DARUNAVIR ETHANOLATE AND COBICISTAT

Other

Oral

Mechanism of Action

12.1 Mechanism of Action PREZCOBIX is a fixed-dose combination of an HIV-1 antiviral drug, darunavir and a CYP3A inhibitor, cobicistat [see Microbiology (12.4) ].

Indications

V32I

L33F

I47V

I50V

I54L

I54M

Contraindications

• phenobarbital
• phenytoin Anti-gout: colchicine
• in patients with renal and/or hepatic impairment Antimycobacterial: rifampin Antipsychotics: lurasidone
• pimozide Cardiac Disorders: dronedarone
• ivabradine

FDA Warnings

5 WARNINGS AND PRECAUTIONS Drug-induced hepatitis (e
, acute hepatitis, cytolytic hepatitis), liver injury, including some fatalities can occur with PREZCOBIX
Patients with pre-existing liver dysfunction, including chronic active hepatitis B or C, have an increased risk for liver function abnormalities including severe hepatic adverse reactions
Post-marketing cases of liver injury, including some fatalities, have also been reported with darunavir co-administered with ritonavir

Known Side Effects

1 documented side effects by frequency

Anxiety

1-10%

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Formulations

Dosage Forms

Tablet

Route

Oral