PREZISTA (darunavir) is a Protease Inhibitor (PI) drug that is used to treat HIV infection in combination with other antiretroviral medications. PREZISTA renders the active site of the HIV replication enzyme protease non-infectious, which stops its participation in producing the final virion. PREZISTA appears to be less susceptible to cross-resistance, although PI drugs and cross-resistance has been seen in a variety of mutations.
Dosing & Administration
PREZISTA is used for adults and children ages three and older (as long as they weigh at least 10 kg) for the treatment of HIV infection. It is also used after occupational or non-occupational settings, including sexual assault or for HIV post-exposure prophylaxis. PREZISTA must be taken with food and is available as oral tablets or liquid suspension. Detailed dosing guidelines are available in the package insert.
For patients with renal impairment or mild to moderate liver dysfunction, PREZISTA does not require dose adjustment. Studies have not been done in patients with severe liver dysfunction, therefore it should not be used in patients with severe liver dysfunction.
PREZISTA is contraindicated in patients with severe liver dysfunction or with hypersensitivity to the drug. Details about the drugs that PREZISTA is contraindicated for are available in the package insert.
PREZISTA can cause hyperglycemia and spontaneous bleeding. Common side effects include nausea/vomiting, abdominal pain, a rash, diarrhea, GERD, and headache. A complete list of potential side effects is available in the package insert.
PREZISTA should be used with caution in sulfa-sensitive patients as it is a sulfonamide drug.
Genotypic/phenotypic HIV testing is necessary to determine the use of PREZISTA in individual patients. PREZISTA should be only used with an agent that acts as a pharmacokinetic enhancer, such as a low-dose ritonavir or cobicistat.
PREZISTA has been associated with potentially fatal hepatic injury and drug-induced hepatitis and patients with pre-existing liver abnormalities may be at increased risk. Detailed instructions about screening and monitoring are available in the package insert.
Patients who test positive for HIV should also be screened for comorbid HCV and HBV infection. Regardless of viral loads or CD4 counts, patients who are found to be co-infected should begin an antiretroviral regimen targeting co-infected viruses. Prescribing considerations and drug regiments are outlined within current HIV treatment guidelines.
PREZISTA is associated with many contraindications and drug to drug interactions. Read the accompanying package insert for additional information.
Pregnancy & Lactation
Regardless of viral load and CD4 count, pregnant women with HIV should use a highly active retroviral combination treatment. When treating pregnant women, current guidelines should be consulted. As it is not yet known if PREZISTA is excreted through breast milk, all HIV positive women should avoid breastfeeding to avoid transmission of the virus.
In the case of a PREZISTA overdose, activated charcoal may be used. PREZISTA is probably not significantly dialyzed.
Alternative Brand Names
Darunavir is also available as a combination product known by Symtuza, Prezcobix, and Rezolsta.
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