Darunavir: Dosage and Administration

 Indication: Darunavir, co-administered with ritonavir (Darunavir/ritonavir), together with other existing antiretroviral agents, is authorized for treating human immunodeficiency virus (HIV-1) infection in adult and pediatric patients aged 3 years and older. 

Standard Dosage in Adult Patients

The darunavir tablet must be co-administered together with ritonavir to exert its therapeutic effect. Failure to correctly co-administer darunavir with ritonavir will result in plasma levels of darunavir that will be insufficient to achieve the required antiviral effect and will alter some drug interactions. Patients who have difficulty swallowing these tablets can use the 100 mg per mL darunavir oral suspension.

Treatment-Naïve Adult Patients: The recommended oral dose of darunavir is 800 mg (1 × 800 mg tablet or 8 mL of 

the oral suspension) taken with ritonavir 100 mg (1 × 100 mg tablet/capsule or 1.25 mL of an 80 mg per mL ritonavir oral solution) once daily and with meals. An 8 mL dose of darunavir needs to be taken as two 4 mL administrations with the included oral dosing syringe.

Treatment-Experienced Adult Patients: The proposed oral dosage for treatment-experienced adult patients is shown in Table. Baseline genotypic testing is required in order to opt for the dose. However, when genotypic testing is not feasible, darunavir 600 mg taken with ritonavir 100  mg twice a day is recommended.

Table: Recommended Darunavir/ritonavir Dosage in Treatment-Experienced Adult Patients:

Baseline Resistance		Formulation and Recommended Dosing
		Darunavir tablets with ritonavir tablets/capsules	Darunavir oral suspension (100 mg/mL) with ritonavir oral solution (80 mg/mL)
With no darunavir resistance-associated substitutions		One 800 mg darunavir tablet with one 100 mg ritonavir tablet/capsule, taken once daily with food	8 mL darunavir oral suspension with 1.25 mL ritonavir oral solution, taken once daily with food
With a minimum of one darunavir resistance-related substitutions, or with no baseline resistance information		One 600 mg darunavir tablet with one 100 mg ritonavir tablet/capsule, taken twice daily with food	6 mL darunavir oral suspension with 1.25 mL ritonavir oral solution, taken twice daily with food

Standard Dosage During Pregnancy: The standard dosage in pregnant patients is darunavir 600 mg taken along with ritonavir 100 mg twice a day with food. Darunavir 800 mg taken with ritonavir 100 mg once in a day should only be considered in certain pregnant patients who are already on a stable darunavir 800 mg with ritonavir 100 mg once in a daily regimen before pregnancy, and are virologically suppressed (HIV-1 RNA less than 50 copies per mL), and in whom a change to twice daily darunavir 600 mg along with ritonavir 100 mg may compromise tolerability or compliance.

Standard Dosage in Pediatric Patients (Aged 3 to less than 18)

Health specialists should pay special attention in order to find out the accurate dose of Darunavir, transcription of the medicine order, dispensing information, and dosing instructions for minimizing the risk for drug errors, overdose, and underdose. Prescribers should pick the apt dose of darunavir/ritonavir for each individual child depending on body weight (kg) and must not exceed the standard dose for adults.

Prior to prescribing Darunavir, children weighing greater than or equal to 15 kg should be evaluated for the ability to swallow tablets. In case a child is not able to reliably swallow a tablet, the use of darunavir oral suspension needs to be considered.

The standard Dose for children aged 3 years and above with ritonavir, and aged 12 years and above with cobicistat, weighing beyond 40 kilograms who have not taken antiretroviral drugs before (your child’s doctor will specify this) is 800 mg (2 tablets containing 400 mg of darunavir or 1 tablet containing 800 mg of darunavir) in combination with 100 mg ritonavir or 150 mg of cobicistat once in a day.

Testing Before Initiating Darunavir/ritonavir: In treatment-experienced patients, treatment history, genotypic or phenotypic testing is required to assess drug susceptibility of the HIV-1 virus. Apt laboratory testing such as serum liver biochemistries needs to be conducted before initiating therapy with darunavir/ritonavir.

Monitoring During Therapy with Darunavir/ritonavir: Patients with underlying chronic hepatitis, cirrhosis or patients with pretreatment elevations of transaminases must be assessed for elevation in serum liver biochemistries, mainly during the first several months of Darunavir/ritonavir therapy. 

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