EU, cobicistat) and other antiretroviral medicines to treat HIV-1 infection in adults and children who can take a full tablet (typically 3 years and older in the EU, 6 years and older in the US, meeting a minimum bodyweight).
- The 800 mg once-daily dose shown on this sheet, taken with ritonavir 100 mg or cobicistat 150 mg once daily and with food, is approved only for treatment-naive adults and certain treatment-experienced adults with no darunavir-resistance mutations - it is not the same regimen as the 600 mg twice-daily dose used with ritonavir in more heavily treatment-experienced patients, so the correct regimen depends on prior treatment history and resistance testing.
- Darunavir must always be given with a boosting agent; it is not effective as monotherapy.
Side Effects
- The most common effects (5% or more of patients) are diarrhoea, nausea, headache, abdominal pain, vomiting and rash.
- Prezista carries no boxed warning, but the label describes serious skin reactions, including rare cases of Stevens-Johnson syndrome and toxic epidermal necrolysis, and drug-induced liver injury reported in about 1 in 200 patients on combination therapy - stop treatment and seek urgent medical attention for a severe or blistering rash, fever, or yellowing of the skin or eyes.
- People with chronic hepatitis B or C may be at higher risk of liver problems and need closer monitoring.
- Take doses at the same time each day with food, since food increases absorption; report any new rash, unusual tiredness or abdominal pain to the prescriber promptly.
Precautions & Warnings
- Prezista with ritonavir or cobicistat must never be combined with drugs that rely heavily on CYP3A for clearance, including alfuzosin, ergot derivatives, cisapride, pimozide, oral midazolam or triazolam, lovastatin or simvastatin, rifampin, St John's Wort, or sildenafil used for pulmonary arterial hypertension - these combinations are contraindicated.
- Liver function should be monitored, particularly in people with pre-existing liver disease or viral hepatitis co-infection.
- Prezista is not a cure for HIV and does not prevent transmission to others; it must be part of a complete antiretroviral regimen, taken consistently, since interruptions can encourage resistance.
- Use in pregnancy should be discussed with the prescriber, as darunavir exposure can differ during pregnancy and dose adjustment or additional monitoring may be needed.
Avoid Interactions
- Prezista boosted with ritonavir or cobicistat strongly inhibits CYP3A and CYP2D6, raising blood levels of many other medicines: dose adjustment or extra monitoring is needed for certain statins (pravastatin, atorvastatin), colchicine, some anti-arrhythmics, immunosuppressants such as ciclosporin and tacrolimus, and PDE-5 inhibitors used for erectile dysfunction.
- Certain antifungals (ketoconazole, itraconazole) may need their own dose capped.
- It must never be combined with pimozide, ergot alkaloids, cisapride, rifampin, St John's Wort, lovastatin or simvastatin, or high-dose sildenafil for pulmonary hypertension, because of serious toxicity or loss of antiviral effect.
- Grapefruit juice is not specifically restricted, but alcohol should be limited due to added liver strain.
- Always give the full list of prescription, over-the-counter and herbal products to the prescriber before starting Prezista.
References
Frequently Asked Questions
Prezista (darunavir) treats HIV-1 infection, always combined with low-dose ritonavir or cobicistat plus other antiretroviral drugs. The 800 mg once-daily dose is reserved for patients who have not previously failed HIV treatment or developed resistance to darunavir. Ask your HIV specialist which dosing schedule is right for you.
Prezista 800 mg is swallowed once daily together with ritonavir 100 mg or cobicistat 150 mg, and taken with food to improve absorption. It must always be combined with a booster drug and other HIV medicines, and is never taken alone.
Diarrhoea, nausea, headache, abdominal pain and rash are the most common effects. Seek urgent care for a severe or blistering rash, fever, or yellowing of the skin or eyes, which can signal a serious skin or liver reaction to the drug.
Avoid pimozide, ergot medicines, rifampin, St John's Wort, and lovastatin or simvastatin, all of which are contraindicated with Prezista. Tell your prescriber about every other medicine you take, since Prezista changes blood levels of many other drugs significantly. This helps prevent dangerous interactions or reduced effectiveness of either medicine.
No. The 800 mg once-daily dose is for people starting HIV treatment for the first time, or without darunavir-resistant virus. People who have used HIV treatment before, or have resistance mutations, may instead need a 600 mg twice-daily regimen. Resistance testing helps your specialist choose the correct dose for you.
Prezista is approved for children from around age 3 in the EU or 6 in the US who meet a minimum bodyweight, using weight-based dosing. Use in pregnancy needs specialist input, since darunavir blood levels can change as pregnancy progresses.
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