PREZCOBIX is a fixed-dose combination of the Protease Inhibitor (PI) darunavir and the pharmacokinetic enhancer cobicistat. PREZCOBIX is used for the treatment of HIV infection in combination with other antiretroviral drugs. Darunavir works by binding to the active site of HIV protease, disrupting viral replication and blocking the production of mature virions. Cobicistat on its own has no antiviral activity.
Dosing & Administration
PREZCOBIX is indicated for the treatment of HIV infection in adults and post-pubertal adolescents (off-label) who do not have darunavir resistance-associated substitutions, as part of a combination drug regimen. The drug must be taken with food. Dosage and administration instructions are detailed in the product monograph.
PREZCOBIX is not recommended for use in patients with severe liver dysfunction. PREZCOBIX should not be used in patients with a creatinine clearance of less than 70 mL/min who are also using tenofovir. Use of PREZCOBIX has not been studied in patients with renal dysfunction, but both components are used in patients with mild to moderate renal failure. Details are given in the product monograph.
PREZCOBIX is contraindicated in patients who are hypersensitive to the drug, those with severe liver dysfunction, or who are taking certain drugs listed in the product monograph.
PREZCOBIX may cause a serious rash, especially in the first four weeks of treatment. Common side effects include nausea/vomiting, diarrhea, abdominal pain, headache, fat redistribution. A complete list of potential adverse effects is provided in the product monograph.
Genotypic testing is recommended prior to initiating therapy with PREZCOBIX due to resistance concerns. Specifics are given in the product monograph.
Darunavir contains a sulfonamide group, so should be used with caution or not at all in patients with sulfa sensitivity.
PREZCOBIX should be used with caution in hemophiliacs due to risk of spontaneous bleeding.
PREZCOBIX is associated with a risk of drug-induced hepatitis, so patients with or without liver dysfunction or risk factors for liver disease should be screened and monitored as described in the product monograph.
All patients who test positive for HIV infection should be screened for comorbid Hepatitis B virus (HBV) and Hepatitis C virus (HCV) infection. Co-infected patients should be started on an antiretroviral regimen targeting co-infected viruses, regardless of CD4 counts or viral loads. Current HIV treatment guidelines outline drug regimens and prescribing considerations.
PREZCOBIX is associated with a large number of drug-drug interactions, especially drugs metabolized by CYP3A. A complete list of drug interactions is provided in the product monograph.
Pregnancy & Lactation
Highly active retroviral combination treatment should be used in all pregnant women. PREZCOBIX is not recommended for use in pregnancy. Current guidelines should be consulted when treating women in pregnancy. It is not known if PREZCOBIX is excreted in breast milk. The CDC recommends that all HIV positive women, treated or untreated, avoid breastfeeding to prevent vertical transmission of the virus.
There is no known antidote for PREZCOBIX overdose, so standard supportive treatment should be used. PREZCOBIX does not dialyze.
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