Finished product reference
Darunavir
Tablet · Oral · 600 mg
- List code
- 22525
- Salt form
- Ethanolate
- Pharmacologic class
- Protease Inhibitor
What it is and how it works
Mechanism of Action Darunavir is an HIV-1 antiviral drug .
Mechanism class: HIV Protease Inhibitors · Cytochrome P450 3A Inhibitors · Cytochrome P450 2D6 Inhibitors
Indications
Darunavir tablets, co-administered with ritonavir (darunavir tablets/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 . Darunavir tablets are a human immunodeficiency virus (HIV-1) protease inhibitor indicated for the treatment of HIV-1 infection in adult and pediatric patients 3 years of age and older. Darunavir tablets must be co-administered with ritonavir (darunavir tablets/ritonavir) and with other antiretroviral agents.
Dosage and administration (summary)
• Testing: o In treatment-experienced patients, treatment history genotypic and/or phenotypic testing is recommended prior to initiation of therapy with darunavir tablets/ritonavir to assess drug susceptibility of the HIV-1 virus ( 2.1 , 12.4 ) o Monitor serum liver chemistry tests before and during therapy with darunavir tablets/ritonavir. ( 2.1 , 2.2, 5.2 ) • Treatment-naïve adult patients and treatment-experienced adult patients with no darunavir resistance associated substitutions: 800 mg (two 400 mg tablets) taken with ritonavir 100 mg once daily and with food.
Contraindications
Co-administration of darunavir tablets/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 othercontraindicated drugs (which may lead to reduced efficacy of darunavir) are listed below .
Warnings and precautions
• Drug-induced hepatitis (e.g., acute hepatitis, cytolytic hepatitis) has been reported with darunavir/ritonavir. Monitor liver function before and during therapy, especially in patients with underlying chronic hepatitis, cirrhosis, or in patients who have pre-treatment elevations of transaminases. Post-marketing cases of liver injury, including some fatalities, have been reported.
Pregnancy
Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to darunavir during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) 1-800-258-4263.
Storage and supply
Darunavir 400 mg tablets are supplied as orange, oval shaped, bevel edged, biconvex, film-coated tablets de-bossed with “H” on one side and “189” on the other side. They are supplied as follows: Bottles of 60 NDC 31722-567-60 Darunavir 600 mg tablets are available as orange, oval shaped, biconvex, film-coated tablets de-bossed with “J” on one side …
Source: Darunavir (Darunavir) — US FDA prescribing information, 2023-10-05, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.
Other presentations of the same active ingredient
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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