PREZISTA (darunavir) is a PI (Protease Inhibitor) drug which is used, in combination with other antiretroviral medications, to treat HIV infection. PREZISTA attaches to the HIV replication enzyme protease at the active site which stops its connection in producing the final virion which makes it non-infectious. Resistance to PI drugs and cross-resistance among PI drugs has been seen through many different mutations. PREZISTA, however, seems to be less susceptible to potential cross-resistance.
Dosing & Administration
PREZISTA is prescribed for HIV positive adults and children who weigh at least 10 kg. It is also recommended off-label for HIV post-exposure prophylaxis following potential sexual assault or other exposures. PREZISTA is available in liquid or tablet form. It must be taken with food. Proper dosage information is available in the package insert.
PREZISTA does not require any dose adjustment in patients with mild to moderate liver dysfunction, or renal impairment. Patients with severe liver dysfunction should not take this drug, and studies have not been done for patients with severe kidney dysfunction.
PREZISTA is contraindicated for use in patients with drug hypersensitivity and for those with severe liver dysfunction (Child-Pugh Class C). Additional drug contraindications for PREZISTA are listed in the package insert.
Common side effects with PREZISTA include a diarrhea, abdominal pain, a rash, nausea/vomiting, headache, abdominal pain, and GERD. The use of PREZISTA may cause spontaneous bleeding and hyperglycemia. Further details about possible side effects are listed in the package insert.
PREZISTA should be used with caution for patients who are sulfa-sensitive as it is a sulfonamide drug.
Genotypic/phenotypic HIV testing should be used to guide the use of PREZISTA in individual patients. PREZISTA should be only used with cobicistat or a low-dose ritonavir as they are agents that act as a pharmacokinetic enhancer.
Patients with pre-existing liver abnormalities may be at an increased risk of a potentially fatal drug-induced hepatitis or hepatic injury. The package insert has further screening and monitoring recommendations.
Patients who are HIV positive should also be screened for comorbid HCV or HBV and infection. Patients who are co-infected should begin an antiretroviral regimen targeting co-infected viruses, regardless of CD4 counts or viral loads. Current HIV treatment guidelines offer support about prescribing considerations and drug regimens.
Contraindications and drug-to-drug interactions have been associated with PREZISTA. Those who are prescribing the drug should become familiar with the details provided in the package insert. Prescribers should familiarize themselves with the list provided in the product monograph.
Pregnancy & Lactation
For pregnant women, current guidelines should be followed regarding treatment. A highly active retroviral combination treatment should be used for women who are pregnant, regardless of CD4 count or viral load. It is still unknown if this drug is transmitted through breast milk, so breastfeeding is strongly discouraged.
PREZISTA is probably not significantly dialyzed, so an overdose of PREZISTA should be treated with supportive care which may include activated charcoal.
Alternative Brand Names
Darunavir is also available as a combination product in Symtuza, Rezolsta, and Prezcobix.
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