Darunavir

What it is used for

Darunavir tablets, co-administered with ritonavir (darunavir/ritonavir), in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection in adult and pediatric patients 3 years of age and older.

Side effects, and when to stop

The following adverse reactions are discussed in other sections of labeling:

• Hepatotoxicity
• Severe Skin Reactions
• Diabetes Mellitus/Hyperglycemia
• Fat Redistribution
• Immune Reconstitution Syndrome
• Hemophilia

Due to the need for co-administration of darunavir tablets with ritonavir, please refer to ritonavir prescribing information for ritonavir-associated adverse reactions.

Who should not take it

Co-administration of darunavir/ritonavir is contraindicated with drugs that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events (narrow therapeutic index). Examples of these drugs and other contraindicated drugs (which may lead to reduced efficacy of darunavir) are listed below. Due to the need for co-administration of darunavir with ritonavir, please refer to ritonavir prescribing information for a description of ritonavir contraindications.

• Alpha 1-adrenoreceptor antagonist: alfuzosin
• Anti-gout: colchicine, in patients with renal and/or hepatic impairment
• Antimycobacterial: rifampin
• Antipsychotics: lurasidone, pimozide
• Cardiac Disorders: dronedarone, ivabradine, ranolazine
• Ergot derivatives, e.g. dihydroergotamine, ergotamine, methylergonovine
• Herbal product: St. John’s wort ( Hypericum perforatum )
• Hepatitis C direct acting antiviral: elbasvir/grazoprevir
• Lipid modifying agents: lomitapide, lovastatin, simvastatin
• Opioid Antagonist: naloxegol
• PDE-5 inhibitor: sildenafil when used for treatment of pulmonary arterial hypertension
• Sedatives/hypnotics: orally administered midazolam, triazolam